Chinese herbal medicines for treating osteoporosis

  • Review
  • Intervention

Authors


Abstract

Background

Chinese herbal medicines have been used for a long time to treat osteoporosis. The evidence of their benefits and harms needs to be systematically reviewed.

Objectives

To assess the beneficial and harmful effects of Chinese herbal medicines as a general experimental intervention for treating primary osteoporosis by comparing herbal treatments with placebo, no intervention and conventional medicine.

Search methods

We searched the following electronic databases to January 2013: the Specialised Register of the Cochrane Complementary Medicine Field, CENTRAL, MEDLINE, EMBASE, LILACS, JICST-E, AMED, Chinese Biomedical Database and CINAHL.

Selection criteria

Randomised controlled trials of Chinese herbal medicines compared with placebo, no intervention or conventional medicine were included.

Data collection and analysis

Two authors extracted data and assessed risk of bias independently. Disagreement was resolved by discussion.

Main results

One hundred and eight randomised trials involving 10,655 participants were included. Ninety-nine different Chinese herbal medicines were tested and compared with placebo (three trials), no intervention (five trials) or conventional medicine (61 trials), or Chinese herbal medicines plus western medicine were compared with western medicine (47 trials). The risk of bias across all studies was unclear for most domains primarily due to inadequate reporting of study design. Although we rated the risk of selective reporting for all studies as unclear, only a few studies contributed numerical data to the key outcomes.

Seven trials reported fracture incidence, but they were small in sample size, suffered from various biases and tested different Chinese herbal medicines. These trials compared Kanggusong capsules versus placebo, Kanggusong granule versus Caltrate or ipriflavone plus Caltrate, Yigu capsule plus calcium versus placebo plus calcium, Xianlinggubao capsule plus Caltrate versus placebo plus Caltrate, Bushen Zhuanggu granules plus Caltrate versus placebo granules plus Caltrate, Kanggusong soup plus Caltrate versus Caltrate, Zhuangguqiangjin tablets and Shujinbogu tablets plus calcitonin ampoule versus calcitonin ampoule. The results were inconsistent.

One trial showed that Bushenhuoxue therapy plus calcium carbonate tablets and alfacalcidol had a better effect on quality of life score (scale 0 to 100, higher is better) than calcium carbonate tablets and alfacalcidol (mean difference (MD) 5.30; 95% confidence interval (CI) 3.67 to 6.93).

Compared with placebo in three separate trials, Chinese herbal medicines (Migu decoction, Bushen Yigu soft extract, Kanggusong capsules) showed a statistically significant increase in bone mineral density (BMD) (e.g. Kanggusong capsules, MD 0.06 g/cm3; 95% CI 0.02 to 0.10). Compared with no intervention in five trials, only two showed that Chinese herbal medicines had a statistically significant effect on increase in BMD (e.g. Shigu yin, MD 0.08 g/cm3; 95% CI 0.03 to 0.13). Compared with conventional medicine in 61 trials, 23 showed that Chinese herbal medicines had a statistically significant effect on increase in BMD. In 48 trials evaluating Chinese herbal medicines plus western medication against western medication, 26 showed better effects of the combination therapy on increase in BMD.

No trial reported death or serious adverse events of Chinese herbal medicines, while some trials reported minor adverse effects such as nausea, diarrhoea, etc.

Authors' conclusions

Current findings suggest that the beneficial effect of Chinese herbal medicines in improving BMD is still uncertain and more rigorous studies are warranted.

Résumé scientifique

Les plantes médicinales chinoises pour le traitement de l'ostéoporose

Contexte

Les plantes médicinales chinoises sont utilisées depuis longtemps pour traiter l'ostéoporose. Les preuves de leurs bénéfices et de leurs préjudices doivent être systématiquement examinées.

Objectifs

Évaluer les effets bénéfiques et nocifs des plantes médicinales chinoises comme une intervention expérimentale générale pour le traitement d'ostéoporose primaire en comparant les traitements à base de plantes à un placebo, à l'absence d'intervention et à la médecine conventionnelle.

Stratégie de recherche documentaire

Nous avons effectué des recherches dans les bases de données électroniques suivantes jusqu'à janvier 2013 : le registre spécialisé du groupe Cochrane du champ de la médecine complémentaire, CENTRAL, MEDLINE, EMBASE, LILACS, JICST-E, AMED, la base de données biomédicale chinoise et CINAHL.

Critères de sélection

Les essais contrôlés randomisés des plantes médicinales chinoises par rapport à un placebo, à l'absence d'intervention ou à la médecine conventionnelle, ont été inclus.

Recueil et analyse des données

Deux auteurs ont indépendamment extrait les données et évalué le risque de biais. Les désaccords ont été résolus par la discussion.

Résultats principaux

Cent huit essais randomisés portant sur 10 655 participants ont été inclus. Quatre-vingt-dix-neuf différentes plantes médicinales chinoises étaient testées et comparées par rapport à un placebo (trois essais), à l'absence d'intervention (cinq essais) ou à la médecine conventionnelle (61 essais), ou les plantes médicinales chinoises + la médecine occidentale étaient comparées avec la médecine occidentale (47 essais). Le risque de biais dans toutes les études n'était pas clairement établi pour la plupart des domaines, principalement en raison de la consignation inadaptée des plans d'étude. Bien que nous ayons évalué le risque de notification sélective pour toutes les études comme étant incertain, seules quelques études fournissaient des données numériques pour les principaux critères de jugement.

Sept essais rapportaient l'incidence des fractures, mais leurs échantillons étaient de petite taille, ils souffraient de différents biais et testaient différentes plantes médicinales chinoises. Ces essais avaient comparé des capsules de Kanggusong par rapport à un placebo, des granulés de Kanggusong par rapport au Caltrate , des capsules de Yigu + calcium par rapport au placebo + calcium, des capsules de Xianlinggubao + Caltrate par rapport au placebo + Caltrate, des granulés de Bushen Zhuanggu + Caltrate par rapport au placebo + Caltrate, la soupe Kanggusong + Caltrate par rapport au Caltrate, les comprimés Zhuangguqiangjin et les comprimés Shujinbogu + les ampoules de calcitonine par rapport aux ampoules de calcitonine. Les résultats étaient contradictoires.

Un essai montrait que la thérapie Bushen Huoxue + les comprimés de carbonate de calcium et l'alfacalcidol avaient un meilleur effet sur le score de qualité de vie (échelle de 0 à 100, le meilleur est le plus élevé) que les comprimés de carbonate de calcium et l'alfacalcidol (différence moyenne (DM) 5,30 ; intervalle de confiance (IC) à 95 % 3,67 à 6,93).

Dans trois essais distincts, par rapport à un placebo, les plantes médicinales chinoises (décoction de Migu, extrait mou de Bushen Yigu, capsules de Kanggusong) montraient une augmentation statistiquement significative de la densité minérale osseuse (DMO) (par exemple, les capsules de Kanggusong, DM de 0,06 g / cm 3 ; IC à 95 % 0,02 à 0,10). Dans cinq essais, par rapport à l'absence d'intervention, seuls deux montraient que les plantes médicinales chinoises avaient un effet statistiquement significatif sur l'augmentation de la DMO (par exemple, Shigu Yin, DM de 0,08 g / cm 3 ; IC à 95 % 0,03 à 0,13). Dans 61 essais, par rapport à un traitement standard, 23 montraient que les plantes médicinales chinoises avaient un effet statistiquement significatif sur l'augmentation de la DMO. Dans 48 essais évaluant des plantes médicinales chinoises + des médicaments occidentaux par rapport aux médicaments occidentaux, 26 montraient de meilleurs effets du traitement combiné sur l'augmentation de la DMO.

Aucun essai ne rapportait de décès ou d'événements indésirables graves dus aux plantes médicinales chinoises, alors que certains essais rapportaient des effets indésirables mineurs, tels que des nausées, de la diarrhée, etc.

Conclusions des auteurs

Les résultats actuels suggèrent que l'effet bénéfique des plantes médicinales chinoises dans l'amélioration de la DMO reste incertain et des études plus rigoureuses sont nécessaires.

摘要

中草藥治療骨質疏鬆症

背景

使用中草藥 (Chinese herbal medicine) 治療骨質疏鬆症已行之有年,必須系統性回顧證據,瞭解中草藥治療的療效和傷害。

目的

比較中草藥治療與安慰劑、無介入組和傳統藥物治療,評估以中草藥作為一般實驗性介入,治療原發性骨質疏鬆症 (primary osteoporosis) 的療效與不良作用。

搜尋策略

我們搜尋截至2013年1月為止,下列電子資料庫的資料:考科藍輔助療法領域專業註冊 (Specialised Register of the Cochrane Complementary Medicine Field)、CENTRAL、MEDLINE、EMBASE、LILACS、JICST-E、AMED、Chinese Biomedical Database和CINAHL。

選擇標準

收錄比較中草藥治療與安慰劑、無介入組或傳統藥物治療的隨機分配對照試驗。

資料收集與分析

由2位作者獨立進行資料萃取並評估偏差風險。透過討論解決意見不一致的問題。

主要結果

我們納入108篇隨機試驗,包含10,655名受試者。有99種不同的中草藥接受試驗,並與安慰劑 (3篇試驗)、無介入組 (5篇試驗) 或傳統藥物治療 (61篇試驗) 進行比較,或針對中草藥合併西藥治療和單獨使用西藥治療進行比較 (47篇試驗)。所有試驗的大部分領域偏差風險不明,主要是由於研究者並未適當報告試驗設計。我們認為所有試驗的選擇性報告風險不明,只有少數試驗在主要結論中提出數據。

有7篇試驗提出骨折發生率,但這些試驗的樣本數很小、具有不同類型的誤差,而且測試不同的中草藥。這些試驗比較抗骨鬆膠囊 (Kanggusong capsule) 和安慰劑;抗骨鬆沖劑 (Kanggusong granule) 和Caltrate或ipriflavone加Caltrate;益骨膠囊 (Yigu capsule) 加鈣和安慰劑加鈣;仙靈骨葆膠囊 (Xianlinggubao capsule) 加Caltrate與安慰劑加Caltrate;補腎壯骨沖劑 (Bushen Zhuanggu granule) 加Caltrate與安慰劑沖劑加Caltrate;抗骨鬆湯 (Kanggusong soup) 加Caltrate和Caltrate;壯骨強筋錠劑 (Zhuangguqiangjin table) 和Shujinbogu tablets加calcitonin安瓿 (針劑) 與calcitonin安瓿。試驗結果並不一致。

有1篇試驗指出補腎活血治療加碳酸鈣錠劑與alfacalcidol,對生活品質分數 (介於0至100分之間,分數愈高愈好) 的療效,優於碳酸鈣錠劑和alfacalcidol (平均差 [mean difference, MD] 為5.30;95%信賴區間 [confidence interval, CI] 為3.67至6.93)。

有3篇與安慰劑比較的試驗顯示,中草藥 (密骨煎劑 [Migu decoction]、補腎益骨膏 [Bushen Yigu soft extract]、抗骨鬆膠囊) 可顯著增加骨質密度 (bone mineral density, BMD) (例如抗骨鬆膠囊,MD為0.06 g/cm3;95% CI為0.02至0.10)。5篇與無介入治療比較的試驗中,只有2篇試驗顯示中草藥可顯著增加BMD (例如Shigu yin,MD為0.08 g/cm3;95% CI為0.03至0.13)。在61篇與傳統藥物治療比較的試驗中,有23篇試驗顯示中草藥可顯著增加BMD。在48篇評估中草藥加西藥與單獨使用西藥的療效試驗中,有26篇試驗顯示合併療法對增加BMD的療效較佳。

並無試驗通報中草藥治療的死亡或嚴重不良事件,不過曾有部分試驗通報發生較輕微的不良作用,例如噁心、腹瀉等等。

作者結論

目前結果顯示,中草藥改善BMD的療效仍然不明,需要進行更多嚴密的試驗。

譯註


翻譯者:臺北醫學大學實證醫學研究中心
本計畫由台灣衛生福利部/臺北醫學大學實證醫學研究中心/東亞考科藍聯盟(EACA)統籌執行

アブストラクト

骨粗鬆症治療に対する漢方薬

背景

漢方薬は骨粗鬆症の治療に昔から使用されている。その利益と有害性に関するエビデンスについて、体系的に調査する必要がある。

目的

漢方薬とプラセボ、非介入、通常医療を比較することで、原発性骨粗鬆症の治療に対する一般的な実験的介入としての漢方薬の効果と有害作用について評価すること。

検索戦略

2013年1月までの以下の電子データベースを検索した。the Specialised Register of the Cochrane Complementary Medicine Field、CENTRAL、MEDLINE、EMBASE、LILACS、JICST-E、AMED、Chinese Biomedical DatabaseおよびCINAHL。

選択基準

漢方薬と、プラセボ、非介入、または通常医療を比較したランダム化比較試験(RCT)。

データ収集と分析

2名の著者が独立してデータを抽出し、バイアスのリスクを評価した。著者らによる討議を経て意見の相違を解決した。

主な結果

10,655例を対象とした108件のRCTを選択した。99種類の異なる漢方薬について調べており、プラセボ(3件の試験)、 非介入(5件)、または通常医療(61件)と比較していた。また、漢方薬と通常医療の併用と、通常医療単独を比較した試験も47件あった。研究デザインの報告が不十分なため、すべての研究のバイアスのリスクが、ほとんどの分野について不明であった。選択的報告のリスクについてすべての研究で不明と評価したが、ごく少数の研究では主要アウトカムに対する数値データを提供していた。

7件の試験では骨折の発生率を報告したが、サンプル・サイズが小さく、さまざまなバイアスがあり、異なる漢方薬について調査していた。これらの試験では以下の比較を行った。Kanggusongカプセルとプラセボの比較、Kanggusong顆粒とカルトレイト単独またはイプリフラボンとカルトレイトの併用の比較、Yiguカプセルとカルシウムの併用とプラセボとカルシウムの併用の比較、Xianlinggubaoカプセルとカルトレイトの併用とプラセボとカルトレイトの併用の比較、Bushen Zhuanggu顆粒とカルトレイトの併用とプラセボ顆粒とカルトレイトの併用の比較、Kanggusong液とカルトレイトの併用とカルトレイト単独の比較、Zhuang- guqiangjin 錠剤とShujinbogu 錠剤とカルシトニンアンプルの併用とカルシトニンアンプル単独の比較。結果には一貫性がなかった。

1件の試験では、Bushenhuoxueと炭酸カルシウム錠剤とアルファカルシドールの併用が、炭酸カルシウム錠剤とアルファカルシドールの併用よりも、QOLのスコア(0~100点、点数が高いほど良好)に対する効果がより大きいことを示した(平均差(MD)5.30;95%信頼区間(CI)3.67~6.93)。

プラセボと比較した3件の異なる試験では、漢方薬(Migu煎じ薬、Bushen Yigu軟エキス、Kanggusongカプセル)が骨密度(BMD)を統計学的に有意に増加させることを示した(例:Kanggusongカプセル、MD 0.06 g/cm3;95%CI 0.02~0.10)。 非介入と比較した5件の試験のうち2件のみが、漢方薬がBMDの増加に対して統計学的に有意な効果があることを示した(例: Shigu yin、MD 0.08 g/cm3;95% CI 0.03~0.13)。 通常医療と比較した61件の試験のうち23件が、漢方薬がBMDの増加に対して統計学的に有意な効果があることを示した。漢方薬と通常医療の併用と通常医療単独を比較した48件の試験では、26件がBMDの増加に対する効果が併用療法でより大きいことを示した。

漢方薬による死亡または重篤な有害事象を報告した試験はなかったが、悪心や下痢などの軽微な有害作用を報告した試験もあった。

著者の結論

現在の知見では、BMDの改善に対する漢方薬の有益な効果は不確かなものであり、より厳密な研究が必要であることを示唆している。

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2015.12.31]
《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

摘要

中草药治疗骨质疏松症

研究背景

中草药被用于治疗骨质疏松症由来已久。有关他们的疗效和安全性证据需要进行系统综述。

研究目的

为了评估中草药作为试验组治疗药物与安慰剂、无治疗和常规药物治疗相比较治疗原发性骨质疏松的有益和有害影响。

检索策略

我们搜索了以下电子数据库:Cochrane补充医学领域专业注册库,CENTRAL,MEDLINE,EMBASE,LILACS,JICST-E,AMED,中国生物医学数据库和CINAHL。截止到2013年1月。

标准/纳入排除标准

纳入中草药与安慰剂、无治疗、常规治疗相比较的随机对照试验。

数据收集与分析

两名作者独立进行数据提取及偏倚风险评估。不一致的地方讨论解决。

主要结果

本研究共纳入108个研究包括10655名受试者。包括99种不同的中草药,及其与安慰剂(3个研究)、无治疗(5个研究)、常规治疗(61个研究)对比的研究,也有中草药加西药单独与西药对比的研究(47个研究)。所有研究的偏倚风险皆为不清楚,主要是由于缺乏对大多数领域具体研究设计的报告。我们将所有研究的选择性结局报告偏倚评为不清楚,但只有少数研究对于关键结局报告了数值资料。

7个研究报告了骨折发生率,但是他们的样本量过小,偏倚风险过大,并且研究的是不同种类的中草药。3个研究比较了抗骨松胶囊与安慰剂,抗骨松颗粒与钙尔奇或依普黄酮联合钙尔奇,益骨胶囊联合钙片与安慰剂联合钙片,仙灵骨葆胶囊联合钙尔奇与安慰剂联合钙尔奇,补肾壮骨颗粒联合钙尔奇与安慰剂颗粒联合钙尔奇,抗骨松汤联合钙尔奇与钙尔奇,壮骨强筋片联合舒筋薄骨片联合降钙素注射液与降钙素注射液。其结果是不一致的。

1个研究比较了补肾活血疗法联合碳酸钙咀嚼片、阿法骨化醇与碳酸钙咀嚼片联合阿法骨化醇比较,结果提示治疗组生活质量评分较高(评分范围0~100,评分越高越好)(均差 (MD) 5.30; 95% 可信区间 (CI) 3.67-6.93)

3个研究比较了中草药(密骨汤,补肾益骨煎膏剂,抗骨松胶囊)与安慰剂,结果提示中草药能显著在改善骨密度(BMD)(例如:抗骨松胶囊 MD 0.06 g/cm3; 95% CI 0.02-0.10)。5个研究比较了中草药和无治疗,只有2个研究显示中草药在提高BMD方面有显著的统计学差异(例如实骨饮,MD 0.08 g/cm3; 95% CI 0.03-0.13)。61个研究比较了中草药与常规药物,23个研究结果提示中草药在改善BMD方面与常规药物相比有显著性差异。在48个评价了中草药联合西药与单独使用西药对比的研究中,26个研究显示在提高BMD方面中草药联合西药由于单独使用西药。

没有研究报告与中草药导致的死亡或严重不良事件,有的研究报告了轻微的不良反应,如恶心、腹泻等。

作者结论

现有的研究结果显示中草药提高BMD的效果仍然不能确定,需要更多严格的试验予以证实。

翻译注解

译者:严晓艺;审校:孙瑾,北京中医药大学循证医学中心。2017年10月19日。

Plain language summary

Chinese herbal medicines for osteoporosis

Review question

We conducted a review of the effects of Chinese herbal medicines for people with primary osteoporosis. We found 108 studies with 10,655 people.

Background: what is primary osteoporosis and what are Chinese herbal medicines?

Bone is a living, growing part of your body. Throughout your lifetime, new bone cells grow and old bone cells break down to make room for the new, stronger bone. When you have osteoporosis, the old bone breaks down faster than the new bone can replace it. As this happens, the bones lose minerals (such as calcium). This makes bones weaker and more likely to break even after a minor injury, like a little bump or fall.

Chinese herbal medicines are products made from any part of medicinal plants (leaves, stems, buds, flowers or roots). Sometimes non-plant based components (for example insects, deer horn, snake, various shells and powdered fossil) are included. These can be used in the form of raw plant materials, or water or alcohol extracts of raw plant materials. Herbs can also be taken by mouth as capsules, tablets or liquids, or as injections.

Chinese herbal medicines are widely used in China for primary osteoporosis but their benefits and harms have not been appraised in order to inform clinical practice.

Study characteristics

After searching for all relevant studies up to January 2013, we found 108 studies with 10,655 people with osteoporosis. Ninety-nine different Chinese herbal medicines were tested and compared with placebo (three trials), no intervention (five trials) or conventional medicine (61 trials), or Chinese herbal medicines plus conventional medicine were compared with conventional medicine (47 trials). The average length of treatment was 5.7 months (ranging from 3 to 12 months).

Key results: what happens to people with osteoporosis who take Chinese herbal medicines?

New fractures

We are uncertain whether Chinese herbal medicines reduce the chance of having a new bone fracture. Seven trials evaluated the incidence of fractures. However, these trials were small and had flaws in their methods.

Quality of life

People who took Bushenhuoxue therapy plus calcium carbonate tablets and alfacalcidol rated their quality of life to be 5.30 points better on a scale of 0 to 100 after three months compared to people who did not take the herbal medicine.

People who took Bushenhuoxue therapy plus calcium carbonate tablets and alfacalcidol rated their quality of life to be 56.05 on a scale of 0 to 100.

People who took calcium carbonate tablets and alfacalcidol rated their quality of life to be 50.75 on a scale of 0 to 100.

Serious side effects or deaths

No serious side effects or deaths occurred in the trials.

We often do not have precise information about side effects and complications. This is particularly true for rare but serious side effects. Possible side effects may include a mild stomach ache or diarrhoea.

Bone mineral density (the amount and type of minerals in the bone)

We found studies that compared Chinese herbal medicines with placebo (fake treatment), with no treatment and with conventional medicine. We also found studies that compared Chinese herbal medicines plus conventional medication with just conventional medication.

Compared to placebo (fake treatment), three studies showed that bone mineral density increased slightly with Chinese herbal medicines.

Compared to no treatment or conventional medicine, some studies showed an increase in bone mineral density with Chinese herbal medicines while others did not.

When Chinese herbal medicines plus conventional medication was compared with just conventional medicine, some studies showed an increase in bone mineral density while others did not.

Quality of the evidence

In people with osteoporosis:

- Chinese herbal medicines may improve bone mineral density and quality of life slightly. Further research is likely to change this estimate of how Chinese herbal medicines affect bone mineral density and quality of life.

- We are uncertain whether Chinese herbal medicines reduce the chance of having a new bone fracture.

- No trial reported death or serious side effects.

Résumé simplifié

Les plantes médicinales chinoises pour l'ostéoporose

Question de la revue

Nous avons évalué les effets des plantes médicinales chinoises chez les personnes atteintes d'ostéoporose primaire. Nous avons trouvé 108 études totalisant 10 655 personnes.

Contexte : Qu'est-ce que l'ostéoporose primaire et que sont les plantes médicinales chinoises ?

L'os est une partie vivante et croissante de votre corps. Tout au long de votre vie, de nouvelles cellules osseuses se développent et les anciennes cellules se décomposent pour laisser place à un nouvel os plus résistant. Lorsque vous souffrez d'ostéoporose, les anciens os se cassent avant que les nouveaux os puissent les remplacer. Alors que cela se produit, les os perdent leurs minéraux (tels que le calcium). Ce qui rend les os plus fragiles et plus susceptibles de casser même après une blessure mineure, telle qu'une petite chute ou un petit coup.

Les herbes médicinales chinoises sont des produits à base de n'importe quelle partie des plantes médicinales (tiges, feuilles, bourgeons ou racines). Parfois, les composants d'origine non végétale (par exemple les insectes, les cornes de cerf, les serpents, différentes gélules et poudres fossiles) sont inclus. Ils peuvent être utilisés sous forme de matériaux végétaux bruts, ou de l'eau ou des extraits d'alcool provenant de matériaux végétaux bruts. Les plantes peuvent également être prises par voie orale sous forme de capsules, de comprimés ou de liquides, ou par injections.

Les plantes médicinales chinoises sont largement utilisées en Chine pour l'ostéoporose primaire, mais leurs effets bénéfiques et délétères n'ont pas été évalués afin d'éclairer la pratique clinique.

Les caractéristiques de l'étude

Après avoir recherché toutes les études pertinentes jusqu'à janvier 2013, nous avons trouvé 108 études totalisant 10 655 personnes atteintes d'ostéoporose. Quatre-vingt-dix-neuf différentes plantes médicinales chinoises étaient testées et comparées à un placebo (trois essais), à l'absence d'intervention (cinq essais) ou à la médecine conventionnelle (61 essais), ou les plantes médicinales chinoises + la médecine conventionnelle étaient comparées à un traitement standard (47 essais). La durée moyenne du traitement était de 5,7 mois (allant de 3 à 12 mois).

Résultats principaux : Qu'arrivent-ils aux personnes atteintes d'ostéoporose qui prennent des plantes médicinales chinoises ?

Nouvelles fractures

Nous ne savons pas si les plantes médicinales chinoises réduisent les risques de nouvelles fractures osseuses. Sept essais évaluaient l'incidence des fractures. Cependant, ces essais étaient de petite taille et présentaient des défauts méthodologiques.

La qualité de vie

Les personnes ayant été administrées la thérapie Bushen Huoxue + les comprimés de carbonate de calcium et de l'alfacalcidol évaluaient leur qualité de vie être supérieure de 5,30 points sur une échelle de 0 à 100, après trois mois par rapport aux personnes qui ne prenaient pas le médicament à base de plantes.

Les personnes ayant été administrées la thérapie Bushen Huoxue + les comprimés de carbonate de calcium et de l'alfacalcidol évaluaient leur qualité de vie de 56,05 sur une échelle de 0 à 100.

Les personnes ayant été administrées les comprimés de carbonate de calcium et de l'alfacalcidol évaluaient leur qualité de vie de 50,75 sur une échelle de 0 à 100.

Effets secondaires graves ou décès

Aucun effet secondaire grave, ni aucun décès n'est survenu dans les essais.

Nous disposons rarement d'informations précises concernant les effets secondaires et les complications. Ceci est particulièrement vrai pour les effets secondaires rares mais graves. De potentiels effets secondaires pourraient inclure une légère douleur à l'estomac ou de la diarrhée.

La densité minérale osseuse (la quantité et les types de minéraux présents dans les os)

Nous avons trouvé des études ayant comparé les plantes médicinales chinoises à un placebo (faux traitement), à l'absence de traitement et à la médecine conventionnelle. Nous avons également trouvé des études ayant comparé les plantes médicinales chinoises + la médecine conventionnelle par rapport à la médecine conventionnelle seule.

Par rapport à un placebo (faux traitement), trois études montraient que la densité minérale osseuse augmentait légèrement avec les plantes médicinales chinoises.

Par rapport à l'absence de traitement ou à la médecine conventionnelle, certaines études montraient une augmentation de la densité minérale osseuse avec les plantes médicinales chinoises, tandis que les autres n'observaient aucune hausse.

Lorsque les plantes médicinales chinoises + la médecine conventionnelle étaient comparées à la médecine conventionnelle seule, certaines études montraient une augmentation de la densité minérale osseuse, tandis que les autres n'observaient aucune hausse.

Qualité des preuves

Chez les personnes atteintes d'ostéoporose :

- Les plantes médicinales chinoises pourraient améliorer légèrement la densité minérale osseuse et la qualité de vie. Des recherches supplémentaires sont susceptibles de modifier cette estimation concernant la manière dont les plantes médicinales chinoises affectent la densité minérale osseuses et la qualité de vie.

- Nous ne savons pas si les plantes médicinales chinoises réduisent le risque de nouvelles fractures osseuses.

- Aucun essai ne rapportait de décès ou d'effets secondaires graves.

Notes de traduction

Traduit par: French Cochrane Centre 22nd June, 2014
Traduction financée par: Financeurs pour le Canada : Instituts de Recherche en Santé du Canada, Ministère de la Santé et des Services Sociaux du Québec, Fonds de recherche du Québec-Santé et Institut National d'Excellence en Santé et en Services Sociaux; pour la France : Ministère en charge de la Santé

淺顯易懂的口語結論

中草藥治療骨質疏鬆症

回顧問題

我們回顧中草藥對原發性骨質疏鬆症患者的療效,納入108篇試驗,包含10,655名受試者。

背景:何謂原發性骨質疏鬆症?何謂中草藥?

骨骼是人體內持續生長的活組織。終我們一生總是有新的骨骼細胞生成,老的骨骼細胞也不斷分解,以便讓更強壯的新骨骼有成長的空間。在罹患骨質疏鬆症 (osteoporosis) 時,老骨骼的分解速率比新骨骼的生成速率快,造成骨骼的礦物質 (例如鈣) 流失,導致骨骼變得脆弱,即使輕微受傷,例如稍稍碰撞或跌倒,也可能發生骨折。

中草藥是由藥用植物的任一部分 (葉、莖、芽、花或根) 所製成的產品,有時也會使用非植物性的成分 (例如昆蟲、鹿角、蛇、各種貝類和粉狀的化石)。中草藥可能使用未經加工的植物,也可能使用植物的水或酒精萃取液。中草藥可以製成口服的膠囊、錠劑或藥液,也可以製成注射劑。

中國廣泛使用中草藥治療原發性骨質疏鬆症,但臨床實務上並無可供參考的療效和傷害評估。

試驗特色

在搜尋截至2013年1月為止的所有相關試驗後,我們找到108篇試驗,包含10,655名骨質疏鬆症患者。有99種不同的中草藥接受試驗,並與安慰劑 (3篇試驗)、無介入組 (5篇試驗) 或傳統藥物治療 (61篇試驗) 進行比較,或針對中草藥合併西藥治療和單獨使用西藥治療進行比較 (47篇試驗)。平均治療時間為5.7個月 (範圍介於1至12個月之間)。

重要結果:使用中草藥的骨質疏鬆症患者發生了什麼事?

新骨折

我們不確定中草藥是否能降低新骨折的發生率。雖然有7篇試驗評估骨折的發生率,不過這些試驗樣本數少,而且具有方法學上的瑕疵。

生活品質

經過3個月後,接受補腎活血治療加碳酸鈣錠劑和alfacalcidol的患者,對自己的生活品質評量 (0-100分的量表) 分數,較未服用中草藥的患者高5.30分。

接受補腎活血治療加碳酸鈣錠劑和alfacalcidol的患者,評量自己的生活品質為56.05分 (使用0-100分的量表)。

服用碳酸鈣錠劑和alfacalcidol的患者,對自己的生活品質評量則為50.75分 (使用0-100分的量表)。

嚴重不良作用或死亡

在這些試驗中並未發生嚴重副作用或死亡。

我們通常並未握有關於副作用和併發症的精確資訊,尤其是罕見但嚴重的副作用。可能的副作用包括輕微胃痛或腹瀉。

骨質密度 (骨骼所含的礦物質量和種類)

我們找出比較中草藥和安慰劑 (假裝治療)、無治療組或傳統藥物治療的試驗,也找出針對中草藥加傳統藥物治療,以及只使用傳統藥物治療進行比較的試驗。

有3項試驗顯示,相對於安慰劑 (假裝治療),使用中草藥可使患者的骨質密度略微增加。

部分試驗顯示,相較於無治療組或傳統藥物治療,使用中草藥可使患者的骨質密度增加,但其他試驗並未證實此項療效。

至於針對中草藥併用傳統藥物治療和單純使用傳統藥物治療進行比較的試驗,則有部分試驗顯示患者的骨質密度增加,但也有部分試驗並未發現此項結果。

證據品質

骨質疏鬆症患者:

- 中草藥可略微改善骨質密度和生活品質。未來的研究結果,可能改變如今對中草藥如何影響骨質密度和生活品質的評估結果。

- 我們並不確定中草藥是否能降低新骨折的發生率。

- 並無試驗通報發生死亡或嚴重副作用。

譯註


翻譯者:臺北醫學大學實證醫學研究中心
本計畫由台灣衛生福利部/臺北醫學大學實證醫學研究中心/東亞考科藍聯盟(EACA)統籌執行

平易な要約

骨粗鬆症に対する漢方薬

レビューの論点

原発性骨粗鬆症の人に対する漢方薬の効果についてレビューを行った。10,655例を対象とした108件の研究を見出した。

背景:原発性骨粗鬆症および漢方薬とは何か?

骨は、生きて成長している身体の一部である。一生を通じて、新しい骨細胞が成長し、新しいより強い骨が育つスペースを作るために古い骨細胞は破壊する。骨粗鬆症の場合、古い骨が新しい骨に置き換わるより早く破壊してしまう。こうなると、骨はカルシウムなどのミネラルを失ってしまう。そのため、骨が弱くなり、ちょっとした衝突や転倒などの軽微な傷害で骨折しやすくなる。

漢方薬は薬用植物のあらゆる部位から作られる製剤である(葉、茎、芽、花、根)。非植物成分を含有することも時々ある(例:昆虫、鹿の角、ヘビ、さまざまな貝殻、化石の粉末)。これらは生の植物原料として、もしくは生の植物原料の水抽出物やアルコール抽出物として使用できる。また、漢方薬はカプセル、錠剤、液体として口から摂取したり、注射したりすることができる。

漢方薬は原発性骨粗鬆症に対して中国では広く使われているが、 その利益と有害性について、臨床診療に役立てるための評価は行われていない。

研究の特性

2013年1月までの関連性のあるあらゆる研究を検索し、骨粗鬆症の人10,655例を対象とした108件の試験を見出した。99種類の異なる漢方薬について調べており、プラセボ(3件の試験)、 非介入(5件)、または通常医療(61件)と比較していた。また、漢方薬と通常医療の併用と、通常医療単独を比較した試験も47件あった。平均治療期間は5.7カ月(3~12カ月)であった。

主な結果:骨粗鬆症の人が漢方薬を摂取するとどうなるのか?

新たな骨折

漢方薬が新たな骨折の可能性を減少させるかについては不明確である。7件の試験が骨折の発生率を評価していた。しかし、これらの試験は小規模で、研究方法に欠陥があった。

QOL

Bushenhuoxueと炭酸カルシウム錠剤とアルファカルシドールを3カ月間併用した人では、漢方薬を摂取しなかった人よりも、0~100点で評価するQOLが5.30点良好であった。

Bushenhuoxueと炭酸カルシウム錠剤とアルファカルシドールを併用した人では、QOLが0~100点中56.05点であった。

炭酸カルシウム錠剤とアルファカルシドールを併用した人では、QOLが0~100点中50.75点であった。

重篤な副作用や死亡

これらの試験では重篤な副作用や死亡はなかった。

副作用や合併症について、多くの場合、詳細な情報を得ることができなかった。稀ではあっても重篤な副作用では特に情報が不足していた。考えられる副作用には軽度の胃痛や下痢がある。

骨塩密度(骨に含まれるミネラルの量と種類)

漢方薬と、プラセボ(偽の治療)、無治療、通常医療を比較した複数の研究を見出した。また、漢方薬と通常医療の併用と通常医療単独を比較した研究も見出した。

プラセボ(偽の治療)と比較して、3件の研究が漢方薬では骨塩密度がわずかに増加することを示した。

無治療や通常医療と比較して、いくつかの研究で漢方薬が骨塩密度を増加させることを示したが、示さなかった研究もあった。

漢方薬と通常医療の併用と通常医療の単独を比較した場合、いくつかの研究で併用療法では骨塩密度が増加することを示したが、示さなかった研究もあった。

エビデンスの質

骨粗鬆症の人:

-漢方薬は骨塩密度とQOLをわずかに改善する可能性がある。さらなる研究によって、漢方薬が骨塩密度やQOLにどの程度影響するかについての見解が変わる可能性がある。

-漢方薬が新たな骨折の可能性を減少させるかについては不明確である。

-死亡や重篤な副作用を報告した試験はなかった。

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2015.12.31]
《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

概要

中草药治疗骨质疏松症

系统综述问题

我们对中草药治疗原发性骨质疏松症患者的疗效进行了综述。共检索到108个研究包括10655名受试者。

背景:什么是原发性骨质疏松?什么是中草药?

骨是身体的一部分,活生生的,不断生长的。纵观人的一生,新的骨细胞长成,旧骨细胞分解,以腾出空间给新的、更健壮的骨头。当你患有骨质疏松症时,旧骨分解大于可代替它的新骨的生成。同时,骨头会丢失矿物质(如钙)。这使骨骼变弱,更容易在轻微的打击后骨折,比如一个小小的撞击或跌倒。

中草药是使用药用植物(叶,茎,芽,花或根)的一部分制造的产品。有时,也包括非植物的成分(例如昆虫,鹿茸,蛇,各种贝壳和化石粉末)。这些成分可以以其植物原料、植物原料的水或乙醇提取物形式使用。草药可制作成胶囊、片剂或液体的形式口服,或作为注射剂使用。

中草药治疗原发性骨质疏松在中国得到了广泛的应用,但是其利弊需要被评估进而指导临床实践。

研究特征

通过检索2013年1月的所有相关研究,我们找到了108个研究纳入了10655名骨质疏松患者。99种不同的中草药纳入研究,并与安慰剂(3个研究)、无治疗(5个研究)、常规治疗(61个研究)、中草药加常规治疗与常规治疗(47个研究)相比较。平均治疗时常为5.7个月(3到12个月)

主要结果:使用了中药材的骨质疏松患者发生了什么?

新发骨折

我们不确定中草药是否会减少新发骨折的机会。7个研究评估了骨折的发生率。但是,这些研究样本量较小并且方法上有缺陷。

生活质量

接受了补肾活血治疗加碳酸钙片和阿法骨化醇治疗的患者与未使用中草药的患者在治疗三个月后相比,其生活质量按0到100的评估,要高5.30分。

接受了补肾活血治疗加碳酸钙片和阿法骨化醇治疗的患者,生活质量评分在0到100的评分中达到了56.05。

接受了碳酸钙片和阿法骨化醇的患者,生活质量评分在0到100的评分中达到了50.75。

严重的副作用或死亡

在试验中没有发生严重的副作用或死亡。

对于副作用与并发症我们通常沒有精确的信息。尤其是少见但是严重的副作用。可能的副作用包括轻度胃痛或腹泻。

骨密度 (骨中矿物质的数量和类型)

我们发现了中草药与安慰剂(假治疗)、无治疗及常规治疗对比的研究。也发现了比较中草药加常规治疗与常规治疗比较的研究。

3个研究结果提示与安慰剂(假治疗)相比,中草药对提升骨密度的轻微的作用。

与不治疗或常规药物相比,有研究表明中草药使骨密度增加了,而在另一些研究中则没有。

中草药加常规药物治疗与仅适用常规药物治疗相比,有些研究结果显示骨密度增加了,但另一些研究中则没有。

证据质量

在患有骨质疏松的人群中:

中草药可能可以轻微提高骨密度与生活质量。进一步的研究可能会改变本研究对中草药材对骨密度和生活质量影响的估计。

我们不能肯定中草药是否减少了新发骨折的机会。

没有研究报告死亡或严重副作用。

翻译注解

译者:严晓艺;审校:孙瑾,北京中医药大学循证医学中心。2017年10月19日。

Summary of findings(Explanation)

Summary of findings for the main comparison. Chinese herbal medicines versus placebo for osteoporosis
  1. 1No information on adequate sequence generation and not all the outcomes that were of interest in this review were reported.
    2The total population size is less than 300 (a threshold rule-of-thumb value).
    3Seven trials reported on the outcome of fracture incidence, but these trials were small in sample size, suffered from various biases, tested different Chinese herbal medicines and the results were not consistent.
    4The total population size is less than 400 (a threshold rule-of-thumb value).

Chinese herbal medicines versus placebo for osteoporosis
Patient or population: patients with osteoporosis
Settings: inpatients
Intervention: Chinese herbal medicine versus placebo
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)

Comments

(95% CI)

Assumed riskCorresponding risk
Control (placebo) Chinese herbal medicine

New fractures

(Kanggusong capsule versus placebo)

Follow-up: 12 months

185 per 1000 0 per 1000
(0 to 157)
RR 0.05
(0 to 0.85)
104
(1 study)
⊕⊝⊝⊝
very low 1,2,3
We are uncertain about the estimate3
Quality of lifeSee commentSee commentNot estimable0
(0)
See commentNo trial reported this outcome
DeathSee commentSee commentNot estimable0
(0)
See commentNo trial reported this outcome
Serious adverse eventsSee commentSee commentNot estimable0
(0)
See commentNo trial reported this outcome

BMD of lumbar spine (Kanggusong capsule versus placebo)

Follow-up: 12 months
Scale from: 0 to 4

The mean BMD in the control groups was 0.82 g/cm3The mean BMD in the intervention groups was 0.06 higher
(0.02 to 0.1 higher)
 140
(1 study)
⊕⊕⊝⊝
low 1,4

MD 0.06 g/cm3 (0.02 to 0.10)

Absolute risk difference 2% (1% to 3%)

Relative per cent change 7% (2% to 12%)

NNT 5 (3 to 13)

BMD of ulna

(Bushen Yigu soft extract versus placebo)
Follow-up: 3 months
Scale from: 0 to 4

The mean BMD in the control groups was 0.59 g/cm3The mean BMD in the intervention groups was 0.06 higher (0.02 to 0.1 higher) 59
(1 study)
⊕⊕⊝⊝
low 1,4

MD 0.06 g/cm3 (0.02 to 0.10)

Absolute risk difference 2% (1% to 3%)

Relative per cent change 10% (3% to 17%)

NNT 3 (2 to 8)

BMD of radius

(Bushen Yigu soft extract versus placebo)

Follow-up: 3 months
Scale from: 0 to 4

The mean BMD in the control groups was 0.58 g/cm3The mean BMD in the intervention groups was 0.06 higher (0.03 to 0.09 higher) 59
(1 study)
⊕⊕⊝⊝
low 1,4

MD 0.06 g/cm3 (0.03 to 0.09)

Absolute risk difference 2% (1% to 2%)

Relative per cent change 10% (5% to 16%)

NNT 3 (2 to 6)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
BMD: bone mineral density; CI: confidence interval; MD: mean difference; NNT: number needed to treat; RR: risk ratio
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Summary of findings 2 Chinese herbal medicines versus no intervention for osteoporosis

Summary of findings 2. Chinese herbal medicines versus no intervention for osteoporosis
  1. 1No information on adequate sequence generation and not all the outcomes that were of interest in this review were reported.
    2The total population size is less than 400 (a threshold rule-of-thumb value).

Chinese herbal medicines versus no intervention for osteoporosis
Patient or population: patients with osteoporosis
Settings: inpatients and outpatients
Intervention: Chinese herbal medicine versus no intervention
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control (no intervention) Chinese herbal medicine
New fracturesSee commentSee commentNot estimable0
(0)
See commentNo trial reported this outcome
Quality of lifeSee commentSee commentNot estimable0
(0)
See commentNo trial reported this outcome
DeathSee commentSee commentNot estimable0
(0)
See commentNo trial reported this outcome
Serious adverse eventsSee commentSee commentNot estimable0
(0)
See commentNo trial reported this outcome

BMD of lumbar spine
(Bushen Shengsui principle versus no intervention)

Follow-up: 6 months
Scale from: 0 to 4

The mean BMD in the control groups was 0.82 g/cm3The mean BMD in the intervention groups was 0.07 higher
(0.06 lower to 0.2 higher)
 61
(1 study)
⊕⊕⊝⊝
low 1,2

MD 0.07 g/cm3 (-0.06 to 0.20)

Absolute risk difference 2% (-2% to 5%)

Relative per cent change 9% (-7% to 24%)

Not statistically significant

BMD of femoral neck

(Shigu yin versus no intervention)

Follow-up: 6 months
Scale from: 0 to 4

The mean BMD in the control groups was 0.60 g/cm3

The mean BMD in the intervention groups was 0.08 higher

(0.03 to 0.13 higher)

 80
(1 study)
⊕⊕⊝⊝
low 1,2

MD 0.08 g/cm3 (0.03 to 0.13)

Absolute risk difference 2% (1% to 3%)

Relative per cent change 13% (5% to 22%)

NNT 4 (3 to 8)

BMD of femoral neck
(Shengu capsule versus no intervention)

Follow-up: 6 months
Scale from: 0 to 4

The mean BMD in the control groups was 0.62 g/cm3The mean in the intervention groups was 0.02 higher
(0.06 lower to 0.09 higher)
 34
(1 study)
⊕⊕⊝⊝
low 1,2

MD 0.02 g/cm3 (-0.06 to 0.09)

Absolute risk difference 1% (-2% to 2%)

Relative per cent change 3% (-10% to 15%)

Not statistically significant

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
BMD: bone mineral density; CI: confidence interval; MD: mean difference; NNT: number needed to treat; RR: risk ratio
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Summary of findings 3 Chinese herbal medicines versus western medicine for osteoporosis

Summary of findings 3. Chinese herbal medicines versus western medicine for osteoporosis
  1. 1No information on adequate sequence generation and not all the outcomes that were of interest in this review were reported.
    2The total population size is less than 400 (a threshold rule-of-thumb value).
    3Only one trial out of 61 reported this outcome.

Chinese herbal medicines versus western medicine for osteoporosis
Patient or population: patients with osteoporosis
Settings: outpatients and inpatients
Intervention: Chinese herbal medicine versus western medicine
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control (western medicine) Chinese herbal medicine

New fractures

(Kanggusong granule versus calcium and vitamin D)

Follow-up: 9 months

0 per 40 0 per 31Not estimable71
(1 study)
⊕⊕⊝⊝
very low 1,2
We are uncertain about the estimate3
Quality of lifeSee commentSee commentNot estimable0
(0)
See commentNo trial reported this outcome
DeathSee commentSee commentNot estimable0
(0)
See commentNo trial reported this outcome
Serious adverse eventsSee commentSee commentNot estimable0
(0)
See commentNo trial reported this outcome

BMD of lumbar spine
(Bushenjianpi Zhuangguyin versus Caltrate and calcitonin)

Follow-up: 12 weeks
Scale from: 0 to 4

The mean BMD in the control groups was 0.79 g/cm3

The mean BMD in the intervention groups was 0.16 higher

(0.1 to 0.22 higher)

 100
(1 study)
⊕⊕⊝⊝
low 1,2

MD 0.16 g/cm3 (0.10 to 0.22)

Absolute risk difference 4% (3% to 6%)

Relative per cent change 20% (13% to 18%)

NNT 3 (2 to 4)

BMD of lumbar spine
(Liuwei Dihuang pills versus calcium and vitamin D)

Follow-up: 6 months
Scale from: 0 to 4

The mean BMD in the control groups was 0.89 g/cm3

The mean BMD in the intervention groups was 0.05 higher

(0.03 to 0.07 higher)

 71
(1 study)
⊕⊕⊝⊝
low 1,2

MD 0.05 g/cm3 (0.03 to 0.07)

Absolute risk difference 1% (1% to 2%)

Relative per cent change 6% (3% to 8%)

NNT 3 (2 to 5)

BMD of femoral neck
(Kanggusong granule versus calcium and vitamin D)

Follow-up: 9 months
Scale from: 0 to 4

The mean BMD in the control groups was 0.71 g/cm3

The mean BMD in the intervention groups was 0.01 higher

(0.03 lower to 0.05 higher)

 71
(1 study)
⊕⊕⊝⊝
low 1,2

MD 0.01 g/cm3 (-0.03 to 0.05)

Absolute risk difference 0.25% (-1% to 1%)

Relative per cent change 1% (-4% to 7%)

Not statistically significant

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
BMD: bone mineral density; CI: confidence interval; MD: mean difference; NNT: number needed to treat; RR: risk ratio
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Summary of findings 4 Chinese herbal medicines plus western medicine versus western medicine for osteoporosis

Summary of findings 4. Chinese herbal medicines plus western medicine versus western medicine for osteoporosis
  1. 1No information on adequate sequence generation and not all the outcomes that were of interest in this review were reported.
    2The total population size is less than 300 (a threshold rule-of-thumb value).
    3Five trials reported on the outcome of fracture incidence, but these trials were small in sample size, suffered from various biases, tested different Chinese herbal medicines and the results were not consistent.

