Shengmai (a traditional Chinese herbal medicine) for heart failure

  • Review
  • Intervention

Authors

  • Qin Zhou,

    1. West China Hospital, Sichuan University, Department of Evidence-Based Medicine and Clinical Epidemiology, Chengdu, China
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  • Wen-Zhe Qin,

    1. West China Hospital, Sichuan University, Department of Evidence-Based Medicine and Clinical Epidemiology, Sichuan, China
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  • Shuai-Bin Liu,

    1. The Second Affiliated Hospital of Chongqing Medical University, Department of Obstetrics & Gynaecology, Chongqing, China
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  • Joey SW Kwong,

    1. The Chinese University of Hong Kong, Institute of Vascular Medicine, Li Ka Shing Institute of Health Sciences, Heart Education And Research Training (HEART) Centre, and Division of Cardiology, Department of Medicine and Therapeutics, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
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  • Jing Zhou,

    1. West China Medical School, Sichuan University, Sichuan, China
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  • Jin Chen

    Corresponding author
    1. West China Hospital, Sichuan University, Department of Evidence-Based Medicine and Clinical Epidemiology, Chengdu, China
    • Jin Chen, Department of Evidence-based Medicine and Clinical Epidemiology, West China Hospital of Sichuan University, No. 37, Guo Xue Xiang, Chengdu, 610041, China. ebm_chenjin@126.com.

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Abstract

Background

Heart failure is a major public health problem worldwide. Shengmai, a traditional Chinese herbal medicine, has long been used as a complementary treatment for heart failure in China. This is an update of a Cochrane Review published in 2012.

Objectives

To determine the effect (both benefits and harms) of Shengmai in treatment of people with heart failure.

Search methods

We searched CENTRAL on The Cochrane Library (Issue 5 of 12, April 2013); DARE on The Cochrane Library (Issue 2 of 4, April 2013); MEDLINE (1948 to June Week 1 2013); EMBASE (1980 to 2013 Week 23); AMED (1985 to August 2008); BIOSIS (1969 to 7 June 2013); CBM (1978 to June 2013); VIP (1989 to June 2013); and CNKI (1979 to June 2013). We also handsearched Chinese journals and did not apply any language restrictions.

Selection criteria

We included randomised controlled trials (RCTs) of Shengmai plus usual treatment for heart failure versus usual treatment alone, or Shengmai versus placebo, irrespective of blinding status. In this update we only included studies with a clear description of randomisation methods and classified as true RCTs.

Data collection and analysis

Two authors independently selected trials, assessed methodological quality and extracted data. We calculated dichotomous data as risk ratios (RRs) and continuous data as mean differences (MDs) or standardized mean differences (SMDs) with corresponding 95% confidence intervals (CIs). We used a fixed-effect model to perform meta-analysis for outcomes without heterogeneity; and a random-effects model to perform meta-analysis for outcomes with heterogeneity.

Main results

We included a total of 14 RCTs (858 patients) in this review update, four of which were new trials. Of these 14 RCTs, 11 trials compared Shengmai plus usual treatment with usual treatment alone, and three trials compared Shengmai with placebo. Improvement of NYHA functional classification was more common in patients taking Shengmai plus usual treatment than in those receiving usual treatment alone (RR 0.37; 95% CI 0.26 to 0.51; 10 trials, 672 participants; low quality evidence). Beneficial effects of Shengmai in treating heart failure were also observed in other outcomes, including exercise test, ejection fraction and cardiac output. The three RCTs (106 patients) comparing Shengmai with placebo reported improvement in NYHA functional classification and in stroke volume. Three of the 14 RCTs reported a total of six patients with mild adverse effects and two were withdrawn due to the adverse effects. The adverse events rate was 1.21%.

Authors' conclusions

Shengmai may exert a positive effect on heart failure, especially for improving NYHA functional classification when Shengmai plus usual treatment is used. The review results should be interpreted with caution due to the high risk of bias of the included studies (particularly regarding allocation concealment and blinding), the small sample size of these studies, and the significant heterogeneity in outcomes such as ejection function, cardiac output and stroke volume. There was no evidence available concerning the effect of Shengmai on mortality, and more high quality studies with long-term follow-up are warranted.

Résumé scientifique

Shengmai (remède traditionnel chinois à base de plantes) pour le traitement de l'insuffisance cardiaque

Contexte

L'insuffisance cardiaque est un problème majeur de santé publique dans le monde. Le shengmai, un remède traditionnel chinois à base de plantes, est utilisé depuis longtemps en tant que traitement complémentaire de l'insuffisance cardiaque en Chine. Ceci est une mise à jour d'une revue Cochrane publiée en 2012.

Objectifs

Déterminer les effets (bénéfiques et délétères) du shengmai dans le traitement des patients atteints d'insuffisance cardiaque.

Stratégie de recherche documentaire

Nous avons consulté CENTRAL dans la Bibliothèque Cochrane (numéro 5, 12 avril 2013), DARE dans la Bibliothèque Cochrane (numéro 2, 4 avril 2013), MEDLINE (de 1948 à la 1ère semaine de juin 2013), EMBASE (de 1980 à la semaine 23 de 2013), AMED (de 1985 à août 2008), BIOSIS (de 1969 au 7 juin 2013), CBM (de 1978 à juin 2013), VIP (de 1989 à juin 2013) et CNKI (de 1979 à juin 2013). Nous avons également effectué des recherches manuelles de revues chinoises, et n'avons appliqué aucune restriction de langue.

Critères de sélection

Nous avons inclus les essais contrôlés randomisés (ECR) comparant le shengmai associé au traitement habituel de l'insuffisance cardiaque versus le traitement habituel seul, ou comparant le shengmai à un placebo, indépendamment de l'assignation en aveugle. Dans cette mise à jour, nous avons uniquement inclus les études avec une description claire des méthodes de randomisation et classées comme de véritables ECR.

Recueil et analyse des données

Deux auteurs ont de manière indépendante sélectionné les essais, évalué la qualité méthodologique et extrait les données. Nous avons calculé les données dichotomiques en tant que risques relatifs (RR) et les données continues sous forme de différences moyennes (DM) ou de différences moyennes standardisées (DMS) avec des intervalles de confiance (IC) à 95 %. Nous avons utilisé un modèle à effets fixes pour réaliser une méta-analyse des critères de jugement sans hétérogénéité, et un modèle à effets aléatoires pour la méta-analyse des critères de jugement avec hétérogénéité.

Résultats principaux

Nous avons inclus un total de 14 ECR (858 patients) dans cette revue mise à jour, dont quatre étaient de nouveaux essais. Sur ces 14 ECR, 11 essais comparaient le shengmai associé au traitement habituel par rapport au traitement habituel seul, et trois essais comparaient le shengmai à un placebo. Une amélioration de la classification fonctionnelle NYHA était plus fréquemment observée chez les patients prenant du shengmai associé au traitement habituel que chez les patients recevant le traitement habituel seul (RR 0,37 ; IC à 95 % 0,26 à 0,51 ; 10 essais, 672 participants ; preuves de faible qualité). Des effets bénéfiques du shengmai dans le traitement de l'insuffisance cardiaque ont également été observés sur d'autres critères de jugement, y compris l'épreuve d'effort, la fraction d'éjection et le débit cardiaque. Les trois ECR (106 patients) comparant le shengmai à un placebo ont rapporté une amélioration de la classification fonctionnelle NYHA et du volume systolique. Trois des 14 ECR ont signalé un total de six patients atteints d'effets indésirables légers et deux patients ont arrêté en raison des effets indésirables. Le taux d'événements indésirables était de 1,21 %.

Conclusions des auteurs

Le shengmai peut potentiellement exercer un effet positif sur l'insuffisance cardiaque, en particulier pour améliorer la classification fonctionnelle NYHA lorsqu'il est associé au traitement habituel. Les résultats de la revue doivent être interprétés avec prudence en raison du risque élevé de biais des études incluses (en particulier concernant l'assignation secrète et la mise en aveugle), de la petite taille d'échantillon de ces études et de l'hétérogénéité significative dans des critères de jugement tels que la fonction d'éjection, le débit cardiaque ou le volume systolique. Aucune preuve n'était disponible concernant l'effet du shengmai sur la mortalité, et d'autres études de haute qualité avec un suivi à long terme sont nécessaires.

アブストラクト

心不全に対するShengmai(伝統的な漢方薬)

背景

心不全は世界中で公衆衛生上の大きな問題となっている。Shengmai(伝統的な漢方薬)は、中国で心不全に対する補助的治療として昔から使われてきた。本システマティック・レビューは2012年発表のレビューの更新である。

目的

心不全に対する治療として、通常の治療にShengmaiを加えた場合を通常の治療単独と比較し、併用治療の影響(利益と有害性)を判定すること。

検索戦略

コクラン・ライブラリ(2013年4月12日、Issue 5) のCENTRALおよびDARE(2013年4月4日、Issue 2)、MEDLINE(1948年~2013年6月第1週)、EMBASE(1980年~2013年第23週)、AMED(1985年~2008年8月)、BIOSIS(1969年~2013年6月)、CBM(1978年~2013年)、VIP(1989年~2013年6月)とCNKI(1979年~2013年6月)を検索した。 また、中国の雑誌をハンドサーチした。言語には制約を設けなかった。

選択基準

盲検化の状況にかかわらず、心不全の通常の治療にShengmaiを加えた場合を通常の治療単独と比較したランダム化比較試験(RCT)またはShengmaiをプラセボと比較したRCTを選択した。この更新レビューでは、さらに厳密な選択基準を適用し、ランダム化の方法を明確に記載した試験のみを真のRCTとして分類し、選択した。

データ収集と分析

2名の著者が独立して試験の選択、方法の質に対する評価、データの抽出を行った。2値変数をリスク比(RR)として、連続データを平均差(MD) として、標準化平均差(SMD)を95%信頼区間(CI)で計算した。異質性のないアウトカムに対するメタアナリシスを実施するために母数モデルを使用し、異質性のあるアウトカムに対するメタアナリシスを実施するために変量効果モデルを使用した。

主な結果

全部で14のRCT(858症例)を本更新レビューの対象とした。内4件は新規の試験であった。これら14件のRCTの内11件で、通常治療単独とShengmai+通常治療を比較し、3件でShengmaiとプラセボを比較した。NYHA機能分類による改善は、通常治療単独よりShengmai+通常治療の患者で最も多く確認された(RR 0.37; 95% CI 0.26 ~0.51; 10 試験、 672例; 質の低いエビデンス)。 心不全治療におけるShengmaiの有益な効果は、運動テスト、駆出率、心拍出量などのその他のアウトカムでも認められた。Shengmaiとプラセボを比較した 3件のRCT(106例)では、NYHA機能分類および1回拍出量において改善の報告があった。14件のRCTの内3件で、軽度の有害事象が6症報告され、2例がその有害事象のために試験を中止した。有害事象発生率は1.21%であった。

著者の結論

Shengmaiは心不全、特に通常治療と併用した場合NYHA機能分類改善に効能がある可能性がある。駆出率、心拍出量、1回拍出量などのアウトカムにおける有意な異質性、研究のサンプルサイズの規模が小さいこと、選択研究のバイアスのリスクが高いこと(特に割りつけの隠蔵化および盲検化)により、本レビューの結果は注意して解釈されるべきである。Shengmaiの死亡率に関する効果についてのエビデンスは、入手不可能であり、長期フォローアップの質の高い研究をさらに行う必要がある。

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/)[2015.12.30]
《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。

Plain language summary

Shengmai (a traditional Chinese herbal medicine) for heart failure

Heart failure is a major public health issue worldwide. Despite advances in treatment, many people are affected and hundreds of thousand of people die each year. Shengmai is a traditional Chinese herbal medicine and is a mixture extracted from three herbs: Panax ginseng, Ophiopogon japonicus and Schisandra chinensis. In China it has been used to treat heart failure and ischemiac heart disease.

In this Cochrane Review update, we included 14 trials which compared Shengmai plus usual treatment with usual treatment alone, or compared Shengmai with placebo. Shengmai may be beneficial in improving heart function (low quality evidence) and in most trials, people who took Shengmai had few unwanted side effects. However, many of the included trials were of poor quality and included a small number of people. More high quality, large trials of Shengmai of treatment heart failure are needed.

Résumé simplifié

Shengmai (remède traditionnel chinois à base de plantes) pour le traitement de l'insuffisance cardiaque

L'insuffisance cardiaque est un problème majeur de santé publique dans le monde. Malgré des progrès dans le traitement, de nombreuses personnes sont atteintes et des centaines de milliers en meurent chaque année. Le shengmai est un remède traditionnel chinois à base de plantes, un mélange extrait de trois plantes : Panax ginseng, Ophiopogon japonicus et Schisandra chinensis. En Chine il a été utilisé pour traiter l'insuffisance cardiaque et la maladie cardiaque ischémique.

Dans cette revue systématique Cochrane mise à jour, nous avons inclus 14 essais comparant le shengmai associé au traitement habituel avec le traitement habituel seul, ou comparant le shengmai à un placebo. Le shengmai peut potentiellement être bénéfique pour améliorer la fonction cardiaque (preuves de faible qualité) et dans la plupart des essais, les personnes ayant pris du shengmai ont eu peu d'effets secondaires indésirables. Néanmoins, plusieurs essais inclus étaient de mauvaise qualité et portaient sur un petit nombre de personnes. D'autres essais de bonne qualité à grande échelle sur le shengmai dans le traitement de l'insuffisance cardiaque sont nécessaires.