    4The total population size is less than 400 (a threshold rule-of-thumb value).

Chinese herbal medicines plus western medicine versus western medicine for osteoporosis
Patient or population: patients with osteoporosis
Settings: inpatients
Intervention: Chinese herbal medicine plus western medicine versus western medicine
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control (western medicine) Chinese herbal medicine plus western medicine

New fractures

(Yigu capsule plus calcium versus placebo plus calcium)

Follow-up: 6 months

114 per 1000 0 per 1000
(0 to 114)
RR 0.06
(0 to 1)
140
(1 study)
⊕⊕⊝⊝
very low 1,2
We are uncertain about the estimate3

New fractures

(Xianlinggubao capsule (low-dose) plus calcium and vitamin D versus placebo plus calcium and vitamin D)

Follow-up: 12 months

17 per 1000 0 per 1000
(0 to 134)
RR 0.33
(0.01 to 8.02)
120
(1 study)
⊕⊕⊝⊝
very low 1,2
We are uncertain about the estimate3

New fractures

(Bushen Zhuanggu granules plus calcium and vitamin D versus placebo granules plus calcium and vitamin D)

Follow-up: 5 years

104 per 1000 46 per 1000
(14 to 149)
RR 0.44
(0.13 to 1.43)
155
(1 study)
⊕⊕⊝⊝
very low 1,2
We are uncertain about the estimate3

New fractures

(Kanggusong soup plus calcium and vitamin D versus calcium and vitamin D)

Follow-up: 3 months

33 per 1000 0 per 1000
(0 to 178)
RR 0.22
(0.01 to 5.34)
75
(1 study)
⊕⊕⊝⊝
very low 1,2
We are uncertain about the estimate3

Quality of life

(Bushenhuoxue therapy plus calcium carbonate tablets and alfacalcidol versus calcium carbonate tablets and alfacalcidol)
Follow-up: 3 months
Scale from: 0 to 100

The mean quality of life in the control groups was 50.75The mean quality of life in the intervention groups was 5.3 higher
(3.67 to 6.93 higher)
 80
(1 study)
⊕⊕⊝⊝
low 1,4

MD 5.30 g/cm3 (3.67 to 6.93)

Absolute risk difference 5% (4% to 7%)

Relative per cent change 10% (7% to 14%)

NNT 2 (2 to 3)

DeathSee commentSee commentNot estimable0
(0)
See commentNo trial reported this outcome
Serious adverse eventsSee commentSee commentNot estimable0
(0)
See commentNo trial reported this outcome
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; MD: mean difference; NNT: number needed to treat; RR: risk ratio
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Background

Description of the condition

Osteoporosis is a worldwide common public health problem with high prevalence (Cole 2008; Woolf 2003). It is defined as a progressive, systemic disease characterised by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased susceptibility to fractures (Diez 2002; NOF 2014; Wylie 2010). While osteoporosis is often thought of as an older person's disease, it can strike at any age (Cole 2008; NOF 2014). It is estimated that worldwide osteoporosis is currently a problem for 200 million middle-aged and elderly persons, and there are 75 million people with osteoporosis in America, Western Europe and Japan. In terms of its incidence rate osteoporosis has been ranked as seventh among common diseases worldwide (Nguyen 2000; Xue 2000). In China, there are already 50 million people with osteoporosis and a large-scale epidemiological study found that the prevalence in people over 50 years is 50% (Qiu 2001). As life expectancy increases, this number is expected to continue to grow (Bengner 1988; Cumming 1997; Kushner 1998).

Osteoporosis is a highly prevalent disorder associated with sequelae that often have devastating effects on the quality of life of those affected, and may be a high risk factor for death. Morbidity and mortality rates from osteoporosis-related injuries are high (Diez 2002; Holroyd 2008). Osteoporosis-related sequelae therefore have a major impact on healthcare costs, both direct and indirect, especially those related to hip fracture (Diez 2002; Holroyd 2008). Three kinds of major fractures are associated with osteoporosis: hip, vertebrae and the distal forearm (such as wrist) (Diez 2002; NOF 2014). Epidemiologic studies from several countries have reported the incidence and impact of hip fractures, and their absolute number is expected to double in the next 25 years, with a projected total of more than six million occurrences per year throughout the world by the year 2050 (Genant 1999). Some studies have found that the mortality rate associated with hip fracture is 15% to 25%, caused by complications such as pneumonia, other infections and cardiac insufficiency. The expense of therapy and hospitalisation is USD 25 billion each year (Xue 2000). It is difficult to calculate the incidence of spinal fractures because many are asymptomatic or may not be diagnosed, however they are also an important fracture in many elderly people (Diez 2002). Therefore, osteoporosis has become an important social and medical care problem.

Osteoporosis is often called the 'silent disease' because bone loss occurs gradually and without symptoms or warning signs until the disease is advanced (Cole 2008; NOF 2014; Wylie 2010). Some people may suffer from chronic or acute pain, muscle fatigue and limited mobility, but they may not know that they have osteoporosis until their bones become so weak that a sudden strain, bump or fall causes a fracture or a vertebra to collapse. Collapsed vertebrae may initially be felt or seen in the form of severe back pain, loss of height or spinal deformities such as kyphosis (stooped posture) (IOF 2014; Xia 2001).

At present, the pathogenesis of osteoporosis is still not clear, but may be associated with heredity, poor nutrition, malabsorption, gonadal insufficiency, inadequate physical activity, lack of sunlight irradiation and smoking (Diez 2002; Raisz 2005; Winsloe 2009; Zhou 2001b).

Description of the intervention

Currently, there are a range of therapeutic approaches for osteoporosis. Conventional medicines include oestrogen, raloxifene, bisphosphonates (such as alendronate, etidronate, risedronate), calcitriol, calcitonin, Caltrate (Confavreux 2012; Diez 2002; Guo 2003a; Guo 2003b; Horst-Sikorska 2011; Leong 2002; Rizzoli 2012; Sambrook 2000; Silverman 2012; Wells 2008a; Wells 2008b; Wells 2008c; Zhang 2012). Although fluoride has the ability to increase bone mineral density (BMD) at the lumbar spine (Haguenauer 2005), it has been found ineffective for reducing vertebral fractures in postmenopausal women with osteoporosis. Oestrogen therapy has limited effectiveness and long-term use increases the risks of breast cancer, endometrial haemorrhage and endometrial cancer (Leong 2002). A Cochrane systematic review shows that exercise has the potential to be a safe and effective way to avert bone loss in postmenopausal women (Howe 2011). Although concerted research efforts have been made to identify safe and effective therapies, treatment options are still needed.

In China and other countries, people are looking for alternative modalities to treat osteoporosis and Chinese herbal medicines are one of the popular therapies used. Chinese herbal medicines are defined in this review as products derived from any part of medicinal plants (e.g. leaves, stems, buds, flowers, roots or tubers) used for the treatment of osteoporosis (Rates 2001) and some non-plant based component (e.g. insects, deer horn, snake, various shells and powdered fossil, etc.) are sometimes included. Chinese herbal medicines can be in the form of raw plant materials, or water or alcohol extracts of raw plant materials, or herbal formulations in capsules, tablets, decoctions or injections.

How the intervention might work

In China, many herbs have been tested in clinical trials and claims made as to their effectiveness in treating osteoporosis (Cao GY 2010; Dong Y 2010; Jian QQ 2010; Wang JM 2008; Zhang XG 2011). For example, Zhang et al found that Zhuangguyin (a formula containing different herbs, such as common yam rhizome, red and white peony root, Chinese angelica, Radix codonopsis pilosulae, liquorice root, etc. plus dry powder of Placenta hominis) improved primary osteoporosis, and proposed that the therapy improved the BMD of the lumbar spine and femoral neck (Zhang XG 2011). One clinical trial found that Gujian capsule (studied and produced by Xiyuan Hospital under the Institute of Traditional Chinese Medicine) improved BMD, increased levels of calcitonin, oestradiol, testosterone, follicle-stimulating hormone and luteinising hormone, and decreased levels of parathyroid hormone (Meng 2003).

Why it is important to do this review

Cochrane reviews have assessed the efficacy of Chinese herbal medicines in the treatment of many conditions such as atopic eczema (Gu 2013), cholelithiasis (Gan 2013), colorectal cancer (Guo 2012), gastric cancer (Yang 2013), endometriosis (Flower 2012), heart failure (Chen 2012), osteoarthritis (Cameron 2013) and nephrotic syndrome (Chen 2013; Feng 2013), but not osteoporosis. Chinese herbal medicines are widely used in China for the treatment of osteoporosis and many herbal drugs have been approved by the China State Food and Drug Administration (SFDA) for the market. Each year, many clinical trials are published in China, however, there is no critical appraisal of the evidence on the potential benefits and harms of Chinese herbal medicines for treating osteoporosis. The purpose of this review is to systematically identify available randomised clinical trials of Chinese herbal medicines for primary osteoporosis to appraise their benefit and harm in order to inform clinical practice.

Objectives

To assess the beneficial and harmful effects of Chinese herbal medicines as a general experimental intervention for treating primary osteoporosis by comparing herbal treatments with placebo, no intervention and conventional medicine.

Methods

Criteria for considering studies for this review

Types of studies

Randomised clinical trials were included irrespective of blinding, publication status or language. For adverse effects associated with medicinal herbs in osteoporosis treatment, we planned to include data from cohort studies for the evaluation of safety.

Types of participants

Study participants with primary osteoporosis or osteopenia regardless of age, gender or ethnic origin were included. Those with secondary osteoporosis including corticosteroid-induced osteoporosis due to diseases affecting metabolism of bone and the liver, kidney and haematopoietic system, and disability of the heart and cerebral vessels, were excluded.

Osteoporosis could be diagnosed on the basis of one of the following criteria for bone mineral density (BMD) levels. BMD was detected by one of the following methods of examination: single photon absorptiometry (SPA), dual photon absorptiometry (DPA), quantitative computed tomography (QCT), dual energy X-ray absorptiometry (DXA) or peripheral dual energy X-ray absorptiometry (pDXA).

The World Health Organization (WHO) have recommended criteria for primary osteoporosis based on BMD levels (WHO 1994):

  • Normal: BMD is within +1 or -1 standard deviations (SD) of the young adult mean.

  • Osteopenia (low bone mass): BMD is between -1 and -2.5 SD below the young adult mean.

  • Osteoporosis: BMD is -2.5 SD or more than the young adult mean.

  • Severe (established) osteoporosis: BMD is more than -2.5 SD and one or more osteoporotic fractures have occurred.

The Chinese diagnostic criteria for primary osteoporosis based on BMD levels (Osteoporosis 1999):

  • Normal: BMD is within +1 or -1 SD of peak bone mass of the same race, gender and region.

  • Osteopenia (low bone mass): BMD is between -1 and -2 standard deviations below peak bone mass of the same race, gender and region.

  • Osteoporosis: BMD is -2 SD or more than the peak bone mass of the same race, gender and region.

  • Severe (established) osteoporosis: BMD is more than -2 SD and one or more osteoporotic fractures have occurred.

Types of interventions

The experimental interventions included single herbs, combinations of herbs or Chinese proprietary medicines. There was no standard for the classification of Chinese herbal medicines. Therefore, to make it easier, we classified Chinese herbal medicines into two major types: a) Chinese proprietary medicine which was approved by the China State Food and Drug Administration (SFDA) and produced by pharmaceutical companies with good manufacture practices; b) herbal formulae prescribed by Chinese medicine practitioners based on a Chinese medicine diagnosis (i.e. pattern differentiation of symptoms). This type of medicine was usually cooked as decoction by the patients themselves or prepared by a hospital pharmacy. As we predicted great variation in the type, timing, dosage and administration of herbs and their combination with other interventions, we did not limit any of these aspects.

The control intervention could be no treatment, placebo or conventional pharmaceutical medicine (such as hormone replacement therapy, bisphosphonate, calcitonin, calcium and vitamin D), as well as non-pharmaceutical interventions such as exercise. Co-intervention was allowed as long as all groups from the randomised allocation received the same co-intervention.

We excluded studies in which the duration of herbal treatment was less than three months.

Types of outcome measures

Major outcomes

Major outcome measures sought at the end of treatment or at maximal follow-up:

  1. Number of individuals with fractures and type of fractures (lumbar spine, radius, femoral neck).

  2. Quality of life or symptoms including pain, muscle fatigue and limited mobility.

  3. Death directly or indirectly attributed to osteoporosis.

  4. Adverse effects including serious adverse events and withdrawals: serious adverse events are defined as any untoward medical occurrence that resulted in death or fracture, was life-threatening, resulted in persistent or significant disability, or any important medical event which may have jeopardised the patient or required intervention to prevent it (ICH GCP 1997). All other adverse effects were considered non-serious. We recorded reports of adverse effects associated with the herbs used in the treatment of osteoporosis from any type of study in order to evaluate harms.

Minor outcomes

Minor outcomes at the end of treatment or at maximal follow-up:

  1. Bone mineral density (BMD).

  2. Biochemical indicators: serum calcium (Ca), phosphorus (P), alkaline phosphatase (ALP), oestradiol (E2), parathyroid hormone (PTH), calcitonin (CT), bone Gla protein (BGP), interleukin-6 (IL-6).

Search methods for identification of studies

Electronic searches

We searched the following electronic databases irrespective of language or publication status: the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (2012, Issue 12), MEDLINE, EMBASE, LILACS, JICST-E (Japan Information Center for Science and Technology), AMED, the database of the Cochrane Complementary Medicine Field, Chinese Biomedical Database (CBM), CINAHL (Cumulative Index to Nursing and Allied Health Literature) and the Chinese Academic Conference Papers Database.

We used the following MeSH and free-text terms: osteoporosis, medicine-Chinese-traditional, plants-medicinal, drugs-Chinese-herbal, plants extracts and herbs. The full search strategies were in Appendix 1 (MEDLINE), Appendix 2 (EMBASE), Appendix 3 (CENTRAL) and Appendix 4 (CBM). All electronic searches were from inception to 9 January 2013.

Searching other resources

We handsearched the following journals published in Chinese: Chinese Journal of Integrated Traditional and Western Medicine (1981 to 2012), Chinese Journal of Osteoporosis (1995 to 2012), Chinese Journal of Geriatrics (1982 to 2012) and Journal of Clinical Orthopaedics (1998 to 2012).

We screened reference lists of all retrieved articles and reviews for possible eligible trials.

Data collection and analysis

Selection of studies

Two authors (Y Liu, Y Xia) independently selected the trials to be included in the review according to the prespecified selection criteria. Any disagreement was resolved by discussion.

Data extraction and management

Two authors (Y Liu, Y Xia) extracted data independently using a self developed data extraction form which was piloted for formal use. Disagreement was resolved by discussion.

We extracted the following characteristics and data from each included trial: primary author, study setting, methodology, mean age, gender and ethnicity of patients, number of randomised patients, reasons and number of patients who dropped out or were lost during the follow-up, patient inclusion and exclusion criteria, symptoms of the patients, diagnostic criteria, type of herb or herbs, route of administration, dosage and duration of the herb, details of comparison regime, outcome measures (end of treatment and follow-up), and number and type of adverse effects.

If the above data were not available in the trial reports, we sought further information by correspondence with the principal author. If the information was still lacking after the author was contacted, we recorded the last reported observed response.

Assessment of risk of bias in included studies

Based on the recommendations in the Cochrane Handbook for Systematic Reviews of Interventions (Chapter 8: Assessing risk of bias in included studies), we made separate critical assessments for seven specific domains: sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective outcome reporting and 'other' issues (the baseline comparability between groups) (Higgins 2011). Two authors (Y Liu, Y Xia) assessed the risk of bias independently and assigned a judgement of 'low' risk of bias, 'high' risk of bias or 'unclear' risk of bias. Any disagreement was resolved by discussion.

Measures of treatment effect

We presented dichotomous data as risk ratio (RR) and continuous outcomes as mean difference (MD), both with 95% confidence intervals (CI).

Unit of analysis issues

For a trial with multiple treatment groups, in order to overcome a unit of analysis error, we selected the following approaches accordingly.

  • Combining groups of the same Chinese herbal medicine with different dosages to create a single pair-wise comparison.

  • Selecting one pair of interventions and excluding the others.

  • Splitting the 'shared' group into two or more groups with smaller sample size, and including two or more (reasonably independent) comparisons.

Dealing with missing data

Based on the recommendations in theCochrane Handbook for Systematic Reviews of Interventions (Chapter 16.1: Missing data), we used two options for dealing with missing data (Higgins 2011).

  • Analysing only the available data when data were assumed to be missing at random (i.e. ignoring the missing data).

  • Imputing the missing data with replacement values (such as a poor outcome) when data were not assumed to be missing at random.

Assessment of heterogeneity

We assessed heterogeneity using the I2 statistic, which describes the percentage of the variability in effect estimates that is due to heterogeneity rather than sampling error (chance) (Higgins 2011). A rough guide to interpretation of I2 is as follows:

  • 0% to 40%: might not be important;

  • 30% to 60%: may represent moderate heterogeneity;

  • 50% to 90%: may represent substantial heterogeneity;

  • 75% to 100%: considerable heterogeneity.

Assessment of reporting biases

We planned to detect reporting biases with funnel plots, which is a simple scatter plot of the intervention effect estimates from individual studies against some measure of each study's size or precision (Higgins 2011).

Data synthesis

We compared types of Chinese herbal medicines with each control (such as placebo) regardless of the treatment regimen. We performed meta-analysis within comparisons of the same herb versus the similar control intervention. Whenever there was significant heterogeneity (I2 > 50%), we used the random-effects model; otherwise we reported fixed-effect models (Altman 2003). We carried out the statistical analyses using Review Manager 5.2 (Cochrane software) (RevMan 2012).

We tabulated the following comparisons when data were available:

  • Chinese herbal medicines versus no intervention or placebo;

  • Chinese herbal medicines versus conventional medicine (such as hormone replacement therapy, bisphosphonate);

  • Chinese herbal medicines versus non-pharmaceutical intervention.

We presented trials of herbs plus active intervention versus active intervention alone as a separate comparison.

Subgroup analysis and investigation of heterogeneity

We performed subgroup analyses on different Chinese herbal medicines and on body parts of participants for BMD measurement. However, due to the limited number of randomised trials for individual Chinese herbal medicines, the following subgroup analyses were not performed: duration of the herbal treatment, types of osteoporosis (for example, senile or postmenopausal osteoporosis) and severity of osteoporosis.

Sensitivity analysis

Similarly, due to the heterogeneity of the interventions, we were unable to pool results into a meta-analysis and therefore could not undertake a sensitivity analysis to explore the influence of trial methodological quality on effect estimates.

'Summary of findings' tables

We created 'Summary of findings' tables for different comparisons and included the following patient-important outcomes (fractures, quality of life, death, serious adverse events, BMD). We assessed the overall quality of the evidence by outcome using the GRADE approach and incorporated this in the tables.

Results

Description of studies

Results of the search

Our initial searches identified 4427 references: 4378 from electronic searches and 49 from handsearches. After reading titles and abstracts, 4176 of these articles were excluded because they were duplicates, non-clinical studies, without a control group, traditional reviews, animal studies, case reports or had study objectives different from this review. We retrieved a total of 251 references published in Chinese or English for further assessment. Of these, 143 references were excluded because they did not meet our inclusion criteria. Reasons for exclusion were shown in the Characteristics of excluded studies table.

In this review, 108 randomised clinical trials met the inclusion criteria. All trials were conducted in China between 1996 and 2012. We did not find any cohort studies for the evaluation of the safety of Chinese herbal medicines for osteoporosis. The included studies reported random allocation of patients with osteoporosis to Chinese herbal medicines versus control (placebo in three trials, no treatment in five trials, conventional pharmaceutical medicine (such as calcium and vitamin D, calcium gluconate, tibolone tablets, nilestriol, calcitonin, alendronate, calcium, vitamin D, etc.) in 61 trials, Chinese herbal medicines plus co-intervention versus the same co-intervention in 47 trials). No trial compared Chinese herbal medicines with non-pharmaceutical interventions. Eighteen trials (An SJ 2000; Chen ZX 2002; Dai Y 2007; Gong L 2001; Liao L 2004; Miu JQ 2008; Peng T 2002; Ruan XY 2006; Song XW 2000; Wang XY 2000; Wu MS 2007; Xiong YH 2008; Xu H 2010; Xu M 2009; Zhan HS 2009; Zhang YS 2003; Zhang YP 2007; Zhu HM 2012) had more than two arms. Attributes of the 108 included studies are shown in the Characteristics of included studies table. Four trials were published in English (Deng WM 2012; Qiu RB 2004; Xie J 2004; Zhu HM 2012) and 104 studies were published in Chinese.

The study flow diagram is shown in Figure 1.

Figure 1.

The study screening flow diagram.

Included studies

Participants

A total of 10,655 patients with osteoporosis were randomised in the 108 trials, among which 65 trials included postmenopausal osteoporosis patients, eight trials included senile osteoporosis patients and 35 trials included primary osteoporosis patients unspecified as to life-stage or co-morbidity. The race/ethnicity of all patients studied was Chinese in all 108 trials. One hundred and five randomised clinical trials included adults with a mean age of 61.3 years. Three trials did not report data on gender or age or both (Lin W 2000; Xiong YH 2008; Zhao LN 2003). The average number of participants in the trials was 98, ranging from 20 to 600 patients per trial.

Diagnosis

Among the 108 included trials, the diagnostic criteria for osteoporosis in 18 trials were based on WHO criteria (An SJ 2000; Cao W 2010; Chen NQ 2006; Chen ZX 2002; Cui TH 1999; Dai Y 2007; Gang PH 2001; Hu J 2012; Li HW 2004; Li YH 2008; Miu JQ 2008; Wang SW 2003; Ye AN 1998; Zhang RH 2004; Zhang YL 1996; Zhao G 2002; Zheng WK 2007; Zhou LZ 2001), and in the others the Chinese diagnostic criteria for osteoporosis were used. BMD was detected by dual energy X-ray absorptiometry (DXA), single photon absorptiometry (SPA) or CUBA ultrasound bone densitometer in all of the studies.

Interventions

Ninety-nine different Chinese herbal medicines were tested in 108 randomised trials. Only eight Chinese herbal medicines were tested twice or more, including Kanggusong granule in two trials (An SJ 2000; Wu MS 2001), Bushen Qiangshen pill in two trials (Mu G 2001; Mu G 2001a), Migu tablets in two trials (Dai Y 2007; Xie J 2004), Gukang oral liquid in three trials (Chen JP 1999; Shao M 2003; Wang JM 2008), Gushukang granule in three trials (Chen ZX 2002; Wu MS 2007; Zhang YS 2003), Qianggu capsule in three trials (Ruan XY 2006; Wang J 2007; Xu H 2010), Liuwei Dihuang pills in two trials (Ma C 2011; Zhang J 2003) and Xianlinggubao capsule in seven trials (Dai Y 2007; Dong Y 2010; Qiu ZX 2010; Wu W 2005; Xu M 2009; Zhang XZ 2004; Zhu HM 2012). However, even when the same Chinese herbal medicines were tested, the control interventions were different for each trial. Therefore, there was no trial which tested exactly the same Chinese herbal medicine and the same control in this review. Seven trials tested two or more different Chinese herbal medicines respectively (Dai Y 2007; Gong L 2001; Wu MS 2007; Xiong YH 2008; Zhan HS 2009; Zhang YS 2003; Zhang ZF 2011). According to the categories of medicinal herbs, two trials tested single herbs (Yang B 2007; Zhao LN 2003) and the remaining trials tested compounds of multiple herbs. Based on our standard classification for Chinese herbal medicines, 45 trials tested Chinese proprietary medicine and the others tested prescribed herbal formulae. The composition and treatment regimens of the Chinese herbal medicines varied (see Table 1: 'The preparation and composition of the Chinese herbal medicines in the included trials'). The median duration of treatment was 5.7 months (ranging from 3 to 12 months).

Table 1. The preparation and composition of the Chinese herbal medicines in the included trials
Name of herbsPreparationEnglish names (Latin names) of the compositionStudy ID
Kanggusong granuleGranuleChinese herbal medicine manufactured by Hebei Handan pharmaceutical factory, which is composed of prepared rhizome of adhesive rehmannia (Radix rehmanniae preparata), Dioscorea batatas (Rhizoma dioscoreae), Cuscuta seed (Semen cuscutae), Epimedium (Herba epimedii), etc.An SJ 2000; Wu MS 2001
Bushenhuoxue recipeDecoctionHerbal mixture composed of deer horn glue (Colla cornus cervi), prepared rhizome of adhesive rehmannia (Radix rehmanniae preparata), Epimedium (Herba epimedii), Cuscuta seed (Semen cuscutae), Psoralea corylifolia (Fructus psoraleae), Eucommia bark (Cortex eucommiae), membranous milk vetch root (Radix astragali), Danshen root (Radix salviae miltiorrhizae), Rhizoma corydalis (Rhizoma corydalis), Fortune's drynaria rhizome (Rhizoma drynariae), Liquorice root (Radix glycyrrhizae), Frankincense (olibanum), Myrrh (Commiphora molmol), Dragon's bones (Os Draconis) and oyster shell (Concha ostreae)Cao GY 2010
Chinese medicine (combinations of 10 herbs)DecoctionHerbal mixture composed of Psoralea corylifolia (Fructus psoraleae), Fortune's drynaria rhizome (Rhizoma drynariae), Glossy privet fruit (Fructus ligustri lucidi), Epimedium (Herba epimedii), liquorice root (Radix glycyrrhizae), Szechuan lovage rhizome (Rhizoma chuanxiong), Chinese angelica (Radix angelicae sinensis), Himalayan teasel root (Radix dipsaci), Ground beetle (Eupolyphaga seu steleophaga) and liquorice root (Radix glycyrrhizae)Cao W 2010
Gushen decoctionDecoctionHerbal mixture composed of 6 herbs: Epimedium (Herba epimedii), King Solomon's seal rhizome (Rhizoma polygonati), Barbary wolfberry fruit (Fructus lycii), human placenta (Placenta hominis), Rehmanniae radix preparata and clematis root (Radix clematidis)Chen FS 2001
Gukang oral liquidOral liquidHerbal mixture manufactured by affiliated orthopedics hospital of Guangzhou University of Traditional Chinese Medicine. It is a combined medicine composed of Epimedium (Herba epimedii), desert-living cistanche (Herba cistanches), liquorice root (Radix glycyrrhizae), Danshen root (Radix salviae miltiorrhizae), etc.Chen JP 1999; Shao M 2003; Wang JM 2008
Shenyao capsulesCapsuleChinese patent herbal medicine composed of Red leaves to kidney (Trachelos permum jasminoides Lem. Var. heterophyllum Tsiang), White leaves to kidney (euonymus fortunei Hand. Mazz), Cotton kidney (Urena procumbens L), Litchi kidney (Agrimonia pilosa Ledeb Var japonica Nakai), Dragon buds kidney (Salvia substolonifera Stib), Fagopyrum esculentum kidney (Fagopyrum cymosum Meisn), etc.Chen NQ 2006
Gukang dectionDecoctionHerbal mixture composed of Epimedium (Herba epimedii), Psoralea corylifolia (Fructus psoraleae), Rehmanniae radix preparata, Danshen root (Radix salviae miltiorrhizae), desert-living cistanche (Herba cistanches), liquorice root (Radix glycyrrhizae), Chinese angelica (Radix angelicae sinensis), white peony root (Radix paeoniae alba), Cuscuta seed (Semen cuscutae), Chinese date (Fructus jujubae), etc.Chen X 2008
Heche Dazao pill DecoctionHerbal mixture composed of human placenta (Placenta hominis), Rehmanniae radix preparata, Radix asparagi, Radix ophiopogonis (Radix ophiopogonis), Eucommia bark (Cortex eucommiae), two-tooth achyranthes root (Radix achyranthis bidentatae), Amur cork tree bark (Cortex phellodendri), tortoise shell (Carapax et plastrum testudinis), liquorice root (Radix glycyrrhizae), Psoralea corylifolia (Fructus psoraleae), Dioscorea batatas (Rhizoma dioscoreae) and Wolfiporia cocos (Poria)Chen XL 2010
Jiarong tabletTabletChinese patent herbal medicine manufactured by Xi'an Boai Medicine limited companyChen YQ 2001
Gushukang granuleGranuleChinese patent herbal medicine composed of Epimedium (Herba epimedii), Rehmanniae radix preparata, liquorice root (Radix glycyrrhizae), Danshen root (Radix salviae miltiorrhizae), Fortune's drynaria rhizome (Rhizoma drynariae), etc.Chen ZX 2002; Wu MS 2007; Zhang YS 2003
Strong Bone capsuleCapsuleHerbal mixture composed of deer horn glue (Colla cornus cervi), desert-living cistanche (Herba cistanches), prepared rhizome of rehmannia (Radix rehmanniae preparata), tortoise shell (Carapax et plastrum testudinis), Eucommia bark (Cortex eucommiae), bitter orange (Fructus aurantii), Suberect spatholobus stem (Caulis spatholobi), etc.Cui TH 1999
Xianlinggubao capsule CapsuleChinese patent herbal medicine composed of Epimedium (Herba epimedii), Himalayan teasel root (Radix dipsaci), Psoralea corylifolia (Fructus psoraleae), etc. Dai Y 2007; Dong Y 2010; Qiu ZX 2010; Wu W 2005; Xu M 2009; Zhang XZ 2004; Zhu HM 2012
Migu tabletTabletThe medicine was developed by Union Hospital of Tongji Medical College and composed of Epimedium (Herba epimedii), Eucommia bark (Cortex eucommiae), Psoralea corylifolia (Fructus psoraleae), etc.Dai Y 2007; Xie J 2004
Herba epimedii prescriptionDecoctionHerbal mixture composed of Epimedium (Herba epimedii), Psoralea corylifolia (Fructus psoraleae), Eucommia bark (Cortex eucommiae), oyster shell (Concha ostreae), common monkshood mother root, processed radix aconiti (Radix aconiti preparata), Kusnezoff monkshood root (Radix aconiti kusnezoffii), Chinese angelica (Radix angelicae sinensis) and Szechuan lovage rhizome (Rhizoma chuanxiong)Dong YF 2004
Gengnian Anyi tabletTabletChinese patent herbal medicine manufactured by Hubei traditional Chinese medicine company. The main composition was Rehmanniae radix preparata, Dioscorea batatas (Rhizoma dioscoreae), Eucommia bark (Cortex eucommiae), desert-living cistanche (Herba cistanches), etc.Fan HX 2004
Gumiling granule GranuleSelf developed herbal mixture (no details on composition)Gang PH 2001
Shengu capsuleCapsuleChinese patent medicine manufactured by Beijing Tianjiu Medicine limited company. The main composition was oyster shell (Concha ostreae)Gong L 2001
Yishen Zhuanggu mixtureDecoctionChinese patented medicine manufactured by Beijing Xuanwu hospital. It is a combined medicine composed of Psoralea corylifolia (Fructus psoraleae), Radix codonopsis pilosulae (Radix codonopsis), Fortune's drynaria rhizome (Rhizoma drynariae), Rehmanniae radix preparata, liquorice root (Radix glycyrrhizae), etc.Gong L 2001
Bushen Kangsong pillPillChinese patent medicine manufactured by the People's Liberation Army General Hospital of Nanjing Military Region. It is composed of Rehmanniae radix preparata, Chinese taxillus twig (Herba taxilli), Dioscorea batatas (Rhizoma dioscoreae), common macrocarpium fruit (Fructus corni), Barbary wolfberry fruit (Fructus lycii), hairy antler (Corn Cervi Pantotrichum), Himalayan teasel root (Radix dipsaci), Psoralea corylifolia (Fructus psoraleae), Eucommia bark (Cortex eucommiae), Epimedium (Herba epimedii), desert-living cistanche (Herba cistanches), two-tooth achyranthes root (Radix achyranthis bidentatae), Cuscuta seed (Semen cuscutae), cassia bark (Cortex cinnamomi), Chinese angelica (Radix angelicae sinensis), liquorice root (Radix glycyrrhizae), Dragon's bones (Os Draconis), oyster shell (Concha ostreae), hawthorn fruit (Fructus crataegi), liquorice root (Radix glycyrrhizae), etc.Guo JH 2008
Shugan zishen huoxue tangDecoctionHerbal mixture composed of Chinese thorowax root (Radix bupleuri), white peony root (Radix paeoniae alba), Nutgrass galingale rhizome (Rhizoma cyperi), bitter orange (Fructus aurantii), Pinellia tuber (Rhizoma pinelliae), Wolfiporia cocos (Poria), prepared rhizome of adhesive rehmannia (Radix rehmanniae preparata), common macrocarpium fruit (Fructus corni), tortoise shell (Carapax et plastrum testudinis), East Asian tree fern rhizome (Rhizoma cibotii), Fructus chaenomelis (Chaenomeles speciosa Nakai), prepared frankincense (olibanum), Myrrh preparata (Commiphora molmol) and Szechuan lovage rhizome (Rhizoma chuanxiong)Han XL 2007
Bushen Jianpi Huoxue recipeDecoctionHerbal mixture composed of Psoralea corylifolia (Fructus psoraleae), Epimedium (Herba epimedii), desert-living cistanche (Herba cistanches), Rehmanniae radix preparata, white peony root (Radix paeoniae alba), liquorice root (Radix glycyrrhizae), Cuscuta seed (Semen cuscutae), Danshen root (Radix salviae miltiorrhizae), Chinese angelica (Radix angelicae sinensis) and Chinese date (Fructus jujubae)He MT 2007
Jiawei Zhuangyao Jianshen tangDecoctionHerbal mixture composed of East Asian tree fern rhizome (Rhizoma cibotii), Cherokee rose fruit (Fructus rosae laevigatae), Chinese taxillus twig (Herba taxilli), suberect spatholobus stem (Caulis spatholobi), Philippine flemingia root (Moghania philippinensis li.), beautiful millettia root (Millettia speciosa champ), Cuscuta seed (Semen cuscutae), glossy privet fruit (Fructus ligustri lucidi), Rhizoma corydalis (Rhizoma corydalis), Chinese angelica (Radix angelicae sinensis), red peony root (Radix paeoniae rubra) and largehead atractylodes rhizome (Rhizoma atractylodis macrocephalae)He N 2006
Bushen Yangxue tangDecoctionHerbal mixture composed of medicinal Indian mulberry root (Radix morindae officinalis), Epimedium (Herba epimedii), Cherokee rose fruit (Fructus rosae laevigatae), Barbary wolfberry fruit (Fructus lycii), Chinese date (Fructus jujubae), Chinese angelica (Radix angelicae sinensis), white peony root (Radix paeoniae alba) and tuber fleece flower root (Radix polygoni multiflori), etc.

He XQ 2006;