Notes de traduction

Traduit par: French Cochrane Centre 22nd July, 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

平易な要約

心不全に対するShengmai(伝統的な漢方薬)

心不全は世界中で公衆衛生上の大きな問題となっている。治療が進歩したにもかかわらず、多くの人が苦しみ、毎年何十万もの人が死亡する。Shengmaiは中国古来の薬で、次にあげる薬草のエキスを混ぜたものである:朝鮮ニンジン、ジャノヒゲ、チョウセンゴミン。 中国では心不全や虚血性心疾患の治療に使われてきた。

このコクラン・レビュー更新版では、通常治療単独とShengmai+通常治療またはShengmaiとプラセボを比較した14件の試験を選択した。Shengmaiは心不全改善に有益である可能性がある(質の低いエビデンス)が、大部分の試験においてShengmaiを摂取していた患者に望ましくない副作用が数例見られた。 しかし選択試験の多くは質が低く、参加者の数が少なかった。より多くの質の高い大規模な心不全に対するShengmai治療試験が必要である。

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/)[2015.12.30]
《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。

Streszczenie prostym językiem

Stosowanie shengmai (tradycyjnego chińskiego leku ziołowego) u chorych z niewydolnością serca

Niewydolność serca stanowi poważny problem zdrowia publicznego na całym świecie. Pomimo postępów w leczeniu, wiele osób jest dotkniętych tym schorzeniem, a setki tysięcy umiera z tego powodu każdego roku. Shengmai to tradycyjny chiński lek, który stanowi mieszankę ekstraktów z trzech ziół: żeń-szenia właściwego, konwalnika japońskiego oraz cytryńca chińskiego. W Chinach shengmai stosuje się w leczeniu niewydolności serca i choroby niedokrwiennej serca.

W niniejszej aktualizacji przeglądu Cochrane uwzględniono 14 badań, w których porównano skuteczność stosowania shengmai łącznie z leczeniem standardowym, w porównaniu z samym leczeniem standardowym lub shengmai w porównaniu z placebo. Stosowanie shengmai może korzystnie wpływać na czynność serca (niska jakość danych), w większości badań stosowanie tego leku wiązało się z występowaniem niewielu objawów niepożądanych. Jednak wiele spośród włączonych do przeglądu badań było niskiej jakości i obejmowało jedynie niewielką grupę osób. Należy przeprowadzić duże badania wysokiej jakości oceniające skuteczność stosowania shengmai u chorych z niewydolnością serca.

Uwagi do tłumaczenia

Tłumaczenie: Bartłomiej Matulewicz Redakcja: Karolina Moćko

Summary of findings(Explanation)

Summary of findings for the main comparison. Shengmai plus usual treatment compared to usual treatment alone for heart failure
  1. 1 Downgraded by 1 level for lacking of blinding and allocation concealment
    2 Downgraded by 1 level for sparse data
    3 Downgraded by 1 level for lacking of concealment
    4 Downgraded by 1 level for unexplained heterogeneity

Shengmai plus usual treatment compared to usual treatment alone for heart failure
Patient or population: patients with heart failure
Settings: inpatients and outpatients
Intervention: Shengmai plus usual treatment
Comparison: usual treatment alone
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(trials)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Usual treatment alone Shengmai plus usual treatment
MortalitySee commentSee commentNot estimable

858

(11 trials)

See comment0 participants died
Lack of improvement in heart failure (NYHA class improved < I class or worsening of heart failure)
NYHA classification grading of cardiac function
Moderate RR 0.37
(0.26 to 0.51)
672
(10 trials)
⊕⊕⊝⊝
low 1,2
This outcome was transformed to be dichotomous and NYHA class improved < I class or worsening of heart failure was the event
279 per 1000 103 per 1000
(73 to 142)
Adverse effectsSee commentSee commentNot estimable

4

(2 trials)

See commentTwo mild asomnia (1 trial) and two dry mouth and fidgety (1 trial)
Mean exercise tolerance test (after treatment) (min) 6 mins 6 higher
(4.48 to 7.52 higher)
 60
(1 trial)
⊕⊕⊝⊝
low2,3
The longer the exercise time, the better the heart function.
Mean change in quality of life
Minnesota Living with Heart Failure Questionnaire (MLWHF) score
20 points 7 higher
(1.98 lower to 15.98 higher)
 60
(1 trial)
⊕⊕⊝⊝
low1,2
 
Mean change in ejection fraction (%) 3 to 13.1 9.02 higher
(5.95 to 12.08 higher)
 354
(4 trials)
⊕⊝⊝⊝
very low1,2,4
 
Mean change in cardiac output (L/min) 0.5 to 0.83 0.94 higher
(0.26 to 1.63 higher)
 360
(4 trials)
⊕⊝⊝⊝
very low1,2,4
 
Mean change in stroke volume (mL) 8.02 to 16.9 8.43 higher
(7.08 to 9.78 higher)
 240
(3 trials)
⊕⊝⊝⊝
very low1,2,4
 
Change in cardiac index (L/min*m²) 0.4 to 0.44 0.79 higher
(0.59 to 0.99 higher)
 160
(2 trials)
⊕⊝⊝⊝
very low1,2,4
 
Hospitalization/rehospitalizationSee commentSee commentNot estimable

858

(12 trials)

See comment0 participants hospitalized or re-hospitalized
*The basis for the assumed risk (e.g. the median control group risk across trials) is provided in the footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; 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 Shengmai compared to placebo for heart failure

Summary of findings 2. Shengmai compared to placebo for heart failure
  1. 1 Downgraded by 1 level for lacking of blinding and concealment
    2 Downgraded by 1 level for sparse data
    3 Downgraded by 1 level for lacking of concealment

Shengmai compared to placebo for heart failure
Patient or population: patients with heart failure
Settings: inpatients and outpatients
Intervention: Shengmai
Comparison: placebo
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
Number of participants
(trials)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Placebo Shengmai
MortalitySee commentSee commentNot estimable

106

(3 trials)

See comment0 participants died
Lack of improvement in heart failure (NYHA class improved < I class or worsening of heart failure)
NYHA classification grading of cardiac function
Moderate RR 0.22
(0.11 to 0.44)
40
(1 trial)
⊕⊕⊝⊝
low 1,2
This outcome was transformed to be dichotomous and NYHA class improved < I class or worsening of heart failure was the event
1000 per 1000 220 per 1000
(110 to 440)
Adverse effectsSee commentSee commentNot estimable

2

(1 trial)

See commentOne stomach discomfort and one hypoglycaemia were reported in one trial.
Mean change in exercise test (mins)
Treadmill exercise test
0.11 3.56 lower
(7.19 lower to 0.07 higher)
 18
(1 trial)
⊕⊕⊝⊝
low2,3
The longer the exercise time, the better the heart function.
Mean change in ejection fraction (%) 0.2 12.45 higher
(8.96 to 15.94 higher)
 52
(1 trial)
⊕⊕⊝⊝
low2,3
 
Mean change in cardiac output (L/min) 0.02 0.53 lower
(1.08 lower to 0.02 higher)
 52
(1 trial)
⊕⊕⊝⊝
low2,3
 
Mean change in cardiac index (L/min*m²) 0.03 0.32 higher
(0.04 to 0.6 higher)
 80
(1 trial)
⊕⊕⊝⊝
low2,3
 
Mean change in ECG: Q-Z 1.48 10.72 higher
(5.1 to 16.34 higher)
 80
(1 trial)
⊕⊕⊝⊝
low2,3
 
Hospitalization/ rehospitalizationSee commentSee commentNot estimable

106

(3 trials)

See comment0 participants hospitalized or re-hospitalized
*The basis for the assumed risk (e.g. the median control group risk across trials) is provided in the footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; 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

Heart failure is a major public health issue, affecting over 5.1 million people in the USA and over 23 million people worldwide (Go 2013, Bui 2012). In the USA, over 650,000 new heart failure cases are diagnosed annually (Yancy 2013). Prevalence of heart failure increases substantially with age. Approximately 1% to 2% of adults in developed countries have heart failure; and this increases to over 10% in people aged 70 years or older (McMurray 2012). Despite developments in heart failure therapy, absolute mortality rates have remained at approximately 50% in the last five years (Yancy 2013), directly leading to 300,000 deaths annually (Lloyd-Jones 2010). It places a considerable burden on the healthcare system due to high rates of hospitalizations, readmissions, and outpatient visits, with costs of over $39 billion annually in the USA alone (Bui 2012).

In 2000, chronic heart failure prevalence was 0.9% for the general population in China (Gu 2003). Around four million patients, aged between 35 to 74 years, have heart failure in China. Prevalence of chronic heart failure among people aged 35 to 44 years was 0.4%, and in people aged over 55 years was 1.3%. With a large aging population, the number of people with heart failure in China is expected to increase (Jiang 2009). Of people hospitalised with cardiac diseases, 17.9% in 1980, 16.3% in 1990 and 16.9% in 2000 had heart failure. The proportion of cardiac disease mortality attributable to heart failure remains unchanged (39.9% in 1980, 37.7% in 1990 and 41.1% in 2000) (CMA 2002). There is little or no updated information available about heart failure in China for the last 10 years (Jiang 2009).

Conventional treatment for heart failure

As the failing heart attempts to maintain adequate function, the heart may adopt several compensatory mechanisms. These include: maintaining cardiac output through increased left ventricular end diastolic volume; increasing wall thickness through ventricular remodeling; and maintaining tissue perfusion with augmented mean arterial pressure through activation of neurohormonal systems. All of these compensatory mechanisms eventually lead to a vicious cycle of worsening heart failure. Treatment strategies have been developed based upon the understanding of these compensatory mechanisms (Kemp 2012). According to the latest guidelines for heart failure, drugs for routine use include diuretics, angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), beta blockers and aldosterone antagonists (McMurray 2012; Yancy 2013). In addition, digoxin may be given to selected people to reduce morbidity or mortality (Gheorghiade 1991; Hood 2004; Yancy 2013).

Diuretics inhibit reabsorption of sodium or chloride at specific sites in the renal tubules and increase urine volume (Faris 2012). The main aim of using diuretics is to relieve symptoms of congestion or decrease physical signs of fluid retention in patients with heart failure (Yancy 2013). ACEIs and ARBs both act on the renin-angiotensin-aldosterone system. ACEIs are now the best studied class of agents in heart failure and ARBs are considered a reasonable alternative for people intolerant to ACEIs (Yancy 2013). Beta blockers inhibit the adverse effects of the sympathetic nervous system in people with heart failure. Long-term treatment with beta blockers can lessen the symptoms of heart failure and enhance the patient's overall sense of well-being (Yancy 2013). Aldosterone receptor antagonists compete with aldosterone to bind at the mineralocorticoid receptor and improve left ventricle structural remodeling and performance by increasing left ventricle ejection fraction as well as decreasing left ventricle end-diastolic and end-systolic volumes (Maron 2010; Jean 2011). Digoxin binds to the sodium-potassium adenosine triphosphatase (Na+-K+ ATPase) pump on the myocardial cell membrane and inhibit its function, resulting in an increase in calcium concentration inside the heart cell and improvement of ventricular performance through a sustained moderate positive inotropic effect (Bers 2010).

How the intervention might work

Chinese herbs and medicine are widely used in Chinese hospitals (Tian 2008; Song 2011), and closely relates to the cultural belief that traditional Chinese medicine is more natural, effective, has fewer adverse effects, and is preferred by patients to Western drugs (Tan 2006; Song 2011).

According to traditional Chinese medicine theory, heart failure results from heart 'Qi' deficiency, which develops into a deficiency of both Yin and Qi (Li 2005). Therefore Chinese medicine treatment aims to nourish Yin and invigorate Qi. Both nourishing Yin and invigorating Qi are terminologies of traditional Chinese medical science. According to traditional Chinese medicine theory, a medicine nourishing Yin mainly works on material aspects of the body, while invigorating Qi mainly works on functional aspects of the body. Shengmai is usually used in China as a complementary treatment to Western treatments recommended for acute heart failure, and also as a single treatment for chronic heart failure. It is a mixture extracted from three herbs: Panax ginseng (invigorates Qi and dispels stagnation), Ophiopogon japonicus (nourishes Yin and grows succus) and Schisandra chinensis (invigorates Qi) (Ma 2003). It is usually mass-produced as a patented drug, based on a standardized formula in different forms (including capsule, powder, oral liquid and injection). Treatment duration varies as there is neither a restriction on the duration of drug administration nor a therapeutic window according to the manufacturer's instructions. In clinical practice, Shengmai is used to facilitate improvement of symptoms and is often discontinued after the relief of symptoms or disease remission. Adverse effects are rare and mild, and include rash, anaphylactic shock, a sense of gastric distention, lumbar and back pain, hypotension and tachycardia (Li 2006b). The adverse event rates in most prospective and retrospective studies are under 1% and allergic reaction is most common(Li 2009, Li 2013, Deng 2012).

Shengmai shows a special pharmacological function to heart failure, which may be divided into the following five aspects:

  1. Positive inotropic effect: Animal experiments show that Shengmai has an intricate adjustment function to the myocardial intracellular calcium concentration and the effect is related to the dosage: low-dose enhances intracellular calcium, while high-dose inhibits it (Wang 2002b). At appropriate doses, Shengmai has a positive inotropic effect and enhances heart pump function, similar to digitalis (Mao 2003).

  2. Dual-directional regulation on blood pressure: Shengmai was shown to exert a dual-directional regulation on blood pressure: the effect varied with patients' conditions. Animal experiments show that Shengmai reduces blood pressures of normal anaesthetized dogs (Chen 2001) but made arterial pressure of rabbits with hemorrhagic shock during recovery period rise (Xia 1999). Another human trial showed that Shengmai reduced initial high blood pressure in some patients and increased other patients' initial low blood pressure (Dong 1984; Li 2003).

  3. Improving haemodynamic parameters: Shengmai could dilate coronary vessels, increase coronary flow and reduce the peripheral resistance to different degrees. Shengmai regulated blood pressure without increasing heart rate. The cardiac output was stable or increased and the left ventricular filling pressure was constant or reduced. Shengmai increased cardiac stroke volume with absence of myocardial oxygen consumption increase (Chen 2002).

  4. Delaying the cardiac remodelling: Shengmai delayed cardiac remodelling in a number of animal experiments (Deng 2008; Xu 2012). The mechanism may entail indirect reduction of heart wall tension and the renin activity (Zhang 2007b).

  5. Antioxidative effect: The antioxidative effect of Shengmai on myocardial injury and its ability to improve cardiac microcirculation by eradicating oxygen free radicals has been observed (Yu 2000; Wang 2002a). Fructus schisandrae has been reported to derive antioxidant activity in Shengmai (Li 1996). However, the components of Shengmai are complex and not every chemical constituent has been isolated and determined yet, so it is unclear what the main active ingredients and their targets are.

Why it is important to do this review

The use of Shengmai plus usual treatment may benefit heart failure patients more than usual treatment alone. This was observed in the previous versions of this review. However, the poor quality of these included trials compromised the reliability of the evidence. Since then, a large number of new studies on Shengmai have emerged, and a review update is required to obtain better evidence for the clinical use of Shengmai.

Objectives

To determine the effects (both benefits and harms) of Shengmai in treatment of people with heart failure.

Methods

Criteria for considering studies for this review

Types of studies

RCTs and randomised cross-over trials of Shengmai plus usual treatment versus usual treatment alone, or Shengmai versus placebo for heart failure, irrespective of blinding status. We only included trials which (a) were classified as true RCTs or true randomised cross-over trials, and (b) clearly stated wash-out period if it was a cross-over trial.

Types of participants

People of any gender, any age or any ethnic group with clinically defined heart failure regardless of its primary causes, such as rheumatic, valvular and congenital heart disease, as well as other relevant characteristics including diastolic and systolic heart failure, acute and chronic heart failure.

Types of interventions

We defined Shengmai as the products extracted from ginseng (Radix codonopsis pilosulae or Panax ginseng), Radix ophiopogonis (Liriope sticata or Ophiopogon japonicus), and Schisandra chinensis (or Fructus schisandrae). We deemed any form of administration of Shengmai acceptable for study inclusion, although it was administered mainly via intravenous infusion. We included trials regardless of treatment duration.

Types of outcome measures

Primary outcomes
  1. Mortality

  2. New York Heart Association (NYHA) function classification

  3. Adverse effects

Secondary outcomes
  1. Exercise test or six-minute walk test performance

  2. Quality of life as measured by various instruments

  3. Change in haemodynamics

  4. Change in myocardial contractility

  5. Hospitalization and rehospitalization

  6. Costs

Search methods for identification of studies

We searched the following electronic databases up to 13 June 2013: CENTRAL on The Cochrane Library (Issue 5 of 12, April 2013); DARE on The Cochrane Library (Issue 2 of 4, April 2013); MEDLINE on Ovid (1948 to June Week 1 2013); EMBASE on Ovid (1980 to 2013 Week 23); AMED (1985 to August 2008) (Note: we did not search AMED for this update as it is no longer available to the person conducting the searches); BIOSIS Citation Index (1969 to 7 June 2013); CBM (1978 to June 2013); VIP (1969 to June 2013); and CNKI (1979 to June 2013). We have included the search strategies from the original review (Appendix 1), the second updated strategies (Appendix 2), the third updated strategies (Appendix 3) and the search strategy for this update (Appendix 4). We did not apply any language restrictions.

Data collection and analysis

Selection of studies

Two authors (ZQ, ZJ) screened the studies identified from the search strategy. They included studies according to the prespecified selection criteria and using a selection form. We resolved any disagreements by discussion. Where necessary, we consulted a third author (CJ) to resolve disagreements.

Data extraction and management

Two authors (ZQ, ZJ) extracted data independently using a self-developed data extraction form. We resolved any disagreements through discussion, or if necessary, in consultation with CJ. We sought data that were unavailable in the trial reports by contacting the principal investigators of the studies. We noted the diagnosis criteria in various studies and we recorded presence of clinical criteria including dyspnoea, orthopnoea, rales, S3 gallop, or peripheral edema, and cardiomegaly on chest X-ray. When available, we recorded objective measurements of ejection fraction from echocardiography, radio nuclide ventriculography, or ventriculography performed at cardiac catheterization. Presence of an ejection fraction of ≥ 0.45 was the basis for identifying a subset of patients who had heart failure with preserved ejection fraction. We also noted the duration of heart failure. The length of the wash-out period should have been at least five times longer than the half-life period of the main ingredients of Shengmai (9.5 days) or proved there was no carry-over effect (Li 2011).

Assessment of risk of bias in included studies

We based the assessment of risk of bias on the Cochrane Collaboration's tool for assessing risk of bias (Higgins 2011).Two authors (ZQ, ZJ) independently appraised the risk of bias in included trials across seven domains, including "sequence generation", "allocation concealment", "blinding of participants", "personnel and outcome assessors", "incomplete outcome data", "selective outcome reporting", and "other potential threats to validity". Each domain had three possible judgements: "low risk", "high risk" or "unclear risk". If necessary, we consulted a third author (CJ) to resolve disagreements.

Unit of analysis issues

We included both RCTs and randomised cross-over trials. When incorporating cross-over trials into a meta-analysis, we followed the approach suggested by Elbourne 2002. For example, when we considered neither carry-over nor period effects a problem, and the mean and standard deviation values of the participant-specific difference between experimental and control group measurements were available, we took all measurements from experimental and control periods for analysis.

Data synthesis

We calculated dichotomous outcomes as risk ratios (RRs), and continuous data as mean differences (MDs) or standardized mean differences (SMDs). We analysed statistical heterogeneity using the Chi2 test (P value > 0.10 for statistical significance) and quantified using the I2 statistic (Higgins 2003). If heterogeneity was not significant (P>0.05, I2 < 50%), we performed a quantitative data synthesis (meta-analysis) using a fixed-effect model. Where heterogeneity was significant (P <0.05), we analysed the cause to determine whether qualitative differences existed. If the clinical heterogeneity was not due to qualitative differences, we applied a random-effects model. Otherwise, we conducted a qualitative description rather than quantitative data synthesis. We used funnel plot analysis (Egger 1997) to assess for publication bias.

Results

Description of studies

For the original review, our systematic searches (up to August 2005) retrieved 800 references. After reading titles and abstracts, 35 articles were retrieved in full text for further assessment. Of these, 15 articles were excluded based on the inclusion criteria (Characteristics of excluded studies), and we included a total of 20 articles. In addition, 23 articles were classed as 'awaiting classification'.

For the first review update, we re-run the electronic search strategies up to September 2008, and 3621 new references were found. After reading titles and abstracts, 51 articles and 23 'awaiting classification' articles were retrieved in full text for further assessment. A total of 69 of these 74 articles were excluded (Characteristics of excluded studies). Three articles were included (Fang 1987; Liu 2007a; Zhao 2006), and two were categorized as 'studies awaiting classification' (Fan 2004; Jiang 1988). Meanwhile, we reassessed the 20 previously-included articles using the updated inclusion criteria and 17 articles were excluded (Characteristics of excluded studies), and three remained as included studies (He 2004; Mao 2003a; Zhang 2002). Therefore, a total of six articles were included in the first update.

For the second review update, search strategies were re-run to April 2011, and 1563 new articles were found. After reading titles and abstracts, 32 articles were retrieved in full text for further assessment. Full text of the two studies previously categorized as 'studies awaiting classification' were also retrieved (Fan 2004; Jiang 1988). A total of 31 of these 34 full-text articles were excluded (Characteristics of excluded studies), and three new articles were included for this second review update (Jiang 1988; Wang 2010a; Zhai 2009).

For the current review update, we performed searches up to 13 June 2013. We identified a total of 1612 new articles (Figure 1). After screening titles and abstracts, we retrieved the full text articles of 37 studies for further assessment. Of these, we excluded 33 articles, for the reasons listed in the Characteristics of excluded studies. We included four new articles in this update (Ding 2012; Su 2012; Wan 2012; Liu 2013) and nine articles from the previous reviews, to give a total of 13 articles.

Figure 1.

Study flow diagram of search results for update of 2014 Cochrane Review.

We have listed the characteristics of the included trials in the Characteristics of included studies section. One article contained two independent RCTs (Mao 2003a). One trial compared Shengmai plus usual treatment with usual treatment alone in 40 patients (Mao 2003a, part A); the other RCT compared Shengmai with placebo in the other 40 participants (Mao 2003a, part B). We included both RCTs but the trial did not originally report any information on the 80 participants. We obtained information of Mao 2003a, part A from its additional paper (Mao 2003b). However, we failed to find participants' information in the latter RCT (Mao 2003a, part B).

Therefore, we included a total of fourteen trials in this review update. Twelve trials were RCTs (Zhang 2002; Mao 2003a, Part A; Mao 2003a, Part B; He 2004; Zhao 2006; Liu 2007a; Zhai 2009; Wang 2010a; Ding 2012; Su 2012; Wan 2012; Liu 2013), and two were cross-over trials (Fang 1987; Jiang 1988). We included 858 participants, of which 54.7% were male, and a mean age ranging from 41 to 70.4 years. The leading causes of heart failure were coronary heart disease, dilated cardiomyopathy and hypertensive heart disease (accounting for 87.5%) (Table 1; Table 2).

Table 1. Characteristics of participants
  1. CHD = coronary heart disease; RHD = rheumatic heart disease; PHD = pulmonary heart disease; DCM = dilated cardiomyopathy; HBP =hypertensive heart disease; HCM = hypertrophic cardiomyopathy; NYHA = New York Heart Association.

TrialNumberSex (male/female)Average age/ (Age range)Duration of heart failureOriginal diseaseHeart function
Fang 19874035/558/(39 to 80) CHD (n = 40)NYHA II (n = 37), NYHA III (n = 3)
He 20046033/2741 CHD (n = 21), RHD (n = 12), HBP (n = 15), DCM (n = 12)NYHA II (n = 8), NYHA III (n = 34), NYHA IV (n = 18)
Liu 2007a12064/56/(38 to 75)3 to 12 yearsCHD (n = 52), HBP (n = 42), DCM (n = 11), RHD (n = 15)NYHA II n = 31), NYHA III n = 52), NYHA IV n = 37)
Mao 2003a, Part A4017/2359/(40 to 70)6.70 ± 6.50 yearsCHD (n = 33), RHD (n = 2), HBP (n = 2), PHD (n = 2)NYHA II (n = 13), NYHA III (n = 27)
Mao 2003a, Part B40    NYHA II (n = 14), NYHA III (n = 26)
Zhang 200210059/41/(34 to 78)0.5 to 8 yearsDCM (n = 100)NYHA II (n = 20), NYHA III (n = 71), NYHA IV (n = 9)
Zhao 20064014/2661(41 to 70)0.5 to 30 yearsCHD (n = 35), RHD (n = 3), PHD (n = 2)NYHA II (n = 18), NYHA III (n = 22)
Zhai 20096034/26/(50 to 75)2 to 14 yearsCHD (n = 39), RHD (n = 7), PHD (n = 2), DCM (n = 4), HBP (n = 6), congenital heart disease (n = 2)NYHA III (n = 35), NYHA IV (n = 25)
Wang 2010a7443/31/(60 to 85) CHD (n = 41), HBP (n = 29), DCM (n = 4)NYHA II (n = 7), NYHA III (n = 45), NYHA IV (n = 22)
Jiang 19882623/343.8/(23 to 60) DCM (n = 26)NYHA II (n = 23), NYHA III (n = 3)
Su 20126632/34/(44 to 85) CHD (n = 38), RHD (n = 5), HBP (n = 11), PHD (n = 12)NYHA II (n = 14), NYHA III (n =39), NYHA IV (n = 13)
Liu 20135033/17/(60 to 75)  NYHA III (n = 33), NYHA IV (n = 17)
Wan 20126228/3462.4/(48 to 70)4 to 11 year/6.9 ± 2.9 yearsHBP (n = 26), CHD (n = 29), diabetes mellitus (n = 32)NYHA II (n = 22), NYHA III (n = 30), NYHA IV (n = 10)
Ding 20128033/4770.74/72.568,07± 6.30 years/8.92 ± 4.68 yearsOld myocardial infarction (n = 25), hypertensive heart disease (n = 56), diabetes mellitus (n = 33), hyperlipidaemia (n = 26)NYHA III (n = 61), NYHA IV (n = 19)
Table 2. Characteristics of Shengmai treatment
  1. po = by mouth; iv gtt = intravenously guttae; GS = glucose and saline.