Zhan ML 2007

Shangke Yishen Zhuanggu pillPillHerbal mixture composed of Rehmanniae radix preparata, Chinese angelica (Radix angelicae sinensis), two-tooth achyranthes root (Radix achyranthis bidentatae), Sanqi (Radix notoginseng), Wolfiporia cocos (Poria), Danshen root (Radix salviae miltiorrhizae), common macrocarpium fruit (Fructus corni), Szechuan lovage rhizome (Rhizoma chuanxiong), membranous milk vetch root (Radix astragali), etc.Hu J 2012
Erxian Yanggu tangDecoctionHerbal mixture composed of medicinal Indian mulberry root (Radix morindae officinalis), common curculigo rhizome (Rhizoma curculiginis), Epimedium (Herba epimedii), Barbary wolfberry fruit (Fructus lycii), Eucommia bark (Cortex eucommiae), Fortune's drynaria rhizome (Rhizoma drynariae), Amur cork tree bark (Cortex phellodendri), common anemarrhena rhizome (Rhizoma anemarrhenae), deer horn glue (Colla cornus cervi), tortoise shell glue (Colla carapacis et plastri testudinis), paniculate swallow wort root (Radix Cynanchi Paniculati), white peony root (Radix paeoniae alba), Chinese angelica (Radix angelicae sinensis), Radix astragali preparata and bitter orange (Fructus aurantii)Huang JW 2008
Zishen Gukang pillPillChinese patent medicine manufactured by the Traditional Chinese Medicine Hospital of Henan province pharmacy. It is composed of Epimedium (Herba epimedii), Chinese angelica (Radix angelicae sinensis), prepared rhizome of adhesive rehmannia (Radix rehmanniae preparata), Psoralea corylifolia (Fructus psoraleae), common macrocarpium fruit (Fructus corni), two-tooth achyranthes root (Radix achyranthis bidentatae), etc.Huang ZJ 2008
ShengsuiyinDecoctionHerbal mixture composed of medicinal Indian mulberry root (Radix morindae officinalis), Chinese taxillus twig (Herba taxilli), Cuscuta seed (Semen cuscutae), tortoise shell glue (Colla carapacis et plastri testudinis), Epimedium (Herba epimedii), common macrocarpium fruit (Fructus corni), Radix codonopsis pilosulae (Radix codonopsis), Dioscorea batatas (Rhizoma dioscoreae), Wolfiporia cocos (Poria) and glossy privet fruit (Fructus ligustri lucidi)Jian QQ 2010
Guli powderPowderChinese patent medicine manufactured by drug manufactory of the research institute of traditional Chinese medicine of Sichuan province. It is composed of Radix codonopsis pilosulae (Radix codonopsis), large head atractylodes rhizome (Rhizoma atractylodis macrocephalae), Wolfiporia cocos (Poria), Radix angelicae (Radix angelicae dahuricae), Epimedium (Herba epimedii), common cnidium fruit (Fructus cnidii), Psoralea fruits (Fructus psoraleae), Rehmanniae radix preparata, two-tooth achyranthes root (Radix achyranthis bidentatae), etc.Lan ZX 2006
Jianshenfang granuleGranuleChinese patent medicine manufactured by Guangzhou Yuexiu District Orthopedic Hospital. It is composed of Himalayan teasel root (Radix dipsaci), clematis root (Radix clematidis), Cherokee rose fruit (Fructus rosae laevigatae), East Asian tree fern rhizome (Rhizoma cibotii), Philippine flemingia root (Moghania philippinensis li.), two-tooth achyranthes root (Radix achyranthis bidentatae), etc.Li BL 2007
Ziyin Bushen Zhuanggu prescriptionDecoctionInvestigator-prescribed herbal mixture composed of Eucommia bark (Cortex eucommiae), Rehmanniae radix preparata, deer horn glue (Colla cornus cervi), liquorice root (Radix glycyrrhizae), Chinese angelica (Radix angelicae sinensis), Rhizoma corydalis (Rhizoma corydalis), two-tooth achyranthes root (Radix achyranthis bidentatae), Danshen root (Radix salviae miltiorrhizae), Psoralea corylifolia (Fructus psoraleae), Wolfiporia cocos (Poria), etc.Li HW 2004
Zhuanggu capsuleCapsuleHerbal mixture composed of Epimedium (Herba epimedii), common cnidium fruit (Fructus cnidii), human placenta (Placenta hominis), liquorice root (Radix glycyrrhizae), Sanqi (Radix notoginseng), etc.Li SL 2004
Jingujian granuleGranuleChinese patent medicine manufactured by Xiyuan Hospital of Chinese Academy of Traditional Chinese Medicine pharmacy. It is composed of Fortune's drynaria rhizome (Rhizoma drynariae), Eucommia bark (Cortex eucommiae), Szechuan lovage rhizome (Rhizoma chuanxiong), large head atractylodes rhizome (Rhizoma atractylodis macrocephalae), Manchurian wild ginger (Herba asari), etc.Li YH 2008
Jingujian granule (1,2,3)GranuleJingujian granule 1: Rehmanniae radix preparata, common macrocarpium fruit (Fructus corni), Cuscuta seed (Semen cuscutae), tortoise shell (Carapax et plastrum testudinis), two-tooth achyranthes root (Radix achyranthis bidentatae), Fortune's drynaria rhizome (Rhizoma drynariae), Eucommia bark (Cortex eucommiae), etc.
Jingujian granule 2: Psoralea corylifolia (Fructus psoraleae), Eucommia bark (Cortex eucommiae), two-tooth achyranthes root (Radix achyranthis bidentatae), Radix codonopsis pilosulae (Radix codonopsis), large-head atractylodes rhizome (Rhizoma atractylodis macrocephalae), etc.
Jingujian granule 3: Eucommia bark (Cortex eucommiae), Fortune's drynaria rhizome (Rhizoma drynariae), Medicinal cyathula root (Radix cyathulae), two-tooth achyranthes root (Radix achyranthis bidentatae), Manchurian wild ginger (Herba asari), large-head atractylodes rhizome (Rhizoma atractylodis macrocephalae), Szechuan lovage rhizome (Rhizoma chuanxiong)
Li YH 2010
Kanggusong soupDecoctionHerbal mixture composed of Rehmanniae radix preparata 18 g, Barbary wolfberry fruit (Fructus lycii) 9 g, Epimedium (Herba epimedii) 18 g, Himalayan teasel root (Radix dipsaci) 9 g, membranous milk vetch root (Radix astragali) 9 g, Wolfiporia cocos (Poria) 9 g, Danshen root (Radix salviae miltiorrhizae) 18 g, Radix puerariae (Radix puerariae) 9 g, suberect spatholobus stem (Caulis spatholobi) 18 g, etc.Li ZP 2011
Xianling Gusong capsuleCapsuleThe capsule included Epimedium (Herba epimedii), common curculigo rhizome (Rhizoma curculiginis), medicinal Indian mulberry root (Radix morindae officinalis), ginseng (Radix ginseng), Chinese angelica (Radix angelicae sinensis), human placenta (Placenta hominis) and common anemarrhena rhizome (Rhizoma anemarrhenae).Li ZY 2006
Bushenhuoxue therapyDecoctionHerbal mixture composed of Rehmanniae radix preparata 24 g, Epimedium (Herba epimedii) 18 g, membranous milk vetch root (Radix astragali) 15 g, common macrocarpium fruit (Fructus corni) 12 g, Dioscorea batatas (Rhizoma dioscoreae) 12 g, Eucommia bark (Cortex eucommiae) 12g, Danshen root (Radix salviae miltiorrhizae) 12 g, tree peony bark (Cortex moutan) 9 g, Wolfiporia cocos (Poria) 9 g, oriental water plantain rhizome (Rhizoma alismatis) 9 g, safflower (Flos carthami) 9 g, Sanqi (Radix notoginseng) 3 gLiang DB 2012
Bushen Shengsui principleDecoctionInvestigator-prescribed herbal mixture composed of Psoralea corylifolia (Fructus psoraleae), Epimedium (Herba epimedii), Eucommia bark (Cortex eucommiae) and glossy privet fruit (Fructus ligustri lucidi)Liao L 2004
Migu decoctionDecoctionSelf developed herbal mixture (no details on composition)Lin W 2000
Bushen Zhuanggu tangDecoctionHerbal mixture composed of East Asian tree fern rhizome (Rhizoma cibotii), Himalayan teasel root (Radix dipsaci), medicinal Indian mulberry root (Radix morindae officinalis), Epimedium (Herba epimedii), Psoralea corylifolia (Fructus psoraleae), liquorice root (Radix glycyrrhizae), white peony root (Radix paeoniae alba), Chinese angelica (Radix angelicae sinensis), Szechuan lovage rhizome (Rhizoma chuanxiong), safflower (Flos carthami) and two-tooth achyranthes root (Radix achyranthis bidentatae)Ling JY 2008
Gukang tabletTabletChinese patent medicine manufactured by Laiyang biological chemical pharmaceutical factory. It is composed of Rehmanniae radix preparata, Epimedium (Herba epimedii), suberect spatholobus stem (Caulis spatholobi), Chinese Pyrola Herb (Herba Pyrolae), Eucommia bark (Cortex eucommiae), medicinal Indian mulberry root (Radix morindae officinalis), common curculigo rhizome (Rhizoma curculiginis), desert-living cistanche (Herba cistanches), two-tooth achyranthes root (Radix achyranthis bidentatae), Chinese angelica (Radix angelicae sinensis), safflower (Flos carthami), etc.Liu JM 2012
Jiawei Bushen ZhuangjintangDecoctionInvestigator-prescribed herbal formulation composed of Rehmanniae radix preparata, Chinese angelica (Radix angelicae sinensis), two-tooth achyranthes root (Radix achyranthis bidentatae), Asiatic cornelian cherry fruit (Fructus corni), Wolfiporia cocos (Poria), Himalayan teasel root (Radix dipsaci), Eucommia bark (Cortex eucommiae), white peony root (Radix paeoniae alba), green tangerine peel (Pericarpium citri reticulatae viride), Slenderstyle acanthopanax bark (Cortex acanthopanacis), hairy antler (Corn Cervi Pantotrichum), etc.Lv ZH 2002
Yiyuanjiangu decoctionDecoctionHerbal mixture composed of Rehmanniae radix preparata 15 g, Psoralea corylifolia (Fructus psoraleae) 15 g, Epimedium (Herba epimedii) 10 g, Radix angelicae pubescentis 10 g, Barbary wolfberry fruit (Fructus lycii) 10 g, East Asian tree fern rhizome (Rhizoma cibotii) 10 g, Chinese angelica (Radix angelicae sinensis) 10 g, membranous milk vetch root (Radix astragali) 20 g, two-tooth achyranthes root (Radix achyranthis bidentatae) 20 g, Chinese taxillus twig (Herba taxilli) 20 g, Himalayan teasel root (Radix dipsaci) 12 g, etc.Ma CZ 2011
Yishen Zhuanggu decoctionDecoctionHerbal mixture composed of Rehmanniae radix preparata 24 g, Fortune's drynaria rhizome (Rhizoma drynariae) 20g, Himalayan teasel root (Radix dipsaci) 20 g, Epimedium (Herba epimedii) 30 g, Chinese angelica (Radix angelicae sinensis) 15 g, white peony root (Radix paeoniae alba) 10 g, Eucommia bark (Cortex eucommiae) 20 g, Chinese taxillus twig (Herba taxilli) 30g, membranous milk vetch root (Radix astragali) 30g, Dioscorea batatas (Rhizoma dioscoreae) 2 0g, tuber fleece flower root (Radix polygoni multiflori) 20 g and Cuscuta seed (Semen cuscutae) 15 gMa YJ 2011
Bushen Jianpi Jingu decoctionDecoctionHerbal mixture composed of Rehmanniae radix preparata 20 g, Dioscorea batatas (Rhizoma dioscoreae) 15 g, common macrocarpium fruit (Fructus corni) 12 g, Barbary wolfberry fruit (Fructus lycii) 12 g, Eucommia bark (Cortex eucommiae) 15 g, Psoralea corylifolia (Fructus psoraleae) 15 g, Fortune's drynaria rhizome (Rhizoma drynariae) 15 g, Radix codonopsis pilosulae (Radix codonopsis) 20 g, membranous milk vetch root (Radix astragali) 20 g, large-head atractylodes rhizome (Rhizoma atractylodis macrocephalae) 10 g, Wolfiporia cocos (Poria) 10 g and liquorice root (Radix glycyrrhizae) 10 gMao YF 2011
Gujian capsuleCapsuleDeveloped by Xiyuan hospital of China academy of TCM  (no details on composition)Meng XD 2003
Traditional Chinese capsuleCapsuleThe capsule included Epimedium (Herba epimedii), Fortune's drynaria rhizome (Rhizoma drynariae), liquorice root (Radix glycyrrhizae), King Solomon's seal rhizome (Rhizoma polygonati), Radix puerariae (Radix puerariae), Rhizoma corydalis (Rhizoma corydalis), etc.Miu JQ 2008
Bushen Qiangshen pillPillChinese patented medicine composed of ginseng (Radix ginseng), hairy antler (Cornu cervi pantotrichum), desert-living cistanche (Herba cistanches), liquorice root (Radix glycyrrhizae), Barbary wolfberry fruit (Fructus lycii), etc.Mu G 2001; Mu G 2001a
Radix rehmanniae preparata and Radix astragaliDecoctionHerbal mixture composed of Rehmanniae radix preparata 30 g, membranous milk vetch root (Radix astragali) 30 g, etc.Ou L 2011
Qianggu soft extractSlurryHerbal mixture composed of medicinal Indian mulberry root (Radix morindae officinalis), Cuscuta seed (Semen cuscutae), liquorice root (Radix glycyrrhizae), Chinese angelica (Radix angelicae sinensis), etc.Peng T 2002
Bushen QianggutangDecoctionInvestigator-prescribed formula composed of Himalayan teasel root (Radix dipsaci), Cuscuta seed (Semen cuscutae), Psoralea corylifolia (Fructus psoraleae), Fortune's drynaria rhizome (Rhizoma drynariae), common macrocarpium fruit (Fructus corni), Barbary wolfberry fruit (Fructus lycii), glossy privet fruit (Fructus ligustri lucidi), Dioscorea batatas (Rhizoma dioscoreae), Wolfiporia cocos (Poria), etc.Qi ZX 1998
Yanghuo Sanzi tangDecoctionHerbal mixture composed of Epimedium (Herba epimedii), Fructus Schisandrae (Fructus schisandrae chinensis), common macrocarpium fruit (Fructus corni), Psoralea corylifolia (Fructus psoraleae), mulberry fruit (Fructus mori), Barbary wolfberry fruit (Fructus lycii), oyster shell (Concha ostreae), prepared fleece flower root (Radix polygoni multiflori preparata) and red ginseng (Radix ginseng rubra)Qiu RB 2004
Jiangu recipeDecoctionHerbal mixture composed of Epimedium (Herba epimedii), medicinal Indian mulberry root (Radix morindae officinalis), common cnidium fruit (Fructus cnidii), liquorice root (Radix glycyrrhizae), Fortune's drynaria rhizome (Rhizoma drynariae), deer horn glue (Colla cornus cervi), hawthorn fruit (Fructus crataegi), common macrocarpium fruit (Fructus corni) and Psoralea corylifolia (Fructus psoraleae)Qiu RB 2008
Qianggu capsuleCapsuleChinese patent medicine manufactured by Beijing Qihuang Pharmaceutical Limited Company; the main composition was Fortune's drynaria rhizome (Rhizoma drynariae)Ruan XY 2006; Wang J 2007; Xu H 2010
Kangshu Jiangu granuleGranuleChinese patent medicine manufactured by Shanxi college of traditional Chinese medicine pharmaceutical factory. It is composed of Epimedium (Herba epimedii) 20 g, Eucommia bark (Cortex eucommiae) 15 g, two-tooth achyranthes root (Radix achyranthis bidentatae) 15 g, Danshen root (Radix salviae miltiorrhizae) 15 g, large-head atractylodes rhizome (Rhizoma atractylodis macrocephalae) 12 g, etc.Shi CD 2012
Kidney-tonifying herbsGranuleHerbal mixture composed of Epimedium (Herba epimedii), desert-living cistanche (Herba cistanches), Psoralea corylifolia (Fructus psoraleae), tuber fleece flower root (Radix polygoni multiflori), Chinese angelica (Radix angelicae sinensis), safflower (Flos carthami), common aucklandia root (Radix aucklandiae), etc.Song XW 2000
Bushen Qianggu Huoxue therapyDecoctionHerbal mixture composed of Psoralea corylifolia (Fructus psoraleae) 15 g, Fortune's drynaria rhizome (Rhizoma drynariae) 10 g, Eucommia bark (Cortex eucommiae) 15 g, Epimedium (Herba epimedii) 10 g, Barbary wolfberry fruit (Fructus lycii) 15 g, Rehmanniae radix preparata 15 g, desert-living cistanche (Herba cistanches) 10 g, deer horn glue (Colla cornus cervi) 10 g, medicinal Indian mulberry root (Radix morindae officinalis) 10 g, Cuscuta seed (Semen cuscutae) 15 g, East Asian tree fern rhizome (Rhizoma cibotii) 10 g, Himalayan teasel root (Radix dipsaci) 10 g, Sanqi (Radix notoginseng) 10 g, Danshen root (Radix salviae miltiorrhizae) 10 g, suberect spatholobus stem (Caulis spatholobi) 15 g, etc.Tang ZA 2012
Gumikang capsuleCapsuleHerbal mixture composed of human placenta (Placenta hominis), hairy antler (Cornu cervi pantotrichum), etc.Wang CC 2005
Qianggu pastePasteChinese patent medicine manufactured by Affiliated Hospital of Wuhan University of Technology pharmacy, composed of flat stem milk vetch seed (Semen astragali complanati), Psoralea corylifolia (Fructus psoraleae), Epimedium (Herba epimedii), Chinese angelica (Radix angelicae sinensis), liquorice root (Radix glycyrrhizae), etc.Wang H 2007
Antai capsuleCapsuleChinese herbal medicine manufactured by the medicine research institute of Fourth Military Medical University.Wang SW 2003
Hugu capsuleCapsuleChinese patent medicine manufactured by Dongguan Super Success Pharmaceutical Co., Ltd. It is composed of tuber fleece flower root (Radix polygoni multiflori), Epimedium (Herba epimedii), Rehmanniae radix preparata, etc.Wang XD 2011
Bushen Yigu soft extractOral liquidHerbal mixture composed of prepared rhizome of adhesive rehmannia (Radix rehmanniae preparata), Epimedium (Herba epimedii), large-head atractylodes rhizome (Rhizoma atractylodis macrocephalae), oriental water plantain rhizome (Rhizoma alismatis), etc.Wang XY 2000
Jiangu capsuleCapsuleChinese patent medicine manufactured by Affiliated Hospital of Luohe Medical College pharmacy, composed of liquorice root (Radix glycyrrhizae), Danshen root (Radix salviae miltiorrhizae), Szechuan lovage rhizome (Rhizoma chuanxiong), Cuscuta seed (Semen cuscutae), Asiatic cornelian cherry fruit (Fructus corni), Dragon's bones (Os Draconis), oyster shell (Concha ostreae) and medicinal Indian mulberry root (Radix morindae officinalis)Wang YZ 2008
Bushen Jianpi Migu prescriptionDecoctionInvestigator-prescribed herbal formulation composed of liquorice root (Radix glycyrrhizae), Cuscuta seed (Semen cuscutae), Epimedium (Herba epimedii), Asiatic cornelian cherry fruit (Fructus corni), Dragon's bones (Os Draconis), oyster shell (Concha ostreae), deer horn glue (Colla cornus cervi), Rehmanniae radix preparata, desert-living cistanche (Herba cistanches), Eucommia bark (Cortex eucommiae), suberect spatholobus stem (Caulis spatholobi), medicinal Indian mulberry root (Radix morindae officinalis), Szechuan lovage rhizome (Rhizoma chuanxiong), liquorice root (Radix glycyrrhizae)Wang ZK 2004
Kanggusong capsule (self developed)CapsuleManufactured by the First Attached Hospital of Hebei Northern Institute, composed of Epimedium (Herba epimedii), Himalayan teasel root (Radix dipsaci), Rehmanniae radix preparata, Barbary wolfberry fruit (Fructus lycii), liquorice root (Radix glycyrrhizae), Wolfiporia cocos (Poria), Danshen root (Radix salviae miltiorrhizae), Radix puerariae (Radix puerariae) and suberect spatholobus stem (Caulis spatholobi)Wei RY 2011
Erxian soupLiquidHerbal mixture composed of common curculigo rhizome (Rhizoma curculiginis), Epimedium (Herba epimedii), medicinal Indian mulberry root (Radix morindae officinalis), Chinese angelica (Radix angelicae sinensis), common anemarrhena rhizome (Rhizoma anemarrhenae), Amur cork tree bark (Cortex phellodendri)Wu JZ 2010
Urinary bladder meridian stickingPatchHerbal mixture composed of  Rehmannia root (Radix rehmanniae), Epimedium (Herba epimedii), Dioscorea batatas (Rhizoma dioscoreae), Danshen root (Radix salviae miltiorrhizae), Fortune's drynaria rhizome (Rhizoma drynariae), Radix angelicae pubescentis, etc.Wu MS 2007
Kidney meridian stickingPatchHerbal mixture composed of  Rehmannia root (Radix rehmanniae), Epimedium (Herba epimedii), Dioscorea batatas (Rhizoma dioscoreae), Danshen root (Radix salviae miltiorrhizae), Fortune's drynaria rhizome (Rhizoma drynariae), Radix angelicae pubescentis, etc.Wu MS 2007
Prescription for tonifying kidneyPillHerbal mixture composed of  Rehmannia root (Radix rehmanniae), Epimedium (Herba epimedii), Dioscorea batatas (Rhizoma dioscoreae), Danshen root (Radix salviae miltiorrhizae), Fortune's drynaria rhizome (Rhizoma drynariae), Radix angelicae pubescentis, etc.Wu MS 2007
Gusong fangDecoctionHerbal mixture composed of nutmeg, Chinese angelica (Radix angelicae sinensis), liquorice root (Radix glycyrrhizae), Psoralea corylifolia (Fructus psoraleae), Epimedium (Herba epimedii), desert-living cistanche (Herba cistanches), etc.Xiao W 2008
Bugu Shengsui capsuleCapsuleHerbal mixture composed of Psoralea corylifolia (Fructus psoraleae), East Asian tree fern rhizome (Rhizoma cibotii), Sanqi (Radix notoginseng), ginseng (Radix ginseng), etc.Xie YM 1997
Jiangu granuleGranuleChinese patent medicine manufactured by Ruijin hospital pharmacy, composed of Epimedium (Herba epimedii), Radix codonopsis pilosulae (Radix codonopsis), large-head atractylodes rhizome (Rhizoma atractylodis macrocephalae), glossy privet fruit (Fructus ligustri lucidi), etc.Xiong YH 2008
Gusongbao granuleGranuleChinese patent medicine composed of Epimedium (Herba epimedii), Rehmanniae radix preparata, oyster shell (Concha ostreae), etc.Xiong YH 2008; Zhan HS 2009
Yishen Yanggan mixtureOral liquidHerbal mixture composed of liquorice root (Radix glycyrrhizae), common macrocarpium fruit (Fructus corni), Epimedium (Herba epimedii), desert-living cistanche (Herba cistanches), Psoralea corylifolia (Fructus psoraleae), Chinese angelica (Radix angelicae sinensis), etc.Xu W 2005
Acupoint sticking of MigudanPatchHerbal mixture composed of Psoralea corylifolia (Fructus psoraleae), Fortune's drynaria rhizome (Rhizoma drynariae), Himalayan teasel root (Radix dipsaci), Szechuan lovage rhizome (Rhizoma chuanxiong), processed radix aconiti (Radix aconiti preparata), tuberculate Speranskia herb (Garden balsam stem), two-tooth achyranthes root (Radix achyranthis bidentatae), Manchurian wild ginger (Herba asari), etc.Xu YL 2007
HuangqiDecoctionSingle herb of liquorice root (Radix glycyrrhizae)Yang B 2007
Bushen ZhuanggutangDecoctionInvestigator-prescribed formula composed of Eucommia bark (Cortex eucommiae), Rehmanniae radix preparata, Fortune's drynaria rhizome (Rhizoma drynariae), Barbary wolfberry fruit (Fructus lycii), Epimedium (Herba epimedii), Radix codonopsis pilosulae (Radix codonopsis), liquorice root (Radix glycyrrhizae), common macrocarpium fruit (Fructus corni) and Sanqi (Radix notoginseng)Ye AN 1998
Shangke Jiegu tabletTabletChinese patent herbal medicine composed of Sanqi (Radix notoginseng), safflower (Flos carthami), frankincense (olibanum), myrrh (Commiphora molmol), ground beetle (Eupolyphaga seu steleophaga), etc.Yuan YN 2000
Xuduanzhuanggu capsule CapsuleChinese patent medicine manufactured by Zhejiang Di'er medicine limited companyZhan HS 2009
Bushenyiqihuoxue soupDecoctionHerbal mixture composed of Psoralea corylifolia (Fructus psoraleae), Fortune's drynaria rhizome (Rhizoma drynariae), glossy privet fruit (Fructus ligustri lucidi), Epimedium (Herba epimedii), liquorice root (Radix glycyrrhizae), white peony root (Radix paeoniae alba), Chinese angelica (Radix angelicae sinensis), Himalayan teasel root (Radix dipsaci), ground beetle (Eupolyphaga seu steleophaga) and liquorice root (Radix glycyrrhizae)Zhang DS 2011
Liuwei Dihuang pillPillChinese patent medicineMa C 2011; Zhang J 2003
Yigu capsuleCapsuleHerbal mixture composed of Epimedium (Herba epimedii), Barbary wolfberry fruit (Fructus lycii), Chinese angelica (Radix angelicae sinensis), two-tooth achyranthes root (Radix achyranthis bidentatae), etc.Zhang RH 2004
Bushenjianpi ZhuangguyinDecoctionHerbal mixture composed of human placenta (Placenta hominis), Dioscorea batatas (Rhizoma dioscoreae), red peony root (Radix paeoniae rubra), white peony root (Radix paeoniae alba), Chinese angelica (Radix angelicae sinensis), Radix codonopsis pilosulae (Radix codonopsis), liquorice root (Radix glycyrrhizae), large-head atractylodes rhizome (Rhizoma atractylodis macrocephalae), common macrocarpium fruit (Fructus corni), common cnidium fruit (Fructus cnidii), Chinese thorowax root (Radix bupleuri), Eucommia bark (Cortex eucommiae), two-tooth achyranthes root (Radix achyranthis bidentatae), Amur cork tree bark (Cortex phellodendri), tortoise shell (Carapax et plastrum testudinis), liquorice root (Radix glycyrrhizae), Psoralea corylifolia (Fructus psoraleae), Wolfiporia cocos (Poria), scorpion, Epimedium (Herba epimedii), Sanqi (Radix notoginseng), leech (Hirudo), etc.Zhang XG 2011
Bushen Huoxue capsuleCapsuleHerbal mixture composed of Epimedium (Herba epimedii), Eucommia bark (Cortex eucommiae), Himalayan teasel root (Radix dipsaci), deer horn glue (Colla cornus cervi), common macrocarpium fruit (Fructus corni), liquorice root (Radix glycyrrhizae), Dioscorea batatas (Rhizoma dioscoreae), Chinese angelica (Radix angelicae sinensis), Safflower (Flos carthami), etc.Zhang XJ 2008
TPF capsuleCapsuleChinese herbal medicine composed of cake uterine, Colla corii asini, Corium stomachium galliZhang YL 1996
Shigu yinLiquidChinese patent medicine manufactured by Third Affiliated Hospital of Luohe Medical College pharmacy, composed of Rehmanniae radix preparata, East Asian tree fern rhizome (Rhizoma cibotii), Epimedium (Herba epimedii), Psoralea corylifolia (Fructus psoraleae), oyster shell (Concha ostreae), Dioscorea batatas (Rhizoma dioscoreae), etc.Zhang YP 2007
Huoluo Gukang pillPillCondensed pill composed of Psoralea corylifolia (Fructus psoraleae), Fortune's drynaria rhizome (Rhizoma drynariae), liquorice root (Radix glycyrrhizae), safflower (Flos carthami), Zedoary (Rhizoma curcumae), deer horn glue (Colla cornus cervi), Lumbricus (Pheretima), etc.Zhang YS 2003
Zhuangguqiangjin tablet TabletManufactured by Dongwan Hospital of Traditional Chinese Medicine, composed of Slenderstyle acanthopanax bark (Cortex acanthopanacis), deer horn glue (Colla cornus cervi), desert-living cistanche (Herba cistanches), Philippine flemingia root (Moghania philippinensis li.), Eucommia bark (Cortex eucommiae), Epimedium (Herba epimedii), two-tooth achyranthes root (Radix achyranthis bidentatae), Radix codonopsis pilosulae (Radix codonopsis), Chinese angelica (Radix angelicae sinensis), tortoise shell (Carapax et plastrum testudinis), tuber fleece flower root (Radix polygoni multiflori), Amur cork tree bark (Cortex phellodendri), Cortex lycii radicis (Cortex lycii), incised notopterygium rhizome (Rhizoma et radix notopterygii) and Radix angelicae pubescentisZhang ZF 2011
Shujinbogu tabletTabletManufactured by Dongwan Hospital of Traditional Chinese Medicine, composed of tree peony bark (Cortex moutan), rhubarb (Radix et rhizoma rhei), two-tooth achyranthes root (Radix achyranthis bidentatae), tuberculate Speranskia herb (Garden balsam stem), Szechuan lovage rhizome (Rhizoma chuanxiong), Chinese angelica (Radix angelicae sinensis), Rehmannia root (Radix rehmanniae), mulberry twig (Ramulus mori), ground beetle (Eupolyphaga seu steleophaga), common cnidium fruit (Fructus cnidii), common aucklandia root (Radix aucklandiae), Fortune's drynaria rhizome (Rhizoma drynariae) and Flos caryophyllata (Flos caryophylli)Zhang ZF 2011
Zishen prescriptionDecoctionInvestigator-prescribed formula composed of Rehmanniae radix preparata, common macrocarpium fruit (Fructus corni), Dioscorea batatas (Rhizoma dioscoreae), Wolfiporia cocos (Poria), Barbary wolfberry fruit (Fructus lycii), tortoise shell glue (Colla carapacis et plastri testudinis), crude Dragon's bones (Os Draconis) and crude oyster shell (Concha ostreae)Zhao G 2002
Kanggusong capsuleCapsuleChinese patent medicine manufactured by Shenzhen Sanjiu medicine limited company, composed of hairy antler (Corn Cervi Pantotrichum), Epimedium (Herba epimedii), desert-living cistanche (Herba cistanches), Psoralea corylifolia (Fructus psoraleae), common cnidium fruit (Fructus cnidii), etc.Zhao HX 2001
YinyanghuoDecoctionSingle herb of Epimedium (Herba epimedii)Zhao LN 2003
Jinwugutong capsuleCapsuleChinese patent medicine manufactured by Guizhou Shenqi Pharmaceutical limited company, composed of Epimedium (Herba epimedii), two-tooth achyranthes root (Radix achyranthis bidentatae), Cibotium barometz (Rhizoma cibotii), Zaocys dhumnade (Zaocys), Psoralea corylifolia (Fructus psoraleae), etc.Zheng WK 2007
Gushen Yijing tangDecoctionHerbal mixture composed of Fortune's drynaria rhizome (Rhizoma drynariae), Psoralea corylifolia (Fructus psoraleae), Barbary wolfberry fruit (Fructus lycii), liquorice root (Radix glycyrrhizae), prepared rhizome of adhesive rehmannia (Radix rehmanniae preparata), white peony root (Radix paeoniae alba), glossy privet fruit (Fructus ligustri lucidi), Dioscorea batatas (Rhizoma dioscoreae), Wolfiporia cocos (Poria), Chinese date (Fructus jujubae), etc.Zhong RQ 2007
Tongbu QianggutangDecoctionHerbal mixture composed of  Epimedium (Herba epimedii), glossy privet fruit (Fructus ligustri lucidi), liquorice root (Radix glycyrrhizae), Sanqi (Radix notoginseng), wine rhubarb (Radix et rhizoma rhei), etc.Zhou LZ 2001
Guilu ErxiantangDecoctionHerbal mixture composed of tortoise shell (Carapax et plastrum testudinis), hairy antler (Corn Cervi Pantotrichum), Epimedium (Herba epimedii), clematis root (Radix clematidis), prepared rhizome of adhesive rehmannia (Radix rehmanniae preparata), desert-living cistanche (Herba cistanches), medicinal Indian mulberry root (Radix morindae officinalis), liquorice root (Radix glycyrrhizae), Radix codonopsis pilosulae (Radix codonopsis), Chinese angelica (Radix angelicae sinensis) and safflower (Flos carthami)Zhou XT 2001
Huangqi Sanxian tangDecoctionHerbal mixture composed of common curculigo rhizome (Rhizoma curculiginis), Epimedium (Herba epimedii), liquorice root (Radix glycyrrhizae), Sanqi (Radix notoginseng), etc.Zhou ZK 2006
Bushen Tianjing Huoxue therapyDecoctionHerbal mixture composed of Eucommia bark (Cortex eucommiae) 15 g, Himalayan teasel root (Radix dipsaci) 15 g, Chinese taxillus twig (Herba taxilli) 10 g, Epimedium (Herba epimedii) 15 g, Psoralea corylifolia (Fructus psoraleae) 15 g, common macrocarpium fruit (Fructus corni) 10 g, Danshen root (Radix salviae miltiorrhizae) 10g, suberect spatholobus stem (Caulis spatholobi) 30 g, Fortune's drynaria rhizome (Rhizoma drynariae) 30 g, two-tooth achyranthes root (Radix achyranthis bidentatae) 30 g, membranous milk vetch root (Radix astragali) 30 g, large-head atractylodes rhizome (Rhizoma atractylodis macrocephalae) 10 g, Wolfiporia cocos (Poria) 20 g and liquorice root (Radix glycyrrhizae) 5 gZhu HJ 2011
Guben Zhuanggu capsuleCapsuleChinese patent medicine manufactured by Zhejiang Di'er medicine limited companyZou JJ 2005
Bushen Zhuanggu granulesGranuleChinese patent medicine manufactured by Yifan Pharmacy Company of Guangdong Province, with the following seven herbal compounds: Epimedium (Herba epimedii), Rehmannia (Rehmannia), Dioscorea batatas (Rhizoma dioscoreae), Cornus officinalis (Fructus corni), Cinnamomum cassia (Cortex cinnamomi), Drynaria fortunei (Rhizoma drynariae) and Morinda officinalis (Radix morindae officinalis)Deng WM 2012

The control interventions included placebo in three trials and no treatment in five trials. In the other trials the control interventions were conventional pharmaceutical medicine or Chinese herbal medicines plus co-intervention versus the same co-intervention.

The interventions in the included trials are described in the Characteristics of included studies table.

Outcomes

Seven trials reported fracture incidence (An SJ 2000; Deng WM 2012; Li ZP 2011; Zhang RH 2004; Zhang ZF 2011; Zhao HX 2001; Zhu HM 2012). None of the 108 trials reported death directly or indirectly caused by osteoporosis. The outcomes reported were mainly surrogate outcomes, including BMD, biochemical indicators (serum calcium, phosphorus, alkaline phosphatase, oestradiol, parathyroid hormone, calcitonin, bone Gla protein, interleukin-6, etc.), the improvement of lumbago and backache, and adverse effects. Only two trials reported quality of life and medical expenses (Liang DB 2012; Zhang ZF 2011). Adverse effects were reported in 44 trials and included nausea, diarrhoea, dry mouth, constipation, tiredness, dental ulcer, epigastric discomfort, breast pain, dizziness, stomach discomfort, etc. All the reported outcomes were measured at the end of treatment.

Risk of bias in included studies

In this review, all 108 trials were reported as parallel-group randomised trials and three trials were multicentre randomised trials (Deng WM 2012; Xiong YH 2008; Zhu HM 2012). Of the 108, only 27 reported the methods used for the generation of the allocation sequence. Among them, four used random numbers generated by a computer or calculator (Xu YL 2007; Zhang RH 2004; Zhao HX 2001; Zhu HM 2012), 20 used a random numbers table (Chen XL 2010; Chen ZX 2002; Dai Y 2007; He N 2006; Hu J 2012; Li BL 2007; Li HW 2004; Li YH 2008; Ma C 2011; Qiu RB 2008; Wang CC 2005; Wu MS 2007; Wu W 2005; Xiong YH 2008; Xu H 2010; Xu M 2009; Zhang DS 2011; Zhang XZ 2004; Zhao G 2002; Zhu HJ 2011) and one used random drawings (Wang ZK 2004).

Only one trial (Zhu HM 2012) provided information about allocation concealment.

Double-blinding was reported in 10 trials (An SJ 2000; Lin W 2000; Wang SW 2003; Wang XD 2011; Xiong YH 2008; Zhan HS 2009; Zhao HX 2001; Zhao LN 2003; Zheng WK 2007; Zhu HM 2012). Eight trials reported use of single-blinding (Chen JP 1999; Chen NQ 2006; Mao YF 2011; Wang XY 2000; Xie YM 1997; Yuan YN 2000; Zhou ZK 2006; Zou JJ 2005).

Two trials (Deng WM 2012; Zhu HM 2012) reported a pre-trial estimation of sample size and reported performing intention-to-treat analysis. Nineteen trials reported withdrawals (Deng WM 2012; He MT 2007; Li SL 2004; Li YH 2010; Ma C 2011; Meng XD 2003; Peng T 2002; Ruan XY 2006; Wang CC 2005; Wang JM 2008; Xiong YH 2008; Xu YL 2007; Zhan HS 2009; Zhang XJ 2008; Zhang RH 2004; Zhang ZF 2011; Zhao HX 2001; Zheng WK 2007; Zhu HM 2012).

None of the 108 trials reported all outcomes of interest in this review.

Seventy trials appeared to be free of other sources of bias, while the 38 other trials did not report the baseline comparability between groups in detail.

The risk of bias in the included studies is shown in detail in Figure 2 and Figure 3.

Figure 2.

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Figure 3.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

The poor availability of information about study design meant that we rated most items as having unclear risk of bias. Based on The Cochrane Collaboration's recommended summary assessments for risk of bias (Higgins 2011), the 'Risk of bias' assessment should be for the important outcomes, therefore for the outcome of fracture we evaluated the risk of bias as 'unclear' for sequence generation, allocation concealment, blinding and selective outcome reporting in those seven studies that reported it (Figure 3).

Assessment of reporting biases

Due to the small number of trials testing the same intervention and same outcome, a meaningful funnel plot analysis could not be conducted.

Effects of interventions

See: Summary of findings for the main comparison Chinese herbal medicines versus placebo for osteoporosis; Summary of findings 2 Chinese herbal medicines versus no intervention for osteoporosis; Summary of findings 3 Chinese herbal medicines versus western medicine for osteoporosis; Summary of findings 4 Chinese herbal medicines plus western medicine versus western medicine for osteoporosis

Chinese herbal medicines versus placebo (Comparison 01)

Three trials (involving 219 patients) compared the effects of Chinese herbal medicines with placebo (Lin W 2000; Wang XY 2000; Zhao HX 2001). Based on our standard classification for Chinese herbal medicines, the tested Chinese herbal medicines included two prescribed herbal formulae (Migu decoction and Bushen Yigu soft extract), and one Chinese proprietary medicine (Kanggusong capsules). The reported outcomes included BMD of the lumbar spine, radius and ulna, and the levels of oestradiol (E2). We were not able to pool the data due to the heterogeneity of the Chinese herbal medicines that were studied.

Based on the included trials, we created a 'Summary of findings' table for patient-important outcomes (fractures, quality of life, death, serious adverse events, BMD) (see Summary of findings for the main comparison).

Fractures

In three trials of Chinese herbal medicines versus placebo, one trial reported new compression fractures of the backbone in the placebo group (0/50 versus 10/54) (RR 0.05; 95% CI 0.00 to 0.85) (Analysis 1.1) (Zhao HX 2001).

Quality of life or symptoms including pain, muscle fatigue and limited mobility

No trials reported quality of life.

One trial reported improvement in bone pain in the group treated with Chinese herbal medicines compared to placebo (49/50 versus 44/54) (RR 1.20; 95% CI 1.05 to 1.37) (Analysis 1.4) (Zhao HX 2001).

Death

No trials reported this outcome.

Adverse effects

In three trials of Chinese herbal medicines versus placebo, one trial reported some mild adverse effects in the Chinese herbal medicines group, including stomach/intestinal upset, headache and dizziness (Zhao HX 2001). Two trials did not report on adverse effects (Lin W 2000; Wang XY 2000).

Bone mineral density (BMD)
BMD of the lumbar spine

Compared with placebo, the group treated with Migu decoction showed a statistically significant increase in BMD of the lumbar spine after four months treatment (MD 0.16 g/cm3; 95% CI 0.06 to 0.26) (Analysis 1.2) (Lin W 2000). The group treated with Kanggusong capsules had a statistically significant increase in BMD when compared to the placebo group after 12 months treatment (MD 0.06 g/cm3; 95% CI 0.02 to 0.10) (Analysis 1.2) (Zhao HX 2001).

BMD of the radius

The group treated with Bushen Yigu soft extract showed a statistically significant increase in BMD of the radius compared to a group treated with placebo after three months treatment (MD 0.06 g/cm3; 95% CI 0.03 to 0.09) (Analysis 1.2) (Wang XY 2000).

BMD of the ulna

Those treated with Bushen Yigu soft extract showed a statistically significant increase in BMD of the ulna when compared to a placebo group after three months treatment (MD 0.06 g/cm3; 95% CI 0.02 to 0.10) (Analysis 1.2) (Wang XY 2000).

Biochemical indicators

The effects of the interventions on biochemical indicators are shown in Appendix 5.

Summary: Comparison 01

In summary, compared with placebo, Migu decoction and Kanggusong capsule seemed to improve the BMD of the lumbar spine; Bushen Yigu soft extract improved the BMD of the radius and the ulna.

Chinese herbal medicines versus no intervention (Comparison 02)

Five trials (involving 628 patients) compared seven different Chinese herbal medicines with no intervention (Gong L 2001; Liao L 2004; Peng T 2002; Zhang YP 2007; Zhang YS 2003). Two trials with two arms compared different herbs with no intervention (Gong L 2001; Zhang YS 2003). The tested herbs included Yishen Zhuanggu mixture, Shengu capsule, Bushen Shengsui principle, Qianggu soft extract, Huoluo Gukang pills, Shigu yin and Gushukang granule. Based on our standard classification for Chinese herbal medicines, five herbs were Chinese proprietary medicine, and two were prescribed herbal formulae. The reported outcomes included BMD of the lumbar spine and femoral neck, and the levels of oestradiol (E2) and osteocalcin, also known as bone Gla protein (BGP), but we were not able to pool the data due to the heterogeneity of the Chinese herbal medicines that were studied.

Based on the included trials, we created a 'Summary of findings' table for patient-important outcomes (fractures, quality of life, death, serious adverse events, BMD) (see Summary of findings 2).

Fractures

None of the five trials reported the outcome fractures.

Quality of life or symptoms including pain, muscle fatigue and limited mobility

None of the five trials reported these outcomes.

Death

None of the five trials reported this outcome.

Adverse effects

Four trials reported some mild adverse effects, such as mild stomach discomfort, intestinal upset or constipation, but this did not affect the continuation of treatment (Gong L 2001; Peng T 2002; Zhang YS 2003; Zhang YP 2007). One trial reported no adverse effects (Liao L 2004).

Bone mineral density (BMD)
BMD of lumbar spine

Compared with no intervention, treatment with Bushen Shengsui principle showed no evidence of effect after six months treatment (MD 0.07 g/cm3; 95% CI -0.06 to 0.20) (Analysis 2.1) (Liao L 2004).

BMD of femoral neck

Compared with no intervention, treatment with Bushen Shengsui principle did not increase the BMD of the femoral neck after six months (MD 0.10 g/cm3; 95% CI 0.00 to 0.20) (Analysis 2.1) (Liao L 2004), and nor did treatment with Yishen Zhuanggu mixture after six months (MD 0.05 g/cm3; 95% CI -0.01 to 0.11) (Analysis 2.1) (Gong L 2001) or Shengu capsule (MD 0.02 g/cm3; 95% CI -0.06 to 0.09) (Analysis 2.1) (Gong L 2001). Treatment with Qianggu soft extract resulted in a statistically significant increase in the BMD of the femoral neck after six months treatment (MD 0.09 g/cm3; 95% CI 0.03 to 0.15) (Analysis 2.1) (Peng T 2002), as did Shigu yin after six months treatment (MD 0.08 g/cm3; 95% CI 0.03 to 0.13) (Analysis 2.1) (Zhang YP 2007).

Biochemical indicators

The effects of the interventions on biochemical indicators are shown in Appendix 5.

Summary: Comparison 02

In summary, compared with no intervention, Qianggu soft extract appeared to improve the BMD of the femoral neck significantly. Shigu yin also seemed to improve the BMD of the femoral neck. However, some groups treated with Chinese herbal medicines showed no significant difference from those receiving no intervention, including Bushen Shengsui principle (BMD of the lumbar spine and femoral neck), Yishen Zhuanggu mixture (BMD of the femoral neck) and Shengu capsule (BMD of the femoral neck) after six months of treatment.

Chinese herbal medicines versus western medicine (Comparison 03)

Sixty-one trials (involving 4805 patients) compared 56 different Chinese herbal medicines with western medicine (An SJ 2000; Chen JP 1999; Chen NQ 2006; Chen X 2008; Chen ZX 2002; Cui TH 1999; Dong YF 2004; Gang PH 2001; He MT 2007; He N 2006; Huang ZJ 2008; Lan ZX 2006; Li BL 2007; Li YH 2008; Li YH 2010; Li ZY 2006; Liao L 2004; Ling JY 2008; Lv ZH 2002; Ma C 2011; Mao YF 2011; Meng XD 2003; Mu G 2001a; Ou L 2011; Peng T 2002; Qi ZX 1998; Qiu RB 2004; Qiu RB 2008; Ruan XY 2006; Shao M 2003; Shi CD 2012; Song XW 2000; Wang CC 2005; Wang H 2007; Wang J 2007; Wang JM 2008; Wang XY 2000; Wang YZ 2008; Wang ZK 2004; Wei RY 2011; Wu JZ 2010; Wu MS 2001; Wu MS 2007; Xie YM 1997; Xu H 2010; Xu M 2009; Xu W 2005; Xu YL 2007; Yang B 2007; Yuan YN 2000; Zhan ML 2007; Zhang XG 2011; Zhang YP 2007; Zhang J 2003; Zhang XJ 2008; Zhang YL 1996; Zhao LN 2003; Zhong RQ 2007; Zhou LZ 2001; Zhou ZK 2006; Zhu HJ 2011). Among them, two trials compared herbs with two different Western pharmaceutical medicines (An SJ 2000; Song XW 2000). One trial (Wu MS 2007) compared two herbs with western medicine.

The tested herbal preparations included Acupoint sticking of Migudan, Bugu Shengsui capsule, Bushen Huoxue capsules, Bushen Jianpi Huoxue recipe, Bushen Jianpi Jingu decoction, Bushen Jianpi Migu prescription, Bushen Qianggutang, Bushen Qiangshen pill, Bushen Tianjing Huoxue therapy, Bushen Shengsui principle, Bushen Yangxue tang, Bushen Yigu soft extract, Bushen Zhuanggu tang, Bushenjianpi Zhuangguyin, Erxian soup, Gujian capsule, Gukang decoction, Gukang oral liquid, Guli powder, Gumikang capsule, Gumiling granule, Gushen Yijing tang, Gushukang granule, Huangqi, Huangqi Sanxian tang, Jiangu capsule, Jiangu recipe, Jianshenfang granule, Jiawei Bushen Zhuangjintang, Jiawei Zhuangyao Jianshen tang, Jingujian granule, Jingujian granule (1,2,3), Kanggusong capsule, Kanggusong granule, Kangshu Jiangu granule, kidney-tonifying herbs, Liuwei Dihuang pills, prescription for tonifying kidney, Qianggu capsule, Qianggu paste, Qianggu soft extract, Radix rehmanniae preparata and Radix astragali, Shangke Jiegu tablet, Shenyao capsules, Shigu yin, Strong Bone capsule, TPF capsule, Tongbu Qianggutang, urinary bladder (Kidney) meridian sticking, Xianling Gusong capsules, Xianlinggubao capsule, Yanghuo Sanzi tang, Yinyanghuo, Herba epimedii prescription (including Herba epimedii, Fructus psoraleae, Cortex eucommiae, Concha ostreae, Radix aconiti preparata, Radix aconiti kusnezoffii, Radix angelicae sinensis and Rhizome chuanxiong), Yishen Yanggan mixture and Zishen Gukang pill. All these herbal preparations except Yinyanghuo and Huangqi (Radix Astragali) are mixtures of herbs. Based on our standard classification for Chinese herbal medicines, 22 herbs were Chinese proprietary medicine, and 34 were prescribed herbal formulae.

The reported outcomes included BMD of the lumbar spine, radius, ulna, femoral neck, Ward's triangle, trochanter, hipbone, distal radius and calcaneus. Levels of oestradiol (E2), serum calcium (Ca), phosphorus (P), alkaline phosphatase (ALP), bone Gla protein (BGP), interleukin-6 (IL-6), parathyroid hormone (PTH) and calcitonin (CT) were also measured, as was the improvement of lumbago and backache.

We were not able to pool the data due to the variations in the herbal preparations and control interventions that were used in the studies.

Based on the included trials, we created a 'Summary of findings' table for patient-important outcomes (fractures, quality of life, death, serious adverse events, BMD) (see Summary of findings 3).

Fractures

Of the 61 trials, one trial reported that no new fracture occurred (An SJ 2000).

Quality of life or symptoms including pain, muscle fatigue and limited mobility

No trials reported the outcome of quality of life.

Twenty trials out of 61 reported the improvement of lumbago and backache. Among these 20 trials, eight reported that Chinese herbal medicines were better than western medicines without reporting the number of cases with ache improvement in each group (Chen NQ 2006; Dong YF 2004; Ou L 2011; Qi ZX 1998; Wang ZK 2004; Xie YM 1997; Xu H 2010; Zhang XJ 2008). The other 12 trials reported as follows:

Death

No trials reported this outcome.

Adverse effects

Twenty-three trials out of 61 reported adverse effects. These included:

  • two patients with midsection discomfort in the herbal group (Cui TH 1999);

  • a few patients with dizziness, rash, nausea, vomiting and cardiopalmus at the beginning of therapy, but no significant difference in comparison groups (Dong Y 2010);

  • 11 patients with dry mouth symptoms, five with stomach discomfort, two with constipation and one with cardiopalmus in the herbal group, and nine patients with stomach discomfort and one with constipation in the western medicine group (Li YH 2010);

  • three patients with spotting vaginal bleeding at the beginning of treatment, which did not affect observation, and five cases with breast pain who withdrew from the western medicine group (Liao L 2004);

  • six patients with constipation and five with dry mouth symptoms in the herbal group, which did not affect observation (Meng XD 2003);

  • two patients with abdominal distention and sour regurgitation in the herbal group, and three with gastrointestinal symptoms in the western medicine group (Ma C 2011);

  • three patients in the herbal group and one in the western medicine group with stomach discomfort (Peng T 2002);

  • one patient with stomach discomfort in the western medicine group (Wang CC 2005);

  • five patients with stomach discomfort in the herbal group and two in the western medicine group (Wang H 2007);

  • two patients with mild constipation and one with dry mouth symptoms in the herbal group (Wang J 2007);

  • a few patients with nausea, stomach ache and dizziness in the western medicine group (Wu MS 2001);

  • two patients with dry and hard stools during treatment in the herbal group (Xie YM 1997);

  • five patients with nausea in the herbal group and three in the western medicine group (Xu H 2010);

  • two patients with nausea in the herbal group and three in the western medicine group (Xu M 2009);

  • three patients with gastrointestinal reactions in the western medicine group (Chen X 2008);

  • one patient with palpitations, two patients with constipation and four patients with stomach discomfort in the Jingujian granule group, and five patients with constipation and two patients with abdominal distention in the western medicine group (Li YH 2008); and

  • one trial (Zhang YP 2007) which reported patients with constipation in the control group without reporting data.

Six trials reported no adverse effects (Chen NQ 2006; Gang PH 2001; Xu YL 2007; Yuan YN 2000; Zhang XJ 2008; Zhou LZ 2001).

Most of the adverse effects did not affect continuation of treatment. Thirty-eight trials did not report adverse effects.

Bone mineral density (BMD)
BMD of the lumbar spine

No significant difference between groups in the BMD of the lumbar spine was reported for any of the following comparisons of treatment groups:

  • Kanggusong granule versus ipriflavone plus Caltrate (MD 0.00 g/cm3; 95% CI -0.05 to 0.05), Kanggusong granule versus Caltrate after nine months treatment (MD 0.04 g/cm3; 95% CI -0.02 to 0.10) (Analysis 3.2) (An SJ 2000);

  • Strong Bone capsule versus Caltrate after three months treatment (MD -0.01 g/cm3; 95% CI -0.08 to 0.06) (Analysis 3.2) (Cui TH 1999);

  • Herba epimedii prescription versus vitamin D plus Caltrate after six months treatment (MD 0.03 g/cm3; 95% CI 0.00 to 0.06) (Analysis 3.2) (Dong YF 2004);

  • Bushen Shengsui principle versus conjugated oestrogens plus medroxyprogesterone after six months treatment (MD 0.00 g/cm3; 95% CI -0.12 to 0.12) (Analysis 3.2) (Liao L 2004);

  • Bushen Jianpi Jingu decoction versus calcitonin after three months treatment (MD 0.02 g/cm3; 95% CI -0.09 to 0.13) (Analysis 3.2) (Mao YF 2011);

  • Gukang oral liquid versus alendronate after six months treatment (MD 0.01 g/cm3; 95% CI -0.03 to 0.05) (Analysis 3.2) (Shao M 2003);

  • kidney-tonifying herbs versus nilestriol (MD -0.02 g/cm3; 95% CI -0.09 to 0.05), kidney-tonifying herbs versus calcium (MD 0.02 g/cm3; 95% CI -0.04 to 0.08) after six months treatment (Analysis 3.2) (Song XW 2000);

  • Bushen Jianpi Huoxue recipe versus alendronate sodium tablets (MD 0.02 g/cm3; 95% CI -0.01 to 0.05) after six months treatment (Analysis 3.2) (He MT 2007);

  • Huangqi Sanxian tang versus nilestriol after three months treatment (MD 0.00 g/cm3; 95% CI -0.03 to 0.04) (Analysis 3.2) (Zhou ZK 2006);

  • Qianggu capsule versus active vitamin D3 after six months treatment (MD 0.04 g/cm3; 95% CI -0.01 to 0.09) (Analysis 3.2) (Wang J 2007);

  • Jianshenfang granule versus alendronate sodium after six months treatment (MD 0.09 g/cm3; 95% CI -0.03 to 0.21) (Analysis 3.2) (Li BL 2007);

  • Jiangu recipe versus alendronate sodium after 12 months treatment (MD 0.02 g/cm3; 95% CI 0.00 to 0.04) (Analysis 3.2) (Qiu RB 2008);

  • Gukang fang versus alendronate sodium tablets after four months treatment (MD 0.00 g/cm3; 95% CI -0.03 to 0.03) (Analysis 3.2) (Chen X 2008);

  • Qianggu capsule versus alendronate (MD 0.01 g/cm3; 95% CI -0.04 to 0.05) after six months treatment (Analysis 3.2) (Xu H 2010);

  • Bushen Huoxue capsules versus Caltrate and calcitonin (MD 0.02 g/cm3; 95% CI -0.05 to 0.09) after 12 months treatment (Analysis 3.2) (Zhang XJ 2008);

  • Yinyanghuo versus conjugated oestrogens (MD 0.03 g/cm3; 95% CI -0.04 to 0.10) after six months treatment (Analysis 3.2) (Zhao LN 2003);

  • Shenyao capsules versus Caltrate (MD 0.00 g/cm3; 95% CI -0.05 to 0.05) after six months treatment (Analysis 3.2) (Chen NQ 2006);

  • Guli powder versus Caltrate after three months treatment (male: MD 0.02 g/cm3; 95% CI -0.01 to 0.05; female: MD 0.04 g/cm3; 95% CI -0.07 to 0.15) (Analysis 3.2) (Lan ZX 2006);

  • Gushen Yijing tang versus Caltrate after six months treatment (MD 0.06 g/cm3; 95% CI -0.02 to 0.14) (Analysis 3.2) (Zhong RQ 2007);

  • Bugu Shengsui capsule versus vitamin D2 plus calcium tablet after six months treatment (MD 0.12 g/cm3; 95% CI -0.01 to 0.26) (Analysis 3.2) (Xie YM 1997);

  • Xianling Gusong capsules versus Caltrate after six months treatment (MD -0.03 g/cm3; 95% CI -0.08 to 0.02) (Analysis 3.2) (Li ZY 2006);

  • Zishen Gukang pill versus Caltrate plus vitamin D after three months treatment (MD -0.00 g/cm3; 95% CI -0.05 to 0.04) (Analysis 3.2) (Huang ZJ 2008);

  • Gukang decoction versus alendronate sodium tablets after four months treatment (MD -0.00 g/cm3; 95% CI -0.03 to 0.03) (Analysis 3.2) (Chen X 2008);

  • Gumiling granule versus chewable bicarbonate calcium after six months treatment (MD 0.04 g/cm3; 95% CI -0.02 to 0.09) (Analysis 3.2) (Gang PH 2001);

  • Gujian capsule versus alfacalcidol after three months treatment (MD 0.08 g/cm3; 95% CI -0.02 to 0.18) (Analysis 3.2) (Meng XD 2003);

  • Xianlinggubao capsule versus alendronate after six months treatment (MD 0.00 g/cm3; 95% CI -0.02 to 0.02) (Analysis 3.2) (Xu M 2009);

  • Bushen Tianjing Huoxue therapy versus Caltrate and calcitriol soft capsule after six months treatment (MD 0.04 g/cm3; 95% CI 0.00 to 0.07) (Analysis 3.2) (Zhu HJ 2011).