TrialAgentDoseFormDuration of treatment (days)
Fang 1987Shanghai10 mL po bidoral liquid20
He 2004Huaxi20 to 40 mL + GS /iv gtt qdinjection14
Liu 2007aShanxi20 mL/40 mL/60 mL 5% GS 250 mL/iv gtt qdinjection15
Mao 2003a, Part AYibin20, 40, 60 mL + 5% 200 mL polarized solution /iv gtt qdinjection14
Mao 2003a, Part BYibin20, 40, 60 mL + 5% 200 mL polarized solution /iv gtt qdinjection14
Zhang 2002Huaxi60 mL + 5% GS 250ml/iv gtt qdinjection14
Zhao 2006Huaxi20 mL/40 mL/60 mL + 5% GS 100 mL + 0.25 g KCL + R-I 1uinjection7
Jiang 1988Shanghai10 mL po bidoral liquid20
Zhai 2009not stated40 mL + 5% GS 250 mL/iv gtt qdinjection15
Wang 2010aJiangsu60 mL + GS 250 mL/iv gtt qdinjection15
Su 2012not stated100 to 180 mL + 5% GS 150 mL/iv gtt qdinjection10
Liu 2013not stated100 mL po bidpowder14
Wan 2012Suzhong40 mL + 5% GS 100 mL/iv gtt qdinjection14
Ding 2012Shanxi40 mL + 5% GS 250 mL or 0.9% NS 250ml/iv gtt qdinjection7

The wash-out period in both Fang 1987 and Jiang 1988 was 10 days, which met our inclusion criteria (9.5 days). Fang 1987 proved they were free from carry-over effect in two ways. Firstly, there were no significant difference (P < 0.05) in serial indexes of the heart function between two groups at the beginning of both phases. Secondly, the overall level of heart function of the participants at the end of phase 1 was not significantly different from that at the end of phase 2.

We assessed the quality of the evidence using the GRADE approach and almost all of the evidence was low quality (Summary of findings for the main comparison; Summary of findings 2).

Methodological quality

All of the included trials were RCTs. Many studies provided a description of "patients were randomly allocated to..." without further detailed information. We contacted the authors for more information of methodology by telephone and eliminated 1608 studies.

We could not obtain the protocols of included trials. Few trials described the blinding method. Two trials mentioned the use of double-blinding (Fang 1987; Jiang 1988), and one assessed one of the reported outcomes blindly (He 2004). None of the included trials mentioned allocation concealment. Only one trial provided detailed information of baseline comparisons other than a description "baseline characteristics are similar between Shengmai group and control group (P > 0.05)" (Zhao 2006).

Participants

All of the 858 participants were Chinese (Table 1), 52.2% (448/858) were male and 43.1% (370/858) were female (Note: as Mao 2003a, Part B did not report any information on its participants, the statistical data did not include these 40 participants). The participants' ages varied from 23 to 85 years, and the mean age ranged from 41 to 70.4 years.

Seven trials reported the duration of heart failure (Zhang 2002; Mao 2003a; Zhao 2006; Liu 2007a; Zhai 2009; Ding 2012; Wan 2012), which varied from 0.5 to 30 years.

The spectrum of primary causes for heart failure differed among the 12 trials that reported this data (Fang 1987; Jiang 1988; Zhang 2002; Mao 2003a, Part A; He 2004; Zhao 2006; Liu 2007a; Zhai 2009; Wang 2010a; Ding 2012; Su 2012; Wan 2012). Of these, 328 patients were coronary heart disease patients from nine trials (Fang 1987; Mao 2003a, Part A; He 2004; Liu 2007a; Zhao 2006; Zhai 2009; Wang 2010a; Su 2012; Wan 2012), 157 patients were dilated cardiomyopathy patients from six trials (Jiang 1988; Zhang 2002; He 2004; Liu 2007a; Zhai 2009; Wang 2010a), 44 patients were rheumatic heart disease patients from six trials (Mao 2003a, Part A; He 2004; Zhao 2006; Liu 2007a; Zhai 2009; Su 2012), 187 patients were hypertensive heart disease patients from eight trials (Mao 2003a, Part A; He 2004; Liu 2007a; Zhai 2009; Wang 2010a; Ding 2012; Su 2012; Wan 2012); 18 patients were pulmonary heart disease from four trials (Mao 2003a, Part A; Zhao 2006; Zhai 2009; Su 2012), and two patients were congenital heart disease patients from Zhai 2009. Twenty-five patients had old myocardial infarction in Ding 2012, 65 patients in two trials had diabetes mellitus (Ding 2012; Wan 2012), and 26 patients in one study had hyperlipidaemia (Ding 2012). Two trials did not report the primary cause of heart failure (Mao 2003a, Part B; Liu 2013).

All included trials provided baseline data on NYHA function classifications (NYHA FC). There were 207 participants with NYHA class II, 481 with NYHA class III and 170 with NYHA class IV.

Diagnosis

Eleven trials stated the diagnostic criteria of heart failure: three based on criteria from the World Health Organization (WHO) (Fang 1987; Jiang 1988; Zhang 2002), three based on Framingham and Boston (Mao 2003a, Part A; Mao 2003a, Part B; Zhao 2006; Ding 2012); one from Guidelines for diagnosis and treatment of chronic heart failure 2007 (Wang 2010a); one based on Guidelines for treatment of systolic heart failure (Zhai 2009); one based on Reference standards for the treatment of left ventricle diastolic heart failure (Wan 2012); one based on Guidelines for clinical research on the treatment of new Chinese traditional medicine in congestive heart failure (Liu 2013). The remaining three articles did not mention the diagnostic criteria, but provided the NYHA class (He 2004; Liu 2007a; Su 2012). All included trials adopted NYHA class for clinical assessment of patients, and one also used the specific activity scale (SAS) (Zhao 2006).

Intervention

Eleven trials administered Shengmai by intravenous infusion (Zhang 2002; Mao 2003a,Part A; Mao 2003a, Part B; He 2004; Zhao 2006, Liu 2007a; Zhai 2009; Wang 2010a; Ding 2012; Su 2012; Wan 2012), and three trials gave it as an oral liquid (Fang 1987; Jiang 1988, Liu 2013). All trials but three (Zhai 2009; Su 2012; Liu 2013) reported the manufacturers of Shengmai and included: Huaxi (Zhang 2002; He 2004; Zhao 2006), Shanghai (Fang 1987; Jiang 1988), Shanxi (Liu 2007a; Ding 2012), Yibin (Mao 2003a), Jiangsu (Wang 2010a) and Suzhong (Wan 2012).

Shengmai dosage varied: the injection ranged from 20 mL to 180 mL per day and according to Pharmacopoeia of the People's Republic of China, 10 mL Shengmai injection is extracted based on a standardized formula: Panax ginseng (1.00 g), Ophiopogon japonicu (3.12 g) and Schisandra chinensis (1.56 g); the volume of oral liquid was 20 mL per day (Jiang 1988) (Panax ginseng,Ophiopogon japonicu and Schisandra chinensis were 11 g in total) or 200 mL per day (Liu 2013) (including: Panax ginseng (24.00 g), Ophiopogon japonicu (24.00 g) and Schisandra chinensis (12.00 g)).

Treatment duration varied from seven days to 20 days, and the mean duration was 13.79 days (SD 3.81).

No study reported the duration of follow up.

Eleven trials compared Shengmai plus usual treatment with usual treatment alone. Of the eleven trials, four provided detailed information about usual treatment, including drug names and administration of medicines (Zhang 2002; Mao 2003a, Part A; Zhao 2006; Su 2012). There were some differences amongst them regarding usual treatment. Seven trials (He 2004; Liu 2007a; Zhai 2009; Wang 2010a; Ding 2012; Wan 2012; Liu 2013) described usual treatment as cardiotonic, diuretic and vasodilator instead of giving detailed information. Three trials compared Shengmai with placebo (Fang 1987; Jiang 1988; Mao 2003a, Part B). We have listed the intervention details in Table 2.

Outcomes

Regarding primary outcomes, only one trial reported on mortality. Twelve trials reported the NYHA classification of clinical status (Zhang 2002; Mao 2003a,Part A; Mao 2003a, Part B; He 2004; Zhao 2006; Liu 2007a; Zhai 2009; Wang 2010a; Ding 2012; Su 2012; Wan 2012; Liu 2013). Three trials reported mild adverse effects in six patients: in the high-dose (60 mL/d) Shengmai group, two had mild asomnia (2/30, 6.67%) (Liu 2007a), two had dry mouth and were fidgety (2/10, 20%) (Zhao 2006), two patients in the Shengmai group (20 mL/d) had stomach discomfort and hypoglycaemia (2/26 7.69%) and were withdrawn from Jiang 1988. Four trials reported no adverse effects at the end of treatment (He 2004; Zhai 2009; Wang 2010a; Ding 2012). Seven trials did not report on this outcome (Fang 1987; Zhang 2002; Mao 2003a,Part A; Mao 2003a, Part B; Su 2012; Wan 2012; Liu 2013).

For secondary outcomes, none of the included trials reported hospitalisation, rehospitalization or costs. Two trials reported exercise test (Jiang 1988; He 2004); one trial reported quality of life ("Minnesota Living with Heart Failure Questionnaire" adopted) (Zhai 2009); eight trials reported the change in haemodynamics (Fang 1987; Jiang 1988; Zhang 2002; Liu 2007a; Zhai 2009; Wang 2010a; Ding 2012, Wan 2012); four trials reported the change in ejection fraction (Zhang 2002; Liu 2007a; Zhai 2009; Ding 2012) and only one trial reported the change of quality of life (Zhai 2009).

No trial reported changes in medication due to worsening of symptoms or heart failure. All fourteen trials reported the outcomes measured at the end of treatment.

Risk of bias in included studies

We presented the risk of bias of included trials in the Risk of bias tables in the 'Characteristics of included studies' section. We have summarized the risk of bias in each domain for each included trial in Figure 2 and as percentages across all included trials in Figure 3.

Figure 2.

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

Figure 3.

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

Although all included trials "randomly allocated" participants, only seven trials reported on sequence generation (Fang 1987; Liu 2007a; Zhai 2009; Wang 2010a; Ding 2012; Wan 2012; Liu 2013). We contacted the authors of the remaining seven trials by telephone for the detailed randomisation method used in their trials. The methods of randomisation sequence generation included computer random number generator (Zhang 2002; Ding 2012), throwing dice (Fang 1987; Jiang 1988; He 2004), and random number table (Mao 2003a, Part A; Mao 2003a, Part B; Zhao 2006; Liu 2007a; Zhai 2009; Wang 2010a; Su 2012; Wan 2012; Liu 2013). None of the included trials reported allocation concealment. Although thirteen of fourteen trials stated there were no significant differences at baseline between treatment and control groups (Fang 1987; Jiang 1988; Zhang 2002; Mao 2003a, Part A; Mao 2003a, Part B; Zhao 2006; Liu 2007a; Zhai 2009; Wang 2010a; Ding 2012; Su 2012; Wan 2012; Liu 2013), only Zhao 2006 detailed baseline characteristics data and He 2004 did not report on baseline comparisons. It was difficult to assess risk of bias in a domain such as sequence generation as baseline data were not available for 13 of 14 trials, so selection bias was still unclear and likely to exist.

Two cross-over trials compared Shengmai to placebo used double-blinding (Fang 1987; Jiang 1988). He 2004 assessed blindly one of the reported outcomes. Other trials did not provide information about blinding and there was high risk of performance bias and detection bias in these trials.

Apart from two participants who were withdrawn due to adverse effects in the Shengmai group in Jiang 1988, trial investigators reported all the other participants' outcomes. As we could not obtain any original trial protocols, the risk of bias of incomplete outcome assessment was unclear. Also, the risk of selective reporting bias was unclear. We generated a funnel plot for NYHA class (Figure 4), and found no evidence of reporting bias. However, there were too few included trials for other outcomes to generate a funnel plot.

Figure 4.

Funnel plot of comparison: 1. Shengmai plus usual treatment versus usual treatment alone, outcome: 1.1 Lack of improvement in heart failure (NYHA class improved < I class or worsening of heart failure).

Zhao 2006 was funded by State Chinese Medicine Administration Bureau, Zhang 2002 was under the support of the National Science and Technology Department's Ninth Five-year Plan, and Mao 2003a was funded by the Education Commission of Tianjin Province. The remaining trials were not funded by any institution and all funding was from public authorities. Based on sources of funding, the included trials were unlikely to have had any conflict of interests.

We had insufficient information to determine bias from other sources.

Effects of interventions

See: Summary of findings for the main comparison Shengmai plus usual treatment compared to usual treatment alone for heart failure; Summary of findings 2 Shengmai compared to placebo for heart failure

Shengmai plus usual treatment versus usual treatment alone

Mortality

There were no data available on this outcome.

NYHA class

Ten trials (Zhang 2002; Mao 2003a, Part A; He 2004; Zhao 2006; Liu 2007a; Zhai 2009; Wang 2010a; Su 2012; Wan 2012; Liu 2013), including 672 participants, provided data on NYHA class. A meta-analysis of data on the change of NYHA classification showed that Shengmai plus usual treatment was more beneficial compared with usual treatment alone. The summary relative risk of NYHA FC improved < I class, or worsening of heart failure was 0.37 (95% CI 0.26 to 0.51; 10 trials, 672 participants; Analysis 1.1).

Exercise test or six-minute walk test performance

He 2004 showed that Shengmai plus usual treatment was better than usual treatment alone for improving exercise tolerance (MD 6.00, 95% CI 4.48 to 7.52; one trial, 60 participants; Analysis 1.2).

Quality of life

Zhai 2009 showed that Shengmai plus usual treatment was not significantly different from usual treatment alone (MD 7.00, 95% CI -1.98 to 15.98; one trial, 60 participants; Analysis 1.3).

Ejection fraction

Four trials with 354 participants presented data on ejection fraction (Zhang 2002; Liu 2007a; Zhai 2009; Wang 2010a). We detected considerable heterogeneity (P < 0.00001, I² = 91%) and we conducted meta-analysis using the random-effects model. Shengmai plus usual treatment was better than usual treatment alone in improving ejection fraction (MD 9.02, 95% CI 5.95 to 12.08; four trials, 354 participants; Analysis 1.4). The intervention effect on this outcome had statistical significance in each of the four trials.

Cardiac output

Four trials including 360 participants presented data on this outcome (Zhang 2002; Liu 2007a; Zhai 2009; Ding 2012). There was considerable heterogeneity (P < 0.00001, I² = 92%) and we conducted random-effects meta-analysis. Shengmai plus usual treatment was better than usual treatment alone for improving cardiac output (MD 0.94, 95% CI 0.26 to 1.63; four trials, 360 participants; Analysis 1.5) and the intervention effect had statistical significance in each of the four trials.

Stroke volume

Three trials which recruited 240 participants reported on stroke volume (Zhang 2002; Zhai 2009; Ding 2012). Substantial heterogeneity was present (P < 0.00001, I² = 97%) and we conducted random-effects meta-analysis. Shengmai plus usual treatment was not significantly different from usual treatment alone in increasing stroke volume (MD 8.53, 95% CI 0.08 to 16.98; three trials, 240 participants; Analysis 1.6).The intervention effect on this outcome had statistical significance in each of the three trials.

Cardiac index

Two trials with 160 participants reported on this outcome (Zhang 2002; Zhai 2009). There was considerable heterogeneity (P = 0.04, I² = 77%) and we undertook random-effects meta-analysis. Shengmai plus usual treatment was better than usual treatment alone at changing cardiac index (MD 0.79, 95% CI 0.59 to 0.99; two trials, 160 participants; Analysis 1.7).The intervention effect on this outcome had statistical significance in each of the two trials.

Left ventricular end-diastolic volume

Wang 2010a studied this outcome in 74 participants and showed that there was no significant difference between Shengmai plus usual treatment and usual treatment alone (MD 7.20, 95% CI -9.80 to 24.20; one trial, 74 participants; Analysis 1.8).

Left ventricular end-systolic volume

Wang 2010a, with 74 participants, reported on left ventricular end-systolic volume and showed that Shengmai plus usual treatment was better than usual treatment alone for improving this outcome (MD 14.60, 95% CI 0.50 to 28.70; one trial, 74 participants; Analysis 1.9).

Hospitalization/rehospitalization

No data were available on this outcome.

Costs

No data were available on this outcome.

Shengmai versus placebo

Mortality

No data were available on this outcome.

NYHA class

Mao 2003a, Part B, which included 40 participants, showed that Shengmai treatment was more beneficial than placebo treatment at improving NYHA classification of clinical status. The summary relative risk of NYHA FC improved < I class, or worsening of heart failure was 0.22 (95% CI 0.11 to 0.44; one trial, 40 participants; Analysis 2.1).

Exercise test (time change)

Jiang 1988 demonstrated that Shengmai treatment was not significantly different from placebo treatment changing exercise test (MD -3.56, 95% CI -7.19 to 0.07; one trial, 18 participants; Analysis 2.2).

Ejection fraction

Jiang 1988 showed that Shengmai treatment was better than placebo treatment improving ejection fraction (MD 12.45, 95% CI 8.96 to 15.94; one trial, 52 participants; Analysis 2.3).

Cardiac output

Jiang 1988 showed that Shengmai treatment was not significantly different from placebo treatment at increasing cardiac output (MD -0.53, 95% CI -1.08 to 0.02; one trial, 52 participants; Analysis 2.4).

Stroke volume

Fang 1987 demonstrated that Shengmai treatment was better than placebo treatment at increasing stroke volume (MD 5.80, 95% CI 0.16 to 11.44; one trial, 80 participants; Analysis 2.5).

Stroke volume index

Fang 1987 showed that Shengmai treatment was not significantly different from placebo treatment changing stroke volume index (MD 3.95, 95% CI -0.10 to 8.00; one trial, 80 participants; Analysis 2.6).

Cardiac index

Fang 1987 demonstrated that Shengmai treatment was better than placebo treatment for changing cardiac index (MD 0.32, 95% CI 0.04 to 0.60; one trial, 80 participants; Analysis 2.7).

Myocardial contractility

Fang 1987 showed that Shengmai treatment was better than placebo treatment for increasing Heather Index (HI) (MD 1.88, 95% CI 0.38 to 3.38; one trial, 80 participants; Analysis 2.8).

Fang 1987 provided data for ECG change and demonstrated that Shengmai treatment was better than placebo treatment for changing Q-Z (MD 10.72, 95% CI 5.10 to 16.34; one trial, 80 participants; Analysis 2.9) and Adz/dtMax (MD 0.10, 95% CI 0.01 to 0.19; one trial, 80 participants; Analysis 2.10), but was not significantly different from placebo treatment at changing Q-B/B-X (MD 0.03, 95% CI -0.00 to 0.06; one trial, 80 participants; Analysis 2.11).

Hospitalization/rehospitalization

No data were available on this outcome.

Costs

No data were available on this outcome.

Adverse effects

Three trials reported mild adverse effects in six patients: mild asomnia occurred in 2/90 patients (2.22%) within the Shengmai group (Liu 2007a), and both were in the high-dose (60 mL/d) Shengmai group (2/30, 6.67%); dry mouth and fidgety responses occurred in 2/30 patients (6.67%) in the Shengmai group (Zhao 2006), and both occurred in the high-dose (60 mL/d) Shengmai group (2/10, 20%); stomach discomfort and hypoglycaemia occurred in 2/26 patients (7.69%) within the Shengmai group and they were withdrawn from the trial (Jiang 1988). Four trials reported no adverse effects at the end of treatment (He 2004; Zhai 2009; Wang 2010a; Ding 2012). Seven trials did not report on this outcome (Fang 1987; Zhang 2002; Mao 2003a Part A; Mao 2003a Part B; Su 2012; Wan 2012; Liu 2013)

Sensitivity analyses and subgroup analyses

We did not perform any sensitivity analyses because the included trials were of similar low quality. We were unable to perform any subgroup analyses because of insufficient sample size and incomplete data of heart failure types.

We made a thorough investigation of heterogeneity, but there was insufficient information to explain the cause of the heterogeneity, so we still applied the random-effects model for these indexes.

Discussion

This review suggests that Shengmai (injection, oral liquid and powder forms) may have some positive effects on heart failure, but the results should be interpreted with great caution due to the poor quality of the included trials.

For the comparison of Shengmai plus usual treatment versus usual treatment, potential benefits of Shengmai were observed for several outcomes, including upgrading NYHA FC and better performances in exercise test, ejection fraction, cardiac output, cardiac index and left ventricular end-systolic volume. Shengmai's positive effects were also reported in ejection fraction, stroke volume, cardiac index and myocardial contractility (Heather index, Q-Z, Adz/dtMax) when Shengmai treatment was compared to placebo treatment in patients with suspected heart failure. In this updated review, no of the included trials reported on hospitalisation. Hospitalization may be a useful outcome for evaluation in Western countries. However, it is difficult to measure accurately in China due to the imbalance in the allocation of medical resources, difficulty in accessing medical treatment in secluded regions, and relatively sparse medical resources. These make hospitalisation unreliable or even misleading. In addition, only one trial ( Zhai 2009) reported on the quality of life and no trials reported on economic outcomes. All of the included trials had relatively short treatment periods without a long-term follow-up, and we could not obtain data on the primary outcome, mortality.

All of the participants in the included trials were Chinese. Traditional Chinese medicine is widely believed in China to be effective for most diseases, with few adverse effects (Tan 2006; Song 2011). Therefore, Chinese herbs and medicine are used more extensively in hospitals in China than in Western countries. All of the participants were from major hospitals and were more likely under more severe medical conditions. These factors could undermined the representativeness of the sample.

The lack of detailed description of randomisation sequence generation and data of baseline characteristics limited our confidence in the random allocation and baseline balance of the included trials. Along with the absence of allocation concealment in all the trials, which could cause selective enrolment of participants on the basis of prognostic factors or other subjective factors, we expected a possible risk of selective bias towards greater effect of the intervention. Almost all of these included trials were conducted without blinding, which caused a high risk of performance bias and detection bias. Lack of blinding in randomised trials is associated with exaggerated results of intervention effect (Pildal 2007). In particular, one of the primary outcomes NYHA FC was a subjective endpoint assessed by physicians and this was very likely to exaggerate the intervention effect. For the three included trials which compared Shengmai with placebo, the lack of blinding of participants also gave rise to the high risk of placebo effect. Although we conducted comprehensive searches and tried to avoid language and location bias, we only found trials published in Chinese. Most trials had positive Shengmai findings and thus we cannot exclude potential publication bias. The overall methodological quality of the trials was poor and care must be taken when interpreting the outcomes.

In the review process, two authors worked independently on trial collection, data extraction and risk of bias assessment. We reached consensus through discussion or in consultation with a third author. The potential biases in the review process were low, but may still exist for inevitable subjective factors when we assessed the risk of bias and the unexplainable significant heterogeneity in the random-effects meta-analysis for the outcomes, including ejection fraction, cardiac output, stroke volume, and cardiac index.

Six out of the 858 participants had mild adverse effects, and the rate of adverse effects was 0.70%. Four of the six participants with adverse effects were in the high-dose Shengmai group. The risk ratio of high dose of Shengmai (> 60 mL per day) was 3.46. Our review suggests that high dose of Shengmai injection would more likely cause adverse effects. Another systematic review (Li 2009) conducted with a total of 28,305 patients using Shangmai reported that 215 patients suffered from adverse events, with a adverse effect rate of 0.76%. Li 2013 conducted a safety evaluation in 2013 on Shengmai in 515 patients. The rate of adverse events in this retrospective study was 0.78% (4/515). Another safety evaluation on Shengmai in 4079 patients (Deng 2012) reported the incidence of adverse events of Shengmai injection was 0.12% (95% CI 0.04% to 0.29%). However, a retrospective study in 1012 patients (Cheng 2011) reported that "main adverse events of Shengmai included 388 cases of fever and systemic damages (38.34%), 202 cases of skin and appendages damages (19.96% ), 113 cases of cardiovascular system damages (11.17%), and 70 cases of gastrointestinal system damages (6.92%)". The adverse rate of the last study was obviously higher than those in the former listed studies, including our review, but we could not find the reason. The inconsistent results of the adverse events should be monitored in the further use of Shengmai. Allergic reaction was most common adverse event, which may result from Individual constitution, age, overdose and unreasonable drug combination. In addition, clinicians should be aware of the rare possibility of anaphylactic shock when applying Shengmai.

According to traditional Chinese medicine theory, heart failure is a deficiency of Yin and Qi, but it is difficult to standardize and quantify as diagnosis is usually based on the clinician's subjective experience. Traditional Chinese medicine scholars have long been devoted to establishing a classification standard for syndromes of Chinese medicine to make it more quantitative, objective and acceptable, by which it is possible to measure deficiency of Yin and Qi of heart failure patients as NYHA classification standards measures heart function. Many problems still exist with these evaluation methods and no uniform standards has been formed (Wang 2008).

Future research needs to employ high quality methodology and more meaningful outcomes relevant to efficacy and safety for long-term follow-up. If efficacy is shown in well-designed trials, isolating the active components of Shengmai and testing it in a different cultural backgrounds is necessary. If there is sufficient evidence in the future, we will attempt to conduct subgroup analysis to determine the effect of Shengmai on patients with different types of heart failure and of different ethnic backgrounds. Moreover, the method and dosage of administration should be analysed to explore the optimal therapeutic regimen of Shengmai for heart failure.

Authors' conclusions

Implications for practice

We could not make a clear judgement about the effects of Shengmai in the presence of concurrent conventional Western drugs for heart failure as none of the included trials were of high enough quality. The cultural context in China and the attitude toward traditional Chinese medicine could possibly generate an expectation bias. Thus the strong treatment effects seen in those given Shengmai might have arisen simply by using a venerable medicine in an unblinded fashion in the context of Chinese patients.

Implications for research

Further research should emphasize methodological quality, especially the design of trials, generation of allocation, allocation concealment, adequacy of blinding, sample size estimation, and clear criteria for diagnosis and for inclusion and exclusion, to avoid selection bias, performance bias, detection bias and confounding bias. More extensive research should be performed, such as including participants from different ethnic groups and research settings in different countries. Also, more meaningful outcome measurements related to effectiveness and safety in the long term should be utilized. If efficacy is shown in well-designed trials, it would be important to define the active ingredients and test them in a different cultural backgrounds . Shengmai's effects on specific heart failure etiologies is not yet known.

Acknowledgements

We appreciate the support from the Chinese Cochrane Centre, China Medical Board of New York, and the Cochrane Complementary Medicine Field. We acknowledge the Cochrane Heart Group for their assistance: Professor Shah Ebrahim and the editorial team for constructive suggestions in the development of this review, amendments and updates, and Margaret Burke and Nicole Martin for revising, re-running the search strategy and providing the search results from English databases for this update. We thank William B. Hood Jr. for locating articles we could not obtain in China. We acknowledge Theresa Moore, Liz Bickerdike, Claire Williams, Fiona Taylor and Diane Horsley for their help in this update and previous versions of this review.