In 13 trials Chinese herbal medicines were reported to have statistically significant better effects on the BMD of the lumbar spine when compared with western medicine (calcium supplementation, vitamin D, hormones or different combinations):

  • Jiawei Bushen Zhuangjintang versus calcium granules after three months treatment (MD 0.10 g/cm3; 95% CI 0.05 to 0.15) (Analysis 3.2) (Lv ZH 2002);

  • Yishen Yanggan mixture versus calcium gluconate after three months treatment (MD 0.04 g/cm3; 95% CI 0.01 to 0.07) (Analysis 3.2) (Xu W 2005);

  • Kanggusong granule versus Caltrate after six months treatment (MD 0.06 g/cm3; 95% CI 0.02 to 0.11) (Analysis 3.2) (Wei RY 2011);

  • Bushen Qianggutang versus Caltrate after three months treatment (MD 0.09 g/cm3; 95% CI 0.01 to 0.17) (Analysis 3.2) (Qi ZX 1998);

  • Bushen Jianpi Migu prescription versus Caltrate after three months treatment (MD 0.06 g/cm3; 95% CI 0.03 to 0.09) (Analysis 3.2) (Wang ZK 2004);

  • Bushen Zhuanggu tang versus alendronate sodium tablets after three months treatment (MD 0.04 g/cm3; 95% CI 0.01 to 0.07) (Analysis 3.2) (Ling JY 2008);

  • Bushenjianpi Zhuangguyin versus Caltrate and calcitonin after 12 weeks treatment (MD 0.16 g/cm3; 95% CI 0.10 to 0.22) (Analysis 3.2) (Zhang XG 2011);

  • Liuwei Dihuang pills versus Caltrate after six months (MD 0.05 g/cm3; 95% CI 0.03 to 0.07) (Analysis 3.2) (Ma C 2011);

  • Gujian capsule versus alfacalcidol after six months treatment (MD 0.14 g/cm3; 95% CI 0.03 to 0.26) (Analysis 3.2) (Meng XD 2003);

  • Radix rehmanniae preparata and Radix astragali versus calcium carbonate tablets after six months treatment (MD 0.05 g/cm3; 95% CI 0.03 to 0.07) (Analysis 3.2) (Ou L 2011);

  • Kangshu Jiangu granule versus Caltrate after six months treatment (MD 0.11 g/cm3; 95% CI 0.01 to 0.21) (Analysis 3.2) (Shi CD 2012);

  • Erxian soup versus Caltrate after six months treatment (MD 0.06 g/cm3; 95% CI 0.02 to 0.11) (Analysis 3.2) (Wu JZ 2010);

  • Shangke Jiegu tablet versus vitamin D2 plus calcium tablet after six months treatment (MD 0.25 g/cm3; 95% CI 0.11 to 0.39) (Analysis 3.2) (Yuan YN 2000).

BMD of the radius

Treatment with Liuwei Dihuang pills statistically significantly increased the BMD of the radius as compared to a group supplemented with calcium. The difference at 12 months between before and after treatment was MD 0.04 g/cm3 (95% CI 0.03 to 0.05) (Analysis 3.2) (Zhang J 2003). Another trial of treatment with Gukang oral liquid as compared to treatment with calcium gluconate reported a significant increase in the BMD of the radius after six months treatment (MD 0.02 g/cm3; 95% CI 0.01 to 0.04) (Analysis 3.2) (Chen JP 1999). A third trial showed positive effects of herbal treatments when compared to vitamin D and Caltrate: compared with vitamin D plus Caltrate, Herba epimedii prescription statistically significantly increased the BMD of the radius after six months treatment (MD 0.07 g/cm3; 95% CI 0.04 to 0.11) (Analysis 3.2) (Dong YF 2004).

Other trials comparing herbal treatments to vitamin D and calcium showed no significant difference in the BMD of the radius, including:

  • Bushen Yigu soft extract versus Alfacalcidol after three months treatment (MD 0.01 g/cm3; 95% CI -0.02 to 0.04) (Analysis 3.2) (Wang XY 2000);

  • Bugu Shengsui capsule versus vitamin D2 and calcium tablets after six months treatment (MD 0.08 g/cm3; 95% CI -0.12 to 0.28) (Analysis 3.2) (Xie YM 1997);

  • Shangke Jiegu tablet versus vitamin D2 and calcium tablets after six months treatment (MD 0.04 g/cm3; 95% CI 0.02 to 0.11) (Analysis 3.2) (Yuan YN 2000).

BMD of the ulna

Four trials showed no significant effects on the BMD of the ulna:

  • Gukang oral liquid versus calcium gluconate (MD 0.00 g/cm3; 95% CI -0.02 to 0.02) (Analysis 3.2) (Chen JP 1999);

  • Bushen Yigu soft extract versus Alfacalcidol after three months treatment (MD 0.02 g/cm3; 95% CI -0.01 to 0.05) (Analysis 3.2) (Wang XY 2000);

  • Bugu Shengsui capsule versus vitamin D2 plus calcium tablets after six months treatment (MD 0.06 g/cm3; 95% CI -0.01 to 0.13) (Analysis 3.2) (Xie YM 1997);

  • Shangke Jiegu tablet versus vitamin D2 plus calcium tablets after six months treatment (MD 0.05 g/cm3; 95% CI 0.00 to 0.11) (Analysis 3.2) (Yuan YN 2000).

After 12 months treatment with Liuwei Dihuang pills, the BMD of the ulna was statistically significantly increased when compared with calcium supplementation (MD 0.02 g/cm3; 95% CI 0.01 to 0.03) (Analysis 3.2) (Zhang J 2003).

BMD of the femoral neck

Eight trials of Chinese herbal medicines compared with supplementation with calcium or calcium plus other western medicine showed a significant increase in the BMD of the femoral neck:

  • Qianggu soft extract versus calcium gluconate after six months treatment (MD 0.07 g/cm3; 95% CI 0.02 to 0.12) (Analysis 3.2) (Peng T 2002);

  • Herba epimedii prescription versus vitamin D plus Caltrate after six months treatment (MD 0.06 g/cm3; 95% CI 0.02 to 0.10) (Analysis 3.2) (Dong YF 2004);

  • Kangshu Jiangu granule versus Caltrate after six months treatment (MD 0.08 g/cm3; 95% CI 0.01 to 0.15) (Analysis 3.2) (Shi CD 2012);

  • kidney-tonifying herbs versus calcium after six months treatment (MD 0.05 g/cm3; 95% CI 0.01 to 0.09) (Analysis 3.2) (Song XW 2000);

  • Qianggu paste versus calcium gluconate after six months treatment (MD 0.07 g/cm3; 95% CI 0.03 to 0.11) (Analysis 3.2) (Wang H 2007);

  • Yanghuo Sanzi Tang versus Caltrate after six months treatment (MD 0.05 g/cm3; 95% CI 0.02 to 0.08) (Analysis 3.2) (Qiu RB 2004);

  • Jiangu capsule versus Caltrate after 12 months treatment (MD 0.04 g/cm3; 95% CI 0.03 to 0.06) (Analysis 3.2) (Wang YZ 2008);

  • Gujian capsule versus alfacalcidol after six months treatment (MD 0.08 g/cm3; 95% CI 0.03 to 0.14) (Analysis 3.2) (Meng XD 2003).

Ten other trials showed no significant difference in the BMD of the femoral neck for those treated with Chinese herbal medicines when compared to control groups:

  • Kanggusong granule versus Caltrate after nine months treatment (MD 0.01 g/cm3; 95% CI -0.03 to 0.05), Kanggusong granule versus ipriflavone plus Caltrate after nine months treatment (MD -0.01 g/cm3; 95% CI -0.04 to 0.02) (Analysis 3.2) (An SJ 2000);

  • Bushen Jianpi decoction versus calcitonin (MD 0.05 g/cm3; 95% CI -0.02 to 0.12) (Analysis 3.2) (Mao YF 2011);

  • Gumikang capsule versus calcium gluconate after six months treatment (MD 0.02 g/cm3; 95% CI -0.04 to 0.08) (Analysis 3.2) (Wang CC 2005);

  • Yanghuo Sanzi Tang versus Caltrate after three months treatment (MD 0.00 g/cm3; 95% CI -0.03 to 0.03) (Analysis 3.2) (Qiu RB 2004);

  • Qianggu capsule versus active vitamin D3 after six months treatment (MD 0.03 g/cm3; 95% CI -0.01 to 0.07) (Analysis 3.2) (Wang J 2007);

  • Shigu yin versus Caltrate after six months treatment (MD 0.03 g/cm3; 95% CI -0.01 to 0.07) (Analysis 3.2) (Zhang YP 2007);

  • Bushen Huoxue capsule versus Caltrate plus calcitriol after 12 months treatment (MD 0.02 g/cm3; 95% CI -0.06 to 0.10) (Analysis 3.2) (Zhang XJ 2008);

  • Bushenjianpi Zhuangguyin versus Caltrate and calcitonin after 12 weeks (MD 0.06 g/cm3; 95% CI 0.00 to 0.12) (Analysis 3.2) (Zhang XG 2011);

  • Bugu Shengsui capsule versus vitamin D2 plus calcium tablet after six months treatment (MD 0.09 g/cm3; 95% CI -0.05 to 0.23) (Analysis 3.2) (Xie YM 1997);

  • Shangke Jiegu tablet versus vitamin D2 plus calcium tablet after six months treatment (MD 0.07 g/cm3; 95% CI -0.06 to 0.20) (Analysis 3.2) (Yuan YN 2000).

Three trials compared Chinese herbal medicines with western medicine and found no significant differences between groups on measurement of BMD of the femoral neck:

  • Bushen Shengsui principle versus conjugated oestrogens plus medroxyprogesterone after six months treatment (MD -0.01 g/cm3; 95% CI -0.11 to 0.09) (Analysis 3.2) (Liao L 2004);

  • kidney-tonifying herbs versus nilestriol after six months treatment (MD 0.02 g/cm3; 95% CI -0.02 to 0.06) (Analysis 3.2) (Song XW 2000);

  • Qianggu capsules versus oestradiol valerate after six months treatment (MD 0.02 g/cm3; 95% CI -0.02 to 0.06) (Analysis 3.2) (Ruan XY 2006).

BMD of Ward's triangle

Two trials showed no evidence of an effect on the BMD of Ward's triangle of Chinese herbal medicines when compared with alendronate after six months treatment:

Two other trials showed no evidence of an effect of Chinese herbal medicines when compared with vitamin D2 plus calcium tablet after six months treatment:

There was no significant difference between Chinese herbal medicine (Kanggusong granule) and ipriflavone plus Caltrate (MD -0.03 g/cm3; 95% CI -0.07 to 0.01), or Caltrate alone (MD 0.00 g/cm3; 95% CI -0.04 to 0.04) after nine months treatment (Analysis 3.2) (An SJ 2000). Gujian capsule appeared statistically significantly better than alfacalcidol after six months treatment (MD 0.08 g/cm3; 95% CI 0.01 to 0.15) (Analysis 3.2) (Meng XD 2003).

The trial comparing kidney-tonifying herbs with treatment with nilestriol (MD 0.06 g/cm3; 95% CI 0.02 to 0.10) or supplementation with calcium (MD 0.10 g/cm3; 95% CI 0.06 to 0.14) (Analysis 3.2) (Song XW 2000) found a significant improvement in the BMD of Ward's triangle.

BMD of the trochanter

One trial showed better treatment effects of Chinese herbal medicines on the BMD of the trochanter when compared with calcium supplementation:

  • Shangke Jiegu tablet versus vitamin D2 plus calcium tablet after six months treatment (MD 0.19 g/cm3; 95% CI 0.04 to 0.33) (Analysis 3.2) (Yuan YN 2000).

However, two other trials showed no evidence of an effect of Chinese herbal medicines:

  • Kanggusong granule versus ipriflavone plus Caltrate after nine months treatment (MD -0.01 g/cm3; 95% CI -0.05 to 0.03) (Analysis 3.2) (An SJ 2000), or versus Caltrate alone (MD 0.03 g/cm3; 95% CI 0.00 to 0.06) (Analysis 3.2) (An SJ 2000);

  • Bugu Shengsui capsule versus vitamin D2 plus calcium tablet after six months treatment (MD 0.11 g/cm3; 95% CI -0.04 to 0.27) (Analysis 3.2) (Xie YM 1997).

There was a significant difference between Gujian capsule and alfacalcidol after six months treatment (MD 0.14 g/cm3; 95% CI 0.07 to 0.20) (Analysis 3.2) (Meng XD 2003).

BMD of the hip bone

There was no significant difference between the Chinese herbal medicine Gushukang granule and Calcium carbonate with vitamin D chewable tablets in the BMD of the hip bone after six months treatment: the MD was 0.02 g/cm3 (95% CI -0.02 to 0.06) (Analysis 3.2) (Chen ZX 2002). There was also no significant difference between the Chinese herbal medicine Guli powder when compared with Caltrate after six months treatment (MD 0.03 g/cm3; 95% CI -0.05 to 0.11) (Analysis 3.2) (Lan ZX 2006).

BMD of the distal radius

TPF capsule compared to calcium granules statistically significantly increased the BMD of the distal radius (MD 0.20 g/cm3; 95% CI 0.17 to 0.23) (Analysis 3.2) (Zhang YL 1996).

BMD of the calcaneus

Jiawei Zhuangyao Jianshen tang compared to compound calcium amino acid chelate capsules statistically significantly increased the BMD of the calcaneus (MD 0.06 g/cm3; 95% CI 0.01 to 0.11) (Analysis 3.2) (He N 2006).

T score in BMD measurement

Two trials reported T score in bone mineral density measurement:

  • Jingujian granule versus Caltrate after three months treatment (MD 0.05; 95% CI -0.57 to 0.67) (Analysis 3.3) (Li YH 2008);

  • Jingujian granule versus Caltrate after three months treatment (MD 0.03; 95% CI -0.04 to 0.10) (Analysis 3.3) (Li YH 2010).

Biochemical indicators

The effects of the interventions on biochemical indicators are shown in Appendix 5.

Summary: Comparison 03

In summary, 61 trials out of the 108 included trials evaluated Chinese herbal medicines compared with conventional western medicines.

The following Chinese herbal medicines increased the BMD of the lumbar spine: Jiawei Bushen Zhuangjintang Yishen Yanggan mixture, Kanggusong granule, Bushen Qianggutang, Bushen Jianpi Migu prescription, Bushen Zhuanggu tang, Bushenjianpi Zhuangguyin, Gujian capsule, Erxian soup, Shangke Jiegu tablet, Liuwei Dihuang pills, Kangshu Jiangu granule, Radix rehmanniae preparata and Radix astragali. However, the following did not increase the BMD of the lumbar spine: Kanggusong granule, Strong Bone capsule, Herba epimedii prescription, Bushen Shengsui principle, Bushen Jianpi Jingu decoction, Gukang oral liquid, kidney-tonifying herbs, Bushen Jianpi Huoxue recipe, Huangqi Sanxian tang, Qianggu capsule, Jianshenfang granule, Jiangu recipe, Gukang fang, Qianggu capsule, Bushen Huoxue capsules, Yinyanghuo, Shenyao capsules, Guli powder, Gushen Yijing tang, Bugu Shengsui capsule, Xianling Gusong capsules, Zishen Gukang pill, Gukang decoction, Gumiling granule, Gujian capsule, Xianlinggubao capsule and Bushen Tianjing Huoxue therapy.

Gukang oral liquid, Herba epimedii prescription and Liuwei Dihuang pills increased the BMD of the radius, while Bushen Yigu soft extract, Bugu Shengsui capsule and Shangke Jiegu tablet did not.

Liuwei Dihuang pills appeared to increase the BMD of the ulna, while Gukang oral liquid, Bushen Yigu soft extract, Bugu Shengsui capsule and Shangke Jiegu tablet did not.

The following Chinese herbal medicines appeared to improve the BMD of the femoral neck: Qianggu soft extract, Herba epimedii prescription, kidney-tonifying herbs, Qianggu paste, Yanghuo Sanzi tang, Jiangu capsule, Kangshu Jiangu granule and Gujian capsule. However, the following did not: Kanggusong granule, Bushen Jianpi decoction, Gumikang capsule, Yanghuo Sanzi Tang, Qianggu capsule, Shigu yin, Bushen Huoxue capsule, Bushenjianpi Zhuangguyin, Bugu Shengsui capsule, Shangke Jiegu tablet and Bushen Shengsui principle.

Gujian capsule and kidney-tonifying herbs seemed to increase the BMD of Ward's triangle, while Qianggu capsule, Xianlinggubao capsule, Bugu Shengsui capsule, Shangke Jiegu capsule and Kanggusong granule did not.

Shangke Jiegu tablet and Gujian capsule appeared to increase the BMD of the trochanter, while Kanggusong granule and Bugu Shengsui capsule did not.

Gushukang granule and Guli powder did not show statistically significant increases in the BMD of the hip bone.

TPF capsule appeared to increase the BMD of the distal radius.

Jiawei Zhuangyao Jianshen tang statistically significantly increased the BMD of the calcaneus.

Jingujian granule did not show a statistically significant increase in the T score of BMD.

Chinese herbal medicines plus western medicine versus western medicine (Comparison 04)

Fourty-seven trials (involving 5529 patients) compared 42 different Chinese herbal medicines plus western medicine with western medicine (Cao GY 2010; Cao W 2010; Chen FS 2001; Chen XL 2010; Chen YQ 2001; Chen ZX 2002; Dai Y 2007; Deng WM 2012; Dong Y 2010; Fan HX 2004; Guo JH 2008; Han XL 2007; He XQ 2006; Hu J 2012; Huang JW 2008; Jian QQ 2010; Liang DB 2012; Li HW 2004; Li SL 2004; Liu JM 2012; Ma C 2011; Ma CZ 2011; Ma YJ 2011; Miu JQ 2008; Mu G 2001; Qiu ZX 2010; Ruan XY 2006; Tang ZA 2012; Wang SW 2003; Wang XD 2011; Wu W 2005; Xie J 2004; Xiong YH 2008; Xu H 2010; Xu M 2009; Yang B 2007; Ye AN 1998; Zhan HS 2009; Zhang DS 2011; Zhang RH 2004; Zhang XZ 2004; Zhang ZF 2011; Zhao G 2002; Zheng WK 2007; Zhou XT 2001; Zhu HM 2012; Zou JJ 2005).

The tested herbs included Antai capsule, Bushenhuoxue therapy, Bushen Qianggu Huoxue therapy, Bushen Qiangshen pill, Bushen Yangxue tang, Bushen Zhuanggutang, Bushen Zhuanggu granules, Bushen Kangsong pill, Bushenyiqihuoxue soup, Chinese medicine (combination of 10 herbs), Chinese medicine Bushenhuoxue recipe, Erxian Yanggu decoction, Gengnian Anyi tablet, Guben Zhuanggu capsules, Guilu Erxiantang, Gukang tablet, Gushen decoction, Gushukang granule, Gusongbao granule, Heche Dazao pill, Huangqi, Hugu capsule, Jiangu granule, Jiarong tablet, Jinwugutong capsules, Kanggusong soup, Liuwei Dihuang pills, Migu tablet, Qianggu capsule, Shangke Yishen Zhuanggu pill, Shengsuiyin recipe, Shugan zishen huoxue tang, traditional Chinese capsule, Xianlinggubao capsule, Xuduanzhuanggu capsule, Yigu capsule, Yishen Zhuanggu decoction, Yiyuanjiangu decoction, Zhuanggu capsule, Zhuangguqiangjin tablet, Zishen prescription and Ziyin Bushen Zhuanggu prescription. All these Chinese herbal medicines, except Huangqi, were mixtures of herbs. Based on our standard classification for Chinese herbal medicines, 17 herbs were Chinese proprietary medicine, and 25 were prescribed herbal formulae.

The reported outcomes included BMD of the lumbar spine, femoral neck, Ward's triangle, trochanter, hip bone and distal radius. Levels of oestradiol (E2), serum calcium (Ca), phosphorus (P), alkaline phosphatase (ALP), bone Gla protein (BGP) and interleukin-6 (IL-6) were also measured, as was the improvement of lumbago and backache. We were not able to pool the data due to the variability of the tested Chinese herbal medicines and control interventions.

Based on the included trials, we created a 'Summary of findings' table for patient-important outcomes (fractures, quality of life, death, adverse effects) (see Summary of findings 4).

Fractures

Five trials reported the outcome fractures. One trial reported that eight new fractures occurred in the control group treated with placebo and calcium (0/70 versus 8/70; RR 0.06; 95% CI 0.00 to 1.00) (Analysis 4.1) (Zhang RH 2004). One trial reported one new fracture in the control group treated with placebo plus calcium and vitamin D (low-dose group: 0/60 versus 1/60; RR 0.33; 95% CI 0.01 to 8.02; high-dose group: 0/56 versus 1/60; RR 0.36; 95% CI 0.01 to 8.58) (Analysis 4.1) (Zhu HM 2012). One trial reported four new fractures in the herbal group (Bushen Zhuanggu granules plus calcium and vitamin D) and seven new fractures in the control group (placebo granules plus calcium and vitamin D) (4/88 versus 7/67; RR 0.44; 95% CI 0.13 to 1.43) (Analysis 4.1) (Deng WM 2012). One trial reported one new fracture in the control group (calcium and vitamin D) (0/45 versus 1/30; RR 0.22; 95% CI 0.01 to 5.34) (Analysis 4.1) (Li ZP 2011). One trial reported that no new fracture occurred in any group (Zhuangguqiangjin tablet and Shujinbogu tablet plus calcitonin ampoule group, and calcitonin ampoule group) (Analysis 4.1) (Zhang ZF 2011).

Quality of life or symptoms including pain, muscle fatigue and limited mobility

Eight of 48 trials reported the improvement of lumbago and backache. Among them, four trials reported that Chinese herbal medicines were better than western medicines without reporting the number of cases with ache improvement in each group (Liang DB 2012; Wang XD 2011; Xu H 2010; Zhan HS 2009). The other three trials reported as follows:

In another trial, no significant difference was found between comparable groups (43/45 versus 35/37: RR 1.01; 95% CI 0.91 to 1.12) (Analysis 4.5) (Zhang ZF 2011).

Only one trial reported the outcome quality of life: the mean difference in quality of life score was 5.30 (95% CI 3.67 to 6.93) (Analysis 4.4) (Liang DB 2012).

Death

No trials reported this outcome.

Adverse effects

Eight trials out of 48 reported no remarkable adverse effects occurring in any groups (Chen FS 2001; Liang DB 2012; Liu JM 2012; Ruan XY 2006; Tang ZA 2012; Xie J 2004; Zheng WK 2007; Zou JJ 2005). Fourteen trials reported some adverse symptoms:

  • a few patients with nausea, vomiting, etc. after one month of treatment (Cao W 2010);

  • three patients with constipation and canker sore symptoms (Chen YQ 2001);

  • 21 (23.86%) and 21 (31.34%) adverse effects in the herbal group and control group, respectively, with the predominant effects being liver enzyme abnormality and gastrointestinal complaints (Deng WM 2012);

  • a few patients with dizziness, rash, nausea, vomiting and cardiopalmus at the beginning of therapy, but no significant difference in comparison groups (Dong Y 2010);

  • one patient with irregular vaginal bleeding and two with breast tenderness in the western medicine group (Fan HX 2004);

  • two cases of abdominal distention, acid reflux, etc. in the Liuwei Dihuang pills group, three cases with similar gastrointestinal symptoms in the Liuwei Dihuang pills plus calcium and vitamin D group, and three with similar gastrointestinal symptoms in the calcium and vitamin D group (Ma C 2011);

  • three patients with mild constipation in the herbal group (Wang XD 2011);

  • four patients with adverse effects (gastrointestinal reaction, nervous system response, anaphylactic reaction, etc.) in the Jiangu granule group, five in the Gusongbao granule group and five in the western medicine group (Xiong YH 2008);

  • six patients with nausea in the herbal group and three in the western medicine group (Xu H 2010);

  • three patients with nausea in the herbal group and three in the western medicine group (Xu M 2009);

  • three patients with constipation, one with dysthesia, one with elevated ALT, six with abdominal discomfort and one with gum swelling in the Xuduanzhuanggu capsule group; one with dizziness, one with skin petechiae, one with abdominal discomfort and one with gum swelling in the Gusongbao granule group; one with constipation, one with abdominal discomfort, one with sore throat, one with gum swelling and one with electrocardiogram abnormality in the control group (Zhan HS 2009);

  • five patients with dry mouth symptoms, dreaminess, dryness-heat in the experimental group, a few with a transient heightened blood calcium in the control group (Zhang RH 2004);

  • five with flushed face, one with nausea and one with vomiting in 90 patients after using calcitonin (Zhang ZF 2011);

  • 11 (18%), 12 (21%) and 11 (18%) adverse effects in the low-dose Xianlinggubao capsule group, high-dose Xianlinggubao capsule group and the control group, respectively, with the predominant effects being liver enzyme abnormality and gastrointestinal complaints (Zhu HM 2012).

The other 26 trials did not report adverse effects.

Bone mineral density (BMD)
BMD of the lumbar spine

Twenty-one trials showed positive effects of Chinese herbal medicines plus western medicine treatments when compared to the same western medicine on the BMD of the lumbar spine:

  • Gushen decoction plus Caltrate and Alfacalcidol versus Caltrate and Alfacalcidol after six months treatment (MD 0.06 g/cm3; 95% CI 0.01 to 0.11) (Analysis 4.2) (Chen FS 2001);

  • Shugan zishen huoxue tang plus Caltrate and alendronate sodium tablets versus Caltrate and alendronate sodium tablets after six months treatment (MD 0.12 g/cm3; 95% CI 0.08 to 0.16) (Analysis 4.2) (Han XL 2007);

  • Shangke Yishen Zhuanggu pill, plus Caltrate and calcitonin, versus Caltrate and calcitonin after three months treatment (MD 0.04 g/cm3; 95% CI 0.03 to 0.05) (Analysis 4.2) (Hu J 2012);

  • Gukang tablet plus oyster shell calcium chewable tablets and vitamin A and D capsules versus oyster shell calcium chewable tablets and vitamin A and D capsules after three months treatment (MD 0.24 g/cm3; 95% CI 0.14 to 0.34) (Analysis 4.2) (Liu JM 2012);

  • Ziyin Bushen Zhuanggu prescription plus Caltrate and calcitonin versus Caltrate plus calcitonin after eight months treatment (MD 0.14 g/cm3; 95% CI 0.08 to 0.20) (Analysis 4.2) (Li HW 2004);

  • Liuwei Dihuang pills plus Caltrate versus Caltrate after six months treatment (MD 0.05 g/cm3; 95% CI 0.02 to 0.08) (Analysis 4.2) (Ma C 2011);

  • Xianlinggubao capsule plus Caltrate versus Caltrate after 12 months treatment (MD 0.30 g/cm3; 95% CI 0.25 to 0.35) (Analysis 4.2) (Wu W 2005);

  • Migu tablet plus Caltrate versus Caltrate after 12 months treatment (MD 0.08 g/cm3; 95% CI 0.07 to 0.09) (Analysis 4.2) (Xie J 2004);

  • Bushen Zhuanggutang plus Caltrate versus Caltrate after six months treatment (MD 0.14 g/cm3; 95% CI 0.06 to 0.22) (Analysis 4.2) (Ye AN 1998);

  • Zishen prescription plus Caltrate and calcitonin versus Caltrate plus calcitonin after eight months treatment (MD 0.14 g/cm3; 95% CI 0.08 to 0.20) (Analysis 4.2) (Zhao G 2002);

  • Guben Zhuanggu capsules plus Caltrate versus Caltrate after six months treatment (MD 0.03 g/cm3; 95% CI 0.01 to 0.05) (Analysis 4.2) (Zou JJ 2005);

  • Qianggu capsule plus alendronate versus alendronate after six months treatment (MD 0.08 g/cm3; 95% CI 0.03 to 0.12) (Analysis 4.2) (Xu H 2010);

  • Xianlinggubao capsule plus alendronate versus alendronate after six months treatment (MD 0.06 g/cm3; 95% CI 0.03 to 0.09) (Analysis 4.2) (Xu M 2009);

  • Xianlinggubao capsule plus Caltrate versus Caltrate after 12 months treatment (MD 0.31 g/cm3; 95% CI 0.28 to 0.34) (Analysis 4.2) (Qiu ZX 2010);

  • Xianlinggubao capsule plus compound calcium amino acid chelate capsule versus compound calcium amino acid chelate capsule after six months treatment (MD 0.18 g/cm3; 95% CI 0.14 to 0.22), and Migu tablet plus compound calcium amino acid chelate capsule versus compound calcium amino acid chelate capsule after six months treatment (MD 0.17 g/cm3; 95% CI 0.14 to 0.20) (Analysis 4.2) (Dai Y 2007);

  • Jinwugutong capsule plus calcium versus placebo plus calcium after six months treatment (MD 0.11 g/cm3; 95% CI 0.07 to 0.15) (Analysis 4.2) (Zheng WK 2007);

  • Chinese medicine Bushenhuoxue recipe plus conventional western medicine (alfacalcidol soft capsules, bisphosphonate and salmon calcitonin, etc.) versus conventional western medicine after three months treatment (MD 0.16 g/cm3; 95% CI 0.09 to 0.22) (Analysis 4.2) (Cao GY 2010);

  • Shengsuiyin recipe plus Caltrate versus Caltrate after 12 months treatment (MD 0.31 g/cm3; 95% CI 0.28 to 0.34) (Analysis 4.2) (Jian QQ 2010);

  • Yigu capsule plus calcium versus placebo plus calcium after six months treatment (MD 0.08 g/cm3; 95% CI 0.04 to 0.12) (Analysis 4.2) (Zhang RH 2004);

  • Chinese medicine (combination of 10 herbs) plus tamoxifen and Caltrate versus tamoxifen and Caltrate after three months treatment (MD 0.10 g/cm3; 95% CI 0.06 to 0.14) (Analysis 4.2) (Cao W 2010);

  • Huangqi plus calcium and vitamin D versus calcium and vitamin D after six months treatment (MD 0.06 g/cm3; 95% CI 0.01 to 0.11) (Analysis 4.2) (Yang B 2007).

No significant difference in the BMD of the lumbar spine was reported for any of the following comparisons of treatment groups:

  • Jiarong tablet plus Caltrate versus Caltrate (MD 0.04 g/cm3; 95% CI -0.06 to 0.14) (Analysis 4.2) (Chen YQ 2001);

  • Bushen Kangsong pill plus calcium carbonate tablets versus calcium carbonate tablets (MD 0.01 g/cm3; 95% CI -0.03 to 0.04) (Analysis 4.2) (Guo JH 2008);

  • Shugan zishen huoxue tang plus Caltrate and alendronate sodium tablets versus Caltrate and alendronate sodium tablets after three months treatment (MD 0.04 g/cm3; 95% CI -0.01 to 0.09) (Analysis 4.2) (Han XL 2007);

  • Bushen Yangxue tang plus Caltrate versus Caltrate (MD 0.02 g/cm3; 95% CI -0.02 to 0.06) (Analysis 4.2) (He XQ 2006);

  • Bushenhuoxue therapy plus calcium carbonate tablets and alfacalcidol versus calcium carbonate tablets and alfacalcidol (MD -0.01 g/cm3; 95% CI -0.04 to 0.02) (Analysis 4.2) (Liang DB 2012);

  • Ziyin Bushen Zhuanggu prescription plus Caltrate and calcitonin versus Caltrate plus calcitonin after four months treatment (MD 0.05 g/cm3; 95% CI 0.00 to 0.10) (Analysis 4.2) (Li HW 2004);

  • Zhuanggu capsule plus Caltrate versus Caltrate (MD 0.01 g/cm3; 95% CI 0.00 to 0.02) (Analysis 4.2) (Li SL 2004);

  • Yiyuanjiangu decoction plus calcitonin ampoule and calcium carbonate tablet versus calcitonin ampoule and calcium carbonate tablet (MD 0.02 g/cm3; 95% CI -0.01 to 0.05) (Analysis 4.2) (Ma CZ 2011);

  • Yishen Zhuanggu decoction plus calcitriol soft capsule versus calcitriol soft capsule (MD 0.02 g/cm3; 95% CI 0.00 to 0.05) (Analysis 4.2) (Ma YJ 2011);

  • Bushen Qianggu Huoxue therapy plus calcium and cod liver oil versus calcium and cod liver oil (MD 0.05 g/cm3; 95% CI -0.01 to 0.11) (Analysis 4.2) (Tang ZA 2012);

  • Antai capsule plus Caltrate versus Caltrate (MD 0.04 g/cm3; 95% CI 0.00 to 0.08) (Analysis 4.2) (Wang SW 2003);

  • Hugu capsule plus Caltrate versus placebo capsule plus Caltrate (MD 0.03 g/cm3; 95% CI 0.00 to 0.06) (Analysis 4.2) (Wang XD 2011);

  • Xianlinggubao capsule plus Caltrate versus Caltrate after six months treatment (MD 0.03 g/cm3; 95% CI -0.02 to 0.08) (Analysis 4.2) (Wu W 2005);

  • Zishen prescription plus Caltrate and calcitonin versus Caltrate plus calcitonin after four months treatment (MD 0.05 g/cm3; 95% CI 0.00 to 0.10) (Analysis 4.2) (Zhao G 2002);

  • Guilu Erxiantang plus calcium carbonate tablet versus calcium carbonate tablet (MD 0.03 g/cm3; 95% CI -0.03 to 0.09) (Analysis 4.2) (Zhou XT 2001);

  • Xianlinggubao capsule (low-dose) plus calcium and vitamin D versus placebo plus calcium and vitamin D (MD 0.00 g/cm3; 95% CI -0.04 to 0.04) and Xianlinggubao capsule (high-dose) plus calcium and vitamin D versus placebo plus calcium and vitamin D (MD 0.00 g/cm3; 95% CI -0.03 to 0.03) (Analysis 4.2) (Zhu HM 2012);

  • Bushen Kangsong pill plus calcium carbonate tablets versus calcium carbonate tablets after six months treatment (MD 0.01 g/cm3; 95% CI -0.03 to 0.04) (Analysis 4.2) (Guo JH 2008);

  • Gusongbao granule plus compound calcium amino acid chelate capsule versus placebo granule plus compound calcium amino acid chelate capsule after six months treatment (MD -0.01 g/cm3; 95% CI -0.07 to 0.05) (Analysis 4.2) (Xiong YH 2008);

  • Xianlinggubao capsule plus salmon calcitonin and Caltrate versus salmon calcitonin plus Caltrate after three months treatment (MD 0.03 g/cm3; 95% CI -0.03 to 0.09) (Analysis 4.2) (Dong Y 2010);

  • Xianlinggubao capsule plus vitamin D3 and calcium amino acid chelate versus vitamin D3 and calcium amino acid chelate after 48 weeks treatment (MD 0.01 g/cm3; 95% CI -0.03 to 0.06) (Analysis 4.2) (Zhang XZ 2004);

  • Jiangu granule plus compound calcium amino acid chelate capsule versus placebo granule plus compound calcium amino acid chelate capsule after six months treatment (MD 0.04 g/cm3; 95% CI -0.02 to 0.10) (Analysis 4.2) (Xiong YH 2008);

  • Xuduanzhuanggu capsule plus calcium tablet versus placebo plus calcium tablet after six months treatment (MD 0.02 g/cm3; 95% CI -0.01 to 0.05) and Gusongbao granule plus calcium tablet versus placebo plus calcium tablet after six months treatment (MD -0.01 g/cm3; 95% CI -0.05 to 0.03) (Analysis 4.2) (Zhan HS 2009);

  • Zhuangguqiangjin tablet and Shujinbogu tablet plus calcitonin ampoule versus calcitonin ampoule after 12 months treatment (MD 0.01 g/cm3; 95% CI -0.04 to 0.06) (Analysis 4.2) (Zhang ZF 2011);

  • Huangqi plus calcium and vitamin D versus calcium and vitamin D after three months treatment (MD 0.03 g/cm3; 95% CI -0.01 to 0.07) (Analysis 4.2) (Yang B 2007).

  • Zhuangguqiangjin tablet and Shujinbogu tablet plus calcitonin ampoule versus calcitonin ampoule after 12 months treatment (MD 0.01 g/cm3; 95% CI -0.04 to 0.06) (Analysis 4.2) (Zhang ZF 2011);

  • Huangqi plus calcium and vitamin D versus calcium and vitamin D after three months treatment (MD 0.03 g/cm3; 95% CI -0.01 to 0.07) (Analysis 4.2) (Yang B 2007).

BMD of the femoral neck

Seven trials showed positive effects of Chinese herbal medicines plus western medicine treatments when compared to the same western medicine on the BMD of the femoral neck:

  • Jiarong tablet plus Caltrate versus Caltrate after six months treatment (MD 0.09 g/cm3; 95% CI 0.02 to 0.15) (Analysis 4.2) (Chen YQ 2001);

  • Xianlinggubao capsule plus Caltrate versus Caltrate after 12 months treatment (MD 0.30 g/cm3; 95% CI 0.25 to 0.35) (Analysis 4.2) (Wu W 2005);

  • Migu tablet plus Caltrate versus Caltrate (MD 0.09 g/cm3; 95% CI 0.08 to 0.10) (Analysis 4.2) (Xie J 2004);

  • Chinese medicine Bushenhuoxue recipe plus conventional western medicine (alfacalcidol soft capsules, bisphosphonate and salmon calcitonin, etc.) versus conventional western medicine after three months treatment (MD 0.17 g/cm3; 95% CI 0.12 to 0.23) (Analysis 4.2) (Cao GY 2010);

  • Xianlinggubao capsule plus compound calcium amino acid chelate capsule versus compound calcium amino acid chelate capsule after six months treatment (MD 0.26 g/cm3; 95% CI 0.22 to 0.30) and Migu tablet plus compound calcium amino acid chelate capsule versus compound calcium amino acid chelate capsule after six months treatment (MD 0.24 g/cm3; 95% CI 0.21 to 0.27) (Analysis 4.2) (Dai Y 2007);

  • Huangqi plus calcium and vitamin D versus calcium and vitamin D after six months treatment (MD 0.07 g/cm3; 95% CI 0.03 to 0.11) (Analysis 4.2) (Yang B 2007);

  • Yigu capsule plus calcium versus placebo plus calcium after six months treatment (MD 0.04 g/cm3; 95% CI 0.01 to 0.07) (Analysis 4.2) (Zhang RH 2004).

No significant difference in the BMD of the femoral neck was reported for any of the following comparisons of treatment groups:

  • Qianggu capsules plus oestradiol valerate versus oestradiol valerate after six months treatment (MD 0.03 g/cm3; 95% CI -0.01 to 0.07) (Analysis 4.2) (Ruan XY 2006);

  • Antai capsule plus Caltrate versus Caltrate after six months treatment (MD 0.01 g/cm3; 95% CI -0.02 to 0.04) (Analysis 4.2) (Wang SW 2003);

  • Xianlinggubao capsule plus Caltrate versus Caltrate after six months treatment (MD 0.03 g/cm3; 95% CI -0.02 to 0.08) (Analysis 4.2) (Wu W 2005);

  • Guben Zhuanggu capsules plus Caltrate versus Caltrate after six months treatment (MD 0.01 g/cm3; 95% CI -0.01 to 0.02) (Analysis 4.2) (Zou JJ 2005);

  • Heche Dazao pill plus oyster shell calcium chewable tablets versus oyster shell calcium chewable tablets after three months treatment (MD 0.04 g/cm3; 95% CI 0.00 to 0.07) (Analysis 4.2) (Chen XL 2010);

  • Gusongbao granule plus compound calcium amino acid chelate capsule versus placebo granule plus compound calcium amino acid chelate capsule after six months treatment (MD 0.01 g/cm3; 95% CI -0.03 to 0.05) and Jiangu granule plus compound calcium amino acid chelate capsule versus placebo granule plus compound calcium amino acid chelate capsule after six months treatment (MD -0.02 g/cm3; 95% CI -0.07 to 0.03) (Analysis 4.2) (Xiong YH 2008);

  • Xuduanzhuanggu capsule plus calcium tablet versus placebo plus calcium tablet after six months treatment (MD 0.01 g/cm3; 95% CI -0.01 to 0.03) and Gusongbao granule plus calcium tablet versus placebo plus calcium tablet after six months treatment (MD 0.00 g/cm3; 95% CI -0.03 to 0.03) (Analysis 4.2) (Zhan HS 2009);

  • Yiyuanjiangu decoction plus calcitonin ampoule and calcium carbonate tablet versus calcitonin ampoule and calcium carbonate tablet after three months treatment (MD 0.01 g/cm3; 95% CI -0.01 to 0.03) (Analysis 4.2) (Ma CZ 2011);

  • Bushen Qianggu Huoxue therapy plus calcium and cod liver oil versus calcium and cod liver oil after three months treatment (MD 0.02 g/cm3; 95% CI -0.02 to 0.05) (Analysis 4.2) (Tang ZA 2012);

  • Xianlinggubao capsule (low-dose or high-dose) plus calcium and vitamin D versus placebo plus calcium and vitamin D (MD -0.01 g/cm3; 95% CI -0.05 to 0.03) (Analysis 4.2) (Zhu HM 2012).

BMD of Ward's triangle

Six trials showed positive effects of Chinese herbal medicines plus western medicine treatments when compared to the same western medicine on the BMD of Ward's triangle:

  • Migu tablet plus Caltrate versus Caltrate (MD 0.09 g/cm3; 95% CI 0.08 to 0.10) (Analysis 4.2) (Xie J 2004);

  • Qianggu capsule plus alendronate versus alendronate after six months treatment (MD 0.05 g/cm3; 95% CI 0.02 to 0.07) (Analysis 4.2) (Xu H 2010);

  • Xianlinggubao capsule plus alendronate versus alendronate after six months treatment (MD 0.04 g/cm3; 95% CI 0.02 to 0.06) (Analysis 4.2) (Xu M 2009);

  • Xianlinggubao capsule plus compound calcium amino acid chelate capsule versus compound calcium amino acid chelate capsule after six months treatment (MD 0.23 g/cm3; 95% CI 0.19 to 0.27) and Migu tablet plus compound calcium amino acid chelate capsule versus compound calcium amino acid chelate capsule after six months treatment (MD 0.28 g/cm3; 95% CI 0.24 to 0.32) (Analysis 4.2) (Dai Y 2007);

  • Bushen Qianggu Huoxue therapy plus calcium and cod liver oil versus calcium and cod liver oil after three months treatment (MD 0.04 g/cm3; 95% CI 0.02 to 0.07) (Analysis 4.2) (Tang ZA 2012);

  • Hugu capsule plus Caltrate versus placebo capsule plus Caltrate after six months treatment (MD 0.05 g/cm3; 95% CI 0.02 to 0.08) (Analysis 4.2) (Wang XD 2011).

No significant difference in the BMD of Ward's triangle was reported for any of the following comparisons of treatment groups:

  • Antai capsule plus Caltrate versus Caltrate after six months treatment (MD 0.00 g/cm3; 95% CI -0.03 to 0.03) (Analysis 4.2) (Wang SW 2003);

  • Gusongbao granule plus compound calcium amino acid chelate capsule versus placebo granule plus compound calcium amino acid chelate capsule after six months treatment (MD -0.01 g/cm3; 95% CI -0.06 to 0.04) and Jiangu granule plus compound calcium amino acid chelate capsule versus placebo granule plus compound calcium amino acid chelate capsule after six months treatment (MD -0.01 g/cm3; 95% CI -0.06 to 0.04) (Analysis 4.2) (Xiong YH 2008);

  • Xuduanzhuanggu capsule plus calcium tablet versus placebo plus calcium tablet after six months treatment (MD 0.02 g/cm3; 95% CI 0.00 to 0.04) and Gusongbao granule plus calcium tablet versus placebo plus calcium tablet after six months treatment (MD 0.01 g/cm3; 95% CI -0.02 to 0.04) (Analysis 4.2) (Zhan HS 2009);

  • Yigu capsule plus calcium versus placebo plus calcium after six months treatment (MD 0.04 g/cm3; 95% CI 0.00 to 0.08) (Analysis 4.2) (Zhang RH 2004).

BMD of the trochanter

Three trials showed positive effects of Chinese herbal medicines plus western medicine treatments when compared to the same western medicine on the BMD of the trochanter:

  • Migu tablet plus Caltrate versus Caltrate after six months treatment (MD 0.15 g/cm3; 95% CI 0.14 to 0.16) (Analysis 4.2) (Xie J 2004);

  • Xianlinggubao capsule plus compound calcium amino acid chelate capsule versus compound calcium amino acid chelate capsule after six months treatment (MD 0.13 g/cm3; 95% CI 0.08 to 0.18) and Migu tablet plus compound calcium amino acid chelate capsule versus compound calcium amino acid chelate capsule after six months treatment (MD 0.12 g/cm3; 95% CI 0.07 to 0.17) (Analysis 4.2) (Dai Y 2007);

  • Yiyuanjiangu decoction plus calcitonin ampoule and calcium carbonate tablet versus calcitonin ampoule and calcium carbonate tablet after six months treatment (MD 0.02 g/cm3; 95% CI 0.01 to 0.04) (Analysis 4.2) (Ma CZ 2011).

No significant difference in the BMD of the trochanter was reported for any of the following comparisons of treatment groups:

  • Antai capsule plus Caltrate versus Caltrate after six months treatment (MD 0.03 g/cm3; 95% CI 0.00 to 0.06) (Analysis 4.2) (Wang SW 2003);

  • Xuduanzhuanggu capsule plus calcium tablet versus placebo plus calcium tablet after six months treatment (MD 0.00 g/cm3; 95% CI -0.02 to 0.02) and Gusongbao granule plus calcium tablet versus placebo plus calcium tablet after six months treatment (MD 0.00 g/cm3; 95% CI -0.03 to 0.03) (Analysis 4.2) (Zhan HS 2009);

  • Yigu capsule plus calcium versus placebo plus calcium after six months treatment (MD 0.02 g/cm3; 95% CI -0.02 to 0.06) (Analysis 4.2) (Zhang RH 2004).

BMD of the hip bone

Compared with Calcium carbonate with vitamin D chewable tablets, Gushukang granule plus Calcium carbonate with vitamin D chewable tablets showed a statistically significantly better effect on the BMD of the hip bone after six months treatment (MD 0.15 g/cm3; 95% CI 0.11 to 0.19) (Analysis 4.2) (Chen ZX 2002). There was no significant difference in the comparison of Jinwugutong capsules plus calcium and placebo plus calcium regarding the BMD of the hip bone (MD 0.01 g/cm3; 95% CI -0.02 to 0.04) (Analysis 4.2) (Zheng WK 2007).

BMD of the distal radius

There was no significant difference in the comparison of Gengnian Anyi tablet plus Caltrate and Caltrate regarding the BMD of the distal radius (MD 0.01 g/cm3; 95% CI -0.06 to 0.08) (Analysis 4.2) (Fan HX 2004). However, Bushen Zhuanggu granules plus calcium and vitamin D showed positive effects on the BMD of the distal radius when compared with placebo granules plus calcium and vitamin D after five-year follow-up (MD 0.10 g/cm3; 95% CI 0.09 to 0.10) (Analysis 4.2) (Deng WM 2012).

T score in BMD measurement

One trial reported the T score in bone mineral density measurement: Erxian Yanggu decoction plus alendronate sodium tablets versus alendronate sodium tablets (MD of T score 0.91; 95% CI 0.57 to 1.25) (Analysis 4.3) (Huang JW 2008).

Biochemical indicators

The effects of the interventions on biochemical indicators are shown in Appendix 5.

Summary: Comparison 04

In summary, 37 trials out of 93 included trials evaluated Chinese herbal medicines plus conventional medicine compared with the same conventional medicine.

The results showed that the following Chinese herbal medicines appeared to increase the BMD of the lumbar spine: Gushen decoction, Shugan zishen huoxue tang, Erxian Yanggu decoction, Ziyin Bushen Zhuanggu prescription, Xianlinggubao capsules, Migu tablet, Bushen Zhuanggutang, Zishen prescription, Guben Zhuanggu capsules, Qianggu capsule, Jinwugutong capsule, Shengsuiyin recipe, Yigu capsule and Huangqi. However, the following did not: Jiarong tablet, Bushen Kangsong pill, Shugan zishen huoxue tang, Bushen Yangxue tang, Bushenhuoxue therapy, Ziyin Bushen Zhuanggu prescription, Zhuanggu capsule, Yiyuanjiangu decoction, Yishen Zhuanggu decoction, Bushen Qianggu Huoxue therapy, Antai capsule, Hugu capsule, Xianlinggubao capsule, Zishen prescription, Guilu Erxiantang, Bushen Kangsong pill, Gusongbao granule, Jiangu granule, Zhuangguqiangjin tablet and Shujinbogu tablet, Xuduanzhuanggu capsule and Huangqi.

The following Chinese herbal medicines appeared to increase the BMD of the femoral neck: Jiarong tablet, Xianlinggubao capsule, Migu tablet, Bushenhuoxue recipe, Huangqi and Yigu capsule. However, the following did not: Qianggu capsules, Antai capsule, Xianlinggubao capsule, Guben Zhuanggu capsules, Heche Dazao pill, Gusongbao granule, Jiangu granule, Xuduanzhuanggu capsule, Yiyuanjiangu decoction and Bushen Qianggu Huoxue therapy.

The following Chinese herbal medicines appeared to increase the BMD of Ward's triangle: Migu tablet, Qianggu capsule, Xianling Gubao capsule, Bushen Qianggu Huoxue therapy and Hugu capsule. However, the following did not: Antai capsule, Gusongbao granule, Xuduanzhuanggu capsule and Yigu capsule.

The following Chinese herbal medicines appeared to increase the BMD of the trochanter: Migu tablet, Yiyuanjiangu decoction and Xianlinggubao capsule. However, the following did not: Antai capsule, Xuduanzhuanggu capsule and Yigu capsule.

Gushukang granule seemed to increase the BMD of the hip bone, while Jinwugutong capsules did not.

Bushen Zhuanggu granules appeared to increase the BMD of the distal radius, while Gengnian Anyi tablet dd not.

Erxian Yanggu decoction appeared to increase the T score of BMD.

Discussion

Due to poor study quality and limited data on the individual herbal interventions, no definitive conclusions can be drawn from this review on the effectiveness of any Chinese herbal medicine intervention tested to date.

Summary of main results

One hundred and eight randomised trials were included in this review. Ninety-nine different Chinese herbal medicines were compared with placebo, no intervention, conventional pharmaceutical medicine or with the same co-intervention received by the Chinese herbal medicines group. In this review, many of the trials showed a symptomatic benefit of Chinese herbal medicines in patients with osteoporosis either when compared with placebo, no intervention or conventional western medicine. However, there was a lack of replicable evidence because no more than one trial ever compared the same Chinese herbal medicine and control treatment. Thus, the finding of a benefit of Chinese herbal medicine treatment may not be conclusive. Furthermore, the findings of this review should be interpreted with caution due to the small sample sizes and generally low methodological quality of the included studies.

Compared with placebo in three trials, Chinese herbal medicines had a statistically significant effect in increasing bone mineral density (BMD) in each trial. One reported some mild adverse effects (such as stomach/intestinal upset, headache and dizziness) from Chinese herbal medicines, but there were no significant differences between the Chinese herbal medicines and placebo groups.

Five randomised trials compared seven different Chinese herbal medicines with no intervention. Two trials showed Chinese herbal medicines to be significantly effective in increasing BMD, while three others showed no better effect. Four trials reported mild adverse effects (e.g. mild stomach discomfort, intestinal upset, etc.) of Chinese herbal medicines, but this did not affect the continuation of the treatment.

Sixty-one trials compared 58 different Chinese herbal medicines with western medicine. Twenty-three trials showed that Chinese herbal medicines were significantly effective in increasing BMD, while 38 showed no better effect. Twenty-three reported some adverse effects (e.g. dizziness, rash, nausea, vomiting, etc.) from Chinese herbal medicines, but most of them did not affect the continuation of the treatment. Six reported no occurrence of adverse effects and 38 did not report adverse effects.

Forty-eight trials compared 42 different Chinese herbal medicines plus western medicine with western medicine. Twenty-six showed better effects in increasing BMD, while 22 did not. Fourteen reported some adverse symptoms (e.g. nausea, vomiting, etc.) from Chinese herbal medicines, but there was no significant difference between comparison groups. Eight reported no remarkable adverse effects and the other 26 did not report adverse effects.

Overall completeness and applicability of evidence

We performed this review to evaluate the benefit and harm of Chinese herbal medicines in patients with osteoporosis. Most of the Chinese herbal medicines evaluated were mixtures of different herbs and most of them were prescribed by the investigators without reporting of the quality standards for the preparations. Interpretation of these findings should therefore be cautious considering that along with the other methodological limitations in the study designs, these studies cannot be replicated. There is a risk that statistically significant findings from a handful of studies at questionable risk of bias are given more prominence than the lack of data for relevant endpoints available from the vast majority of included studies in the review.

The Chinese herbal medicines evaluated generally appeared to be safe. However, we cannot conclude that using Chinese herbal medicines in osteoporosis patients is safe, because adverse effects were not sufficiently and adequately reported in all the included trials. In clinical trials beneficial and harmful effects should receive equal attention, and the recording and reporting of adverse effects must improve if we are to draw any conclusions about safety.

Quality of the evidence

Due to the variations in the Chinese herbal medicines tested and the methodological limitations of the included trials, the evidence for Chinese herbal medicines for the treatment of osteoporosis is not conclusive. In general, Chinese herbal medicines might be a promising treatment. However, it is premature to recommend Chinese herbal medicines for routine use in osteoporosis considering the generally low quality of the evidence.

Most of the included trials suffered from insufficient reporting or inadequate methods of randomisation. The majority of the trials did not report how the random allocation was generated and concealed. Some trials had a significantly skewed distribution of participants among the groups compared which could not be explained if randomisation had been carried out properly. These trials were highly prone to selection bias.

Very few trials used a double-blinding method. The majority of treatment approaches in the included trials aimed to improve pain symptoms, which is a subjective indicator. If the outcome assessment is not blinded, then performance and detection bias may be a problem.

Most of the included trials were small. Although some data analyses did not demonstrate a statistically significant difference between the groups compared, the results were likely to have been underpowered to demonstrate equivalence. Therefore, the analyses from the small sample trials may not be able to establish with confidence that the two interventions had equivalent effects.

Overall the evidence is limited: potential bias may have occurred in the selection of participants, the administration of treatment and the assessment of outcomes in the included trials, which may obscure or exaggerate treatment effects. Methodologically less rigorous trials have been shown to have significantly larger intervention effects than trials conducted with more rigour (Egger 2003; Moher 1998; Schulz 1995). Therefore, the implications of our findings for clinical practice are very limited.

The trials identified in this review were mostly Chinese and all were conducted in Chinese participants: publication bias might therefore be an issue. An empirical study has shown that Chinese trials are significantly affected by publication bias (Vickers 1998). Furthermore, it is certainly an issue that so few of the included studies actually reported the right outcomes and we downgraded studies for selective reporting. Accordingly, publication bias should be taken into consideration when interpreting the present findings. Moreover, most of the trials were of short duration and were not followed up long-term, thus they were unable to detect endpoint outcomes such as fracture or long-term adverse effects of the herbal treatments in patients with osteoporosis. Primary outcomes such as the occurrence of new fractures were reported in only a few trials, so we could not draw any conclusions about efficacy and safety.

Potential biases in the review process

In this review, we comprehensively searched for studies from appropriate databases, and selected trials and extracted data in duplicate. However, we did not find any unpublished studies or studies published in languages other than Chinese or English. Secondly, due to our limited resources, including time, we were not able to contact the original authors to verify unclear information, such as the methods used for random allocation generation and concealment. Furthermore, almost all Chinese herbal medicines in the included trials were tested only once and on small samples. This made it impossible for us to pool data to draw a robust conclusion.

Agreements and disagreements with other studies or reviews

We could not find any other reviews evaluating the benefits and harms of Chinese herbal medicines in patients with osteoporosis. Therefore, this review is the first time this has been reported. Many trials are not included in this review and are listed as excluded studies. Due to the variation among the Chinese herbal medicine interventions, it is not meaningful to compare the results from these excluded trials with those included in this review.

Authors' conclusions

Implications for practice

Based on this systematic review, some Chinese herbal medicines may have beneficial effects on the bone mineral density at anatomical sites in people with osteoporosis. However, a large number of the included studies have an uncertain risk of bias, there is a lack of relevant clinical endpoints in the available literature and the evidence is of low quality. Further rigorous studies are needed to demonstrate whether these effects are clinically meaningful and to detect other effects.

Implications for research

The potential benefit of Chinese herbal medicines as a treatment for osteoporosis needs to be further investigated by conducting high-quality trials to produce convincing evidence. Trials comparing Chinese herbal medicines with conventional pharmaceutical medicine should be designed rigorously. It would also be interesting to verify the additional benefits of Chinese herbal medicines when combined with conventional medicine versus the same medicine by itself. There are a wide range of therapeutic strategies in Traditional Chinese Medicine that address osteoporosis and the related Chinese medicine diagnosis of kidney deficiency. It would be useful for those with expertise in Chinese herbal medicine to group the herbal formulae by therapeutic strategy, so that the Chinese herbal medicines can be tested with reference to the therapeutic framework from which they were derived.

Outcome measures should include both clinical and surrogate outcomes. Standardised monitoring and reporting should be used for assessment of adverse effects. The methodological quality of randomised trials of Chinese herbal medicines for osteoporosis needs to be improved. The following aspects should be addressed: (i) detailed reporting of the methods used to generate the allocation sequence and conceal allocation; (ii) sufficient application of double-blinding with the use of an adequate placebo; (iii) clear descriptions of withdrawals/drop-outs during the trial and use of intention-to-treat analysis; (iv) reporting of clinically important outcome measures from long-term follow-up; and (v) reporting of the trial according to the CONSORT Statement guidelines (www.consort-statement.org).

Acknowledgements

The authors wish to acknowledge the helpful comments from Elizabeth Ghogomu, Lara Maxwell and the editorial group and their long-term support to make this review possible, and Christine Wade's contributions to the protocol and review.

This work is partially supported by the grant number 2011ZX09302-006(5) from the Ministry of Science and Technology of China. Jian Ping Liu was partially supported by grant number R24 AT001293 from the National Center for Complementary and Alternative Medicine of the US National Institutes of Health.

Data and analyses

Download statistical data

Comparison 1. Chinese herbal medicines versus placebo
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 New fractures1104Risk Ratio (M-H, Fixed, 95% CI)0.05 [0.00, 0.85]
1.1 Kanggusong capsule versus placebo (12 months)1104Risk Ratio (M-H, Fixed, 95% CI)0.05 [0.00, 0.85]
2 Bone mineral density (BMD)3 Mean Difference (IV, Fixed, 95% CI)Subtotals only
2.1 Migu decoction versus placebo (BMD of lumbar spine, 4 months)120Mean Difference (IV, Fixed, 95% CI)0.16 [0.06, 0.26]
2.2 Kanggusong capsule versus placebo (BMD of lumbar spine, 12 months)1140Mean Difference (IV, Fixed, 95% CI)0.06 [0.02, 0.10]
2.3 Bushen Yigu soft extract versus placebo (BMD of radius, 3 months)159Mean Difference (IV, Fixed, 95% CI)0.06 [0.03, 0.09]
2.4 Bushen Yigu soft extract versus placebo (BMD of ulna, 3 months)159Mean Difference (IV, Fixed, 95% CI)0.06 [0.02, 0.10]
3 Oestradiol (E2)1 Mean Difference (IV, Random, 95% CI)Subtotals only
3.1 Bushen Yigu soft extract versus placebo (3 months)159Mean Difference (IV, Random, 95% CI)122.89 [92.97, 152.81]
4 Symptoms including pain, muscle fatigue and limited mobility1104Risk Ratio (M-H, Fixed, 95% CI)1.20 [1.05, 1.37]
4.1 Kanggusong capsule versus placebo (Bone pain at lumbar spine, 12 months)1104Risk Ratio (M-H, Fixed, 95% CI)1.20 [1.05, 1.37]
Analysis 1.1.

Comparison 1 Chinese herbal medicines versus placebo, Outcome 1 New fractures.

Analysis 1.2.

Comparison 1 Chinese herbal medicines versus placebo, Outcome 2 Bone mineral density (BMD).

Analysis 1.3.

Comparison 1 Chinese herbal medicines versus placebo, Outcome 3 Oestradiol (E2).

Analysis 1.4.

Comparison 1 Chinese herbal medicines versus placebo, Outcome 4 Symptoms including pain, muscle fatigue and limited mobility.

Comparison 2. Chinese herbal medicines versus no intervention
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Bone mineral density (BMD)4 Mean Difference (IV, Fixed, 95% CI)Subtotals only
1.1 Bushen Shengsui principle versus no intervention (BMD of lumbar spine, 6 months)161Mean Difference (IV, Fixed, 95% CI)0.07 [-0.06, 0.20]
1.2 Bushen Shengsui principle versus no intervention (BMD of femoral neck, 6 months)161Mean Difference (IV, Fixed, 95% CI)0.10 [-0.00, 0.20]
1.3 Qianggu soft extract versus no intervention (BMD of femoral neck, 6 months)197Mean Difference (IV, Fixed, 95% CI)0.09 [0.03, 0.15]
1.4 Shigu yin versus no treatment (BMD of Femoral neck, 6 months)180Mean Difference (IV, Fixed, 95% CI)0.08 [0.03, 0.13]
1.5 Yishen Zhuanggu mixture versus no intervention (BMD of femoral neck, 6months)163Mean Difference (IV, Fixed, 95% CI)0.05 [-0.01, 0.11]
1.6 Shengu capsule versus no intervention (BMD of femoral neck, 6 months)134Mean Difference (IV, Fixed, 95% CI)0.02 [-0.06, 0.09]
2 Oestradiol (E2)3 Mean Difference (IV, Fixed, 95% CI)Subtotals only
2.1 Bushen Shengsui principle versus no intervention (6 months)161Mean Difference (IV, Fixed, 95% CI)4.40 [-4.61, 13.41]
2.2 Yishen Zhuanggu mixture versus no treatment (6 months)122Mean Difference (IV, Fixed, 95% CI)2.10 [-6.22, 10.42]
2.3 Huoluo Gukang pills versus no intervention (6 months)1136Mean Difference (IV, Fixed, 95% CI)2.40 [-1.22, 6.02]
2.4 Gushukang granule versus no intervention (6 months)1129Mean Difference (IV, Fixed, 95% CI)2.10 [-1.69, 5.89]
3 Bone Gla protein (BGP)3 Mean Difference (IV, Random, 95% CI)Subtotals only
3.1 Yishen Zhuanggu mixture versus no treatment (6 months)163Mean Difference (IV, Random, 95% CI)-1.0 [-6.15, 4.15]
3.2 Shengu capsule versus no treatment (6 months)134Mean Difference (IV, Random, 95% CI)-5.10 [-10.63, 0.43]
3.3 Huoluo Gukang pills versus no treatment (6 months)1136Mean Difference (IV, Random, 95% CI)2.70 [1.23, 4.17]
3.4 Gushukang granule versus no treatment (6 months)1129Mean Difference (IV, Random, 95% CI)3.5 [1.92, 5.08]
3.5 Shigu yin versus no treatment (6 months)180Mean Difference (IV, Random, 95% CI)1.2 [0.17, 2.23]
Analysis 2.1.

Comparison 2 Chinese herbal medicines versus no intervention, Outcome 1 Bone mineral density (BMD).

Analysis 2.2.

Comparison 2 Chinese herbal medicines versus no intervention, Outcome 2 Oestradiol (E2).

Analysis 2.3.

Comparison 2 Chinese herbal medicines versus no intervention, Outcome 3 Bone Gla protein (BGP).

Comparison 3. Chinese herbal medicines versus western medicine
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 New fractures1142Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.1 Kanggusong granule versus Caltrate (9 months)171Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.2 Kanggusong granule versus ipriflavone plus Caltrate (9 months)171Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
2 Bone mineral density (BMD)51 Mean Difference (IV, Random, 95% CI)Subtotals only
2.1 Kanggusong granule versus ipriflavone plus Caltrate (BMD of lumbar spine, 9 months)171Mean Difference (IV, Random, 95% CI)0.0 [-0.05, 0.05]
2.2 Kanggusong granule versus Caltrate (BMD of lumbar spine, 9 months)171Mean Difference (IV, Random, 95% CI)0.04 [-0.02, 0.10]
2.3 Kanggusong capsule versus Caltrate (BMD of lumbar spine, 6 months)180Mean Difference (IV, Random, 95% CI)0.06 [0.02, 0.11]
2.4 Strong Bone capsule versus Caltrate (BMD of lumbar spine, 3 months)1105Mean Difference (IV, Random, 95% CI)-0.01 [-0.08, 0.06]
2.5 Qianggu capsule versus active vitamin D3 (BMD of lumbar spine, 6 months)154Mean Difference (IV, Random, 95% CI)0.04 [-0.01, 0.09]
2.6 Qianggu capsule versus alendronate (BMD of lumbar spine, 6 months)180Mean Difference (IV, Random, 95% CI)0.01 [-0.04, 0.05]
2.7 Herba epimedii prescription versus vitamin D plus Caltrate (BMD of lumbar spine, 6 months)180Mean Difference (IV, Random, 95% CI)0.03 [-0.00, 0.06]
2.8 Bushen Shengsui principle versus conjugated oestrogens plus medroxyprogesterone (BMD of lumbar spine, 6 months)166Mean Difference (IV, Random, 95% CI)0.0 [-0.12, 0.12]
2.9 Bushen Qianggutang versus Caltrate (BMD of lumbar spine, 3 months)140Mean Difference (IV, Random, 95% CI)0.09 [0.01, 0.17]
2.10 Bushen Jianpi Migu prescription versus Caltrate (BMD of lumbar spine, 3 months)1150Mean Difference (IV, Random, 95% CI)0.06 [0.03, 0.09]
2.11 Bushen Jianpi Huoxue recipe versus alendronate sodium tablets (BMD of lumbar spine, 6 months)1141Mean Difference (IV, Random, 95% CI)0.02 [-0.01, 0.05]
2.12 Bushen Huoxue capsules versus Caltrate and Rocalirol (BMD of lumbar spine, 12 months)160Mean Difference (IV, Random, 95% CI)0.02 [-0.05, 0.09]
2.13 Bushen Zhuanggu tang versus alendronate sodium tablets (BMD of lumbar spine, 3 months)160Mean Difference (IV, Random, 95% CI)0.04 [0.01, 0.07]
2.14 Bushenjianpi Zhuangguyin versus Caltrate and calcitonin (BMD of lumbar spine, 12 weeks)1100Mean Difference (IV, Random, 95% CI)0.16 [0.10, 0.22]
2.15 Jiawei Bushen Zhuangjintang versus calcium granule (BMD of lumbar spine, 3 months)190Mean Difference (IV, Random, 95% CI)0.10 [0.05, 0.15]
2.16 Gukang oral liquid versus alendronate (BMD of lumbar spine, 6 months)160Mean Difference (IV, Random, 95% CI)0.01 [-0.03, 0.05]
2.17 Kidney-tonifying herbs versus nilestriol (BMD of lumbar spine, 6 months)146Mean Difference (IV, Random, 95% CI)-0.02 [-0.09, 0.05]
2.18 Kidney-tonifying herbs versus calcium (BMD of lumbar spine, 6 months)146Mean Difference (IV, Random, 95% CI)0.02 [-0.04, 0.08]
2.19 Yishen Yanggan mixture versus calcium gluconate (BMD of lumbar spine, 6 months)1110Mean Difference (IV, Random, 95% CI)0.04 [0.01, 0.07]
2.20 Yinyanghuo versus conjugated oestrogens (BMD of lumbar spine, 3 to 6 months)125Mean Difference (IV, Random, 95% CI)0.03 [-0.04, 0.10]
2.21 Shenyao capsules versus Caltrate (BMD of lumbar spine, 6 months)1100Mean Difference (IV, Random, 95% CI)0.0 [-0.05, 0.05]
2.22 Guli powder versus Caltrate (BMD of lumbar spine, 3 months, male)130Mean Difference (IV, Random, 95% CI)0.02 [-0.01, 0.05]
2.23 Guli powder versus Caltrate (BMD of lumbar spine, 3 months, female)130Mean Difference (IV, Random, 95% CI)0.04 [-0.07, 0.15]
2.24 Gushen Yijing tang versus Caltrate (BMD of lumbar spine, 6 months)180Mean Difference (IV, Random, 95% CI)0.06 [-0.02, 0.14]
2.25 Bugu Shengsui capsule versus vitamin D2 plus calcium tablet (BMD of lumbar spine, 6 months)130Mean Difference (IV, Random, 95% CI)0.12 [-0.01, 0.26]
2.26 Huangqi Sanxian tang versus nilestriol (BMD of lumbar spine, 3 months)150Mean Difference (IV, Random, 95% CI)0.00 [-0.03, 0.04]
2.27 Zishen Gukang pill versus Caltrate plus vitamin D (BMD of lumbar spine, 3 months)160Mean Difference (IV, Random, 95% CI)-0.00 [-0.05, 0.04]
2.28 Xianling Gusong capsules versus Caltrate (BMD of lumbar spine, 6 months)143Mean Difference (IV, Random, 95% CI)-0.03 [-0.08, 0.02]
2.29 Jianshenfang granule versus alendronate sodium (BMD of lumbar spine, 6 months)160Mean Difference (IV, Random, 95% CI)0.09 [-0.03, 0.21]
2.30 Jiangu recipe versus alendronate sodium tablets (BMD of lumbar spine, 12 months)1120Mean Difference (IV, Random, 95% CI)0.02 [-0.00, 0.04]
2.31 Gukang decoction versus alendronate sodium tablets (BMD of lumbar spine, 4 months)183Mean Difference (IV, Random, 95% CI)-0.00 [-0.03, 0.03]
2.32 Gumiling granule versus bicarbonate calcium chewable (BMD of lumbar spine, 6 months)125Mean Difference (IV, Random, 95% CI)0.04 [-0.02, 0.09]
2.33 Gujian capsule versus alfacalcidol (BMD of lumbar spine, 6 months)165Mean Difference (IV, Random, 95% CI)0.14 [0.03, 0.26]
2.34 Xianlinggubao capsule versus alendronate (BMD of lumbar spine, 6 months)1104Mean Difference (IV, Random, 95% CI)0.0 [-0.02, 0.02]
2.35 Erxian soup versus Caltrate (BMD of lumbar spine, 6 months)158Mean Difference (IV, Random, 95% CI)0.06 [0.02, 0.11]
2.36 Shangke Jiegu tablet versus vitamin D2 plus calcium tablet (BMD of lumbar spine, 6 months)130Mean Difference (IV, Random, 95% CI)0.25 [0.11, 0.39]
2.37 Gukang oral liquid versus calcium gluconate (BMD of radius, 6 months)161Mean Difference (IV, Random, 95% CI)0.02 [0.01, 0.04]
2.38 Herba epimedii prescription versus vitamin D plus Caltrate (BMD of radius, 6 months)180Mean Difference (IV, Random, 95% CI)0.07 [0.04, 0.11]
2.39 Bushen Yigu soft extract versus Alfacalcidol (BMD of radius, 3 months)174Mean Difference (IV, Random, 95% CI)0.01 [-0.02, 0.04]
2.40 Bugu Shengsui capsule versus vitamin D2 plus calcium tablet (BMD of radius, 6 months)150Mean Difference (IV, Random, 95% CI)0.08 [-0.12, 0.28]
2.41 Shangke Jiegu tablet versus vitamin D2 plus calcium tablet (BMD of radius, 6 months)160Mean Difference (IV, Random, 95% CI)0.04 [-0.02, 0.11]
2.42 Liuwei Dihuang pills versus calcium (BMD of radius, 12 months)142Mean Difference (IV, Random, 95% CI)0.04 [0.03, 0.05]
2.43 Gukang oral liquid versus calcium gluconate (BMD of ulna, 6 months)161Mean Difference (IV, Random, 95% CI)0.0 [-0.02, 0.02]
2.44 Bushen Yigu soft extract versus Alfacalcidol (BMD of ulna, 3 months)174Mean Difference (IV, Random, 95% CI)0.02 [-0.01, 0.05]
2.45 Bugu Shengsui capsule versus vitamin D2 plus calcium tablet (BMD of ulna, 6 months)150Mean Difference (IV, Random, 95% CI)0.06 [-0.01, 0.13]
2.46 Shangke Jiegu tablet versus vitamin D2 plus calcium tablet (BMD of ulna, 6 months)160Mean Difference (IV, Random, 95% CI)0.05 [-0.00, 0.11]
2.47 Liuwei Dihuang pills versus calcium (BMD of ulna, 12 months)142Mean Difference (IV, Random, 95% CI)0.02 [0.01, 0.03]
2.48 Kanggusong granule versus ipriflavone plus Caltrate (BMD of femoral neck, 9 months)171Mean Difference (IV, Random, 95% CI)-0.01 [-0.04, 0.02]
2.49 Kanggusong granule versus Caltrate (BMD of femoral neck, 9 months)171Mean Difference (IV, Random, 95% CI)0.01 [-0.03, 0.05]
2.50 Herba epimedii prescription versus vitamin D plus Caltrate (BMD of femoral neck, 6 months)180Mean Difference (IV, Random, 95% CI)0.06 [0.02, 0.10]
2.51 Bushen Shengsui principle versus conjugated oestrogens plus medroxyprogesterone (BMD of femoral neck, 6 months)166Mean Difference (IV, Random, 95% CI)-0.01 [-0.11, 0.09]
2.52 Kidney-tonifying herbs versus nilestriol (BMD of femoral neck, 6 months)146Mean Difference (IV, Random, 95% CI)0.02 [-0.02, 0.06]
2.53 Kidney-tonifying herbs versus calcium (BMD of femoral neck, 6 months)146Mean Difference (IV, Random, 95% CI)0.05 [0.01, 0.09]
2.54 Gumikang capsule versus calcium gluconate (BMD of femoral neck, 6 months)160Mean Difference (IV, Random, 95% CI)0.02 [-0.04, 0.08]
2.55 Yanghuo Sanzi tang versus Caltrate (BMD of femoral neck, 6 months)160Mean Difference (IV, Random, 95% CI)0.05 [0.02, 0.08]
2.56 Qianggu soft extract versus calcium gluconate (BMD of femoral neck, 6 months)199Mean Difference (IV, Random, 95% CI)0.07 [0.02, 0.12]
2.57 Qianggu capsules versus oestradiol valerate (BMD of femoral neck, 6 months)190Mean Difference (IV, Random, 95% CI)0.02 [-0.02, 0.06]
2.58 Qianggu paste versus calcium gluconate tablets (BMD of femoral neck, 6 months)1123Mean Difference (IV, Random, 95% CI)0.07 [0.03, 0.11]
2.59 Qianggu capsule versus active vitamin D3 (BMD of femoral neck, 6 months)154Mean Difference (IV, Random, 95% CI)0.03 [-0.01, 0.07]
2.60 Shigu yin versus Caltrate (BMD of femoral neck, 6 months)180Mean Difference (IV, Random, 95% CI)0.03 [-0.01, 0.07]
2.61 Jiangu capsule versus Caltrate (BMD of femoral neck, 12 months)1125Mean Difference (IV, Random, 95% CI)0.04 [0.03, 0.06]
2.62 Gujian capsule versus alfacalcidol (BMD of femoral neck, 6 months)165Mean Difference (IV, Random, 95% CI)0.08 [0.03, 0.14]
2.63 Bushenhuoxue capsules versus Caltrate and Rocalirol (BMD of femoral neck, 12 months)160Mean Difference (IV, Random, 95% CI)0.02 [-0.06, 0.10]
2.64 Bushenjianpi Zhuangguyin versus Caltrate and calcitonin (BMD of femoral neck, 12 weeks)1100Mean Difference (IV, Random, 95% CI)0.06 [0.00, 0.12]
2.65 Bugu Shengsui capsule versus vitamin D2 plus calcium tablet (BMD of femoral neck, 6 months)130Mean Difference (IV, Random, 95% CI)0.09 [-0.05, 0.23]
2.66 Shangke Jiegu tablet versus vitamin D2 plus calcium tablet (BMD of femoral neck, 6 months)130Mean Difference (IV, Random, 95% CI)0.07 [-0.06, 0.20]
2.67 Kanggusong granule versus ipriflavone plus Caltrate (BMD of Ward's, 9 months)171Mean Difference (IV, Random, 95% CI)-0.03 [-0.07, 0.01]
2.68 Kanggusong granule versus Caltrate (BMD of Ward's, 9 months)171Mean Difference (IV, Random, 95% CI)0.0 [-0.04, 0.04]
2.69 Kidney-tonifying herbs versus nilestriol (BMD of Ward's, 6 months)146Mean Difference (IV, Random, 95% CI)0.06 [0.02, 0.10]
2.70 Kidney-tonifying herbs versus calcium (BMD of Ward's, 6 months)146Mean Difference (IV, Random, 95% CI)0.10 [0.06, 0.14]
2.71 Gujian capsule versus alfacalcidol (BMD of Ward's, 6 months)165Mean Difference (IV, Random, 95% CI)0.08 [0.01, 0.15]
2.72 Qianggu capsule versus alendronate (BMD of Ward's, 6 months)180Mean Difference (IV, Random, 95% CI)0.01 [-0.02, 0.03]
2.73 Xianlinggubao capsule versus alendronate (BMD of Ward's, 6 months)1104Mean Difference (IV, Random, 95% CI)-0.00 [-0.02, 0.02]
2.74 Bugu Shengsui capsule versus vitamin D2 plus calcium tablet (BMD of Ward's, 6 months)130Mean Difference (IV, Random, 95% CI)0.07 [-0.05, 0.19]
2.75 Shangke Jiegu tablet versus vitamin D2 plus calcium tablet (BMD of Ward's, 6 months)130Mean Difference (IV, Random, 95% CI)0.10 [-0.01, 0.22]
2.76 Kanggusong granule versus ipriflavone plus Caltrate (BMD of trochanter, 9 months)171Mean Difference (IV, Random, 95% CI)-0.01 [-0.05, 0.03]
2.77 Kanggusong granule versus Caltrate (BMD of trochanter, 9 months)171Mean Difference (IV, Random, 95% CI)0.03 [-0.00, 0.06]
2.78 Gujian capsule versus alfacalcidol (BMD of trochanter, 6 months)165Mean Difference (IV, Random, 95% CI)0.14 [0.07, 0.20]
2.79 Bugu Shengsui capsule versus vitamin D2 plus calcium tablet (BMD of trochanter, 6 months)130Mean Difference (IV, Random, 95% CI)0.11 [-0.04, 0.27]
2.80 Shangke Jiegu tablet versus vitamin D2 plus calcium tablet (BMD of trochanter, 6 months)130Mean Difference (IV, Random, 95% CI)0.19 [0.04, 0.33]
2.81 Gushukang granule versus Calcium carbonate with vitamin D chewable tablets (BMD of hip bone, 6 months)139Mean Difference (IV, Random, 95% CI)0.02 [-0.02, 0.06]
2.82 Guli powder versus Caltrate (BMD of hip bone, 3 months, male)130Mean Difference (IV, Random, 95% CI)0.0 [-0.04, 0.04]
2.83 Guli powder versus Caltrate (BMD of hip bone, 3 months, female)130Mean Difference (IV, Random, 95% CI)0.03 [-0.05, 0.11]
2.84 TPF capsule versus calcium granule (BMD of distal radius, 6 months)1120Mean Difference (IV, Random, 95% CI)0.20 [0.17, 0.23]
2.85 Jiawei Zhuangyao Jianshen tang versus compound calcium amino acid chelate capsules (BMD of calcaneus, 3 months)158Mean Difference (IV, Random, 95% CI)0.06 [0.01, 0.11]
2.86 Liuwei Dihuang pills versus Caltrate (BMD of lumbar spine, 6 months)171Mean Difference (IV, Random, 95% CI)0.05 [0.03, 0.07]
2.87 Bushen Jianpi Jingu decoction versus calcitonin (BMD of lumbar spine, 3 months)175Mean Difference (IV, Random, 95% CI)0.02 [-0.09, 0.13]
2.88 Bushen Jianpi Jingu decoction versus calcitonin (BMD of femoral neck, 3 months)175Mean Difference (IV, Random, 95% CI)0.05 [-0.02, 0.12]
2.89 Radix rehmanniae preparata and Radix astragali versus calcium carbonate tablets (BMD of lumbar spine, 6 months)164Mean Difference (IV, Random, 95% CI)0.05 [0.03, 0.07]
2.90 Kangshu Jiangu granule versus Caltrate (BMD of femoral neck, 6 months)176Mean Difference (IV, Random, 95% CI)0.08 [0.01, 0.15]
2.91 Kangshu Jiangu granule versus Caltrate (BMD of lumbar spine, 6 months)176Mean Difference (IV, Random, 95% CI)0.11 [0.01, 0.21]
2.92 Bushen Tianjing Huoxue therapy versus Caltrate and calcitriol soft capsule (BMD of lumbar spine, 6 months)161Mean Difference (IV, Random, 95% CI)0.04 [-0.00, 0.07]
3 T score in BMD measurement2330Std. Mean Difference (IV, Random, 95% CI)0.11 [-0.12, 0.34]
3.1 Jingujian granule versus Caltrate (T score, 3 months)1120Std. Mean Difference (IV, Random, 95% CI)0.03 [-0.35, 0.41]
3.2 Jingujian granule versus Caltrate (T score, 3 months)1210Std. Mean Difference (IV, Random, 95% CI)0.16 [-0.12, 0.45]
4 Symptoms including pain, muscle fatigue and limited mobility12 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
4.1 Jiawei Bushen Zhuangjintang versus calcium granule (3 months)190Risk Ratio (M-H, Fixed, 95% CI)1.68 [1.28, 2.19]
4.2 Qianggu soft extract versus calcium gluconate (6 months)199Risk Ratio (M-H, Fixed, 95% CI)1.86 [1.24, 2.80]
4.3 Kanggusong granule versus ipriflavone (3 months)160Risk Ratio (M-H, Fixed, 95% CI)1.6 [1.07, 2.39]
4.4 Yishen Yanggan mixture versus calcium gluconate (6 months)1110Risk Ratio (M-H, Fixed, 95% CI)1.70 [1.28, 2.25]
4.5 Yinyanghuo versus conjugated oestrogens (3 to 6 months)125Risk Ratio (M-H, Fixed, 95% CI)0.96 [0.72, 1.28]
4.6 Gumiling granule versus bicarbonate calcium chewable (6 months)125Risk Ratio (M-H, Fixed, 95% CI)4.26 [1.43, 12.72]
4.7 Jiawei Zhuangyao Jianshen tang versus compound calcium amino acid chelate capsules (3 months)158Risk Ratio (M-H, Fixed, 95% CI)1.25 [0.94, 1.66]
4.8 Zishen Gukang pill versus Caltrate plus vitamin D (3 months)160Risk Ratio (M-H, Fixed, 95% CI)1.27 [1.01, 1.61]
4.9 Xianling Gusong capsules versus Caltrate (3 months)143Risk Ratio (M-H, Fixed, 95% CI)1.57 [1.03, 2.39]
4.10 Kanggusong capsule versus Caltrate (6 months)180Risk Ratio (M-H, Fixed, 95% CI)1.51 [1.12, 2.04]
4.11 Jiangu recipe versus alendronate sodium tablets (12 months)1120Risk Ratio (M-H, Fixed, 95% CI)1.65 [1.31, 2.08]
4.12 Jingujian granule versus Caltrate (3 months)1100Risk Ratio (M-H, Fixed, 95% CI)3.15 [1.89, 5.26]
5 Oestradiol (E2)25 Mean Difference (IV, Random, 95% CI)Subtotals only
5.1 Kanggusong granule versus ipriflavone plus Caltrate (9 months)171Mean Difference (IV, Random, 95% CI)12.17 [8.27, 16.07]
5.2 Kanggusong granule versus Caltrate (9 months)171Mean Difference (IV, Random, 95% CI)11.0 [6.97, 15.03]
5.3 Strong Bone capsule versus Caltrate (3 months)1105Mean Difference (IV, Random, 95% CI)10.46 [4.29, 16.63]
5.4 Bushen Shengsui principle versus conjugated oestrogens plus medroxyprogesterone (6 months)166Mean Difference (IV, Random, 95% CI)4.0 [-3.92, 11.92]
5.5 Bushen Qiangshen pill versus Caltrate (3 months)130Mean Difference (IV, Random, 95% CI)6.71 [-2.28, 15.70]
5.6 Qianggu soft extract versus calcium gluconate (6 months)199Mean Difference (IV, Random, 95% CI)4.20 [0.89, 7.51]
5.7 Gukang oral liquid versus alendronate (6 months)160Mean Difference (IV, Random, 95% CI)3.90 [-6.64, 14.44]
5.8 Gumikang capsule versus calcium gluconate (6 months)160Mean Difference (IV, Random, 95% CI)3.5 [1.14, 5.86]
5.9 Bushen Yigu soft extract versus Alfacalcidol (3 months)174Mean Difference (IV, Random, 95% CI)76.29 [31.19, 121.39]
5.10 Kanggusong granule versus ipriflavone (3 months)160Mean Difference (IV, Random, 95% CI)4.18 [-13.85, 22.21]
5.11 Yanghuo Sanzi tang versus Caltrate (6 months)160Mean Difference (IV, Random, 95% CI)23.07 [17.83, 28.31]
5.12 Gusong recipe versus alendronate sodium tablets (5 months)140Mean Difference (IV, Random, 95% CI)3.90 [-9.01, 16.81]
5.13 Gushukang granule versus ipriflavone (6 months)160Mean Difference (IV, Random, 95% CI)13.98 [3.90, 24.06]
5.14 Bushen Jianpi Huoxue recipe versus alendronate sodium tablets (6 months)1141Mean Difference (IV, Random, 95% CI)3.15 [0.28, 6.02]
5.15 Prescription for tonifying kidney versus ipriflavone (6 months)160Mean Difference (IV, Random, 95% CI)14.00 [3.68, 24.32]
5.16 Kidney meridian sticking versus ipriflavone (6 months)160Mean Difference (IV, Random, 95% CI)11.99 [1.15, 22.83]
5.17 Urinary bladder meridian sticking versus ipriflavone (6 months)160Mean Difference (IV, Random, 95% CI)17.99 [7.65, 28.33]
5.18 Huangqi Sanxian tang versus nilestriol (3 months)150Mean Difference (IV, Random, 95% CI)-32.97 [-39.42, -26.52]
5.19 Gukang oral liquid versus alendronate sodium tablets (6 months)170Mean Difference (IV, Random, 95% CI)5.09 [2.81, 7.37]
5.20 Gukang decoction versus alendronate sodium tablets (4 months)183Mean Difference (IV, Random, 95% CI)-0.65 [-9.04, 7.74]
5.21 Jianshenfang granule versus alendronate sodium (6 months)160Mean Difference (IV, Random, 95% CI)5.83 [4.21, 7.45]
5.22 Jiangu recipe versus alendronate sodium tablets (6 months)1120Mean Difference (IV, Random, 95% CI)5.82 [3.69, 7.95]
5.23 Jiangu recipe versus alendronate sodium tablets (12 months)1120Mean Difference (IV, Random, 95% CI)10.75 [8.55, 12.95]
5.24 Bushen Zhuanggu tang versus alendronate sodium tablets (3 months)160Mean Difference (IV, Random, 95% CI)5.37 [2.07, 8.67]
5.25 Bushen Huoxue capsule versus Caltrate and Rocalirol (12 months)159Mean Difference (IV, Random, 95% CI)2.13 [0.42, 3.84]
5.26 Jingujian granule versus Caltrate (3 months)1210Mean Difference (IV, Random, 95% CI)4.85 [4.56, 5.14]
5.27 Qianggu paste versus calcium gluconate tablets (6 months)1123Mean Difference (IV, Random, 95% CI)4.20 [1.79, 6.61]
5.28 Tongbu Qianggutang versus calcium plus vitamin D3 (female, 3 months)118Mean Difference (IV, Random, 95% CI)5.03 [-8.01, 18.07]
5.29 Tongbu Qianggutang versus calcium plus vitamin D3 (male, 3 months)122Mean Difference (IV, Random, 95% CI)1.89 [-17.98, 21.77]
5.30 Gujian capsule versus alfacalcidol (6 months)158Mean Difference (IV, Random, 95% CI)22.35 [-10.51, 55.21]
5.31 Radix rehmanniae preparata and Radix astragali versus calcium carbonate tablets (6 months)164Mean Difference (IV, Random, 95% CI)8.78 [0.92, 16.64]
6 Serum calcium (Ca)22 Mean Difference (IV, Random, 95% CI)Subtotals only
6.1 Kanggusong granule versus ipriflavone plus Caltrate (9 months)171Mean Difference (IV, Random, 95% CI)-0.09 [-0.17, -0.01]
6.2 Kanggusong granule versus Caltrate (9 months)171Mean Difference (IV, Random, 95% CI)-0.03 [-0.11, 0.05]
6.3 Gushukang granule versus Calcium carbonate with vitamin D chewable tablets (6 months)139Mean Difference (IV, Random, 95% CI)-0.02 [-0.10, 0.06]
6.4 Strong Bone capsule versus Caltrate (3 months)1105Mean Difference (IV, Random, 95% CI)-0.13 [-0.22, -0.04]
6.5 Qianggu soft extract versus calcium gluconate (6 months)199Mean Difference (IV, Random, 95% CI)-0.03 [-0.05, -0.01]
6.6 Gumikang capsule versus calcium gluconate (6 months)160Mean Difference (IV, Random, 95% CI)1.40 [1.39, 1.41]
6.7 Bushen Jianpi Migu prescription versus Caltrate (3 months)1150Mean Difference (IV, Random, 95% CI)0.01 [-0.05, 0.07]
6.8 Kanggusong granule versus ipriflavone (3 months)160Mean Difference (IV, Random, 95% CI)0.10 [0.03, 0.17]
6.9 Bugu Shengsui capsule versus vitamin D2 plus calcium tablet (6 months)144Mean Difference (IV, Random, 95% CI)0.10 [-0.05, 0.25]
6.10 Yinyanghuo versus conjugated oestrogens (3 to 6 months)125Mean Difference (IV, Random, 95% CI)0.54 [0.23, 0.85]
6.11 Gushukang granule versus ipriflavone (6 months)160Mean Difference (IV, Random, 95% CI)-0.02 [-0.07, 0.03]
6.12 Shenyao capsules versus Caltrate (6 months)1100Mean Difference (IV, Random, 95% CI)0.02 [-0.08, 0.12]
6.13 Guli powder versus Caltrate (3 months)160Mean Difference (IV, Random, 95% CI)0.09 [0.02, 0.16]
6.14 Prescription for tonifying kidney versus ipriflavone (6 months)160Mean Difference (IV, Random, 95% CI)0.0 [-0.05, 0.05]
6.15 Kidney meridian sticking versus ipriflavone (6 months)160Mean Difference (IV, Random, 95% CI)-0.01 [-0.06, 0.04]
6.16 Urinary bladder meridian sticking versus ipriflavone (6 months)160Mean Difference (IV, Random, 95% CI)-0.01 [-0.06, 0.04]
6.17 Gushen Yijing tang versus Caltrate (6 months)180Mean Difference (IV, Random, 95% CI)0.23 [0.11, 0.35]
6.18 Gukang oral liquid versus alendronate sodium tablets (6 months)170Mean Difference (IV, Random, 95% CI)-0.02 [-0.06, 0.02]
6.19 Qianggu capsule versus active vitamin D3 (6 months)154Mean Difference (IV, Random, 95% CI)0.01 [-0.06, 0.08]
6.20 Jiangu capsule versus Caltrate (12 months)1125Mean Difference (IV, Random, 95% CI)-0.06 [-0.11, -0.01]
6.21 Bushen Yangxue tang versus calcium gluconate (6 months)140Mean Difference (IV, Random, 95% CI)0.13 [-0.00, 0.26]
6.22 Bushenjianpi Zhuangguyin versus Caltrate and calcitonin (12 weeks)1100Mean Difference (IV, Random, 95% CI)0.74 [0.66, 0.82]
6.23 Erxian soup versus Caltrate (6 months)158Mean Difference (IV, Random, 95% CI)-0.02 [-0.25, 0.21]
6.24 Qianggu paste versus calcium gluconate tablets (6 months)1123Mean Difference (IV, Random, 95% CI)-0.03 [-0.06, -0.00]
6.25 Tongbu Qianggutang versus calcium plus vitamin D3 (3 months)140Mean Difference (IV, Random, 95% CI)-0.02 [-0.10, 0.06]
6.26 Radix rehmanniae preparata and Radix astragali versus calcium carbonate tablets (6 months)164Mean Difference (IV, Random, 95% CI)-0.01 [-0.05, 0.03]
7 Phosphorus (P)17 Mean Difference (IV, Fixed, 95% CI)Subtotals only
7.1 Kanggusong granule versus ipriflavone plus Caltrate (9 months)171Mean Difference (IV, Fixed, 95% CI)0.06 [-0.03, 0.15]
7.2 Kanggusong granule versus Caltrate (9 months)171Mean Difference (IV, Fixed, 95% CI)-0.01 [-0.29, 0.27]
7.3 Gushukang granule versus Calcium carbonate with vitamin D chewable tablets (6 months)139Mean Difference (IV, Fixed, 95% CI)0.01 [-0.09, 0.11]
7.4 Strong Bone capsule versus Caltrate (3 months)1105Mean Difference (IV, Fixed, 95% CI)-0.12 [-0.21, -0.03]
7.5 Bushen Jianpi Migu prescription versus Caltrate (3 months)1150Mean Difference (IV, Fixed, 95% CI)0.03 [-0.02, 0.08]
7.6 Kanggusong granule versus ipriflavone (3 months)160Mean Difference (IV, Fixed, 95% CI)-0.07 [-0.20, 0.06]
7.7 Yinyanghuo versus conjugated oestrogens (3 to 6 months)125Mean Difference (IV, Fixed, 95% CI)0.13 [-0.13, 0.39]
7.8 Shenyao capsules versus Caltrate (6 months)1100Mean Difference (IV, Fixed, 95% CI)-0.01 [-0.08, 0.06]
7.9 Gushukang granule versus ipriflavone (6 months)160Mean Difference (IV, Fixed, 95% CI)-0.01 [-0.13, 0.11]
7.10 Guli powder versus Caltrate (3 months)160Mean Difference (IV, Fixed, 95% CI)-0.05 [-0.13, 0.03]
7.11 Prescription for tonifying kidney versus ipriflavone (6 months)160Mean Difference (IV, Fixed, 95% CI)-0.04 [-0.15, 0.07]
7.12 Kidney meridian sticking versus ipriflavone (6 months)160Mean Difference (IV, Fixed, 95% CI)-0.01 [-0.13, 0.11]
7.13 Urinary bladder meridian sticking versus ipriflavone (6 months)160Mean Difference (IV, Fixed, 95% CI)-0.01 [-0.13, 0.11]
7.14 Gushen Yijing tang versus Caltrate (6 months)180Mean Difference (IV, Fixed, 95% CI)0.04 [-0.09, 0.17]
7.15 Qianggu capsule versus active vitamin D3 (6 months)154Mean Difference (IV, Fixed, 95% CI)0.02 [-0.05, 0.09]
7.16 Jiangu capsule versus Caltrate (12 months)1125Mean Difference (IV, Fixed, 95% CI)0.09 [-0.20, 0.38]
7.17 Bushenzhuanggu decoction versus alendronate sodium tablets (3 months)160Mean Difference (IV, Fixed, 95% CI)0.24 [0.10, 0.38]
7.18 Bushenjianpi Zhuangguyin versus Caltrate and calcitonin (12 weeks)1100Mean Difference (IV, Fixed, 95% CI)-0.37 [-0.48, -0.26]
7.19 Erxian soup versus Caltrate (6 months)158Mean Difference (IV, Fixed, 95% CI)-0.03 [-0.20, 0.14]
7.20 Tongbu Qianggutang versus calcium plus vitamin D3 (3 months)140Mean Difference (IV, Fixed, 95% CI)-0.01 [-0.12, 0.10]
7.21 Radix rehmanniae preparata and Radix astragali versus calcium carbonate tablets (6 months)164Mean Difference (IV, Fixed, 95% CI)0.0 [-0.15, 0.15]
8 Alkaline phosphatase (ALP)32 Mean Difference (IV, Fixed, 95% CI)Subtotals only
8.1 Kanggusong granule versus ipriflavone plus Caltrate (9 months)171Mean Difference (IV, Fixed, 95% CI)1.69 [0.79, 2.59]
8.2 Kanggusong granule versus Caltrate (9 months)171Mean Difference (IV, Fixed, 95% CI)1.28 [0.30, 2.26]
8.3 Gushukang granule versus Calcium carbonate with vitamin D chewable tablets (6 months)139Mean Difference (IV, Fixed, 95% CI)-0.5 [-1.70, 0.70]
8.4 Strong Bone capsule versus Caltrate (3 months)1105Mean Difference (IV, Fixed, 95% CI)-0.07 [-0.25, 0.11]
8.5 Bushen Qiangshen pill versus Caltrate (3 months)130Mean Difference (IV, Fixed, 95% CI)0.27 [-1.27, 1.81]
8.6 Qianggu soft extract versus calcium gluconate (6 months)199Mean Difference (IV, Fixed, 95% CI)3.60 [2.62, 4.58]
8.7 Gukang oral liquid versus alendronate (6 months)160Mean Difference (IV, Fixed, 95% CI)-1.06 [-2.54, 0.42]
8.8 Gumikang capsule versus calcium gluconate (6 months)160Mean Difference (IV, Fixed, 95% CI)3.41 [2.84, 3.98]
8.9 Bushen Jianpi Migu prescription versus Caltrate (3 months)1150Mean Difference (IV, Fixed, 95% CI)0.10 [0.01, 0.19]
8.10 Kanggusong granule versus ipriflavone (3 months)160Mean Difference (IV, Fixed, 95% CI)0.13 [-0.07, 0.33]
8.11 Bugu Shengsui capsule versus vitamin D2 plus calcium tablet (6 months)144Mean Difference (IV, Fixed, 95% CI)-0.29 [-1.67, 1.09]
8.12 Liuwei Dihuang pills versus calcium (12 months)142Mean Difference (IV, Fixed, 95% CI)0.55 [-0.12, 1.22]
8.13 TPF capsule versus calcium granule (6 months)1120Mean Difference (IV, Fixed, 95% CI)3.84 [2.53, 5.15]
8.14 Yinyanghuo versus conjugated oestrogens (3 to 6 months)125Mean Difference (IV, Fixed, 95% CI)-7.0 [-11.17, -2.83]
8.15 Gusong recipe versus alendronate sodium tablets (5 months)140Mean Difference (IV, Fixed, 95% CI)-1.05 [-2.86, 0.76]
8.16 Shenyao capsules versus Caltrate (6 months)1100Mean Difference (IV, Fixed, 95% CI)-2.40 [-3.58, -1.22]
8.17 Bushen Jianpi Huoxue recipe versus alendronate sodium tablets (6 months)1141Mean Difference (IV, Fixed, 95% CI)-2.94 [-4.34, -1.54]
8.18 Guli powder versus Caltrate (3 months)160Mean Difference (IV, Fixed, 95% CI)0.30 [-2.97, 3.57]
8.19 Huangqi Sanxian tang versus nilestriol (3 months)150Mean Difference (IV, Fixed, 95% CI)-0.03 [-1.14, 1.08]
8.20 Gushen Yijing tang versus Caltrate (6 months)180Mean Difference (IV, Fixed, 95% CI)2.17 [0.73, 3.61]
8.21 Gukang oral liquid versus alendronate sodium Tablets170Mean Difference (IV, Fixed, 95% CI)0.48 [-0.34, 1.30]
8.22 Qianggu capsule versus active vitamin D3 (6 months)154Mean Difference (IV, Fixed, 95% CI)0.71 [-1.17, 2.59]
8.23 Jiangu capsule versus Caltrate (12 months)1125Mean Difference (IV, Fixed, 95% CI)2.04 [1.32, 2.76]
8.24 Jianshenfang granule versus alendronate sodium tablets (3 months)160Mean Difference (IV, Fixed, 95% CI)0.33 [-2.79, 3.45]
8.25 Jingujian granule versus Caltrate (3 months)1120Mean Difference (IV, Fixed, 95% CI)0.53 [-0.69, 1.75]
8.26 Jianshenfang granule versus alendronate sodium tablets (6 months)160Mean Difference (IV, Fixed, 95% CI)0.33 [-2.78, 3.44]
8.27 Bushen Zhuanggu tang versus alendronate sodium tablets (3 months)160Mean Difference (IV, Fixed, 95% CI)-0.11 [-0.99, 0.77]
8.28 Bushenjianpi Zhuangguyin versus Caltrate and calcitonin (12 weeks)1100Mean Difference (IV, Fixed, 95% CI)-0.82 [-2.83, 1.19]
8.29 Jingujian granule versus Caltrate (3 months)1210Mean Difference (IV, Fixed, 95% CI)2.40 [2.21, 2.59]
8.30 Erxian soup versus Caltrate (6 months)158Mean Difference (IV, Fixed, 95% CI)0.0 [-0.87, 0.87]
8.31 Qianggu paste versus calcium gluconate tablets (6 months)1123Mean Difference (IV, Fixed, 95% CI)3.60 [2.86, 4.34]
8.32 Bushen Yangxue tang versus calcium gluconate (6 months)140Mean Difference (IV, Fixed, 95% CI)2.62 [0.84, 4.40]
8.33 Tongbu Qianggutang versus calcium plus vitamin D3 (3 months)140Mean Difference (IV, Fixed, 95% CI)0.18 [-1.08, 1.44]
8.34 Radix rehmanniae preparata and Radix astragali versus calcium carbonate tablets (6 months)164Mean Difference (IV, Fixed, 95% CI)0.91 [0.15, 1.67]
9 Bone Gla protein (BGP)14 Mean Difference (IV, Random, 95% CI)Subtotals only
9.1 Bushen Jianpi Huoxue recipe versus alendronate sodium tablets (6 months)1141Mean Difference (IV, Random, 95% CI)-2.13 [-2.74, -1.52]
9.2 Acupoint sticking of Migudan versus oyster shell calcium chewable tablets (3 months)196Mean Difference (IV, Random, 95% CI)1.55 [1.24, 1.86]
9.3 Gukang oral liquid versus alendronate (6 months)160Mean Difference (IV, Random, 95% CI)-0.10 [-0.93, 0.73]
9.4 Gusong recipe versus alendronate sodium tablets (5 months)140Mean Difference (IV, Random, 95% CI)-0.10 [-1.11, 0.91]
9.5 Yanghuo Sanzi tang versus Caltrate (6 months)160Mean Difference (IV, Random, 95% CI)2.71 [-0.30, 5.72]
9.6 Strong Bone capsule versus Caltrate (3 months)1105Mean Difference (IV, Random, 95% CI)-0.49 [-2.17, 1.19]
9.7 Shigu yin versus Caltrate (6 months)180Mean Difference (IV, Random, 95% CI)0.80 [-0.34, 1.94]
9.8 Jingujian granule versus Caltrate (3 months)1120Mean Difference (IV, Random, 95% CI)2.53 [-0.38, 5.44]
9.9 Jianshenfang granule versus alendronate sodium (6 months)160Mean Difference (IV, Random, 95% CI)0.49 [-1.59, 2.57]
9.10 Jiangu recipe versus alendronate sodium tablets (12 months)1120Mean Difference (IV, Random, 95% CI)1.81 [-0.31, 3.93]
9.11 Bushen Huoxue capsules versus Caltrate and Rocalirol (12 months)160Mean Difference (IV, Random, 95% CI)0.93 [0.35, 1.51]
9.12 Kanggusong capsule versus Caltrate (6 months)180Mean Difference (IV, Random, 95% CI)1.78 [0.40, 3.16]
9.13 Liuwei Dihuang pills versus calcium (12 months)142Mean Difference (IV, Random, 95% CI)17.9 [12.43, 23.37]
9.14 Tongbu Qianggutang versus calcium plus vitamin D3 (3 months)140Mean Difference (IV, Random, 95% CI)-1.50 [-5.07, 2.08]
10 Interleukin-6 (IL-6)7 Mean Difference (IV, Fixed, 95% CI)Subtotals only
10.1 Bushen Jianpi Huoxue recipe versus alendronate sodium tablets (6 months)1141Mean Difference (IV, Fixed, 95% CI)-5.72 [-14.05, 2.61]
10.2 Gukang oral liquid versus alendronate (6 months)160Mean Difference (IV, Fixed, 95% CI)-3.5 [-15.93, 8.93]
10.3 Yanghuo Sanzi tang versus Caltrate (6 months)160Mean Difference (IV, Fixed, 95% CI)-20.29 [-35.67, -4.91]
10.4 Jianshenfang granule versus alendronate sodium (6 months)160Mean Difference (IV, Fixed, 95% CI)-12.56 [-29.26, 4.14]
10.5 Jiangu recipe versus alendronate sodium tablets (12 months)1120Mean Difference (IV, Fixed, 95% CI)-19.99 [-30.92, -9.06]
10.6 Bushen Huoxue capsules versus Caltrate and Rocalirol (12 months)160Mean Difference (IV, Fixed, 95% CI)-18.70 [-34.16, -3.24]
10.7 Gusong recipe versus alendronate sodium tablets (5 months)140Mean Difference (IV, Fixed, 95% CI)-3.5 [-18.72, 11.72]
11 Parathyroid hormone (PTH)6 Mean Difference (IV, Fixed, 95% CI)Subtotals only
11.1 Prescription for tonifying kidney versus ipriflavone (6 months)160Mean Difference (IV, Fixed, 95% CI)-13.0 [-41.67, 15.67]
11.2 Kidney meridian sticking versus ipriflavone (6 months)160Mean Difference (IV, Fixed, 95% CI)-13.01 [-41.95, 15.93]
11.3 Urinary bladder meridian sticking versus ipriflavone (6 months)160Mean Difference (IV, Fixed, 95% CI)-3.01 [-31.44, 25.42]
11.4 Kanggusong granule versus ipriflavone (3 months)160Mean Difference (IV, Fixed, 95% CI)11.81 [-14.64, 38.26]
11.5 Bugu Shengsui capsule versus vitamin D2 plus calcium tablet (6 months)144Mean Difference (IV, Fixed, 95% CI)-10.63 [-140.92, 119.66]
11.6 TPF capsule versus calcium granule (6 months)1120Mean Difference (IV, Fixed, 95% CI)-254.0 [-399.06, -108.94]
11.7 Gujian capsule versus alfacalcidol (6 months)148Mean Difference (IV, Fixed, 95% CI)-22.57 [-60.92, 15.78]
11.8 Gushukang granule versus ipriflavone (6 months)160Mean Difference (IV, Fixed, 95% CI)-3.02 [-30.91, 24.87]
11.9 Radix rehmanniae preparata and Radix astragali versus calcium carbonate tablets (6 months)164Mean Difference (IV, Fixed, 95% CI)-2.06 [-6.74, 2.62]
12 Computed tomography (CT)8 Mean Difference (IV, Random, 95% CI)Subtotals only
12.1 Prescription for tonifying kidney versus ipriflavone (6 months)160Mean Difference (IV, Random, 95% CI)0.96 [-3.71, 5.63]
12.2 Kidney meridian sticking versus ipriflavone (6 months)160Mean Difference (IV, Random, 95% CI)-1.01 [-5.44, 3.42]
12.3 Urinary bladder meridian sticking versus ipriflavone (6 months)160Mean Difference (IV, Random, 95% CI)-0.01 [-4.68, 4.66]
12.4 Bugu Shengsui capsule versus vitamin D2 plus calcium tablet (6 months)144Mean Difference (IV, Random, 95% CI)15.93 [-24.16, 56.02]
12.5 Strong Bone capsule versus Caltrate (3 months)1105Mean Difference (IV, Random, 95% CI)16.25 [10.43, 22.07]
12.6 Jingujian granule versus Caltrate (3 months)1210Mean Difference (IV, Random, 95% CI)21.98 [17.01, 26.95]
12.7 TPF capsule versus Calcium granule (6 months)1120Mean Difference (IV, Random, 95% CI)17.71 [11.53, 23.89]
12.8 Tongbu Qianggutang versus calcium plus vitamin D3 (3 months)140Mean Difference (IV, Random, 95% CI)-6.18 [-12.89, 0.52]
12.9 Gujian capsule versus alfacalcidol (6 months)157Mean Difference (IV, Random, 95% CI)-12.77 [-70.92, 45.38]
12.10 Gushukang granule versus ipriflavone (6 months)160Mean Difference (IV, Random, 95% CI)-0.01 [-4.44, 4.42]
12.11 Radix rehmanniae preparata and Radix astragali versus calcium carbonate tablets (6 months)164Mean Difference (IV, Random, 95% CI)0.11 [-0.04, 0.26]
Analysis 3.1.