Data and analyses

Download statistical data

Comparison 1. Shengmai plus usual treatment versus usual treatment alone
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Lack of improvement in heart failure (NYHA class improved < I class or worsening of heart failure)10672Risk Ratio (M-H, Fixed, 95% CI)0.37 [0.26, 0.51]
2 Exercise test (after treatment)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
3 Change in quality of life1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
4 Change in ejection fraction (%)4354Mean Difference (IV, Random, 95% CI)9.02 [5.95, 12.08]
5 Change in cardiac output (L/min)4360Mean Difference (IV, Random, 95% CI)0.94 [0.26, 1.63]
6 Change in stroke volume (mL)3240Mean Difference (IV, Random, 95% CI)8.53 [0.08, 16.98]
7 Change in cardiac index L/min*m²2160Mean Difference (IV, Random, 95% CI)0.79 [0.59, 0.99]
8 Change in left ventricular end-diastolic volume (mL)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
9 Change in left ventricular end-systolic volume (mL)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
Analysis 1.1.

Comparison 1 Shengmai plus usual treatment versus usual treatment alone, Outcome 1 Lack of improvement in heart failure (NYHA class improved < I class or worsening of heart failure).

Analysis 1.2.

Comparison 1 Shengmai plus usual treatment versus usual treatment alone, Outcome 2 Exercise test (after treatment).

Analysis 1.3.

Comparison 1 Shengmai plus usual treatment versus usual treatment alone, Outcome 3 Change in quality of life.

Analysis 1.4.

Comparison 1 Shengmai plus usual treatment versus usual treatment alone, Outcome 4 Change in ejection fraction (%).

Analysis 1.5.

Comparison 1 Shengmai plus usual treatment versus usual treatment alone, Outcome 5 Change in cardiac output (L/min).

Analysis 1.6.

Comparison 1 Shengmai plus usual treatment versus usual treatment alone, Outcome 6 Change in stroke volume (mL).

Analysis 1.7.

Comparison 1 Shengmai plus usual treatment versus usual treatment alone, Outcome 7 Change in cardiac index L/min*m².

Analysis 1.8.

Comparison 1 Shengmai plus usual treatment versus usual treatment alone, Outcome 8 Change in left ventricular end-diastolic volume (mL).

Analysis 1.9.

Comparison 1 Shengmai plus usual treatment versus usual treatment alone, Outcome 9 Change in left ventricular end-systolic volume (mL).

Comparison 2. Shengmai versus placebo
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Lack of improvement in heart failure (NYHA class improved < I class or worsening of heart failure)1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
2 Change in exercise test (mins)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
3 Change in ejection fraction (%)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
4 Change in cardiac output (L/min)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
5 Change in stroke volume (mL)1 Mean Difference (IV, Random, 95% CI)Totals not selected
6 Change in stroke volume index1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
7 Change in cardiac index L/min*m²1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
8 Change in Heather Index1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
9 Change in ECG: Q-Z1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
10 Change in ECG: Adz/dtMax1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
11 Change in ECG: Q-B/B-X1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
Analysis 2.1.

Comparison 2 Shengmai versus placebo, Outcome 1 Lack of improvement in heart failure (NYHA class improved < I class or worsening of heart failure).

Analysis 2.2.

Comparison 2 Shengmai versus placebo, Outcome 2 Change in exercise test (mins).

Analysis 2.3.

Comparison 2 Shengmai versus placebo, Outcome 3 Change in ejection fraction (%).

Analysis 2.4.

Comparison 2 Shengmai versus placebo, Outcome 4 Change in cardiac output (L/min).

Analysis 2.5.

Comparison 2 Shengmai versus placebo, Outcome 5 Change in stroke volume (mL).

Analysis 2.6.

Comparison 2 Shengmai versus placebo, Outcome 6 Change in stroke volume index.

Analysis 2.7.

Comparison 2 Shengmai versus placebo, Outcome 7 Change in cardiac index L/min*m².

Analysis 2.8.

Comparison 2 Shengmai versus placebo, Outcome 8 Change in Heather Index.

Analysis 2.9.

Comparison 2 Shengmai versus placebo, Outcome 9 Change in ECG: Q-Z.

Analysis 2.10.

Comparison 2 Shengmai versus placebo, Outcome 10 Change in ECG: Adz/dtMax.

Analysis 2.11.

Comparison 2 Shengmai versus placebo, Outcome 11 Change in ECG: Q-B/B-X.

Appendices

Appendix 1. Search strategies 2004/2005

The Cochrane Library

#1 shengmai*
#2 sengmai
#3 senmai
#4 MEDICINE CHINESE TRADITIONAL (*ME)
#5 DRUGS CHINESE HERBAL (*ME)
#6 herb*
#7 (chinese near medicine*)
#8 (chinese near drug*)
#9 ginseng*
#10 liriope
#11 schisandra
#12 (shen next mai)
#13 (sen next mai)
#14 panax
#15 schizandra
#16 ophiopogon*
#17 (#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9)
#18 (#10 or #11 or #12 or #13 or #14 or #15 or #16)
#19 (#17 or #18)
#20 HEART FAILURE CONGESTIVE (*ME)
#21 (heart next failure)
#22 (cardiac next failure)
#23 VENTRICULAR DYSFUNCTION (*ME)
#24 (ventricular near dysfunction)
#25 (cardiac next insufficiency)
#26 (heart next insufficiency)
#27 (ventric* next fail*)
#28 (#20 or #21 or #22 or #23 or #24 or #25 or #26 or #27)
#29 (#28 and #19)
[ *ME = explode MeSH term, all other terms are textword searches, * = truncation term]

MEDLINE (1966 to May 2005)

1.shengmai*
2.sengmai
3.senmai
4.MEDICINE CHINESE TRADITIONAL
5.DRUGS CHINESE HERBAL
6.herb*
7.chinese near medicine*
8.chinese near drug*
9.ginseng*
10.liriope
11.schisandra
12.shen next mai
13.sen next mai
14.panax
15.schizandra
16.ophiopogon*
17.#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9
18.#10 or #11 or #12 or #13 or #14 or #15 or #16
19.#17 or #18
20.HEART FAILURE CONGESTIVE
21.heart next failure
22.cardiac next failure
23.VENTRICULAR DYSFUNCTION
24.(ventricular near dysfunction)
25.(cardiac next insufficiency)
26.heart next insufficiency
27.ventric* next fail*
28.#20 or #21 or #22 or #23 or #24 or #25 or #26 or #27
29.#28 and #19

EMBASE (1984 to March 2004)

1.shengmai*
2.sengmai
3.senmai
4.MEDICINE CHINESE TRADITIONAL
5.DRUGS CHINESE HERBAL
6.(chinese near medicine*)
7.chinese near drug
8.ginseng*
9.liriope
10.schisandra
11.herb*
12.shen next mai
13.sen next mai
14.panax
15.schizandra
16.ophiopogon*
17.#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9
18.#10 or #11 or #12 or #13 or #14 or #15 or #16
19.#17 or #18
20.HEART FAILURE CONGESTIVE
21.heart failure
22.cardiac failure
23.VENTRICULAR DYSFUNCTION
24.ventricular near dysfunction
25.cardiac insufficiency
26.heart insufficiency
27.ventric* fail*
28.#20 or #21 or #22 or #23 or #24 or #25 or #26 or #27
29.#28 and #19

AMED (1985 to July 2005)

1.shengmai$
2.sengmai
3.senmai
4.Traditional medicine chinese
5.Drugs chinese herbal
6.herb$
7.chinese near medicine$
8.chinese near drug$
9.ginseng$
10.liriope
11.schisandra
12.shen near mai
13.sen next mai
14.panax
15.schizandra
16.ophiopogon$
17.1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9
18.10 or 11 or 12 or 13 or 14 or 15 or 16
19.17 or 18
20.Heart failure congestive
21.heart next failure
22.cardiac next failure
23.Heart disease
24.ventricular near dysfunction
25.cardiac next insufficiency
26.heart next insufficiency
27.ventric$ next fail$
28.20 or 21 or 22 or 23 or 24 or 25 or 26 or 27
29.19 and 28

BIOSIS (1997 to 2004)

1.shengmai$
2.sengmai
3.senmai
4.MEDICINE CHINESE TRADITIONAL
5.DRUGS CHINESE HERBAL
6.herb$
7.chinese medicine$
8.chinese drug$
9.ginseng$
10.liriope
11.schisandra
12.shen mai
13.sen mai
14.panax
15.schizandra
16.ophiopogon$
17.1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9
18.10 or 11 or 12 or 13 or 14 or 15 or 16
19.17 or 18
20.HEART FAILURE CONGESTIVE
21.heart failure
22.cardiac failure
23.VENTRICULAR DYSFUNCTION
24.ventricular dysfunction
25.cardiac insufficiency
26.heart insufficiency
27.ventric$ fail$
28.20 or 21 or 22 or 23 or 24 or 25 or 26 or 27
29.28 and 19

Appendix 2. Search strategy 2008

The Cochrane Library

#1 shengmai* in All Text
#2 sengmaiin All Text
#3 senmai in All Text
#4 MeSH descriptor Medicine, Chinese Traditional explode all trees
#5 MeSH descriptor Drugs, Chinese Herbal this term only
#6 herb* in All Text
#7 (chinese in All Text near/6 medicine* in All Text)
#8 (chinese in All Text near/6 drug* in All Text)
#9 ginseng* in All Text
#10 liriope in All Text
#11 schisandra in All Text
#12 shen next mai in All Text
#13 sen next mai in All Text
#14 panax in All Text
#15 schizandra in All Text
#16 ophiopogon* in All Text
#17 (#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9)
#18 (#10 or #11 or #12 or #13 or #14 or #15 or #16)
#19 (#17 or #18)
#20 MeSH descriptor Heart Failure explode all trees
#21 heart next failure in All Text
#22 cardiac next failure in All Text
#23 MeSH descriptor ventricular dysfunction explode all trees
#24 (ventricular in All Text near/6 dysfunction in All Text)
#25 cardiac next insufficiency in All Text
#26 heart next insufficiency in All Text
#27 ventric* next fail* in All Text
#28 (#20 or #21 or #22 or #23 or #24 or #25 or #26 or #27)
#29 (#28 and #19)

MEDLINE

1.shengmai$.tw.
2.sengmai.tw.
3.senmai.tw.
4.Drugs, Chinese Herbal/
5.Medicine, Chinese Traditional/
6.Medicine, Herbal/
7.chinese medicine$.tw.
8.chinese herb$.tw.
9.Panax/
10.ginseng.tw.
11."liriope (plant)"/
12.liriope.tw.
13.schisandraceae/
14.schisandra$.tw.
15.shen mai.tw.
16.sen mai.tw.
17.panax.tw.
18.ophiopogon$.tw.
19.or/1-18
20.exp Heart Failure/
21.heart failure.tw.
22.cardiac failure.tw.
23.exp Ventricular Dysfunction/
24.ventricular dysfunction.tw.
25.cardiac insufficiency.tw.
26.heart insufficiency.tw.
27.ventric$ fail$.tw.
28.or/20-27
29.19 and 28
30.randomized controlled trial.pt.
31.controlled clinical trial.pt.
32.Randomized controlled trials/
33.random allocation/
34.double blind method/
35.single-blind method/
36.or/30-35
37.exp animal/ not humans/
38.36 not 37
39.clinical trial.pt.
40.exp Clinical Trials as Topic/
41.(clin$ adj25 trial$).ti,ab.
42.((singl$ or doubl$ or trebl$ or tripl$) adj (blind$ or mask$)).ti,ab.
43.placebos/
44.placebo$.ti,ab.
45.random$.ti,ab.
46.research design/
47.or/39-46
48.47 not 37
49.38 or 48
50.49 and 29
51.limit 50 to yr="2005 - 2008"

EMBASE

1.shengmai/
2.shengmai$.tw.
3.sengmai.tw.
4.senmai.tw.
5.Chinese Herb/
6.chinese medicine/
7.Chinese Drug/
8.herbal medicine/
9.chinese medicine$.tw.
10.chinese herb$.tw.
11.Ginseng/
12.ginseng.tw.
13."liriope (plant)"/
14.liriope.tw.
15.schisandraceae/
16.schisandra$.tw.
17.shen mai.tw.
18.sen mai.tw.
19.panax.tw.
20."Ophiopogon Root"/
21.ophiopogon$.tw.
22.or/1-21
23.exp Heart Failure/
24.heart failure.tw.
25.cardiac failure.tw.
26.heart ventricle function/
27.ventricular dysfunction.tw.
28.cardiac insufficiency.tw.
29.heart insufficiency.tw.
30.ventric$ fail$.tw.
31.or/23-30
32.22 and 31
33.controlled study/
34.clinical trial/
35.major clinical study/
36.random$.tw.
37.randomized controlled trial/
38.trial$.tw.
39.compar$.tw.
40.control$.tw.
41.follow-up.tw.
42.blind$.tw.
43.double blind procedure/
44.placebo$.tw.
45.clinical article/
46.placebo/
47.doubl$.tw.
48.or/33-47
49.32 and 48
50. (exp animal/ or nonhuman/ or exp animal experiment/) not exp human/
51.49 not 50
52.limit 51 to yr="2004 - 2008"

AMED

1.shengmai$.tw.
2.sengmai.tw.
3.senmai.tw.
4.Drugs Chinese Herbal/
5.exp traditional medicine chinese/
6.herbal drugs/
7.chinese medicine$.tw.
8.chinese herb$.tw.
9.exp Panax/
10.ginseng.tw.
11.liriope.tw.
12.schisandra$.tw.
13.shen mai.tw.
14.sen mai.tw.
15.panax.tw.
16.ophiopogon$.tw.
17.or/1-16
18.heart failure congestive/
19.heart failure.tw.
20.cardiac failure.tw.
21.ventricular dysfunction.tw.
22.cardiac insufficiency.tw.
23.heart insufficiency.tw.
24.ventric$ fail$.tw.
25.or/18-24
26.17 and 25
27.limit 26 to yr="2005 - 2008"