Comparison 3 Chinese herbal medicines versus western medicine, Outcome 1 New fractures.

Analysis 3.2.

Comparison 3 Chinese herbal medicines versus western medicine, Outcome 2 Bone mineral density (BMD).

Analysis 3.3.

Comparison 3 Chinese herbal medicines versus western medicine, Outcome 3 T score in BMD measurement.

Analysis 3.4.

Comparison 3 Chinese herbal medicines versus western medicine, Outcome 4 Symptoms including pain, muscle fatigue and limited mobility.

Analysis 3.5.

Comparison 3 Chinese herbal medicines versus western medicine, Outcome 5 Oestradiol (E2).

Analysis 3.6.

Comparison 3 Chinese herbal medicines versus western medicine, Outcome 6 Serum calcium (Ca).

Analysis 3.7.

Comparison 3 Chinese herbal medicines versus western medicine, Outcome 7 Phosphorus (P).

Analysis 3.8.

Comparison 3 Chinese herbal medicines versus western medicine, Outcome 8 Alkaline phosphatase (ALP).

Analysis 3.9.

Comparison 3 Chinese herbal medicines versus western medicine, Outcome 9 Bone Gla protein (BGP).

Analysis 3.10.

Comparison 3 Chinese herbal medicines versus western medicine, Outcome 10 Interleukin-6 (IL-6).

Analysis 3.11.

Comparison 3 Chinese herbal medicines versus western medicine, Outcome 11 Parathyroid hormone (PTH).

Analysis 3.12.

Comparison 3 Chinese herbal medicines versus western medicine, Outcome 12 Computed tomography (CT).

Comparison 4. Chinese herbal medicines plus western medicine versus western medicine
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 New fractures5 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 Yigu capsule plus calcium versus placebo plus calcium (6 months)1140Risk Ratio (M-H, Fixed, 95% CI)0.06 [0.00, 1.00]
1.2 Xianlinggubao capsule (low-dose) plus calcium and vitamin D versus placebo plus calcium and vitamin D (12 months)1120Risk Ratio (M-H, Fixed, 95% CI)0.33 [0.01, 8.02]
1.3 Xianlinggubao capsule (high-dose) plus calcium and vitamin D versus placebo plus calcium and vitamin D (12 months)1116Risk Ratio (M-H, Fixed, 95% CI)0.36 [0.01, 8.58]
1.4 Bushen Zhuanggu granules plus calcium and vitamin D versus placebo granules plus calcium and vitamin D (5 years)1155Risk Ratio (M-H, Fixed, 95% CI)0.44 [0.13, 1.43]
1.5 Kanggusong soup plus Caltrate versus Caltrate (3 months)175Risk Ratio (M-H, Fixed, 95% CI)0.22 [0.01, 5.34]
1.6 Zhuangguqiangjin tablet and Shujinbogu tablet plus calcitonin versus calcitonin (12 months)190Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
2 Bone mineral density (BMD)43 Mean Difference (IV, Random, 95% CI)Subtotals only
2.1 Gushen decoction plus Caltrate and Alfacalcidol versus Caltrate and Alfacalcidol (BMD of lumbar spine, 6 months)164Mean Difference (IV, Random, 95% CI)0.06 [0.01, 0.11]
2.2 Jiarong tablet plus Caltrate versus Caltrate (BMD of lumbar spine, 6 months)141Mean Difference (IV, Random, 95% CI)0.04 [-0.05, 0.14]
2.3 Ziyin Bushen Zhuanggu prescription plus Caltrate and calcitonin versus Caltrate plus calcitonin (BMD of lumbar spine, 8 months)145Mean Difference (IV, Random, 95% CI)0.14 [0.08, 0.20]
2.4 Zhuanggu capsule plus Caltrate versus Caltrate (BMD of lumbar spine, 6 months)160Mean Difference (IV, Random, 95% CI)0.01 [0.00, 0.02]
2.5 Antai capsule plus Caltrate versus Caltrate (BMD of lumbar spine, 6 months)1128Mean Difference (IV, Random, 95% CI)0.04 [-0.00, 0.08]
2.6 Bushen Zhuanggutang plus Caltrate versus Caltrate (BMD of lumbar spine, 6 months)160Mean Difference (IV, Random, 95% CI)0.14 [0.06, 0.22]
2.7 Zishen prescription plus Caltrate and calcitonin versus Caltrate plus calcitonin (BMD of lumbar spine, 8 months)145Mean Difference (IV, Random, 95% CI)0.14 [0.08, 0.20]
2.8 Guilu Erxiantang plus calcium carbonate tablet versus calcium carbonate tablet (BMD of lumbar spine, 6 months)185Mean Difference (IV, Random, 95% CI)0.03 [-0.03, 0.09]
2.9 Guben Zhuanggu capsules plus Caltrate versus Caltrate (BMD of lumbar spine, 6 months)160Mean Difference (IV, Random, 95% CI)0.03 [0.01, 0.05]
2.10 Migu tablet plus Caltrate versus Caltrate (BMD of Lumbar spine, 12 months)144Mean Difference (IV, Random, 95% CI)0.08 [0.07, 0.09]
2.11 Shugan zishen huoxue tang plus Caltrate and alendronate sodium versus Caltrate plus alendronate sodium (BMD of lumbar spine, 6 months)142Mean Difference (IV, Random, 95% CI)0.12 [0.08, 0.16]
2.12 Bushen Yangxue tang plus Caltrate versus Caltrate (BMD of lumbar spine, 6 months)160Mean Difference (IV, Random, 95% CI)0.02 [-0.02, 0.06]
2.13 Bushen Kangsong pill plus calcium carbonate tablets versus calcium carbonate tablets (BMD of lumbar spine, 6 months)184Mean Difference (IV, Random, 95% CI)0.01 [-0.03, 0.04]
2.14 Gusongbao granule plus compound calcium amino acid chelate capsule versus placebo granule plus compound calcium amino acid chelate capsule (BMD of lumbar spine, 6 months)196Mean Difference (IV, Random, 95% CI)-0.01 [-0.07, 0.05]
2.15 Qianggu capsule plus alendronate versus alendronate (BMD of lumbar spine, 6 months)180Mean Difference (IV, Random, 95% CI)0.08 [0.03, 0.12]
2.16 Xianlinggubao capsule plus Caltrate versus Caltrate (BMD of lumbar spine, 12 months)168Mean Difference (IV, Random, 95% CI)0.30 [0.25, 0.35]
2.17 Xianlinggubao capsule plus salmon calcitonin and Caltrate versus salmon calcitonin plus Caltrate (BMD of lumbar spine, 3 months)1107Mean Difference (IV, Random, 95% CI)0.03 [-0.03, 0.09]
2.18 Xianlinggubao capsule plus alendronate versus alendronate (BMD of lumbar spine, 6 months)1104Mean Difference (IV, Random, 95% CI)0.06 [0.03, 0.09]
2.19 Xianlinggubao capsule plus vitamin D3 and calcium amino acid chelate versus vitamin D3 and calcium amino acid chelate (BMD of lumbar spine, 48 weeks)1112Mean Difference (IV, Random, 95% CI)0.01 [-0.03, 0.06]
2.20 Xianlinggubao capsule plus Caltrate versus Caltrate (BMD of lumbar spine, 12 months)1136Mean Difference (IV, Random, 95% CI)0.31 [0.28, 0.34]
2.21 Xianlinggubao capsule plus compound calcium amino acid chelate capsule versus compound calcium amino acid chelate capsule (BMD of lumbar spine, 6 months)1106Mean Difference (IV, Random, 95% CI)0.18 [0.14, 0.22]
2.22 Jiangu granule plus compound calcium amino acid chelate capsule versus placebo granule plus compound calcium amino acid chelate capsule (BMD of lumbar spine, 6 months)196Mean Difference (IV, Random, 95% CI)0.04 [-0.02, 0.10]
2.23 Jinwugutong capsules plus calcium versus placebo plus calcium (BMD of lumbar spine, 6 months)1120Mean Difference (IV, Random, 95% CI)0.11 [0.07, 0.15]
2.24 Xuduanzhuanggu capsule plus calcium tablet versus placebo plus calcium tablet (BMD of lumbar spine, 6 months)1480Mean Difference (IV, Random, 95% CI)0.02 [-0.01, 0.05]
2.25 Chinese medicine Bushenhuoxue recipe plus conventional western medicine versus conventional western medicine (BMD of lumbar spine, 3 months)157Mean Difference (IV, Random, 95% CI)0.16 [0.09, 0.22]
2.26 Gusongbao granule plus calcium tablet versus placebo plus calcium tablet (BMD of lumbar spine, 6 months)1240Mean Difference (IV, Random, 95% CI)-0.01 [-0.05, 0.03]
2.27 Shengsuiyin recipe plus Caltrate versus Caltrate (BMD of Lumbar spine, 12 months)1144Mean Difference (IV, Random, 95% CI)0.31 [0.28, 0.34]
2.28 Yigu capsule plus calcium versus placebo plus calcium (BMD of lumbar spine, 6 months)1140Mean Difference (IV, Random, 95% CI)0.08 [0.04, 0.12]
2.29 Chinese medicine (combination of 10 herbs) plus tamoxifen and Caltrate versus tamoxifen and Caltrate (BMD of lumbar spine, 3 months)1120Mean Difference (IV, Random, 95% CI)0.10 [0.06, 0.14]
2.30 Zhuangguqiangjin tablet and Shujinbogu tablet plus calcitonin versus calcitonin (BMD of lumbar spine, 12 months)190Mean Difference (IV, Random, 95% CI)0.01 [-0.04, 0.06]
2.31 Migu tablet plus compound calcium amino acid chelate capsule versus compound calcium amino acid chelate capsule (BMD of lumbar spine, 6 months)1107Mean Difference (IV, Random, 95% CI)0.17 [0.14, 0.20]
2.32 Huangqi plus Caltrate versus Caltrate (BMD of lumbar spine, 6 months)136Mean Difference (IV, Random, 95% CI)0.06 [0.01, 0.11]
2.33 Jiarong tablet plus Caltrate versus Caltrate (BMD of femoral neck, 6 months)141Mean Difference (IV, Random, 95% CI)0.09 [0.02, 0.15]
2.34 Antai capsule plus Caltrate versus Caltrate (BMD of femoral neck, 6 months)1128Mean Difference (IV, Random, 95% CI)0.01 [-0.02, 0.04]
2.35 Xianlinggubao capsule plus Caltrate versus Caltrate (BMD of femoral neck, 12 months)168Mean Difference (IV, Random, 95% CI)0.3 [0.25, 0.35]
2.36 Guben Zhuanggu capsules plus Caltrate versus Caltrate (BMD of femoral neck, 6 months)160Mean Difference (IV, Random, 95% CI)0.01 [-0.01, 0.02]
2.37 Migu tablet plus Caltrate versus Caltrate (BMD of femoral neck, 12 months)144Mean Difference (IV, Random, 95% CI)0.09 [0.08, 0.10]
2.38 Qianggu capsules plus oestradiol valerate versus oestradiol valerate (BMD of femoral neck, 6 months)188Mean Difference (IV, Random, 95% CI)0.03 [-0.01, 0.07]
2.39 Chinese medicine Bushenhuoxue recipe plus conventional western medicine versus conventional western medicine (BMD of femoral neck, 3 months)157Mean Difference (IV, Random, 95% CI)0.17 [0.12, 0.23]
2.40 Heche Dazao pill plus oyster shell calcium chewable tablets versus oyster shell calcium chewable tablets (BMD of femoral neck, 3 months)1114Mean Difference (IV, Random, 95% CI)0.04 [0.00, 0.07]
2.41 Xianlinggubao capsule plus compound calcium amino acid chelate capsule versus compound calcium amino acid chelate capsule (BMD of femoral neck, 6 months)1106Mean Difference (IV, Random, 95% CI)0.26 [0.22, 0.30]
2.42 Huangqi plus Caltrate versus Caltrate (BMD of femoral neck, 6 months)136Mean Difference (IV, Random, 95% CI)0.07 [0.03, 0.11]
2.43 Gusongbao granule plus compound calcium amino acid chelate capsule versus placebo granule plus compound calcium amino acid chelate capsule (BMD of femoral neck, 6 months)196Mean Difference (IV, Random, 95% CI)0.01 [-0.03, 0.05]
2.44 Jiangu granule plus compound calcium amino acid chelate capsule versus placebo granule plus compound calcium amino acid chelate capsule (BMD of femoral neck, 6 months)196Mean Difference (IV, Random, 95% CI)-0.02 [-0.07, 0.03]
2.45 Xuduanzhuanggu capsule plus calcium tablet versus placebo plus calcium tablet (BMD of femoral neck, 6 months)1480Mean Difference (IV, Random, 95% CI)0.01 [-0.01, 0.03]
2.46 Gusongbao granule plus calcium tablet versus placebo plus calcium tablet (BMD of femoral neck, 6 months)1240Mean Difference (IV, Random, 95% CI)0.0 [-0.03, 0.03]
2.47 Yigu capsule plus calcium versus placebo plus calcium (BMD of femoral neck, 6 months)1140Mean Difference (IV, Random, 95% CI)0.04 [0.01, 0.07]
2.48 Migu tablet plus compound calcium amino acid chelate capsule versus compound calcium amino acid chelate capsule (BMD of femoral neck, 6 months)1107Mean Difference (IV, Random, 95% CI)0.24 [0.21, 0.27]
2.49 Antai capsule plus Caltrate versus Caltrate (BMD of Ward's, 6 months)1128Mean Difference (IV, Random, 95% CI)0.0 [-0.03, 0.03]
2.50 Migu tablet plus Caltrate versus Caltrate (BMD of Ward's, 12 months)144Mean Difference (IV, Random, 95% CI)0.09 [0.08, 0.10]
2.51 Qianggu capsule plus alendronate versus alendronate (BMD of Ward's, 6 months)180Mean Difference (IV, Random, 95% CI)0.05 [0.02, 0.07]
2.52 Xianlinggubao capsule plus alendronate versus alendronate (BMD of Ward's, 6 months)1104Mean Difference (IV, Random, 95% CI)0.04 [0.02, 0.06]
2.53 Gusongbao granule plus compound calcium amino acid chelate capsule versus placebo granule plus compound calcium amino acid chelate capsule (BMD of Ward's, 6 months)196Mean Difference (IV, Random, 95% CI)-0.01 [-0.06, 0.04]
2.54 Xianlinggubao capsule plus compound calcium amino acid chelate capsules versus compound calcium amino acid chelate capsules (BMD of Ward's, 6 months)1106Mean Difference (IV, Random, 95% CI)0.23 [0.19, 0.27]
2.55 Migu tablet plus compound calcium amino acid chelate capsules versus compound calcium amino acid chelate capsules (BMD of Ward's, 6 months)1107Mean Difference (IV, Random, 95% CI)0.28 [0.24, 0.32]
2.56 Jiangu granule plus compound calcium amino acid chelate capsule versus placebo granule plus compound calcium amino acid chelate capsule (BMD of Ward's, 6 months)196Mean Difference (IV, Random, 95% CI)-0.01 [-0.06, 0.04]
2.57 Xuduanzhuanggu capsule plus calcium tablet versus placebo plus calcium tablet (BMD of Ward's, 6 months)1480Mean Difference (IV, Random, 95% CI)0.02 [-0.00, 0.04]
2.58 Gusongbao granule plus calcium tablet versus placebo plus calcium tablet (BMD of Ward's, 6 months)1240Mean Difference (IV, Random, 95% CI)0.01 [-0.02, 0.04]
2.59 Yigu capsule plus calcium versus placebo plus calcium (BMD of Ward's, 6 months)1140Mean Difference (IV, Random, 95% CI)0.04 [0.00, 0.08]
2.60 Antai capsule plus Caltrate versus Caltrate (BMD of trochanter, 6 months)1128Mean Difference (IV, Random, 95% CI)0.03 [0.00, 0.06]
2.61 Migu tablet plus Caltrate versus Caltrate (BMD of trochanter, 12 months)144Mean Difference (IV, Random, 95% CI)0.15 [0.14, 0.16]
2.62 Xuduanzhuanggu capsule plus calcium tablet versus placebo plus calcium tablet (BMD of trochanter, 6 months)1480Mean Difference (IV, Random, 95% CI)0.0 [-0.02, 0.02]
2.63 Migu tablet plus compound calcium amino acid chelate capsules versus compound calcium amino acid chelate capsules (BMD of trochanter, 6 months)1107Mean Difference (IV, Random, 95% CI)0.12 [0.07, 0.17]
2.64 Xianlinggubao capsule plus compound calcium amino acid chelate capsules versus compound calcium amino acid chelate capsules (BMD of trochanter, 6 months)1106Mean Difference (IV, Random, 95% CI)0.13 [0.08, 0.18]
2.65 Gusongbao granule plus calcium tablet versus placebo plus calcium tablet (BMD of trochanter, 6 months)1240Mean Difference (IV, Random, 95% CI)0.0 [-0.03, 0.03]
2.66 Yigu capsule plus calcium versus placebo plus calcium (BMD of trochanter, 6 months)1140Mean Difference (IV, Random, 95% CI)0.02 [-0.02, 0.06]
2.67 Gushukang granule plus Calcium carbonate with vitamin D chewable tablets versus Calcium carbonate with vitamin D chewable tablets (BMD of hip bone, 6 months)142Mean Difference (IV, Random, 95% CI)0.15 [0.11, 0.19]
2.68 Jinwugutong capsules plus calcium versus placebo plus calcium (BMD of hip bone, 6 months)1120Mean Difference (IV, Random, 95% CI)0.01 [-0.02, 0.04]
2.69 Gengnian Anyi tablet plus Caltrate versus Caltrate (BMD of distal radius, 6 months)142Mean Difference (IV, Random, 95% CI)0.01 [-0.06, 0.08]
2.70 Shangke Yishen Zhuanggu pill plus Caltrate and calcitonin versus Caltrate and calcitonin (BMD of lumbar spine, 3 months)1300Mean Difference (IV, Random, 95% CI)0.04 [0.03, 0.05]
2.71 Bushenhuoxue therapy plus calcium carbonate tablets and alfacalcidol versus calcium carbonate tablets and alfacalcidol (BMD of lumbar spine, 3 months)180Mean Difference (IV, Random, 95% CI)-0.01 [-0.04, 0.02]
2.72 Gukang tablet plus oyster shell calcium chewable tablets and vitamin A and D capsules versus oyster shell calcium chewable tablets and vitamin A and D capsules (BMD of lumbar spine, for 3 months)180Mean Difference (IV, Random, 95% CI)0.24 [0.14, 0.34]
2.73 Liuwei Dihuang pills plus Caltrate versus Caltrate (BMD of lumbar spine, 6 months)172Mean Difference (IV, Random, 95% CI)0.05 [0.02, 0.08]
2.74 Yiyuanjiangu decoction plus calcitonin and calcium carbonate tablet versus calcitonin and calcium carbonate tablet (BMD of lumbar spine,3 months)1120Mean Difference (IV, Random, 95% CI)0.02 [-0.01, 0.05]
2.75 Yiyuanjiangu decoction plus calcitonin and calcium carbonate tablet versus calcitonin and calcium carbonate tablet (BMD of femoral neck, 3 months)1120Mean Difference (IV, Random, 95% CI)0.01 [-0.01, 0.03]
2.76 Yiyuanjiangu decoction plus calcitonin and calcium carbonate tablet versus calcitonin and calcium carbonate tablet (BMD of trochanter, 3 months)1120Mean Difference (IV, Random, 95% CI)0.02 [0.01, 0.04]
2.77 Yishen Zhuanggu decoction plus calcitriol soft capsule versus calcitriol soft capsule (BMD of lumbar spine, 3 months)1100Mean Difference (IV, Random, 95% CI)0.02 [-0.00, 0.05]
2.78 Hugu capsule plus Caltrate versus placebo capsule plus Caltrate (BMD of lumbar spine, 6 months)1122Mean Difference (IV, Random, 95% CI)0.03 [-0.00, 0.06]
2.79 Hugu capsule plus Caltrate versus placebo capsule plus Caltrate (BMD of Ward's, 6 months)1122Mean Difference (IV, Random, 95% CI)0.05 [0.02, 0.08]
2.80 Bushen Qianggu Huoxue therapy plus calcium and cod liver oil versus calcium and cod liver oil (BMD of lumbar spine, 3 months)184Mean Difference (IV, Random, 95% CI)0.05 [-0.01, 0.11]
2.81 Bushen Qianggu Huoxue therapy plus calcium and cod liver oil versus calcium and cod liver oil (BMD of femoral neck, 3 months)184Mean Difference (IV, Random, 95% CI)0.02 [-0.02, 0.05]
2.82 Bushen Qianggu Huoxue therapy plus calcium and cod liver oil versus calcium and cod liver oil (BMD of Ward's, 3 months)184Mean Difference (IV, Random, 95% CI)0.04 [0.02, 0.07]
2.83 Xianlinggubao capsule (low-dose) plus calcium and vitamin D versus placebo plus calcium and vitamin D (BMD of lumbar spine, 12 months)1120Mean Difference (IV, Random, 95% CI)0.0 [-0.04, 0.04]
2.84 Xianlinggubao capsule (high-dose) plus calcium and vitamin D versus placebo plus calcium and vitamin D (BMD of lumbar spine, 12 months)1116Mean Difference (IV, Random, 95% CI)0.0 [-0.03, 0.03]
2.85 Xianlinggubao capsule (low-dose) plus calcium and vitamin D versus placebo plus calcium and vitamin D (BMD of femoral neck, 12 months)1120Mean Difference (IV, Random, 95% CI)-0.01 [-0.05, 0.03]
2.86 Xianlinggubao capsule (high-dose) plus calcium and vitamin D versus placebo plus calcium and vitamin D (BMD of femoral neck, 12 months)1116Mean Difference (IV, Random, 95% CI)-0.01 [-0.05, 0.03]
2.87 Bushen Zhuanggu granules plus calcium and vitamin D versus placebo granules plus calcium and vitamin D (BMD of distal radius, 5 years)1155Mean Difference (IV, Random, 95% CI)0.10 [0.09, 0.10]
3 T score in BMD measurement167Mean Difference (IV, Fixed, 95% CI)0.91 [0.57, 1.25]
3.1 Erxian Yanggu decoction plus alendronate sodium tablets versus alendronate sodium tablets (T score, 6 months)167Mean Difference (IV, Fixed, 95% CI)0.91 [0.57, 1.25]
4 Quality of life180Mean Difference (IV, Fixed, 95% CI)5.30 [3.67, 6.93]
4.1 Bushenhuoxue therapy plus calcium carbonate tablets and alfacalcidol versus calcium carbonate tablets and alfacalcidol (3 months)180Mean Difference (IV, Fixed, 95% CI)5.30 [3.67, 6.93]
5 Symptoms including pain, muscle fatigue and limited mobility4 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
5.1 Heche Dazao pill plus oyster shell calcium chewable tablets versus oyster shell calcium chewable tablets (3 months)1114Risk Ratio (M-H, Fixed, 95% CI)1.15 [1.01, 1.30]
5.2 Xianlinggubao capsule plus salmon calcitonin and Caltrate versus salmon calcitonin plus Caltrate (3 months)1107Risk Ratio (M-H, Fixed, 95% CI)1.33 [1.09, 1.61]
5.3 Zhuangguqiangjin tablet and Shujinbogu tablet plus calcitonin versus calcitonin (12 months)182Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.91, 1.12]
5.4 Kanggusong soup plus Caltrate versus Caltrate (3 months)175Risk Ratio (M-H, Fixed, 95% CI)1.48 [1.09, 2.02]
6 Oestradiol (E2)9 Mean Difference (IV, Random, 95% CI)Subtotals only
6.1 Gushen decoction plus Caltrate and Alfacalcidol versus Caltrate and Alfacalcidol (6 months)164Mean Difference (IV, Random, 95% CI)4.54 [0.47, 8.61]
6.2 Ziyin Bushen Zhuanggu prescription plus Caltrate and Calcitonin versus Caltrate plus Calcitonin (8 months)145Mean Difference (IV, Random, 95% CI)23.21 [14.46, 31.96]
6.3 Zhuanggu capsule plus Caltrate versus Caltrate (6 months)160Mean Difference (IV, Random, 95% CI)4.06 [2.56, 5.56]
6.4 Bushen Qiangshen pill plus Caltrate versus Caltrate (3 months)140Mean Difference (IV, Random, 95% CI)7.60 [-0.51, 15.71]
6.5 Antai capsule plus Caltrate versus Caltrate (6 months)1128Mean Difference (IV, Random, 95% CI)11.0 [8.14, 13.86]
6.6 Zishen prescription plus Caltrate and calcitonin versus Caltrate plus calcitonin (8 months)145Mean Difference (IV, Random, 95% CI)23.21 [14.46, 31.96]
6.7 Shugan zishen huoxue tang plus Caltrate and alendronate sodium tablets versus Caltrate plus alendronate sodium tablets (6 months)142Mean Difference (IV, Random, 95% CI)26.99 [18.44, 35.54]
6.8 Xianlinggubao capsule plus vitamin D3 and calcium amino acid chelate versus vitamin D3 and calcium amino acid chelate (48 weeks)1112Mean Difference (IV, Random, 95% CI)6.04 [4.61, 7.47]
6.9 Yigu capsule plus calcium versus placebo plus calcium (6 months)1140Mean Difference (IV, Random, 95% CI)40.85 [33.61, 48.09]
7 Serum calcium (Ca)12 Mean Difference (IV, Random, 95% CI)Subtotals only
7.1 Gushen decoction plus Caltrate and Alfacalcidol versus Caltrate and Alfacalcidol (6 months)164Mean Difference (IV, Random, 95% CI)0.05 [-0.02, 0.12]
7.2 Gushukang granule plus Calcium carbonate with vitamin D chewable tablets versus Calcium carbonate with vitamin D chewable tablets (6 months)142Mean Difference (IV, Random, 95% CI)-0.01 [-0.09, 0.07]
7.3 Zhuanggu capsule plus Caltrate versus Caltrate (6 months)160Mean Difference (IV, Random, 95% CI)0.01 [-0.07, 0.09]
7.4 Antai capsule plus Caltrate versus Caltrate (6 months)1128Mean Difference (IV, Random, 95% CI)-0.03 [-0.09, 0.03]
7.5 Jinwugutong capsules plus calcium versus placebo plus calcium (6 months)1120Mean Difference (IV, Random, 95% CI)-0.05 [-0.11, 0.01]
7.6 Xianlinggubao capsule plus salmon calcitonin and Caltrate versus salmon calcitonin plus Caltrate (3 months)1107Mean Difference (IV, Random, 95% CI)0.03 [-0.09, 0.15]
7.7 Bushenyiqihuoxue soup plus tamoxifen and Caltrate versus tamoxifen and Caltrate (3 months)1120Mean Difference (IV, Random, 95% CI)0.37 [0.32, 0.42]
7.8 Yigu capsule plus calcium versus placebo plus calcium (6 months)1140Mean Difference (IV, Random, 95% CI)-0.07 [-0.13, -0.01]
7.9 Chinese medicine (combination of 10 herbs) plus tamoxifen and Caltrate versus tamoxifen and Caltrate (3 months)1120Mean Difference (IV, Random, 95% CI)0.37 [0.32, 0.42]
7.10 Zhuangguqiangjin tablet and Shujinbogu tablet plus calcitonin versus calcitonin (12 months)190Mean Difference (IV, Random, 95% CI)-0.02 [-0.10, 0.06]
7.11 Huangqi plus Caltrate versus Caltrate (6 months)136Mean Difference (IV, Random, 95% CI)0.28 [0.11, 0.45]
7.12 Yiyuanjiangu decoction plus calcitonin and calcium carbonate tablet versus calcitonin and calcium carbonate tablet (3 months)1120Mean Difference (IV, Random, 95% CI)-0.02 [-0.06, 0.02]
8 Phosphorus (P)10 Mean Difference (IV, Fixed, 95% CI)Subtotals only
8.1 Gushen decoction plus Caltrate and Alfacalcidol versus Caltrate and Alfacalcidol (6 months)164Mean Difference (IV, Fixed, 95% CI)-0.13 [-0.27, 0.01]
8.2 Gushukang granule plus Calcium carbonate with vitamin D chewable tabletsl versus Calcium carbonate with vitamin D chewable tablets (6 months)142Mean Difference (IV, Fixed, 95% CI)-0.02 [-0.11, 0.07]
8.3 Zhuanggu capsule plus Caltrate versus Caltrate (6 months)160Mean Difference (IV, Fixed, 95% CI)0.01 [-0.06, 0.08]
8.4 Antai capsule plus Caltrate versus Caltrate (6 months)1128Mean Difference (IV, Fixed, 95% CI)-0.01 [-0.23, 0.21]
8.5 Jinwugutong capsules plus calcium versus placebo plus calcium (6 months)1120Mean Difference (IV, Fixed, 95% CI)-0.02 [-0.09, 0.05]
8.6 Xianlinggubao capsule plus salmon calcitonin and Caltrate versus salmon calcitonin plus Caltrate (3 months)1107Mean Difference (IV, Fixed, 95% CI)0.01 [-0.12, 0.14]
8.7 Yigu capsule plus calcium versus placebo plus calcium (6 months)1140Mean Difference (IV, Fixed, 95% CI)-0.03 [-0.08, 0.02]
8.8 Zhuangguqiangjin tablet and Shujinbogu tablet plus calcitonin versus calcitonin (12 months)190Mean Difference (IV, Fixed, 95% CI)-0.02 [-0.08, 0.04]
8.9 Huangqi plus Caltrate versus Caltrate (6 months)136Mean Difference (IV, Fixed, 95% CI)0.31 [0.14, 0.48]
8.10 Yiyuanjiangu decoction plus calcitonin and calcium carbonate tablet versus calcitonin and calcium carbonate tablet (3 months)1120Mean Difference (IV, Fixed, 95% CI)0.06 [-0.22, 0.34]
9 Alkaline phosphatase (ALP)15 Mean Difference (IV, Fixed, 95% CI)Subtotals only
9.1 Gushukang granule plus Calcium carbonate with vitamin D chewable tablets versus Calcium carbonate with vitamin D chewable tablets (6 months)139Mean Difference (IV, Fixed, 95% CI)-0.5 [-1.70, 0.70]
9.2 Zhuanggu capsule plus Caltrate versus Caltrate (6 months)160Mean Difference (IV, Fixed, 95% CI)0.0 [-1.55, 1.55]
9.3 Bushen Qiangshen pill plus Caltrate versus Caltrate (3 months)140Mean Difference (IV, Fixed, 95% CI)-0.31 [-1.72, 1.10]
9.4 Xianlinggubao capsule plus salmon calcitonin and Caltrate versus salmon calcitonin plus Caltrate (3 months)1107Mean Difference (IV, Fixed, 95% CI)-0.99 [-1.52, -0.46]
9.5 Antai capsule plus Caltrate versus Caltrate (6 months)1128Mean Difference (IV, Fixed, 95% CI)1.28 [0.55, 2.01]
9.6 Traditional Chinese capsule plus calcium gluconate versus calcium gluconate (9 months)160Mean Difference (IV, Fixed, 95% CI)1.77 [1.20, 2.34]
9.7 Jinwugutong capsules plus calcium versus placebo plus calcium (6 months)1120Mean Difference (IV, Fixed, 95% CI)1.01 [-0.04, 2.06]
9.8 Yigu capsule plus calcium versus placebo plus calcium (6 months)1140Mean Difference (IV, Fixed, 95% CI)1.73 [0.71, 2.75]
9.9 Chinese medicine (combination of 10 herbs) plus tamoxifen and Caltrate versus tamoxifen and Caltrate (3 months)1120Mean Difference (IV, Fixed, 95% CI)-0.26 [-1.64, 1.12]
9.10 Zhuangguqiangjin tablet and Shujinbogu tablet plus calcitonin versus calcitonin (12 months)190Mean Difference (IV, Fixed, 95% CI)0.08 [-0.54, 0.70]
9.11 Bushenyiqihuoxue soup plus tamoxifen and Caltrate versus tamoxifen and Caltrate (3 months)1120Mean Difference (IV, Fixed, 95% CI)3.54 [1.68, 5.40]
9.12 Huangqi plus Caltrate versus Caltrate (6 months)136Mean Difference (IV, Fixed, 95% CI)0.82 [0.63, 1.01]
9.13 Xianlinggubao capsule plus vitamin D3 and calcium amino acid chelate versus vitamin D3 and calcium amino acid chelate (48 weeks)1112Mean Difference (IV, Fixed, 95% CI)10.48 [9.81, 11.15]
9.14 Kanggusong soup plus Caltrate versus Caltrate (3 months)175Mean Difference (IV, Fixed, 95% CI)-1.61 [-3.17, -0.05]
9.15 Yiyuanjiangu decoction plus calcitonin and calcium carbonate tablet versus calcitonin and calcium carbonate tablet (3 months)1120Mean Difference (IV, Fixed, 95% CI)0.31 [-0.48, 1.10]
10 Bone Gla protein (BGP)8 Mean Difference (IV, Fixed, 95% CI)Subtotals only
10.1 Zhuanggu capsule plus Caltrate versus Caltrate (6 months)160Mean Difference (IV, Fixed, 95% CI)-2.3 [-4.07, -0.53]
10.2 Traditional Chinese capsule plus calcium gluconate versus calcium gluconate (9 months)160Mean Difference (IV, Fixed, 95% CI)1.23 [0.88, 1.58]
10.3 Xianlinggubao capsule plus salmon calcitonin and Caltrate versus salmon calcitonin plus Caltrate (3 months)1107Mean Difference (IV, Fixed, 95% CI)0.56 [-0.30, 1.42]
10.4 Yigu capsule plus calcium versus placebo plus calcium (6 months)1140Mean Difference (IV, Fixed, 95% CI)2.60 [1.66, 3.54]
10.5 Xianlinggubao capsule plus vitamin D3 and calcium amino acid chelate versus vitamin D3 and calcium amino acid chelate (48 weeks)1112Mean Difference (IV, Fixed, 95% CI)6.24 [5.69, 6.79]
10.6 Xianlinggubao capsule plus Caltrate versus Caltrate (12 months)168Mean Difference (IV, Fixed, 95% CI)1.85 [0.87, 2.83]
10.7 Jinwugutong capsules plus calcium versus placebo plus calcium (6 months)1120Mean Difference (IV, Fixed, 95% CI)2.47 [1.44, 3.50]
10.8 Huangqi plus Caltrate versus Caltrate (6 months)136Mean Difference (IV, Fixed, 95% CI)0.63 [0.50, 0.76]
11 Interleukin-6 (IL-6)3 Mean Difference (IV, Fixed, 95% CI)Subtotals only
11.1 Erxian Yanggu decoction plus alendronate sodium tablets versus alendronate sodium tablets (6 months)167Mean Difference (IV, Fixed, 95% CI)-16.18 [-19.62, -12.74]
11.2 Xianlinggubao capsule plus vitamin D3 and calcium amino acid chelate versus vitamin D3 and calcium amino acid chelate (48 weeks)1112Mean Difference (IV, Fixed, 95% CI)-133.3 [-139.94, -126.66]
11.3 Kanggusong soup plus Caltrate versus Caltrate (3 months)175Mean Difference (IV, Fixed, 95% CI)-16.32 [-31.60, -1.04]
Analysis 4.1.

Comparison 4 Chinese herbal medicines plus western medicine versus western medicine, Outcome 1 New fractures.

Analysis 4.2.

Comparison 4 Chinese herbal medicines plus western medicine versus western medicine, Outcome 2 Bone mineral density (BMD).

Analysis 4.3.

Comparison 4 Chinese herbal medicines plus western medicine versus western medicine, Outcome 3 T score in BMD measurement.

Analysis 4.4.

Comparison 4 Chinese herbal medicines plus western medicine versus western medicine, Outcome 4 Quality of life.

Analysis 4.5.

Comparison 4 Chinese herbal medicines plus western medicine versus western medicine, Outcome 5 Symptoms including pain, muscle fatigue and limited mobility.

Analysis 4.6.

Comparison 4 Chinese herbal medicines plus western medicine versus western medicine, Outcome 6 Oestradiol (E2).

Analysis 4.7.

Comparison 4 Chinese herbal medicines plus western medicine versus western medicine, Outcome 7 Serum calcium (Ca).

Analysis 4.8.

Comparison 4 Chinese herbal medicines plus western medicine versus western medicine, Outcome 8 Phosphorus (P).

Analysis 4.9.

Comparison 4 Chinese herbal medicines plus western medicine versus western medicine, Outcome 9 Alkaline phosphatase (ALP).

Analysis 4.10.

Comparison 4 Chinese herbal medicines plus western medicine versus western medicine, Outcome 10 Bone Gla protein (BGP).

Analysis 4.11.

Comparison 4 Chinese herbal medicines plus western medicine versus western medicine, Outcome 11 Interleukin-6 (IL-6).

Appendices

Appendix 1. MEDLINE search strategy

DatabaseTime spanSearch strategy
MEDLINE1966 to 20131. exp bone diseases, metabolic/
2. osteoporos#s.tw.
3. bone density/
4. bone densit$.tw.
5. bone mineral densit$.tw.
6. exp bone/ and bones.mp. [mp=title, original title, abstract, name of substance word, subject heading word]
7. bone loss$.tw.
8. osteomalacia.tw.
9. osteodystrophy.tw.
10. exp bone demineralization, pathologic/
11. (bone adj demineralization).tw.
12. osteopenia.tw.
13. bone mass.tw.
14. exp densitometry/
15. densitometry.tw.
16. dexa.tw.
17. exp fractures/
18. fracture$.tw.
19. or/1-18
20. exp Medicine, Herbal/
21. exp Plants, Medicinal/
22. exp Medicine, Traditional/
23. exp Drugs, Chinese Herbal/
24. herb$.tw.
25. plant.mp. or plants.tw. [mp=title, original title, abstract, name of substance word, subject heading word]
26. phytomedicine.tw.
27. botanical.tw.
28. weed$.tw.
29. algae.tw.
30. (fungi or fungus).tw.
31. ((traditional or chinese or herbal) adj medicine).tw.
32. ((oriental or chinese) adj tradition$).tw.
33. or/20-32
34. 19 and 33

Appendix 2. EMBASE search strategy

DatabaseTime spanSearch strategy
EMBASE1998 to 20131. exp OSTEOPOROSIS/
2. exp Metabolic Bone Disease/
3. osteoporo$.tw.
4. exp Bone Density/
5. (bone adj2 densit$).tw.
6. exp BONE/
7. bone loss.tw.
8. osteomalacia.tw.
9. osteodystrophy.tw.
10. exp Bone Demineralization/
11. (bone adj deminerali#ation).tw.
12. osteopenia.tw.
13. bone mass.tw.
14. exp bone densitometry/
15. densitometry.tw.
16. dexa.tw.
17. exp Fracture/
18. fracture$.tw.
19. or/1-18
20. exp Herbal Medicine/
21. exp Medicinal Plant/
22. exp Traditional Medicine/
23. exp Chinese Medicine/
24. herb$.tw.
25. (plant or plants).tw.
26. phytomedicine.tw.
27. botanical.tw.
28. weed$.tw.
29. algae.tw.
30. (fungi or fungus).tw.
31. ((traditional or chinese or herbal) adj medicine).tw.
32. ((oriental or chinese) adj tradition$).tw.
33. or/20-32
34. 19 and 33
35. random$.ti,ab.
36. factorial$.ti,ab.
37. (crossover$ or cross over$ or cross-over$).ti,ab.
38. placebo$.ti,ab.
39. (doubl$ adj blind$).ti,ab.
40. (singl$ adj blind$).ti,ab.
41. assign$.ti,ab.
42. allocat$.ti,ab.
43. volunteer$.ti,ab.
44. crossover procedure.sh.
45. double blind procedure.sh.
46. randomized controlled trial.sh.
47. single blind procedure.sh.
48. or/35-47
49. exp animal/ or nonhuman/ or exp animal experiment/
50. exp human/
51. 49 and 50
52. 49 not 51
53. 48 not 52
54. 34 and 53

Appendix 3. CENTRAL search strategy

DatabaseTime spanSearch strategy
CENTRAL in The Cochrane LibraryIssue 12, 2012#1 MeSH descriptor Osteoporosis explode all trees in MeSH products
#2 MeSH descriptor Bone Diseases, Metabolic explode all trees in MeSH products
#3 osteoporo* in All Fields in all products
#4 MeSH descriptor Bone Density explode all trees in MeSH products
#5 bone near/j2 densit* in All Fields in all products
#6 MeSH descriptor Bone and Bones explode all trees in MeSH products
#7 bone loss in All Fields in all products
#8 osteomalacia in All Fields in all products
#9 osteodystrophy in All Fields in all products
#10 MeSH descriptor Bone Demineralization, Pathologic explode all trees in MeSH products
#11 bone next deminerali* in All Fields in all products
#12 osteopenia in All Fields in all products
#13 bone mass in All Fields in all products
#14 MeSH descriptor Densitometry explode all trees in MeSH products
#15 densitometry in All Fields in all products
#16 dexa in All Fields in all products
#17 MeSH descriptor Fractures, Bone explode all trees in MeSH products
#18 fractur* in All Fields in all products
#19 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18)
#20 MeSH descriptor Medicine, Herbal explode all trees in MeSH products
#21 MeSH descriptor Plants, Medicinal explode all trees in MeSH products
#22 MeSH descriptor Medicine, Traditional explode all trees in MeSH products
#23 MeSH descriptor Drugs, Chinese Herbal explode all trees in MeSH products
#24 herb* in All Fields in all products
#25 plant or plants in All Fields in all products
#26 phytomedicine in All Fields in all products
#27 botanical in All Fields in all products
#28 weed* in All Fields in all products
#29 algae in All Fields in all products
#30 fungi or fungus in All Fields in all products
#31 (traditional or chinese or herbal) next medicine in All Fields in all products
#32 (oriental or chinese) next tradition* in All Fields in all products
#33 (#20 OR #21 OR #22 OR #23 OR #24 OR #25 OR #26 OR #27 OR #28 OR #29 OR #30 OR #31 OR #32)
#34 (#19 AND #33)

Appendix 4. CBM search strategy

DatabaseTime spanSearch strategy
CBM1979 to 20131 explode "osteoporosis"/cure of Chinese traditional medicine, the combination of Western and traditional medicine
2 osteoporosis/tw
3 Chinese herbal medicine/tw
4 Chinese traditional medicine/tw
5 2 and (3 or 4)
6 1 or 5

Appendix 5. Effects of interventions on biochemical indicators

Chinese herbal medicines versus placebo (Comparison 01)

Oestradiol (E2) levels

Compared with the placebo group, those treated with Bushen Yigu soft extract after three months treatment had statistically significantly increased serum levels of oestradiol (mean difference (MD) 122.89 pg/ml; 95% confidence interval (CI) 92.97 to 152.81) (Analysis 1.3) (Wang XY 2000).

Chinese herbal medicines versus no intervention (Comparison 02)

Oestradiol (E2) levels

There was no significant difference in levels of serum or urinary oestradiol between Chinese herbal medicines (Bushen Shengsui principle (Analysis 2.2) (Liao L 2004), Yishen Zhuanggu mixture (Analysis 2.2) (Gong L 2001), Huoluo Gukang pills or Gushukang granule (Analysis 2.2) (Zhang YS 2003)) and no intervention after six months treatment.

Bone Gla protein (BGP) levels

Compared with the no intervention group, in those treated with Yishen Zhuanggu mixture or Shengu capsule there were no statistically significant effects on BGP after six months treatment (MD -1.00 μg/L; 95% CI -6.15 to 4.15 and MD -5.10 μg/L; 95% CI -10.63 to 0.43, respectively) (Analysis 2.3) (Gong L 2001). Those treated with Huoluo Gukang pills or Gushukang granule had statistically significant increases in BGP after six months treatment (MD 2.70 μg/L; 95% CI 1.23 to 4.17 and MD 3.50 μg/L; 95% CI 1.92 to 5.08, respectively) (Analysis 2.3) (Zhang YS 2003). Treatment with Shigu yin also increased BGP after six months treatment (MD 1.20 μg/L; 95% CI 0.17 to 2.23) (Analysis 2.3) (Zhang YP 2007).

Chinese herbal medicines versus western medicine (Comparison 03)

Oestradiol (E2) levels

Nine trials showed positive effects of herbal treatments on serum or urinary measures of oestradiol when compared to calcium supplementation, or calcium combined with vitamin D supplementation, or calcium combined with synthesised isoflavone (ipriflavone):

  • Kanggusong granule versus Caltrate after nine months treatment (MD 11.00 pg/ml; 95% CI 6.97 to 15.03), Kanggusong granule versus ipriflavone plus Caltrate after nine months treatment (MD 12.17 pg/ml; 95% CI 8.27 to 16.07) (Analysis 3.5) (An SJ 2000);

  • Strong Bone capsule versus Caltrate after three months treatment (MD 10.46 pg/ml; 95% CI 4.29 to 16.63) (Analysis 3.5) (Cui TH 1999);

  • Radix rehmanniae preparata and Radix astragali versus calcium carbonate tablets after six months treatment (MD 8.78 pg/ml; 95% CI 0.92 to 16.64) (Analysis 3.5) (Ou L 2011);

  • Qianggu soft extract versus calcium gluconate after six months treatment (MD 4.20 pg/ml; 95% CI 0.89 to 7.51) (Analysis 3.5) (Peng T 2002);

  • Gumikang capsule versus calcium gluconate after six months treatment (MD 3.50 pg/ml; 95% CI 1.14 to 5.86) (Analysis 3.5) (Wang CC 2005);

  • Yanghuo Sanzi tang versus Caltrate after six months treatment (MD 23.06 pg/ml; 95% CI 17.82 to 28.30) (Analysis 3.5) (Qiu RB 2004);

  • Jingujian granule versus Caltrate after three months treatment (MD 4.85 pg/ml; 95% CI 4.56 to 5.14) (Analysis 3.5) (Li YH 2010);

  • Qianggu paste versus calcium gluconate tablets after six months treatment (MD 4.20 pg/ml; 95% CI 1.79 to 6.61) (Analysis 3.5) (Wang H 2007);

  • Bushen Huoxue capsule versus Caltrate plus Rocalirol after 12 months treatment (MD 2.13 pg/ml; 95% CI 0.42 to 3.84) (Analysis 3.5) (Zhang XJ 2008).

However, in the following two trials, Chinese herbal medicines did not show a significant effect:

  • Bushen Qiangshen pill versus Caltrate (MD 6.71 pg/ml; 95% CI -2.28 to 15.70) (Analysis 3.5) (Mu G 2001a);

  • Tongbu Qianggutang versus calcium plus vitamin D3 after three months treatment (female MD 5.03 pg/ml; 95% CI -8.01 to 18.07; male MD 1.89 pg/ml; 95% CI -17.98 to 21.77) (Analysis 3.5) (Zhou LZ 2001).

Seven trials showed a better effect of Chinese herbal medicines when compared with western medicine:

  • Bushen Jianpi Huoxue recipe versus alendronate sodium tablets after six months treatment (MD 3.15 pg/ml; 95% CI 0.28 to 6.02) (Analysis 3.5) (He MT 2007);

  • prescription for tonifying kidney versus ipriflavone (MD 14.00 pg/ml; 95% CI 3.68 to 24.32), kidney meridian sticking versus ipriflavone (MD 11.99 pg/ml; 95% CI 1.15 to 22.83), urinary bladder meridian sticking versus ipriflavone (MD 17.99 pg/ml; 95% CI 7.65 to 28.33), Gushukang granule versus ipriflavone (MD 13.98 pg/ml; 95% CI 3.90 to 24.06) after six months treatment (Analysis 3.5) (Wu MS 2007);

  • Gukang oral liquid versus alendronate sodium tablets after six months treatment (MD 5.09 pg/ml; 95% CI 2.81 to 7.37) (Analysis 3.5) (Wang JM 2008);

  • Jianshenfang granule versus alendronate sodium tablets after six months treatment (MD 5.83 pg/ml; 95% CI 4.21 to 7.45) (Analysis 3.5) (Li BL 2007);

  • Jiangu recipe versus alendronate sodium tablets after 12 months treatment (MD 10.75 pg/ml; 95% CI 8.55 to 12.95) (Analysis 3.5) (Qiu RB 2008);

  • Bushen Zhuanggu tang versus alendronate sodium tablets after three months treatment (MD 5.37 pg/ml; 95% CI 2.07 to 8.67) (Analysis 3.5) (Ling JY 2008);

  • Bushen Yigu soft extract versus Alfacalcidol after three months treatment (MD 76.29 nmol/L; 95% CI 31.19 to 121.39) (Analysis 3.5) (Wang XY 2000).

However, another five trials found no significant difference between groups in levels of oestradiol:

  • Bushen Shengsui principle versus conjugated oestrogens plus medroxyprogesterone after six months treatment (MD 4.00 pg/ml; 95% CI -3.92 to 11.92) (Analysis 3.5) (Liao L 2004);

  • Gukang oral liquid versus alendronate after six months treatment (MD 3.90 pg/ml; 95% CI -6.64 to 14.44) (Analysis 3.5) (Shao M 2003);

  • Kanggusong granule versus ipriflavone after three months treatment (MD 4.18 pg/ml; 95% CI -13.85 to 22.21) (Analysis 3.5) (Wu MS 2001);

  • Gukang decoction versus alendronate sodium tablets after four months treatment (MD -0.65 pg/ml; 95% CI -9.04 to 7.74) (Analysis 3.5) (Chen X 2008);

  • Gujian capsule versus alfacalcidol after six months treatment (MD 22.35 pg/ml; 95% CI -10.51 to 55.21) (Analysis 3.5) (Meng XD 2003).

One trial showed a worse effect of Chinese herbal medicine: Huangqi Sanxian tang versus nilestriol after three months treatment (MD -32.97 pg/ml; 95% CI -39.42 to -26.52) (Analysis 3.5) (Zhou ZK 2006).

Serum calcium (Ca) levels

In 12 trials comparing herbal treatments to calcium and vitamin D and, in one case, isoflavone, there were no significant differences between groups in changes in serum calcium:

  • Kanggusong granule versus Caltrate after nine months treatment (MD -0.03 mmol/L; 95% CI -0.11 to 0.05) (Analysis 3.6) (An SJ 2000);

  • Gushukang granule versus Calcium carbonate with vitamin D chewable tablets after six months treatment (MD -0.02 mmol/L; 95% CI -0.10 to 0.06) (Analysis 3.6) (Chen ZX 2002);

  • Radix rehmanniae preparata and Radix astragali versus calcium carbonate tablets after six months treatment (MD -0.01 mmol/L; 95% CI -0.05 to 0.03) (Analysis 3.6) (Ou L 2011);

  • Bushen Jianpi Migu prescription versus Caltrate after three months treatment (MD 0.01 mmol/L; 95% CI -0.05 to 0.07) (Analysis 3.6) (Wang ZK 2004);

  • Bugu Shengsui capsule versus vitamin D2 plus calcium tablet after six months treatment (MD 0.10 mmol/L; 95% CI -0.05 to 0.25) (Analysis 3.6) (Xie YM 1997);

  • Shenyao capsules versus Caltrate after six months treatment (MD 0.02 mmol/L; 95% CI -0.08 to 0.12) (Analysis 3.6) (Chen NQ 2006);

  • prescription for tonifying kidney versus ipriflavone (MD 0.00 mmol/L; 95% CI -0.05 to 0.05), kidney meridian sticking versus ipriflavone (MD -0.01 mmol/L; 95% CI -0.06 to 0.04), urinary bladder meridian sticking versus ipriflavone (MD -0.01 mmol/L; 95% CI -0.06 to 0.04), Gushukang granule versus ipriflavone (MD -0.02 mmol/L; 95% CI -0.07 to 0.03) after six months treatment (Analysis 3.6) (Wu MS 2007);

  • Gukang oral liquid versus alendronate sodium tablets after six months treatment (MD -0.02 mmol/L; 95% CI -0.06 to 0.02) (Analysis 3.6) (Wang JM 2008);

  • Qianggu capsule versus active vitamin D3 after six months treatment (MD 0.01 mmol/L; 95% CI -0.06 to 0.08) (Analysis 3.6) (Wang J 2007);

  • Bushen Yangxue tang versus calcium gluconate after six months treatment (MD 0.13 mmol/L; 95% CI -0.00 to 0.26) (Analysis 3.6) (Zhan ML 2007);

  • Erxian soup versus Caltrate after six months treatment (MD -0.02 mmol/L; 95% CI -0.25 to 0.21) (Analysis 3.6) (Wu JZ 2010);

  • Tongbu Qianggutang versus calcium plus vitamin D3 after three months treatment (MD -0.02 mmol/L; 95% CI -0.10 to 0.06) (Analysis 3.6) (Zhou LZ 2001).

Patients treated with herbal formulae for three to six months showed significantly higher levels of serum calcium in six trials comparing herbal treatment with calcium supplementation, isoflavone supplementation or conjugated hormones:

  • Gumikang capsule versus calcium gluconate after six months treatment (MD 1.40 mmol/L; 95% CI 1.39 to 1.41) (Analysis 3.6) (Wang CC 2005);

  • Kanggusong granule versus ipriflavone after three months treatment (MD 0.10 mmol/L; 95% CI 0.03 to 0.17) (Analysis 3.6) (Wu MS 2001);

  • Yinyanghuo versus conjugated oestrogens after three to six months treatment (MD 0.54 mmol/L; 95% CI 0.23 to 0.85) (Analysis 3.6) (Zhao LN 2003);

  • Guli powder versus Caltrate after three months treatment (MD 0.09 mmol/L; 95% CI 0.02 to 0.16) (Analysis 3.6) (Lan ZX 2006);

  • Gushen Yijing tang versus Caltrate after six months treatment (MD 0.23 mmol/L; 95% CI 0.11 to 0.35) (Analysis 3.6) (Zhong RQ 2007);

  • Bushenjianpi Zhuangguyin versus Caltrate and calcitonin ampoule after 12 weeks (MD 0.74 mmol/L; 95% CI 0.66 to 0.82) (Analysis 3.6) (Zhang XG 2011).

Five trials reported statistically significantly lower levels of serum calcium in the group treated with Chinese herbal medicines compared to supplementation with calcium or calcium and vitamin D and, in one case, isoflavone plus Caltrate:

  • Kanggusong granule versus ipriflavone plus Caltrate after nine months treatment (MD -0.09 mmol/L; 95% CI -0.17 to -0.01) (Analysis 3.6) (An SJ 2000);

  • Strong Bone capsule versus Caltrate after three months treatment (MD -0.13 mmol/L; 95% CI -0.22 to -0.04) (Analysis 3.6) (Cui TH 1999);

  • Qianggu soft extract versus calcium gluconate (MD -0.03 mmol/L; 95% CI -0.05 to -0.01) (Analysis 3.6) (Peng T 2002);

  • Qianggu paste versus calcium gluconate tablets after six months treatment (MD -0.03 mmol/L; 95% CI -0.06 to -0.00) (Analysis 3.6) (Wang H 2007);

  • Jiangu capsule versus Caltrate after 12 months treatment (MD -0.06 mmol/L; 95% CI -0.11 to -0.01) (Analysis 3.6) (Wang YZ 2008).

Phosphorus (P) levels

Eleven trials showed no significant effects of herbal treatments on phosphorus when compared to calcium supplementation, or calcium combined with vitamin D supplementation, or calcium combined with synthesised isoflavone (ipriflavone):

  • Kanggusong granule versus ipriflavone plus Caltrate (MD 0.06 mmol/L; 95% CI -0.03 to 0.15), Kanggusong granule versus Caltrate (MD -0.01 mmol/L; 95% CI -0.29 to 0.27) after nine months treatment (Analysis 3.7) (An SJ 2000);

  • Gushukang granule versus Calcium carbonate with vitamin D chewable tablets after six months treatment (MD 0.01 mmol/L; 95% CI -0.09 to 0.11) (Analysis 3.7) (Chen ZX 2002);

  • Radix rehmanniae preparata and Radix astragali versus calcium carbonate tablets after six months treatment (MD 0.00 mmol/L; 95% CI -0.15 to 0.15) (Analysis 3.7) (Ou L 2011);

  • Bushen Jianpi Migu prescription versus Caltrate after three months treatment (MD 0.03 mmol/L; 95% CI -0.02 to 0.08) (Analysis 3.7) (Wang ZK 2004);

  • Shenyao capsules versus Caltrate after six months treatment (MD -0.01 mmol/L; 95% CI -0.08 to 0.06) (Analysis 3.7) (Chen NQ 2006);

  • Guli powder versus Caltrate after three months treatment (MD -0.05 mmol/L; 95% CI -0.13 to 0.03) (Analysis 3.7) (Lan ZX 2006);

  • Gushen Yijing tang versus Caltrate after six months treatment (MD 0.04 mmol/L; 95% CI -0.09 to 0.17) (Analysis 3.7) (Zhong RQ 2007);

  • Qianggu capsule versus active vitamin D3 after six months treatment (MD 0.02 mmol/L; 95% CI -0.05 to 0.09) (Analysis 3.7) (Wang J 2007);

  • Jiangu capsule versus Caltrate after 12 months treatment (MD 0.09 mmol/L; 95% CI -0.20 to 0.38) (Analysis 3.7) (Wang YZ 2008);

  • Erxian soup versus Caltrate after six months treatment (MD -0.03 mmol/L; 95% CI -0.20 to 0.14) (Analysis 3.7) (Wu JZ 2010);

  • Tongbu Qianggutang versus calcium plus vitamin D3 after three months treatment (MD -0.01 mmol/L; 95% CI -0.12 to 0.10) (Analysis 3.7) (Zhou LZ 2001).

Three trials found no significant differences between groups for phosphorus when comparing herbal formulae to conventional western medicines:

  • Kanggusong granule versus ipriflavone after three months treatment (MD -0.07 mmol/L; 95% CI -0.20 to 0.06) (Analysis 3.7) (Wu MS 2001);

  • Yinyanghuo versus conjugated oestrogens after three to six months treatment (MD 0.13 mmol/L; 95% CI -0.13 to 0.39) (Analysis 3.7) (Zhao LN 2003);

  • prescription for tonifying kidney versus ipriflavone (MD -0.04 mmol/L; 95% CI -0.15 to 0.07), kidney meridian sticking versus ipriflavone (MD -0.01 mmol/L; 95% CI -0.13 to 0.11), urinary bladder meridian sticking versus ipriflavone (MD -0.01 mmol/L; 95% CI -0.13 to 0.11), Gushukang granule versus ipriflavone (MD -0.01 mmol/L; 95% CI -0.13 to 0.11) after six months treatment (Analysis 3.7) (Wu MS 2007).

One trial showed better effects of Bushen Zhuanggu tang compared to alendronate sodium tablets after three months treatment (MD 0.24 mmol/L; 95% CI 0.10 to 0.38) (Analysis 3.7) (Ling JY 2008).

Two other trials showed worse effects of Chinese herbal medicines:

  • Strong Bone capsule compared with Caltrate after three months treatment (MD -0.12 mmol/L; 95% CI -0.21 to -0.03) (Analysis 3.7) (Cui TH 1999);

  • Bushenjianpi Zhuangguyin versus Caltrate and calcitonin ampoule after 12 weeks treatment (MD -0.37 mmol/L; 95% CI -0.48 to -0.26) (Analysis 3.7) (Zhang XG 2011).

Alkaline phosphatase (ALP) levels

Eleven trials showed no significant effects of herbal treatments on alkaline phosphatase when compared to calcium supplementation, or calcium combined with vitamin D supplementation, or calcium combined with synthesised isoflavone (ipriflavone):

  • Gushukang granule versus Calcium carbonate with vitamin D chewable tablets after six months treatment (MD -0.50 μmol s-1/L; 95% CI -1.70 to 0.70) (Analysis 3.8) (Chen ZX 2002);

  • Strong Bone capsule versus Caltrate after three months treatment (MD -0.07 μmol s-1/L; 95% CI -0.25 to 0.11) (Analysis 3.8) (Cui TH 1999);

  • Bushen Qiangshen pill versus Caltrate after three months treatment (MD 0.27 μmol s-1/L; 95% CI -1.27 to 1.81) (Analysis 3.8) (Mu G 2001a);

  • Bugu Shengsui capsule versus vitamin D2 plus calcium tablet after six months treatment (MD -0.29 μmol s-1/L; 95% CI -1.67 to 1.09) (Analysis 3.8) (Xie YM 1997);

  • Liuwei Dihuang pills versus calcium after 12 months treatment (MD 0.55 μmol s-1/L; 95% CI -0.12 to 1.22) (Analysis 3.8) (Zhang J 2003);

  • Guli powder versus Caltrate after three months treatment (MD 0.30 μmol s-1/L; 95% CI -2.97 to 3.57) (Analysis 3.8) (Lan ZX 2006);

  • Qianggu capsule versus active vitamin D3 after six months treatment (MD 0.71 μmol s-1/L; 95% CI -1.17 to 2.59) (Analysis 3.8) (Wang J 2007);

  • Jingujian granule versus Caltrate after three months treatment (MD 0.53 μmol s-1/L; 95% CI -0.69 to 1.75) (Analysis 3.8) (Li YH 2008);

  • Bushenjianpi Zhuangguyin versus Caltrate and calcitonin ampoule after 12 weeks treatment (MD -0.82 μmol s-1/L; 95% CI -2.83 to 1.19) (Analysis 3.8) (Zhang XG 2011);

  • Erxian soup versus Caltrate after six months treatment (MD 0.00 μmol s-1/L; 95% CI -0.87 to 0.87) (Analysis 3.8) (Wu JZ 2010);

  • Tongbu Qianggutang versus calcium plus vitamin D3 after three months treatment (MD 0.18 μmol s-1/L; 95% CI -1.08 to 1.44) (Analysis 3.8) (Zhou LZ 2001).

Twelve trials showed better effects of herbal treatments on alkaline phosphatase when compared to calcium supplementation, or calcium combined with vitamin D supplementation, or calcium combined with synthesised isoflavone (ipriflavone):

  • Kanggusong granule versus ipriflavone plus Caltrate (MD 1.69 μmol s-1/L; 95% CI 0.79 to 2.59), Kanggusong granule versus Caltrate (MD 1.28 μmol s-1/L; 95% CI 0.30 to 2.26) after nine months treatment (Analysis 3.8) (An SJ 2000);

  • Radix rehmanniae preparata and Radix astragali versus calcium carbonate tablets after six months treatment (MD 0.91 μmol s-1/L; 95% CI 0.15 to 1.67) (Analysis 3.8) (Ou L 2011);

  • Qianggu soft extract versus calcium gluconate after six months treatment (MD 3.60 μmol s-1/L; 95% CI 2.62 to 4.58) (Analysis 3.8) (Peng T 2002);

  • Gumikang capsule versus calcium gluconate after six months treatment (MD 3.41 μmol s-1/L; 95% CI 2.84 to 3.98) (Analysis 3.8) (Wang CC 2005);

  • Bushen Jianpi Migu prescription versus Caltrate after three months treatment (MD 0.10 μmol s-1/L; 95% CI 0.01 to 0.19) (Analysis 3.8) (Wang ZK 2004);

  • Liuwei Dihuang pills versus calcium after six months treatment (MD 0.43 μmol s-1/L; 95% CI 0.11 to 0.75) (Analysis 3.8) (Zhang J 2003);

  • TPF capsule versus calcium granule after six months treatment (MD 3.84 μmol s-1/L; 95% CI 2.53 to 5.15) (Analysis 3.8) (Zhang YL 1996);

  • Gushen Yijing tang versus Caltrate after six months treatment (MD 2.17 μmol s-1/L; 95% CI 0.73 to 3.61) (Analysis 3.8) (Zhong RQ 2007);

  • Jiangu capsule versus Caltrate after 12 months treatment (MD 2.04 μmol s-1/L; 95% CI 1.32 to 2.76) (Analysis 3.8) (Wang YZ 2008);

  • Jingujian granule versus Caltrate after three months treatment (MD 2.40 μmol s-1/L; 95% CI 2.21 to 2.59) (Analysis 3.8) (Li YH 2010);

  • Qianggu paste versus calcium gluconate tablets after six months treatment (MD 3.60 μmol s-1/L; 95% CI 2.86 to 4.34) (Analysis 3.8) (Wang H 2007);

  • Bushen Yangxue tang versus calcium gluconate after six months treatment (MD 2.62 μmol s-1/L; 95% CI 0.84 to 4.40) (Analysis 3.8) (Zhan ML 2007).

Seven trials showed no significant effects of herbal treatments on alkaline phosphatase when compared to conventional western medicines:

  • Gukang oral liquid versus alendronate sodium tablets after six months treatment (MD -1.06 μmol s-1/L; 95% CI -2.54 to 0.42) (Analysis 3.8) (Shao M 2003);

  • Kanggusong granule versus ipriflavone after three months treatment (MD 0.13 μmol s-1/L; 95% CI -0.07 to 0.33) (Analysis 3.8) (Wu MS 2001);

  • Huangqi Sanxian tang versus nilestriol after three months treatment (MD -0.03 μmol s-1/L; 95% CI -1.14 to 1.08) (Analysis 3.8) (Zhou ZK 2006);

  • Gukang oral liquid versus alendronate sodium tablets after six months treatment (MD 0.48 μmol s-1/L; 95% CI -0.34 to 1.30) (Analysis 3.8) (Wang JM 2008);

  • Jianshenfang granule versus alendronate sodium tablets after six months treatment (MD 0.33 μmol s-1/L; 95% CI -2.78 to 3.44) (Analysis 3.8) (Li BL 2007);

  • Bushen Zhuanggu tang versus alendronate sodium tablets after three months treatment (MD -0.11 μmol s-1/L; 95% CI -0.99 to 0.77) (Analysis 3.8) (Ling JY 2008);

  • Gusong recipe versus alendronate sodium tablets after five months treatment (MD -1.05 μmol s-1/L; 95% CI -2.86 to 0.76) (Analysis 3.8) (Xiao W 2008).

Another three trials showed a worse effect of herbal treatments when compared to calcium supplementation, hormones or alendronate sodium tablets:

  • Shenyao capsules versus Caltrate after six months treatment (MD -2.40 μmol s-1/L; 95% CI -3.58 to -1.22) (Analysis 3.8) (Chen NQ 2006);

  • Yinyanghuo versus conjugated oestrogens after three to six months treatment (MD -7.00 μmol s-1/L; 95% CI -11.17 to -2.83) (Analysis 3.8) (Zhao LN 2003);

  • Bushen Jianpi Huoxue recipe versus alendronate sodium tablets after six months treatment (MD -2.94 μmol s-1/L; 95% CI -4.34 to 1.54) (Analysis 3.8) (He MT 2007).

Bone Gla protein (BGP) levels

One trial found that there was a significant difference in BGP between Chinese herbal and western medicines:

  • Acupoint sticking of Migudan versus oyster shell calcium chewable tablets after three months treatment (MD 1.55 μg/L; 95% CI 1.24 to 1.86) (Analysis 3.9) (Xu YL 2007).

Three trials showed a statistically significantly better effect on BGP when compared with calcium supplementation:

  • Bushen Huoxue capsule versus Caltrate plus Rocalirol after 12 months treatment (MD 0.93 μg/L; 95% CI 0.35 to 1.51) (Analysis 3.9) (Zhang XJ 2008);

  • Kanggusong capsule versus Caltrate after six months treatment (MD 1.78 μg/L; 95% CI 0.40 to 3.16) (Analysis 3.9) (Wei RY 2011);

  • Liuwei Dihuang pills versus calcium after 12 months treatment (MD 17.90 μg/L; 95% CI 12.43 to 23.37) (Analysis 3.9) (Zhang J 2003).

Three trials showed no significant effects of herbal treatments on BGP when compared to western medicines:

  • Gukang oral liquid versus alendronate after six months treatment (MD -0.10 μg/L; 95% CI -0.93 to 0.73) (Analysis 3.9) (Shao M 2003);

  • Jianshenfang granule versus alendronate sodium tablets after six months treatment (MD 0.49 μg/L; 95% CI -1.59 to 2.57) (Analysis 3.9) (Li BL 2007);

  • Jiangu recipe versus alendronate sodium tablets after 12 months treatment (MD 1.81 μg/L; 95% CI -0.31 to 3.93) (Analysis 3.9) (Qiu RB 2008).

Five trials showed no significant effects of herbal treatments when compared with calcium supplementation:

  • Strong Bone capsule versus Caltrate after three months treatment (MD -0.49 μg/L; 95% CI -2.17 to 1.19) (Analysis 3.9) (Cui TH 1999);

  • Yanghuo Sanzitang versus Caltrate after six months treatment (MD 2.71 μg/L; 95%CI -0.30 to 5.72) (Analysis 3.9) (Qiu RB 2004);

  • Shigu yin versus Caltrate after six months treatment (MD 0.80 μg/L; 95% CI -0.34 to 1.94) (Analysis 3.9) (Zhang YP 2007);

  • Jingujian granule versus Caltrate after three months treatment (MD 2.53 μg/L; 95% CI -0.38 to 5.44) (Analysis 3.9) (Li YH 2008);

  • Tongbu Qianggutang versus calcium plus vitamin D3 after three months treatment (MD -1.50 μg/L; 95% CI -5.07 to 2.08) (Analysis 3.9) (Zhou LZ 2001).

Another trial showed a worse effect of Bushen Jianpi Huoxue recipe when compared to alendronate sodium tablets after six months treatment (MD -2.13 μg/L; 95% CI -2.74 to -1.52) (Analysis 3.9) (He MT 2007).

Interleukin-6 (IL-6) levels

There was no significant difference between herbal drugs and western medicine in interleukin-6 in three trials:

  • Bushen Jianpi Huoxue recipe versus alendronate sodium tablets after six months treatment (MD -5.72 pg/ml; 95% CI -14.05 to 2.61) (Analysis 3.10) (He MT 2007);

  • Gukang oral liquid versus alendronate sodium tablets after six months treatment (MD -3.50 pg/ml; 95% CI -15.93 to 8.93) (Analysis 3.10) (Shao M 2003);

  • Jianshenfang granule versus alendronate sodium tablets after six months treatment (MD -12.56 pg/ml; 95% CI -29.26 to 4.14) (Analysis 3.10) (Li BL 2007).

Three trials showed statistically significantly better effects on interleukin-6:

  • Jiangu recipe versus alendronate sodium tablets after 12 months treatment (MD -19.99 pg/ml; 95% CI -30.92 to -9.06) (Analysis 3.10) (Qiu RB 2008);

  • Yanghuo Sanzi tang versus Caltrate after six months treatment (MD -20.29 pg/ml; 95% CI -35.67 to -4.91) (Analysis 3.10) (Qiu RB 2004);

  • Bushen Huoxue capsule versus Caltrate plus Rocalirol (MD -18.70 pg/ml; 95% CI -34.16 to -3.24) (Analysis 3.10) (Zhang XJ 2008).

Parathyroid hormone (PTH) levels

Four trials showed no significant effects of herbal treatments on PTH when compared to common western medicines:

  • prescription for tonifying kidney versus ipriflavone (MD -13.00 μg/L; 95% CI -41.67 to 15.67), kidney meridian sticking versus ipriflavone (MD -13.01 μg/L; 95% CI -41.95 to 15.93), urinary bladder meridian sticking versus ipriflavone (MD -3.01 μg/L; 95% CI -31.44 to 25.42), Gushukang granule versus ipriflavone (MD -3.02 μg/L; 95% CI -30.91 to 24.87) after six months treatment (Analysis 3.11) (Wu MS 2007);

  • Kanggusong granule versus ipriflavone after three months treatment (MD 11.81 μg/L; 95% CI -14.64 to 38.26) (Analysis 3.11) (Wu MS 2001);

  • Bugu Shengsui capsule versus vitamin D2 plus calcium tablet after six months treatment (MD -10.63 μg/L; 95% CI -140.92 to 119.66) (Analysis 3.11) (Xie YM 1997);

  • Gujian capsule versus alfacalcidol after six months treatment (MD -22.57 pg/ml; 95% CI -60.92 to 15.78) (Analysis 3.11) (Meng XD 2003);

  • Radix rehmanniae preparata and Radix astragali versus calcium carbonate tablets after six months treatment (MD -2.06 pg/ml; 95% CI -6.74 to 2.62) (Analysis 3.11) (Ou L 2011).

In another trial, TPF capsule showed a better effect than calcium granule after six months treatment (MD -254.00 pg/ml; 95% CI -399.06 to -108.94) (Analysis 3.11) (Zhang YL 1996).

Calcitonin (CT) levels

Five trials showed no significant effects of herbal treatments on calcitonin when compared to common western medicines:

  • prescription for tonifying kidney versus ipriflavone (MD 0.96 ng/L; 95% CI -3.71 to 5.63), kidney meridian sticking versus ipriflavone (MD -1.01 ng/L; 95% CI -5.44 to 3.42), urinary bladder meridian sticking versus ipriflavone (MD -0.01 ng/L; 95% CI -4.68 to 4.66), Gushukang granule versus ipriflavone (MD -0.01 ng/L; 95% CI -4.44 to 4.42) after six months treatment (Analysis 3.12) (Wu MS 2007);

  • Bugu Shengsui capsule versus vitamin D2 plus calcium tablet (MD 15.93 ng/L; 95% CI -24.16 to 56.02) (Analysis 3.12) (Xie YM 1997);

  • Tongbu Qianggutang versus calcium plus vitamin D3 after three months treatment (MD -6.18 ng/L; 95% CI -12.89 to 0.52) (Analysis 3.12) (Zhou LZ 2001);

  • Gujian capsule versus alfacalcidol after six months treatment (MD -12.77 ng/L; 95% CI -70.92 to 45.38) (Analysis 3.12) (Meng XD 2003);

  • Radix rehmanniae preparata and Radix astragali versus calcium carbonate tablets after six months treatment (MD 0.11 ng/L; 95% CI -0.04 to 0.26) (Analysis 3.12) (Ou L 2011).

Three trials showed a statistically significantly better effect on calcitonin when compared with calcium supplementation:

  • Strong Bone capsule versus Caltrate after three months treatment (MD 16.25 ng/L; 95% CI 10.43 to 22.07) (Analysis 3.12) (Cui TH 1999);

  • Jingujian granule versus Caltrate after three months treatment (MD 21.98 ng/L; 95% CI 17.01 to 26.95) (Analysis 3.12) (Li YH 2010)

  • TPF capsule versus calcium granule after six months treatment (MD 17.71 ng/L; 95% CI 11.53 to 23.89) (Analysis 3.12) (Zhang YL 1996).

Chinese herbal medicines plus western medicine versus western medicine (Comparison 04)

Oestradiol (E2) levels

Eight trials showed positive effects of Chinese herbal medicines plus western medicine treatments on E2 when compared to the same western medicines:

  • Gushen decoction plus Caltrate and Alfacalcidol versus Caltrate and Alfacalcidol after six months treatment (MD 4.54 pg/ml; 95% CI 0.47 to 8.61) (Analysis 4.6) (Chen FS 2001);

  • Shugan zishen huoxue tang plus Caltrate and alendronate sodium tablets versus Caltrate and alendronate sodium tablets after six months treatment (MD 26.99 pg/ml; 95% CI 18.44 to 35.54) (Analysis 4.6) (Han XL 2007);

  • Ziyin Bushen Zhuanggu prescription plus Caltrate and calcitonin versus Caltrate plus calcitonin after eight months treatment (MD 23.21 pg/ml; 95% CI 14.46 to 31.96) (Analysis 4.6) (Li HW 2004);

  • Zhuanggu capsule plus Caltrate versus Caltrate after six months treatment (MD 4.06 pg/ml; 95% CI 2.56 to 5.56) (Analysis 4.6) (Li SL 2004);

  • Antai capsule plus Caltrate versus Caltrate after six months treatment (MD 11.00 pg/ml; 95% CI 8.14 to 13.86) (Analysis 4.6) (Wang SW 2003);

  • Zishen prescription plus Caltrate and calcitonin versus Caltrate plus calcitonin (MD 23.21 pg/ml; 95% CI 14.46 to 31.96) (Analysis 4.6) (Zhao G 2002);

  • Xianlinggubao capsule plus vitamin D3 and calcium amino acid chelate versus vitamin D3 and calcium amino acid chelate after 48 weeks treatment (MD 6.04 pg/ml; 95% CI 4.61 to 7.47) (Analysis 4.6) (Zhang XZ 2004);

  • Yigu capsule plus calcium versus placebo plus calcium after six months treatment (MD 40.85 pg/ml; 95% CI 33.61 to 48.09) (Analysis 4.6) (Zhang RH 2004).

Compared with Caltrate alone, Bushen Qiangshen pill plus Caltrate did not have significant effect on oestradiol (MD 7.60 pg/ml; 95% CI -0.51 to 15.71) (Analysis 4.6) (Mu G 2001).

Serum calcium (Ca) levels

Three trials showed positive effects of Chinese herbal medicines plus western medicine treatments on calcium when compared to the same western medicines:

  • Bushenyiqihuoxue soup plus tamoxifen and Caltrate versus tamoxifen and Caltrate after three months treatment (MD 0.37 mmol/L; 95% CI 0.32 to 0.42) (Analysis 4.7) (Zhang DS 2011);

  • Chinese medicine (combinations of 10 herbs) plus tamoxifen and Caltrate versus tamoxifen and Caltrate after three months treatment (MD 0.37 mmol/L; 95% CI 0.32 to 0.42) (Analysis 4.7) (Cao W 2010);

  • Huangqi plus Caltrate versus Caltrate after six months treatment (MD 0.28 mmol/L; 95% CI 0.11 to 0.45) (Analysis 4.7) (Yang B 2007).

While Yigu capsule plus calcium versus placebo plus calcium had a negative effect on calcium after six months treatment (MD -0.07 mmol/L; 95% CI -0.13 to -0.01) (Analysis 4.7) (Zhang RH 2004).

Eight trials did not show positive effects of herbal treatments plus western medicines when compared to the same western medicines:

  • Gushen decoction plus Caltrate and Alfacalcidol versus Caltrate and Alfacalcidol after six months treatment (MD 0.05 mmol/L; 95% CI -0.02 to 0.12) (Analysis 4.7) (Chen FS 2001);

  • Gushukang granule plus Calcium carbonate with vitamin D chewable tablets versus Calcium carbonate with vitamin D chewable tablets after six months treatment (MD -0.01 mmol/L; 95% CI -0.09 to 0.07) (Analysis 4.7) (Chen ZX 2002);

  • Zhuanggu capsule plus Caltrate versus Caltrate after six months treatment (MD 0.01 mmol/L; 95% CI -0.07 to 0.09) (Analysis 4.7) (Li SL 2004);

  • Yiyuanjiangu decoction plus calcitonin ampoule and calcium carbonate tablet versus calcitonin ampoule and calcium carbonate tablet after three months treatment (MD -0.02 mmol/L; 95% CI -0.06 to 0.02) (Analysis 4.7) (Ma CZ 2011);

  • Antai capsule plus Caltrate versus Caltrate after six months treatment (MD -0.03 mmol/L; 95% CI -0.09 to 0.03) (Analysis 4.7) (Wang SW 2003);

  • Jinwugutong capsule plus calcium versus placebo plus calcium after six months treatment (MD -0.05 mmol/L; 95% CI -0.11 to 0.01) (Analysis 4.7) (Zheng WK 2007);

  • Xianlinggubao capsule plus salmon calcitonin and Caltrate versus salmon calcitonin plus Caltrate after three months treatment (MD 0.03 mmol/L; 95% CI -0.09 to 0.15) (Analysis 4.7) (Dong Y 2010)

  • Zhuangguqiangjin tablet and Shujinbogu tablet plus calcitonin ampoule versus calcitonin ampoule after 12 months treatment (MD -0.02 mmol/L; 95% CI -0.10 to 0.06) (Analysis 4.7) (Zhang ZF 2011).