BIOSIS

TS=((shengmai* or sengmai or senmai or shen mai or sen mai or ginseng* or liriope or schisandra or panax or schizandra or ophiopogon*)

and (heart failure or cardiac failure or ventricular dysfunction or cardiac insufficiency or heart insufficiency or ventric* fail*))

CBM English

#1 916 ALL: SHENGMAI* or SENGMAI* or SENMAI* or SHENMAI*
#2 9303 ALL: HERB* or GINSENG* or LIRIOPE* or PANAX* or OPHIOPOGON*
#3 39 ALL: SCHISANDRA* or SCHIZANDRA*
#4 99695 ALL: DRUG* or MEDICAL* or MEDICINE* or HERB*
#5 36687 ALL: CHINESE
#6 23499 #4 and #5
#7 29095 #2 or #3 or #6
#8 29990 #1 or #7
#9 47716 ALL: HEART* or CARDIAC* or VENTRIC*
#10 19498 ALL: FAIL* or INSUFFICIENCY or DYSFUNCTION
#11 7356 #9 and #10
#12 292 #8 and #11
#13 110 #12 2004-2008;
#14 135 #12 2004-2008

CBM Chinese

1. 缺省字段

表示输入的检索词同时在中文题目、文摘、作者、主题词、特征词、关键词、期刊这些主要字段检索。

2. 全部字段

表示输入的检索词同时在所有可检索的字符型字段中查找。

序号 命中文献数 检索表达式 1978˜2008.7

#1 41865 心*衰
#2 50144 心*功能
#3 34528 心力衰竭, 充血性 【扩展全部树】
/ 全部副主题词
#4 10143 心室功能 【扩展全部树】
/ 全部副主题词
#5 378 心室功能障碍 【扩展全部树】
/ 全部副主题词
#6 80997 #1 or #2 or #3 or #4 or #5
#7 6429 ALL: 生脉 or 生麦 or 参麦 or 参脉
#8 2049 ALL: 五味子 or 乌梅子 or 山花椒 or 五梅子
#9 3932 ALL: 麦冬 or 红木香 or 地血香
#10 240019 ALL: 参
#11 230 #8 and #9 and #10
#12 6573 #7 or #11
#13 218212 ALL: 随机 or 随意 or 任意 or 单盲 or 双盲 or 三盲 or 盲法
#14 408 #6 and #12 and #13
#15 390 #14 【限定】人类
#16 230 #14 【限定】2004-2008; 人类

VIP English

〖检索时间〗2008-09-25 16:19:08
〖检索范围〗全部期刊
〖起止年代〗1989-2008
〖检索条件〗(((任意字段=CHINESE*(MEDICINE MEDICAL DRUG)) (任意字段=SHENGMAI SENGMAI SENMAI SHENMAI HERB GINSENG LIRIOPE SCHISANDRA SCHIZANDRA PANAX OPHIOPOGON)*全部期刊*年=1989-2008)*(任意字段=HEART CARDIAC VENTRICLE VENTRICULAR))-(题名或关键词=ANIMAL DOG RAT MOUSE MICE RABBIT CAT)
〖检索结果〗检中117篇,选中104篇

VIP Chinese

〖检索时间〗2008-09-29 15:18:18
〖检索范围〗全部期刊
〖起止年代〗1989-2008
〖检索条件〗((((((任意字段=五味子 乌梅子 山花椒 五梅子)*(任意字段=麦冬 红木香 地血香))*(任意字段=参)*全部期刊*年=1989-2008) (任意字段=生脉 生麦 参麦 参脉))-(题名或关键词=动物实验 猫 鼠 犬 狗 兔 猴 蛙))*(任意字段=随机 随意 任意 单盲 双盲 盲法 三盲))*(任意字段=心力衰竭 心衰 心功能)
〖检索结果〗检中364篇,选中200篇

CNKI English

9.25ENGLISH ZHIJIE

检索条件: (((((全文=chinese) 或者 (全文=chinese /NEAR 6 medicine+chinese /NEAR 6 medical+chinese /NEAR 6 drug)) 并且 (全文=heart failure+heart insufficiency+cardiac failure+cardiac insufficiency+ventricular dysfunction+ventricle dysfunction)AND (全文=controlled study+randomized+controlled clinical)) 不包含 (主题=animal+dog+rat+mouse+mice+rabbit+cat))) (模糊匹配); 所属学科:医药卫生科技; 数据库:中国图书全文数据库,中国重要报纸全文数据库,中国博士学位论文全文数据库,中国学术期刊网络出版总库,中国优秀硕士学位论文全文数据库,中国重要会议论文全文数据库,中国年鉴网络出版总库,中国专利数据库,中国标准数据库,国家科技成果数据库,国外标准数据库,SPRINGER期刊数据库; 检索方式:跨库检索; 检索到:370条记录

CNKI Chinese

最终检索时2008.9.18
((((全文=五味子+乌梅子+山花椒+五梅子) AND (全文=麦冬+红木香+地血香) AND (全文=参)) OR (全文=生脉+生麦+参麦+参脉)) AND (主题%心功能+心衰 OR 关键词%心功能+心衰 OR 摘要%心功能+心衰)AND 全文=随机+随意+任意+单盲+双盲+盲法+三盲) NOT (关键词=动物+猫+鼠+犬+狗+兔+猴+蛙 OR 主题=动物+猫+鼠+犬+狗+兔+猴+蛙) AND 年=1979˜2008
http://epub.cnki.net/grid2008/brief/history.aspx

1 检索条件: ((((全文=五味子+乌梅子+山花椒+五梅子) AND (全文=麦冬+红木香+地血香) AND (全文=参)) OR (全文=生脉+生麦+参麦+参脉)) AND (主题%心功能+心衰 OR 关键词%心功能+心衰 OR 摘要%心功能+心衰)AND 全文=随机+随意+任意+单盲+双盲+盲法+三盲) NOT (关键词=动物+猫+鼠+犬+狗+兔+猴+蛙 OR 主题=动物+猫+鼠+犬+狗+兔+猴+蛙) AND 年=1979˜2008 (模糊匹配)
检索方式:跨库检索; 检索到:2192条记录
数据库:中国学术期刊网络出版总库,中国博士学位论文全文数据库,中国优秀硕士学位论文全文数据库,中国重要会议论文全文数据库,中国重要报纸全文数据库,中国图书全文数据库,中国专利数据库,中国标准数据库,国家科技成果数据库,国外标准数据库,中国年鉴网络出版总库;

3 检索条件: ((((全文=五味子+乌梅子+山花椒+五梅子) AND (全文=麦冬+红木香+地血香) AND (全文=参)) OR (全文=生脉+生麦+参麦+参脉)) AND (主题%心功能+心衰 OR 关键词%心功能+心衰)AND 全文=随机+随意+任意+单盲+双盲+盲法+三盲) NOT (关键词=动物+猫+鼠+犬+狗+兔+猴+蛙 OR 主题=动物+猫+鼠+犬+狗+兔+猴+蛙) AND 年=1979˜2008 (模糊匹配)
检索方式:跨库检索; 检索到:2192条记录
数据库:中国学术期刊网络出版总库,中国博士学位论文全文数据库,中国优秀硕士学位论文全文数据库,中国重要会议论文全文数据库,中国重要报纸全文数据库,中国图书全文数据库,中国专利数据库,中国标准数据库,国家科技成果数据库,国外标准数据库,中国年鉴网络出版总库;
4 检索条件: ((((全文=五味子+乌梅子+山花椒+五梅子) AND (全文=麦冬+红木香+地血香) AND (全文=参)) OR (全文=生脉+生麦+参麦+参脉)) AND (主题=心功能+心衰 OR 关键词=心功能+心衰)AND 全文=随机+随意+任意+单盲+双盲+盲法+三盲) NOT (关键词=动物+猫+鼠+犬+狗+兔+猴+蛙 OR 主题=动物+猫+鼠+犬+狗+兔+猴+蛙) AND 年=1979˜2008 (精确匹配)
检索方式:跨库检索; 检索到:1642条记录
数据库:中国学术期刊网络出版总库,中国博士学位论文全文数据库,中国优秀硕士学位论文全文数据库,中国重要会议论文全文数据库,中国重要报纸全文数据库,中国图书全文数据库,中国专利数据库,中国标准数据库,国家科技成果数据库,国外标准数据库,中国年鉴网络出版总库;

Appendix 3. Search strategy 2011

CENTRAL

#1 shengmai*
#2 senmai
#3 sengmai
#4 MeSH descriptor Medicine, Chinese Traditional explode all trees
#5 MeSH descriptor Drugs, Chinese Herbal, this term only
#6 herb*
#7 chinese near/6 medicine*
#8 chinese near/6 drug*
#9 ginseng*
#10 liriope
#11 schisandra
#12 shen next mai
#13 sen next mai
#14 panax
#15 schizandra
#16 ophiopogon*
#17 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9)
#18 (#10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16)
#19 (#17 OR #18)
#20 MeSH descriptor Heart Failure explode all trees
#21 heart next failure
#22 cardiac next failure
#23 MeSH descriptor Ventricular Dysfunction explode all trees
#24 ventricular near/6 dysfunction
#25 cardiac next insufficiency
#26 heart next insufficiency
#27 ventric* next fail*
#28 (#20 OR #21 OR #22 OR #23 OR #24 OR #25 OR #26 OR #27)
#29 (#19 AND #28)

MEDLINE Ovid

1 shengmai$.tw.
2 sengmai.tw.
3 senmai.tw.
4 Drugs, Chinese Herbal/
5 Medicine, Chinese Traditional/
6 Herbal Medicine/
7 chinese medicine$.tw.
8 chinese herb$.tw.
9 Panax/
10 ginseng.tw.
11 Liriope Plant/
12 liriope.tw.
13 Schisandraceae/
14 schisandra$.tw.
15 shen mai.tw.
16 sen mai.tw.
17 panax.tw.
18 ophiopogon$.tw.
19 or/1-18
20 exp Heart Failure/
21 heart failure.tw.
22 cardiac failure.tw.
23 exp Ventricular Dysfunction/
24 ventricular dysfunction.tw.
25 cardiac insufficienc$.tw.
26 heart insufficienc$.tw.
27 ventric$ fail$.tw.
28 or/20-27
29 19 and 28
30 randomized controlled trial.pt.
31 controlled clinical trial.pt.
32 randomized.ab.
33 placebo.ab.
34 drug therapy.fs.
35 randomly.ab.
36 trial.ab.
37 groups.ab.
38 30 or 31 or 32 or 33 or 34 or 35 or 36 or 37
39 exp animals/ not humans.sh.
40 38 not 39
41 29 and 40
42 (200809* or 200810* or 200811* or 200812* or 2009* or 2010* or 2011*).ed.
43 41 and 42

EMBASE Ovid

1 shengmai/
2 shengmai$.tw.
3 sengmai.tw.
4 senmai.tw.
5 Chinese herb/
6 Chinese medicine/
7 Chinese drug/
8 herbal medicine/
9 chinese medicine$.tw.
10 chinese herb$.tw.
11 ginseng/
12 ginseng.tw.
13 "LIRIOPE (PLANT)"/
14 liriope.tw.
15 SCHISANDRACEAE/
16 schisandra$.tw.
17 shen mai.tw.
18 sen mai.tw.
19 panax.tw.
20 "Ophiopogon root"/
21 ophiopogon$.tw.
22 or/1-21
23 exp heart failure/
24 heart failure.tw.
25 cardiac failure.tw.
26 heart ventricle function/
27 ventricular dysfunction.tw.
28 cardiac insufficienc$.tw.
29 heart insufficienc$.tw.
30 ventric$ fail$.tw.
31 or/23-30
32 22 and 31
33 random$.tw.
34 factorial$.tw.
35 crossover$.tw.
36 cross over$.tw.
37 cross-over$.tw.
38 placebo$.tw.
39 (doubl$ adj blind$).tw.
40 (singl$ adj blind$).tw.
41 assign$.tw.
42 allocat$.tw.
43 volunteer$.tw.
44 crossover procedure/
45 double blind procedure/
46 randomized controlled trial/
47 single blind procedure/
48 33 or 34 or 35 or 36 or 37 or 38 or 39 or 40 or 41 or 42 or 43 or 44 or 45 or 46 or 47
49 (animal/ or nonhuman/) not human/
50 48 not 49
51 32 and 50
52 (200809* or 200810* or 200811* or 200812* or 2009* or 2010* or 2011*).dd.
53 51 and 52

BIOSIS Preview on Web of Knowledge

# 21 #20 Timespan=2008-2011
# 20 #19 AND #12
# 19 #18 OR #17 OR #16 OR #15 OR #14 OR #13
# 18 TS=ventric* fail*
# 17 TS=heart insufficienc*
# 16 TS=cardiac insufficienc*
# 15 TS=ventricular dysfunction
# 14 TS=cardiac failure*
# 13 TS=heart failure*
# 12 #11 OR #10 OR #9 OR #8 OR #7 OR #6 OR #5 OR #4 OR #3 OR #2 OR #1
# 11 TS=ophiopogon*
# 10 TS=schizandra
# 9 TS=panax
# 8 TS=schisandra
# 7 TS=liriope
# 6 TS=ginseng*
# 5 TS=sen mai
# 4 TS=shen mai
# 3 TS=senmai
# 2 TS=sengmai
# 1 TS=shengmai*