Phosphorus (P) levels

Nine trials did not show positive effects of herbal treatments plus western medicines when compared to the same western medicines:

  • Gushen decoction plus Caltrate and Alfacalcidol versus Caltrate and Alfacalcidol (MD -0.13 mmol/L; 95% CI -0.27 to 0.01) (Analysis 4.8) (Chen FS 2001);

  • Gushukang granule plus Calcium carbonate with vitamin D chewable tablets versus Calcium carbonate with vitamin D chewable tablets after six months treatment (MD -0.02 mmol/L; 95% CI -0.11 to 0.07) (Analysis 4.8) (Chen ZX 2002);

  • Zhuanggu capsule plus Caltrate versus Caltrate (MD 0.01 mmol/L; 95% CI -0.06 to 0.08) (Analysis 4.8) (Li SL 2004);

  • Yiyuanjiangu decoction plus calcitonin ampoule and calcium carbonate tablet versus calcitonin ampoule and calcium carbonate tablet after three months treatment (MD 0.06 mmol/L; 95% CI -0.22 to 0.34) (Analysis 4.8) (Ma CZ 2011);

  • Antai capsule plus Caltrate versus Caltrate (MD -0.01 mmol/L; 95% CI -0.23 to 0.21) (Analysis 4.8) (Wang SW 2003);

  • Jinwugutong capsule plus calcium versus placebo plus calcium after six months treatment (MD -0.02 mmol/L; 95% CI -0.09 to 0.05) (Analysis 4.8) (Zheng WK 2007);

  • Xianlinggubao capsule plus salmon calcitonin and Caltrate versus salmon calcitonin plus Caltrate after three months treatment (MD 0.01 mmol/L; 95% CI -0.12 to 0.14) (Analysis 4.8) (Dong Y 2010);

  • Yigu capsule plus calcium versus placebo plus calcium after six months treatment (MD -0.03 mmol/L; 95% CI -0.08 to 0.02) (Analysis 4.8) (Zhang RH 2004);

  • Zhuangguqiangjin tablet and Shujinbogu tablet plus calcitonin ampoule versus calcitonin ampoule after 12 months treatment (MD -0.02 mmol/L; 95% CI -0.08 to 0.04) (Analysis 4.8) (Zhang ZF 2011).

Alkaline phosphatase (ALP) levels

Seven trials did not show significant effects of herbal treatments plus western medicines on alkaline phosphatase levels when compared to the same western medicines:

  • Gushukang granule plus Calcium carbonate with vitamin D chewable tablets versus Calcium carbonate with vitamin D chewable tablets after six months treatment (MD -0.50 μmol s-1/L; 95% CI -1.70 to 0.70) (Analysis 4.9) (Chen ZX 2002);

  • Zhuanggu capsule plus Caltrate versus Caltrate after six months treatment (MD 0.00 μmol s-1/L; 95% CI -1.55 to 1.55) (Analysis 4.9) (Li SL 2004);

  • Yiyuanjiangu decoction plus calcitonin ampoule and calcium carbonate tablet versus calcitonin ampoule and calcium carbonate tablet after three months treatment (MD 0.31 μmol s-1/L; 95% CI -0.48 to 1.10) (Analysis 4.9) (Ma CZ 2011);

  • Bushen Qiangshen pill plus Caltrate versus Caltrate after three months treatment (MD -0.31 μmol s-1/L; 95% CI -1.72 to 1.10) (Analysis 4.9) (Mu G 2001);

  • Jinwugutong capsule plus calcium versus placebo plus calcium after six months treatment (MD 1.01 μmol s-1/L; 95% CI -0.04 to 2.06) (Analysis 4.9) (Zheng WK 2007);

  • Chinese medicine (combinations of 10 herbs) plus tamoxifen and Caltrate versus tamoxifen and Caltrate after three months treatment (MD -0.26 μmol s-1/L; 95% CI -1.64 to 1.12) (Analysis 4.9) (Cao W 2010);

  • Zhuangguqiangjin tablet and Shujinbogu tablet plus calcitonin ampoule versus calcitonin ampoule after 12 months treatment (MD 0.08 μmol s-1/L; 95% CI -0.54 to 0.70) (Analysis 4.9) (Zhang ZF 2011).

Six trials showed that herbal drugs plus western medicine could increase the alkaline phosphatase level when compared with the same western medicine:

  • Antai capsule plus Caltrate versus Caltrate regarding alkaline phosphatase before and after six months treatment (MD 1.28 μmol s-1/L; 95% CI 0.55 to 2.01) (Analysis 4.9) (Wang SW 2003);

  • Chinese decoction plus calcium gluconate versus calcium gluconate after nine months treatment (MD 1.77 μmol s-1/L; 95% CI 1.20 to 2.34) (Analysis 4.9) (Miu JQ 2008);

  • Bushenyiqihuoxue soup plus tamoxifen and Caltrate versus tamoxifen and Caltrate after three months treatment (MD 3.54 μmol s-1/L; 95% CI 1.68 to 5.40) (Analysis 4.9) (Zhang DS 2011);

  • Yigu capsule plus calcium versus placebo plus calcium after six months treatment (MD 1.73 μmol s-1/L; 95% CI 0.71 to 2.75) (Analysis 4.9) (Zhang RH 2004);

  • Huangqi plus Caltrate versus Caltrate after six months treatment (MD 0.82 μmol s-1/L; 95% CI 0.63 to 1.01) (Analysis 4.9) (Yang B 2007);

  • Xianlinggubao capsule plus vitamin D3 and calcium amino acid chelate versus vitamin D3 and calcium amino acid chelate after 48 weeks (MD 10.48 μmol s-1/L; 95% CI 9.81 to 11.15) (Analysis 4.9) (Zhang XZ 2004).

Two trials showed the opposite effect:

  • Xianlinggubao capsule plus salmon calcitonin and Caltrate versus salmon calcitonin plus Caltrate after three months treatment (MD -0.99 μmol s-1/L; 95% CI -1.52 to -0.46) (Analysis 4.9) (Dong Y 2010);

  • Kanggusong soup plus Caltrate versus Caltrate after three months treatment (MD -1.61 μmol s-1/L; 95% CI -3.17 to -0.05) (Analysis 4.9) (Li ZP 2011).

Bone Gla protein (BGP) levels

One trial showed a better effect of herbal drugs plus western medicine:

  • Zhuanggu capsule plus Caltrate versus Caltrate (MD -2.30 μg/L; 95% CI -4.07 to -0.53) (Analysis 4.10) (Li SL 2004).

Seven trials showed a worse effect of herbal drugs plus western medicine:

  • Traditional Chinese capsule plus calcium gluconate versus calcium gluconate after nine months treatment (MD 1.23 μg/L; 95% CI 0.88 to 1.58) (Analysis 4.10) (Miu JQ 2008);

  • Jinwugutong capsule plus calcium versus placebo plus calcium after six months treatment (MD 2.47 μg/L; 95% CI 1.44 to 3.50) (Analysis 4.10) (Zheng WK 2007);

  • Yigu capsule plus calcium versus placebo plus calcium after six months treatment (MD 2.60 μg/L; 95% CI 1.66 to 3.54) (Analysis 4.10) (Zhang RH 2004);

  • Xianlinggubao capsule plus vitamin D3 and calcium amino acid chelate versus vitamin D3 and calcium amino acid chelate after 48 weeks treatment (MD 6.24 μg/L; 95% CI 5.69 to 6.79) (Analysis 4.10) (Zhang XZ 2004);

  • Xianlinggubao capsules plus Caltrate versus Caltrate after 12 months treatment (MD 1.85 μg/L; 95% CI 0.87 to 2.83) (Analysis 4.10) (Wu W 2005);

  • Huangqi plus Caltrate versus Caltrate after six months treatment (MD 0.63 μg/L; 95% CI 0.50 to 0.76) (Analysis 4.10) (Yang B 2007).

There was no significant difference between Xianlinggubao capsule plus salmon calcitonin and Caltrate versus salmon calcitonin plus Caltrate after three months treatment (MD 0.56 μg/L; 95% CI -0.30 to 1.42) (Analysis 4.10) (Dong Y 2010).

Interleukin-6 (IL-6) levels

Three trials showed a better effect of herbal drugs plus western medicine on interleukin-6:

  • Erxian Yanggu tang plus alendronate sodium tablets versus alendronate sodium tablets (MD -16.18 pg/ml; 95% CI -19.62 to -12.74) (Analysis 4.11) (Huang JW 2008);

  • Kanggusong soup plus Caltrate versus Caltrate after three months treatment (MD -16.32 pg/ml; 95% CI -31.60 to -1.04) (Analysis 4.11) (Li ZP 2011);

  • Xianlinggubao capsule plus vitamin D3 and calcium amino acid chelate versus vitamin D3 and calcium amino acid chelate after 48 weeks treatment (MD -133.30 pg/ml; 95% CI -139.94 to -126.66) (Analysis 4.11) (Zhang XZ 2004).

History

DateEventDescription
26 August 2008AmendedConverted to new review format. C041-R

Contributions of authors

Y Liu: drafted the protocol, developed the search strategy, selected trials, assessed trial quality, extracted data, performed data analyses and drafted the review.

Y Xia: updated the searches and selected trials, assessed trial quality, extracted data, performed data analyses and co-developed the review.

JP Liu: conceived the study, revised the protocol and the review, provided a methodological perspective and performed data analyses.

Declarations of interest

We certify that we have no affiliations with or involvement in any organisation or entity with a direct financial interest in the subject matter of the review (e.g. employment, consultancy, stock ownership, honoraria, expert testimony).

Sources of support

Internal sources

  • School of Public Health, Shandong University, China.

  • Beijing University of Chinese Medicine, China.

External sources

  • National Basic Research Program ('973' program, grant number 2006CB504602), China.

  • International Science & Technology Cooperation Project (grant number 2009DFA31460), China.

  • The Program for Innovative Research Team of Beijing University of Chinese Medicine (no. 2011-CXTD-09), China.

Differences between protocol and review

Chinese diagnostic criteria for osteoporosis were added, besides the WHO criteria, as many trials used the Chinese criteria (these were adapted from the WHO criteria).

Characteristics of studies

Characteristics of included studies [ordered by study ID]

An SJ 2000

Methods

Country: China

Setting: hospital based

Aim: to observe the therapeutic effect and mechanism of kidney-tonifying herbs on postmenopausal osteoporosis

Study design: double-blind, randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

111 postmenopausal osteoporosis patients enrolled: 31 in Kanggusong granule group, 40 in ipriflavone group, 40 in Caltrate group

Inclusion criteria: diagnostic criteria for osteoporosis based on bone density levels recommended by WHO; BMD detected by DXA

Exclusion criteria: secondary osteoporosis

Interventions

Experimental: Kanggusong granule, 12 g, twice daily, for 9 months

Control 1: ipriflavone (200 mg, 3 times a day) and Caltrate (1 tablet per day), for 9 months

Control 2: Caltrate (1 tablet per day), for 9 months

OutcomesBMD, E2, Ca, P, ALP, fractures
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Low riskIt was described as double-blind but did not describe who was blinded
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Cao GY 2010

Methods

Country: China

Setting: hospital based

Aim: to observe the therapeutic effect of integrated traditional Chinese and western medicine on primary osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese
57 primary osteoporosis patients enrolled: 30 in trial group, 27 in control group

Inclusion criteria: WHO diagnostic criteria for osteoporosis based on bone density levels

Exclusion criteria: secondary osteoporosis

Interventions

Experimental: Chinese medicine Bushenhuoxue recipe (1 dose per day, water fried) and conventional western medicine (alfacalcidol soft capsules, bisphosphonate and salmon calcitonin, etc.) based on the patient's condition, for 3 months

Control: conventional western medicine based on the patient's condition, for 3 months

OutcomesBMD
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskPatients were randomly allocated
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasUnclear riskNo detailed description and P value for the baseline comparison not stated

Cao W 2010

Methods

Country: China

Setting: hospital based

Aim: to observe the therapeutic effect of integrated traditional Chinese and western medicine on postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test, Chi2 test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese
120 postmenopausal osteoporosis patients enrolled: 60 in trial group, 60 in control group

Inclusion criteria: WHO diagnostic criteria for osteoporosis based on bone density levels

Exclusion criteria: serious women's illnesses, malignant tumour, diabetes, etc.

Interventions

Experimental: Chinese medicine (combinations of herbs) (1 dose per day, water fried 300 ml, twice a day), tamoxifen (20 mg per day) and Caltrate (600 mg, 1 to 2 tablets per day), for 3 months

Control: tamoxifen (20 mg per day) and Caltrate (600 mg, 1 to 2 tablets per day), for 3 months

OutcomesBMD, Ca, ALP, adverse events
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskPatients were randomly allocated
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'.
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Chen FS 2001

Methods

Country: China

Setting: outpatients and inpatients

Aim: to observe the therapeutic effect of integrated traditional Chinese and western medicine on postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

64 postmenopausal osteoporosis patients enrolled: 32 in trial group, 32 in control group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis based on bone density levels, BMD detected by DXA

Exclusion criteria: not mentioned

Interventions

Experimental: Gushen decoction (1 dose per day), Caltrate (600 mg per day) and Alfacalcidol (0.25 μg per day), for 24 weeks

Control: Caltrate (600 mg per day) and Alfacalcidol (0.25 μg per day), for 24 weeks

OutcomesBMD, E2, Ca, P, adverse effects
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasUnclear riskP value for the baseline comparison not stated

Chen JP 1999

Methods

Country: China

Setting: outpatients

Aim: to observe the therapeutic effect of Gukang oral liquid on postmenopausal osteoporosis

Study design: single-blind, randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese
61 postmenopausal osteoporosis patients enrolled: 36 in trial group, 25 in control group

Inclusion criteria: diagnostic criteria for osteoporosis based on bone density levels, BMD detected by single photon absorptiometry (SPA)

Exclusion criteria: secondary osteoporosis, etc.

Interventions

Experimental: Gukang oral liquid (a basic herbal compound), 10 ml, 3 times a day, for 6 months

Control: Tridin, 1 tablet, 3 times a day, for 6 months

OutcomesBMD
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Low riskSingle-blind but did not describe who was blinded
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasUnclear riskP value for the baseline comparison not stated

Chen NQ 2006

Methods

Country: China

Setting: outpatients

Aim: to observe the therapeutic effect of Shenyao capsules on primary osteoporosis

Study design: single-blind, randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

100 primary osteoporosis patients enrolled: 50 in trial group, 50 in control group

Inclusion criteria: WHO diagnostic criteria for osteoporosis, BMD detected by DXA

Exclusion criteria: secondary osteoporosis, endocrine disease

Interventions

Experimental: Shenyao capsules (2 capsules, 3 times a day) for 6 months

Control: Caltrate (600 mg, once a day), for 6 months

OutcomesBMD, Ca, P, ALP, adverse effects
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Low riskSingle-blind but did not describe who was blinded
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasUnclear riskNo detailed description and P value for baseline comparison not stated

Chen X 2008

Methods

Country: China

Setting: hospital based

Aim: to observe the therapeutic effect of Gukang decoction on primary osteoporosis

Study design: randomised controlled trial

Analysis: T-test, Chi2test

Loss to follow-up: not reported

Participants

Ethnicity: China

83 primary osteoporosis patients enrolled: 42 in trial group, 41 in control group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis, BMD detected by DXA

Exclusion criteria: not mentioned

Interventions

Experimental: Gukang decoction, 1 dose per day, for 4 months

Control: alendronate sodium tablets, 10 mg, once a day, for 4 months

OutcomesBMD, E2, adverse effects
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationHigh riskSequence generated by some rule based on clinic time
Allocation concealmentHigh riskAllocation based on clinic time
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Chen XL 2010

Methods

Country: China

Setting: outpatients

Aim: to observe the therapeutic effect of Heche Dazao pill on primary osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

114 primary osteoporosis patients enrolled: 57 in trial group, 57 in control group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis

Exclusion criteria: liver or kidney disease, endocrine diseases, etc.

Interventions

Experimental: Heche Dazao pill (1 dose per day, water fried twice, twice a day) and Gaitianli (300 mg, 3 times a day), for 3 months

Control: Gaitianli (300 mg, 3 times a day), for 3 months

OutcomesBMD
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationLow riskRandom numbers
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Chen YQ 2001

Methods

Country: China

Setting: outpatients

Aim: to observe the therapeutic effect of Jiarong tablet on postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

61 postmenopausal osteoporosis patients enrolled: 20 in trial group, 20 in Livial group, 21 in Caltrate group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis based on bone density levels, BMD detected by DXA

Exclusion criteria: not mentioned

InterventionsExperimental: Jiarong tablet (5 g, 3 times a day) and Caltrate (1 tablet per day), for 6 months
Control: Livial (2.5 mg, every other day) and Caltrate (1 tablet per day), or Caltrate (1 tablet per day), for 6 months
OutcomesBMD, adverse effects
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasUnclear riskNo information on baseline comparison

Chen ZX 2002

Methods

Country: China

Setting: hospital based

Aim: to observe the therapeutic effect of Gushukang granule on postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese
62 postmenopausal osteoporosis patients enrolled: 23 in Gushukang granule and Calcium carbonate with vitamin D chewable tablets group, 20 in Gushukang granule group, 19 in Calcium carbonate with vitamin D chewable tablets group

Inclusion criteria: diagnostic criteria for osteoporosis based on bone density levels recommended by WHO, BMD detected by DXA

Exclusion criteria: secondary osteoporosis

Interventions

Experimental: Gushukang granule (10 g, twice a day) and Calcium carbonate with vitamin D chewable tablets (1 tablet, twice a day), or Gushukang granule (10 g, twice a day), for 6 months

Control: Calcium carbonate with vitamin D chewable tablets, 1 tablet, twice a day, for 6 months

OutcomesBMD, Ca, P, ALP
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationLow riskRandom numbers table
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Cui TH 1999

Methods

Country: China

Setting: hospital based

Aim: to observe the therapeutic effect of Strong Bone capsule on postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

105 postmenopausal osteoporosis patients enrolled: 74 in trial group, 31 in control group

Inclusion criteria: diagnostic criteria for osteoporosis based on bone density levels recommended by WHO; BMD detected by DXA

Exclusion criteria: not mentioned

Interventions

Experimental: Strong Bone capsule (a basic herbal compound), 5 capsules, 3 times a day, for 3 months

Control: Caltrate, 1 tablet per day, for 3 months

OutcomesBMD, E2, Ca, P, ALP, BGP, CT, adverse effects
NotesThe study was supported by administration of traditional Chinese medicine scientific research funds in Jiangsu Province, but no declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasUnclear riskNo information on baseline comparison

Dai Y 2007

Methods

Country: China

Setting: hospital based

Aim: to observe the therapeutic effect of Migu tablet on BMD, OPG, etc. in patients with postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: analysis of variance (F-test)

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

160 postmenopausal osteoporosis patients enrolled: 54 in Migu tablet trial group, 53 in Xianlinggubao group, 53 in compound calcium amino acid chelate capsules group

Inclusion criteria: diagnostic criteria for osteoporosis, BMD detected by DXA

Exclusion criteria: disease-affected bone metabolism, endocrine diseases, etc

Interventions

Experimental: Migu tablet group: Migu tablet, 1 tablet, 3 times a day and compound calcium amino acid chelate capsule, 1 g, once a day; for 24 weeks

Xianlinggubao group: Xianlinggubao capsule, 0.5, g 3 times a day and compound calcium amino acid chelate capsule, 1 g, once a day, for 24 weeks

Control: compound calcium amino acid chelate capsule, 1 g, once a day, for 24 weeks

OutcomesBMD
NotesThe study was supported by a health department funded project in Hubei Province, but no declarations of interest for the primary researchers was reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationLow riskRandom numbers
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasUnclear riskNo information on baseline comparison

Deng WM 2012

Methods

Country: China

Setting: hospital based

Aim: to observe the kidney-tonifying herbal Fufangs with phytoestrogenic Epimedium for prevention of postmenopausal osteoporosis with both BMD and fracture as study endpoints

Study design: a multicentre, double-blind, randomised controlled trial

Analysis: F-test, Chi2 test based on the intention-to-treat (ITT) principle

Loss to follow-up: 5-year follow-up. At the end of 5 years, 155 participants had completed the study (13 drop-outs in the treatment group, 26 drop-outs in the control group); the difference in drop-out rate was statistically significant between the 2 groups (P < 0.05)

Participants

Ethnicity: Chinese

194 postmenopausal osteoporosis patients enrolled: 101 in experimental group, 93 in placebo group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis

Exclusion criteria: those who used any kind of anti-osteoporosis drugs or had been under HRT during the past year; current medical disease(s) associated with potential development of metabolic bone diseases, including Paget disease, osteomalacia, bone marrow disease, hereditary disorders of calcium or mineral metabolism, adrenal disorders, poorly controlled diabetes mellitus, severe connective tissue disorders, gastrointestinal diseases and current or past history of clinically significant haematological, endocrinological, cardiovascular, renal, hepatic, gastrointestinal, psychiatric or neurological diseases

Interventions

Experimental: Bushen Zhuanggu granules (10 g per day, twice per day), plus calcium (600 mg) and vitamin D (400 IU)

Control: placebo granules (10 g per day, twice per day), plus calcium (600 mg) and vitamin D (400 IU)

OutcomesBMD, fracture, adverse effects
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasUnclear riskNo information on baseline comparison

Dong Y 2010

Methods

Country: China

Setting: outpatients

Aim: to evaluate the efficacy and safety of salmon calcitonin plus Xianlinggubao for osteoporosis and ostealgia in postmenopausal women

Study design: randomised controlled trial

Analysis: T-test, Chi2 test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

160 postmenopausal osteoporosis patients enrolled: 54 in Xianlinggubao plus salmon calcitonin group, 53 in Xianlinggubao group, 53 in salmon calcitonin control group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis, BMD detected by DXA

Exclusion criteria: disease-affected bone metabolism, endocrine diseases, secondary osteoporosis, liver or kidney disease, etc.

Interventions

Experimental: Xianlinggubao plus salmon calcitonin group: Xianlinggubao (1.5 g, twice a day), salmon calcitonin (500 IU, once a day) and Caltrate (1 tablet per day), for 3 months

Xianlinggubao group: Xianlinggubao (1.5 g, twice a day) and Caltrate (1 tablet per day), for 3 months

Control: salmon calcitonin (500 IU, once a day) and Caltrate (1 tablet per day), for 3 months

OutcomesBMD, ALP, BGP, Ca, P, adverse effects
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskPatients were randomly allocated
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Dong YF 2004

Methods

Country: China

Setting: outpatients

Aim: to observe the therapeutic effect of traditional Chinese herbs on primary osteoporosis

Study design: randomised controlled trial

Analysis: T-test, Chi2 test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

80 senile osteoporosis patients enrolled: 40 in trial group, 40 in control group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis, BMD detected by DXA

Exclusion criteria: endocrine diseases, secondary osteoporosis, etc.

Interventions

Experimental: traditional Chinese herbs (Longspur Epimedium, etc.), 1 dose per day, for 6 months

Control: vitamin D (10000 U, once a day), Caltrate (600 mg, once a day), for 6 months

OutcomesBMD
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasUnclear riskP value for the baseline comparison not stated

Fan HX 2004

Methods

Country: China

Setting: outpatients

Aim: to observe the therapeutic effect of Gengnian Anyi tablet on postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

60 postmenopausal osteoporosis patients enrolled: 22 in herb trial group, 18 in nilestriol control group, 20 in Caltrate group

Inclusion criteria: international diagnostic criteria for osteoporosis, BMD detected by SPA

Exclusion criteria: endocrine diseases, etc.

Interventions

Experimental: Gengnian Anyi tablet (6 tablets, 3 times a day) and Caltrate (1 tablet per day), for 6 months

Control: nilestriol (2 mg, once a half month) and Caltrate (1 tablet per day), or Caltrate (1 tablet per day), for 6 months

OutcomesBMD, adverse effects
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasUnclear riskNo information on baseline comparison

Gang PH 2001

Methods

Country: China

Setting: outpatients

Aim: to observe the therapeutic effect of Gumiling granule on primary osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

25 primary osteoporosis patients enrolled: 15 in herb trial group, 10 in control group

Inclusion criteria: BMD, detected by DXA

Exclusion criteria: secondary osteoporosis, liver or kidney disease, etc.

Interventions

Experimental: Gumiling granule (10 g, 3 times a day), for 6 months

Control: bicarbonate calcium chewable(1 g, twice a day), for 6 months

OutcomesBMD, adverse effects
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasUnclear riskNo information on baseline comparison

Gong L 2001

Methods

Country: China

Setting: outpatients

Aim: to observe the therapeutic effect of Yishen Zhuanggu mixture on primary osteoporosis

Study design: randomised controlled trial

Analysis: T-test, F-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

80 primary osteoporosis patients enrolled: 46 in herb trial group, 17 in herb control group, 17 in blank control group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis based on bone density levels, BMD detected by DXA

Exclusion criteria: endocrine diseases, etc.

Interventions

Experimental: Yishen Zhuanggu mixture (25 ml, twice a day) in herb trial group, Shengu capsule (2 capsules, 3 times a day) in herb control group, for 6 months

Control: blank

OutcomesBMD, BGP, adverse effects
NotesThe study was supported by a Science and Technology Commission funded project in Beijing, but no declarations of interest of the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Guo JH 2008

Methods

Country: China

Setting: outpatients

Aim: to explore the effect of Bushen Kangsong pill on BMD in postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

84 postmenopausal osteoporosis patients enrolled: 42 in trial group, 42 in control group

Inclusion criteria: diagnostic criteria for osteoporosis based on bone density levels, BMD detected by DXA

Exclusion criteria: disease-affected bone metabolism, liver or kidney disease, etc.

Interventions

Experimental: Bushen Kangsong pill, 3 g, 3 times a day, calcium carbonate, 4 tablets, 3 times a day, for 6 months

Control: calcium carbonate, 4 tablets, 3 times a day, for 6 months

OutcomesBMD
NotesThe study was supported by the Science Foundation for Post-doctoral Scientists of Jiangsu Province, but no declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Han XL 2007

Methods

Country: China

Setting: outpatients and inpatients

Aim: to explore the effect of Shugan Zishen Huoxue tang on postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test, Chi2 test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

42 postmenopausal osteoporosis patients enrolled: 25 in herb trial group, 17 in control group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis based on bone density levels, BMD detected by DXA

Exclusion criteria: endocrine diseases, etc.

Interventions

Experimental: Shugan Zishen Huoxue tang (100 ml, twice a day), Caltrate (1.2 g, twice a day) and alendronate sodium (10 mg, once a day), for 6 months

Control: Caltrate (1.2 g, twice a day) and alendronate sodium tablets (10 mg, once a day), for 6 months

OutcomesBMD, E2
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

He MT 2007

Methods

Country: China

Setting: outpatients

Aim: to explore the effect of Bushen Jianpi Huoxue recipe on postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

160 postmenoporosis patients enrolled: 80 in herb trial group, 80 in control group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis based on bone density levels, BMD detected by DXA

Exclusion criteria: endocrine diseases, fractures, metabolic disease, etc.

Interventions

Experimental: Bushen Jianpi Huoxue recipe (1 dose per day), for 6 months

Control: alendronate sodium tablets (70 mg per week), for 6 months

OutcomesBMD, IL-6, BGP, ALP, E2
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

He N 2006

Methods

Country: China

Setting: hospital based

Aim: to explore the effect of Jiawei Zhuangyao Jianshen tang on postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

58 postmenopausal osteoporosis patients enrolled: 29 in trial group, 29 in control group

Inclusion criteria: diagnostic criteria for osteoporosis based on bone density levels, BMD detected by DXA

Exclusion criteria: not mentioned

Interventions

Experimental: Jiawei Zhuangyao Jianshen tang (1 dose per day) for 3 months

Control: compound calcium amino acid chelate capsules (1 g, once a day), for 3 months

OutcomesBMD
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationLow riskRandom numbers
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

He XQ 2006

Methods

Country: China

Setting: outpatients and inpatients

Aim: to explore the effect of Bushen Yangxue tang on postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

60 postmenopausal osteoporosis patients enrolled: 32 in trial group, 28 in control group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis, BMD detected by DXA

Exclusion criteria: endocrine disease, liver or kidney disease

Interventions

Experimental: Bushen Yangxue tang (1 dose per day) and Caltrate (once a day), for 6 months

Control: Caltrate (once a day), for 6 months

OutcomesBMD
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Hu J 2012

Methods

Country: China

Setting: inpatients

Aim: to explore the effect of Shangke Yishen Zhuanggu pill on primary osteoporosis

Study design: randomised controlled trial

Analysis: T-test, F-test, Chi2 test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

300 primary osteoporosis patients enrolled: 155 in trial group, 145 in control group

Inclusion criteria: WHO diagnostic criteria for osteoporosis

Exclusion criteria: not mentioned

Interventions

Experimental: Shangke Yishen Zhuanggu pill (6 g, 3 times a day), Caltrate (1.2 g, twice a day), and miacalcic ampoule (50 U, 3 times a day, intramuscular injection), for 3 months

Control: Caltrate (1.2 g, twice a day), and miacalcic ampoule (50 U, 3 times a day, intramuscular injection), for 3 months

OutcomesBMD
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationLow riskRandom numbers
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Huang JW 2008

Methods

Country: China

Setting: hospital based

Aim: to explore the effect of Erxian Yanggu decoction on postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

67 postmenopausal osteoporosis patients enrolled: 34 in trial group, 33 in control group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis based on bone density levels, BMD detected by DXA

Exclusion criteria: endocrine diseases, secondary osteoporosis, patients with uterine/breast disease

Interventions

Experimental: Erxian Yanggu decoction, 1 dose per day, alendronate sodium tablets, 70 mg per week, for 6 months

Control: alendronate sodium tablets, 70 mg per week, for 6 months

OutcomesIL-6
NotesThe study was supported by administration of traditional Chinese medicine scientific research funds in Zhejiang Province, but no declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Huang ZJ 2008

Methods

Country: China

Setting: hospital based

Aim: to study the effects of Zishen Gukang pill in the treatment of postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

60 postmenopausal osteoporosis patients enrolled: 30 in trial group, 30 in control group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis based on bone density levels, BMD detected by DXA, DPA, SPA, etc.

Exclusion criteria: disease-affected bone metabolism, etc.

Interventions

Experimental: Zishen Gukang pill (6 g, 3 times a day)

Control: Caltrate (2 pills, once a day), for 3 months

OutcomesBMD
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationHigh riskSequence generated by some rule based on clinic time
Allocation concealmentHigh riskAllocation based on clinic time
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Jian QQ 2010

Methods

Country: China

Setting: inpatients

Aim: to study the effects of Shengsuiyin recipe in the treatment of postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

144 postmenopausal osteoporosis patients enrolled: 73 in trial group, 71 in control group

Inclusion criteria: diagnostic criteria for osteoporosis on Obstetrics and Gynecology in Chinese Medicine

Exclusion criteria: not mentioned

Interventions

Experimental: Shengsuiyin recipe (1 dose per day, water fried) and Caltrate (750 mg, once a day), for 12 months

Control: Caltrate, 750 mg, once a day, for 12 months

OutcomesBMD
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskPatients were randomly allocated
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasUnclear riskP value for the baseline comparison not stated

Lan ZX 2006

Methods

Country: China

Setting: hospital based

Aim: to study the effects of Guli powder in the treatment of primary osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

60 primary osteoporosis patients enrolled: 30 in trial group, 30 in control group

Inclusion criteria: diagnostic criteria for osteoporosis based on bone density levels, BMD detected by DXA

Exclusion criteria: disease-affected bone metabolism

Interventions

Experimental: Guli powder (10 g, 3 times a day), for 3 months

Control: Caltrate (once a day), for 3 months

OutcomesBMD, Ca, P, ALP
NotesThe study was supported by administration of traditional Chinese medicine scientific research funds in Sichuan Province, but no declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Li BL 2007

Methods

Country: China

Setting: hospital based

Aim: to observe the mechanism of Jianshen decoction in treating patients with postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

60 postmenopausal osteoporosis patients enrolled: 30 in trial group, 30 in control group

Inclusion criteria: diagnostic criteria for osteoporosis, BMD detected by DXA

Exclusion criteria: endocrine diseases, disease-affected bone metabolism

Interventions

Experimental: Jianshen decoction, 1 dose per day, for 6 months

Control: alendronate sodium tablets, 10 mg, once a day, for 6 months

OutcomesBMD, ALP, BGP, E2, IL-6
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasUnclear riskP value for the baseline comparison not stated

Li HW 2004

Methods

Country: China

Setting: hospital based

Aim: to study the effects of Ziyin Bushen Zhuanggu prescription in the treatment of postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test, Chi2 test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

45 postmenopausal osteoporosis patients enrolled: 25 in trial group, 20 in control group

Inclusion criteria: international diagnostic criteria for osteoporosis, BMD detected by DXA

Exclusion criteria: endocrine diseases, etc

Interventions

Experimental: Ziyin Bushen Zhuanggu prescription (1 dose per day), Caltrate (1.2 g, twice a day) and miacalcin (50 IU, injection, twice per week), for 8 months

Control: Caltrate (1.2 g, twice a day) and miacalcin (50 IU, injection, twice a week), for 8 months

OutcomesBMD, E2
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationLow riskRandom numbers
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Li SL 2004

Methods

Country: China

Setting: hospital based

Aim: to study the effects of Zhuanggu capsule in the treatment of postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

60 postmenopausal osteoporosis patients enrolled: 30 in trial group, 30 in control group

Inclusion criteria: diagnostic criteria for osteoporosis based on bone density levels, BMD detected by DXA

Exclusion criteria: endocrine diseases, etc

Interventions

Experimental: Zhuanggu capsule (4 capsules, 3 times a day) and Caltrate (600 mg, once a day), for 6 months

Control: Caltrate (600 mg, once a day), for 6 months

OutcomesBMD, E2, Ca, P, ALP, BGP
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Li YH 2008

Methods

Country: China

Setting: outpatients and inpatients

Aim: to study the effects of Jingujian granule in the treatment of senile osteoporosis

Study design: randomised controlled trial

Analysis: T-test, Chi2 test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

120 senile osteoporosis patients enrolled: 80 in trial group, 40 in control group

Inclusion criteria: diagnostic criteria for osteoporosis based on bone density levels recommended by WHO

Exclusion criteria: secondary osteoporosis, liver or kidney disease

Interventions

Experimental: Jingujian granule, 8 g, twice a day, for 3 months

Control: Caltrate, 600 mg, once a day, for 3 months

OutcomesBMD, ALP, BGP, adverse effects
NotesThe study was supported by a China academy of traditional Chinese medicine advantage diseases research project, but no declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationLow riskRandom numbers
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Li YH 2010

Methods

Country: China

Setting: outpatients and inpatients

Aim: to study the effects of Jingujian granule 1, 2 or 3 in the treatment of primary osteoporosis based on epigastralgia traditional Chinese medicine

Study design: randomised controlled trial

Analysis: T-test, Chi2 test

Loss to follow-up: 30 drop-outs (11 in trial group, 19 in control group) were not included in the analysis

Participants

Ethnicity: Chinese

210 primary osteoporosis patients enrolled: 140 in trial group (11 drop-outs), 70 in control group (19 drop-outs)

Inclusion criteria: Chinese diagnostic criteria for osteoporosis and guiding principles for clinical research on new drugs in traditional Chinese medicine, BMD detected by DXA

Exclusion criteria: secondary osteoporosis, liver or kidney disease, etc.

Interventions

Experimental: Jingujian granule 1, 2 or 3 based on epigastralgia traditional Chinese medicine (kidney deficiency; spleen and kidney deficiency; spleen and kidney deficiency, and blood stasis), 8 g, twice a day, for 3 months

Control: Caltrate, 600 mg, once a day, for 3 months

OutcomesBMD, ALP, E2, CT, BGP, adverse events
NotesThe study was supported by a China academy of traditional Chinese medicine advantage diseases research project, but no declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Li ZP 2011

Methods

Country: China

Setting: hospital based

Aim: to study the effects of Kanggusong soup in the treatment of postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test, Chi2 test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

75 postmenopausal osteoporosis patients enrolled: 45 in trial group, 30 in control group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis

Exclusion criteria: secondary osteoporosis, endocrine disease, liver or kidney disease, etc.

Interventions

Experimental: Kanggusong soup (1 dose per day, twice a day) and Caltrate (1 tablet per night), for 3 months

Control: Caltrate (1 tablet per night), for 3 months

OutcomesALP, IL-6, fractures
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskPatients were randomly allocated
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Li ZY 2006

Methods

Country: China

Setting: hospital based

Aim: to study the effects of Xianling Gusong capsules in the treatment of postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test, Chi2 test, Ridit test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

43 postmenopausal osteoporosis patients enrolled: 21 in trial group, 22 in control group

Inclusion criteria: diagnostic criteria for osteoporosis based on bone density levels, BMD detected by DXA

Exclusion criteria: secondary osteoporosis, liver or kidney disease

Interventions

Experimental: Xianling Gusong capsules (4 capsules, 3 times a day), for 6 months

Control: Caltrate (1 pill, twice a day), for 6 months

OutcomesBMD
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Liang DB 2012

Methods

Country: China

Setting: hospital based

Aim: to study the effects of Bushenhuoxue therapy in the treatment of primary osteoporosis

Study design: randomised controlled trial

Analysis: T-test, Chi2 test, Ridit test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

80 primary osteoporosis patients enrolled: 40 in trial group, 40 in control group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis

Exclusion criteria: secondary osteoporosis, liver or kidney disease, etc.

Interventions

Experimental: Bushenhuoxue therapy (1 dose, per day), calcium carbonate tablets (1 tablet (0.5 g), twice a day), and alfacalcidol (1 tablet (0.5 μg) per day), for 3 months

Control: calcium carbonate tablets (1 tablet (0.5 g), twice a day), and alfacalcidol (1 tablet (0.5 μg) per day), for 3 months

OutcomesBMD, quality of life, adverse events
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationLow riskRandom numbers
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskNo information provided
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Liao L 2004

Methods

Country: China

Setting: hospital based

Aim: to study the effects of Bushen Shengsui principle in the treatment of postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

100 postmenopausal osteoporosis patients enrolled: 32 in herb trial group, 39 in control group, 29 in blank group
Inclusion criteria: diagnostic criteria for osteoporosis, BMD detected by DXA

Exclusion criteria: endocrine diseases, etc.

Interventions

Experimental: Bushen Shengsui principle, 1 dose per day, for 6 months

Control: Premarin (1 tablet per day) and medroxyprogesterone (2.5 mg per day), or blank, for 6 months

OutcomesBMD, E2, adverse effects
NotesThe study was supported by a science and technology planning project Zhongshan, Guangdong Province, but no declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Lin W 2000

Methods

Country: China

Setting: hospital based

Aim: to study the effects of Migu decoction in the treatment of postmenopausal osteoporosis

Study design: double-blind, randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

20 postmenopausal osteoporosis patients enrolled: 13 in trial group, 7 in control group

Inclusion criteria: diagnostic criteria for osteoporosis based on bone density levels, BMD detected by DXA

Exclusion criteria: endocrine diseases

Interventions

Experimental: Migu decoction, for 4 months

Control: placebo, for 4 months

OutcomesBMD
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Low riskDouble-blind but did not describe who was blind
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasUnclear riskNo information on baseline

Ling JY 2008

Methods

Country: China

Setting: outpatients

Aim: to study the effects of Bushen Zhuanggu decoction in the treatment of primary osteoporosis

Study design: randomised controlled trial

Analysis: T-test, Ridit test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

60 primary osteoporosis patients enrolled: 30 in trial group, 30 in control group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis, BMD detected by DXA

Exclusion criteria: endocrine diseases, liver or kidney disease, etc

Interventions

Experimental: Bushen Zhuanggu decoction, 1 dose per day, for 3 months

Control: alendronate sodium tablets, 10 mg, once a day, for 3 months

OutcomesBMD, E2, ALP, P
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Liu JM 2012

Methods

Country: China

Setting: outpatients

Aim: to study the effects of Gukang tablet in the treatment of primary osteoporosis

Study design: randomised controlled trial

Analysis: T-test, Chi2 test, Ridit test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

80 primary osteoporosis patients enrolled: 40 in trial group, 40 in control group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis

Exclusion criteria: endocrine diseases, liver or kidney disease, etc.

Interventions

Experimental: Gukang tablet (0.5 g per tablet, 6, 3 times a day), Gaitianli tablets (50 mg per tablet, 2 tablets, 3 times a day) and vitamin A and D capsules (1 pill, twice a day), for 3 months

Control: Gaitianli tablets (50 mg per tablet, 2 tablets, 3 times a day), and vitamin A and D capsules (1 pill, twice a day), for 3 months

OutcomesBMD, adverse effects
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskPatients were randomly allocated
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Lv ZH 2002

Methods

Country: China

Setting: hospital based

Aim: to study the effects of Jiawei Bushen Zhuangjintang in the treatment of primary osteoporosis

Study design: randomised controlled trial

Analysis: T-test, Chi2 test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

90 primary osteoporosis patients enrolled: 48 in trial group, 42 in control group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis based on bone density levels, BMD detected by DXA

Exclusion criteria: not mentioned

Interventions

Experimental: Jiawei Bushen Zhuangjintang, 1 dose per day, for 3 months

Control: calcium granule, 5 g, 3 times a day, for 3 months

OutcomesBMD
NotesThe study was supported by administration of traditional Chinese medicine scientific research funds in Guangdong Province, but no declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Ma C 2011

Methods

Country: China

Setting: outpatients and inpatients

Aim: to study the effects of Liuwei Dihuang pills in the treatment of postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: F-test, Chi2 test

Loss to follow-up: 1 drop-out in Liuwei Dihuang pills group was not included in the analysis

Participants

Ethnicity: Chinese

108 postmenopausal osteoporosis patients enrolled: 36 in Liuwei Dihuang pills group, 36 in Caltrate group, 36 in Liuwei Dihuang pills plus Caltrate group

Inclusion criteria: diagnostic criteria for osteoporosis, BMD detected by DXA

Exclusion criteria: endocrine diseases, etc.

Interventions

Liuwei Dihuang pills group: Liuwei Dihuang pills, 8 pills, 3 times a day, for 6 months

Caltrate group: Caltrate, 1 tablet, 3 times a day, for 6 months

Liuwei Dihuang pills plus Caltrate group: Liuwei Dihuang pills (8 pills, 3 times a day) and Caltrate (1 tablet, 3 times a day), for 6 months

OutcomesBMD, adverse effects
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationLow riskRandom numbers
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Ma CZ 2011

Methods

Country: China

Setting: outpatients and inpatients

Aim: to study the effects of Yiyuanjiangu decoction in the treatment of primary osteoporosis

Study design: randomised controlled trial

Analysis: T-test, Chi2 test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

120 primary osteoporosis patients enrolled: 60 in trial group, 60 in control group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis

Exclusion criteria: endocrine diseases, liver or kidney disease, etc.

Interventions

Experimental: Yiyuanjiangu decoction (1 dose per day), Miacalcin ampoule (50 U, once a day, intramuscular), and calcium carbonate tablet (1 tablet (0.75 g), twice a day), for 3 months

Control: Miacalcin ampoule (50 U, once a day, intramuscular) and calcium carbonate tablet (1 tablet (0.75 g), twice a day), for 3 months

OutcomesBMD, ALP, Ca, P
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskPatients were randomly allocated
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Ma YJ 2011

Methods

Country: China

Setting: outpatients

Aim: to study the effects of Yishen Zhuanggu decoction in the treatment of senile osteoporosis

Study design: randomised controlled trial

Analysis: T-test, Ridit test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

100 senile osteoporosis enrolled: 50 in trial group, 50 in control group

Inclusion criteria: Chinese diagnostic criteria for osteoporosis

Exclusion criteria: secondary osteoporosis, endocrine diseases, liver or kidney disease, etc.

Interventions

Experimental: Yishen Zhuanggu decoction (1 dose per day) and calcitriol soft capsule (0.25 mg, twice a day), for 3 months

Control: calcitriol soft capsule (0.25 mg, twice a day), for 3 months

OutcomesBMD
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskPatients were randomly allocated
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Mao YF 2011

Methods

Country: China

Setting: outpatients

Aim: to study the effects of Bushen Jianpi Jingu decoction in the treatment of postmenopausal osteoporosis

Study design: single-blind, randomised controlled trial

Analysis: T-test, Chi2 test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

75 postmenopausal osteoporosis patients enrolled: 39 in trial group, 36 in control group

Inclusion criteria: diagnostic criteria for osteoporosis recommend by WHO, BMD detected by DXA

Exclusion criteria: liver or kidney disease, disease-affected bone metabolism, etc.

Interventions

Experimental: Bushen Jianpi Jingu decoction, 1 dose per day, for 3 months

Control:  Miacalcin ampoule (50 U), for 3 months

OutcomesBGP
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskPatients were randomly allocated
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskSingle-blind but did not describe who was blind
Incomplete outcome data addressed
All outcomes
Unclear riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Meng XD 2003

Methods

Country: China

Setting: hospital based

Aim: to study the effects of Gujian capsule in the treatment of primary osteoporosis

Study design: randomised controlled trial

Analysis: T-test, Chi2 test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

68 primary osteoporosis patients enrolled: 35 in trial group (1 drop-out), 33 in control group (2 drop-out)

Inclusion criteria: Chinese diagnostic criteria for osteoporosis, BMD detected by DXA

Exclusion criteria: secondary osteoporosis, liver or kidney disease, etc.

Interventions

Experimental: Gujian capsule (2 capsules, 3 times a day), for 6 months

Control: alfacalcidol (0.5 μg, twice a day), for 6 months

OutcomesBMD, PTH, CT, E2, adverse effects
NotesNo funding sources or declarations of interest for the primary researchers reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided
Allocation concealmentUnclear riskNo information provided
Blinding
All outcomes
Unclear riskInsufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data addressed
All outcomes
Low riskNo missing outcome data
Free of selective reportingUnclear riskNot all the outcomes that were of interest in this review were reported
Free of other biasLow riskThe study appears to be free of other sources of bias

Miu JQ 2008

Methods

Country: China

Setting: outpatients and inpatients

Aim: to study the effects of a traditional Chinese medicine capsule in the treatment of postmenopausal osteoporosis

Study design: randomised controlled trial

Analysis: T-test

Loss to follow-up: not reported

Participants

Ethnicity: Chinese

90 postmenopausal osteoporosis patients enrolled: 60 in trial group, 30 in