CBM English

2011-04-06 16:20
序号 命中文献数 检索表达式
1 1172 全部字段:SHENGMAI% or SENGMAI% or SENMAI% or SHENMAI%
2 12647 全部字段:HERB% or GINSENG% or LIRIOPE% or PANAX% or OPHIOPOGON%
3 338 全部字段:SCHISANDRA% or SCHIZANDRA%
4 137144 全部字段:DRUG% or MEDICAL% or MEDICINE% or HERB%
5 49257 全部字段:CHINESE
6 31916 #4 and #5
7 39880 #2 or #3 or #6
8 41027 #1 or #7
9 60101 全部字段:HEART% or CARDIAC% or VENTRIC%
10 27390 全部字段:FAIL% or INSUFFICIENCY% or DYSFUNCTION%
11 10368 #9 and #10
12 416 #8 and #11
13 416 #12
14 86 #12 -限定:2008-2011; 人类

CBM Chinese

1. 缺省字段
表示输入的检索词同时在中文题目、文摘、作者、主题词、特征词、关键词、期刊这些主要字段检索。

2. 全部字段
表示输入的检索词同时在所有可检索的字符型字段中查找。

检索时间:2011-04-04
选择 序号 命中文献数 检索表达式
1 21306 全部字段:心衰
2 35990 全部字段:心功能
3 42477 主题词:心力衰竭/全部树/全部副主题词
4 14083 主题词:心室功能/全部树/全部副主题词
5 537 主题词:心室功能障碍/全部树/全部副主题词
6 78350 #1 or #2 or #3 or #4 or #5
7 7938 全部字段:生脉 or 生麦 or 参麦 or 参脉
8 2749 全部字段:五味子 or 乌梅子 or 山花椒 or 五梅子
9 5065 全部字段:麦冬 or 红木香 or 地血香
10 347832 全部字段:参
11 330 #8 and #9 and #10
12 8148 #7 or #11
13 365342 全部字段:随机 or 随意 or 任意 or 单盲 or 双盲 or 三盲 or 盲法
14 585 #6 and #12 and #13
15 124301 全部字段:随机 or 随意 or 任意 or 单盲 or 双盲 or 三盲 or 盲法 -限定:2008-2011; 人类
16 165 #6 and #12 and #15

VIP English

〖检索时间〗2011-04-7 23:33:08
〖检索范围〗全部期刊
〖起止年代〗2008-2011
〖检索条件〗((((任意字段=CHINESE)*(任意字段=MEDICINE+MEDICAL+DRUG))*(任意字段=SHENGMEI+SENGMAI+SHENMAI+SENMAI+HERB+GINSENG+LIRIOPE+SCHISANDRA+SCHIZANDRA+PANAX+OPHIOPOGON))*(任意字段=HEART+CARDIAC+VENTRICLE+VENTRICULAR)*全部期刊*年=1989-2011)-((题名或关键词=ANIMAL+DOG+MOUSE+MICE+RABBT)*Year=2008-2011)
〖检索结果〗检中9篇

VIP Chinese

检索时间2011-04-03
〖检索范围〗全部期刊
〖起止年代〗2008-2011
〖检索条件〗(((((任意字段=五味子+乌梅子+山花椒+五梅子)*(任意字段=麦冬+红木香+地血香))*(任意字段=参))+(任意字段=生脉+生麦+参麦+参脉))*(任意字段=随机+随意+任意+单盲+双盲+三盲+盲法)*全部期刊*年=2008-2011)*((任意字段=心力衰竭+心衰+心功能)*Year=2008-2011)
〖检索结果〗检中172篇

CNKI English

检索条件:(发表时间 between (2008-9-25,2011-03-31)) 并且 (((((全文=shengmai+sengmai+senmai+shenmai+herb+ginseng+liriope+schisandra+schizandra+panax+ophiopogon) 或者 全文=chinese /NEAR 6 medicine+chinese /NEAR 6 medical+chinese /NEAR 6 drug) 并且 全文=heart failure+heart insufficiency+cardiac failure+cardiac insufficiency+ventricular dysfunction+ventricle dysfunction) 并且 全文=controlled study+randomized+controlled clinical) 不包含 主题=animal+dog+rat+mouse+mice+rabbit+cat) (模糊匹配)
检索方式:跨库检索; 检索到:336条记录 所属学科:医药卫生科技; 数据库:中国学术期刊网络出版总库,中国博士学位论文全文数据库,中国优秀硕士学位论文全文数据库,中国优秀硕士学位论文全文数据库_增刊,中国重要会议论文全文数据库,中国重要报纸全文数据库,中国年鉴网络出版总库,中国图书全文数据库,中国专利数据库,国家标准全文数据库,中国行业标准全文数据库,国外标准数据库,国家科技成果数据库,德国SPRINGER公司期刊数据库,TAYLOR期刊数据库,Earthscan期刊数据库;

CNKI Chinese

最终检索时2008.9.18-2011.4.3
((((全文=五味子+乌梅子+山花椒+五梅子) AND (全文=麦冬+红木香+地血香) AND (全文=参)) OR (全文=生脉+生麦+参麦+参脉)) AND (主题%心功能+心衰 OR 关键词%心功能+心衰 OR 摘要%心功能+心衰)AND 全文=随机+随意+任意+单盲+双盲+盲法+三盲) NOT (关键词=动物+猫+鼠+犬+狗+兔+猴+蛙 OR 主题=动物+猫+鼠+犬+狗+兔+猴+蛙) AND 年=2008˜2011
http://epub.cnki.net/grid2008/brief/result.aspx

1.检索条件:((((全文=五味子+乌梅子+山花椒+五梅子) AND (全文 =麦冬+红木香+地血香) AND (全文=参)) OR (全文=生脉+生麦+参麦+ 参脉)) AND (主题=心功能+心衰 OR 关键词=心功能+心衰 OR 摘要= 心功能+心衰)AND 全文=随机+随意+任意+单盲+双盲+盲法+三盲) NOT (关键词=动物+猫+鼠+犬+狗+兔+猴+蛙 OR 主题=动物+猫+鼠+犬+狗+ 兔+猴+蛙) AND 年=2008˜2011 (精确匹配)
检索方式:跨库检索; 检索到:1891条记录 (选中:491条)
数据库:中国学术期刊网络出版总库,中国博士学位论文全文数据库,中国优秀硕士学位论文全文数据库,中国优秀硕士学位论文全文数据库_增刊,中国重要会议论文全文数据库,中国重要报纸全文数据库,中国年鉴网络出版总库,中国图书全文数据库,中国专利数据库,国家标准全文数据库,中国行业标准全文数据库,国外标准数据库,国家科技成果数据库;


2.检索条件:((((全文=五味子+乌梅子+山花椒+五梅子) AND (全文=麦冬+红木香+地血香) AND (全文=参)) OR (全文=生脉+生麦+参麦+参脉)) AND (主题=心功能+心衰 OR 关键词=心功能+心衰 OR 摘要=心功能+心衰)AND 全文=随机+随意+任意+单盲+双盲+盲法+三盲) NOT (关键词=动物+猫+鼠+犬+狗+兔+猴+蛙 OR 主题=动物+猫+鼠+犬+狗+兔+猴+蛙) AND 年=2008˜2011 (模糊匹配)
检索方式:跨库检索; 检索到:2561条记录 (选中:687条)
数据库:中国学术期刊网络出版总库,中国博士学位论文全文数据库,中国优秀硕士学位论文全文数据库,中国优秀硕士学位论文全文数据库_增刊,中国重要会议论文全文数据库,中国重要报纸全文数据库,中国专利数据库,国家标准全文数据库,中国行业标准全文数据库,国外标准数据库,国家科技成果数据库;


3.检索条件:((((全文=五味子+乌梅子+山花椒+五梅子) AND (全文=麦冬+红木香+地血香) AND (全文=参)) OR (全文=生脉+生麦+参麦+参脉)) AND (主题=心功能+心衰 OR 关键词=心功能+心衰)AND 全文=随机+随意+任意+单盲+双盲+盲法+三盲) NOT (关键词=动物+猫+鼠+犬+狗+兔+猴+蛙 OR 主题=动物+猫+鼠+犬+狗+兔+猴+蛙) AND 年=2008˜2011 (模糊匹配)
检索方式:跨库检索; 检索到:2544条记录 (选中:686条)
数据库:中国学术期刊网络出版总库,中国博士学位论文全文数据库,中国优秀硕士学位论文全文数据库,中国优秀硕士学位论文全文数据库_增刊,中国重要会议论文全文数据库,中国重要报纸全文数据库,中国专利数据库,国家标准全文数据库,中国行业标准全文数据库,国外标准数据库,国家科技成果数据库;

Appendix 4. Search strategy 2013

CENTRAL and DARE

#1 shengmai*
#2 senmai
#3 sengmai
#4 MeSH descriptor Medicine, Chinese Traditional explode all trees
#5 MeSH descriptor Drugs, Chinese Herbal, this term only
#6 herb*
#7 chinese near/6 medicine*
#8 chinese near/6 drug*
#9 ginseng*
#10 liriope
#11 schisandra
#12 shen next mai
#13 sen next mai
#14 panax
#15 schizandra
#16 ophiopogon*
#17 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9)
#18 (#10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16)
#19 (#17 OR #18)
#20 MeSH descriptor Heart Failure explode all trees
#21 heart next failure
#22 cardiac next failure
#23 MeSH descriptor Ventricular Dysfunction explode all trees
#24 ventricular near/6 dysfunction
#25 cardiac next insufficiency
#26 heart next insufficiency
#27 ventric* next fail*
#28 (#20 OR #21 OR #22 OR #23 OR #24 OR #25 OR #26 OR #27)
#29 (#19 AND #28)

MEDLINE OVID

1 shengmai$.tw.
2 sengmai.tw.
3 senmai.tw.
4 Drugs, Chinese Herbal/
5 Medicine, Chinese Traditional/
6 Herbal Medicine/
7 chinese medicine$.tw.
8 chinese herb$.tw.
9 Panax/
10 ginseng.tw.
11 Liriope Plant/
12 liriope.tw.
13 Schisandraceae/
14 schisandra$.tw.
15 shen mai.tw.
16 sen mai.tw.
17 panax.tw.
18 ophiopogon$.tw.
19 or/1-18
20 exp Heart Failure/
21 heart failure.tw.
22 cardiac failure.tw.
23 exp Ventricular Dysfunction/
24 ventricular dysfunction.tw.
25 cardiac insufficienc$.tw.
26 heart insufficienc$.tw.
27 ventric$ fail$.tw.
28 or/20-27
29 19 and 28
30 randomized controlled trial.pt.
31 controlled clinical trial.pt.
32 randomized.ab.
33 placebo.ab.
34 drug therapy.fs.
35 randomly.ab.
36 trial.ab.
37 groups.ab.
38 30 or 31 or 32 or 33 or 34 or 35 or 36 or 37
39 exp animals/ not humans.sh.
40 38 not 39
41 29 and 40
42 (2011* or 2012* or 2013*).ed.
43 41 and 42

EMBASE OVID

1 shengmai/
2 shengmai$.tw.
3 sengmai.tw.
4 senmai.tw.
5 Chinese herb/
6 Chinese medicine/
7 Chinese drug/
8 herbal medicine/
9 chinese medicine$.tw.
10 chinese herb$.tw.
11 ginseng/
12 ginseng.tw.
13 "LIRIOPE (PLANT)"/
14 liriope.tw.
15 SCHISANDRACEAE/
16 schisandra$.tw.
17 shen mai.tw.
18 sen mai.tw.
19 panax.tw.
20 "Ophiopogon root"/
21 ophiopogon$.tw.
22 or/1-21
23 exp heart failure/
24 heart failure.tw.
25 cardiac failure.tw.
26 heart ventricle function/
27 ventricular dysfunction.tw.
28 cardiac insufficienc$.tw.
29 heart insufficienc$.tw.
30 ventric$ fail$.tw.
31 or/23-30
32 22 and 31
33 random$.tw.
34 factorial$.tw.
35 crossover$.tw.
36 cross over$.tw.
37 cross-over$.tw.
38 placebo$.tw.
39 (doubl$ adj blind$).tw.
40 (singl$ adj blind$).tw.
41 assign$.tw.
42 allocat$.tw.
43 volunteer$.tw.
44 crossover procedure/
45 double blind procedure/
46 randomized controlled trial/
47 single blind procedure/
48 33 or 34 or 35 or 36 or 37 or 38 or 39 or 40 or 41 or 42 or 43 or 44 or 45 or 46 or 47
49 (animal/ or nonhuman/) not human/
50 48 not 49
51 32 and 50
52 (2011* or 2012* or 2013*).dd.
53 51 and 52

BIOSIS

# 21 #20 Timespan=2011-2013
# 20 #19 AND #12
# 19 #18 OR #17 OR #16 OR #15 OR #14 OR #13
# 18 TS=ventric* fail*
# 17 TS=heart insufficienc*
# 16 TS=cardiac insufficienc*
# 15 TS=ventricular dysfunction
# 14 TS=cardiac failure*
# 13 TS=heart failure*
# 12 #11 OR #10 OR #9 OR #8 OR #7 OR #6 OR #5 OR #4 OR #3 OR #2 OR #1
# 11 TS=ophiopogon*
# 10 TS=schizandra
# 9 TS=panax
# 8 TS=schisandra
# 7 TS=liriope
# 6 TS=ginseng*
# 5 TS=sen mai
# 4 TS=shen mai
# 3 TS=senmai
# 2 TS=sengmai
# 1 TS=shengmai*

CBM English

2013-6-13 19:44
序号 命中文献数 检索表达式
1 1552 全部字段:SHENGMAI% or SENGMAI% or SENMAI% or SHENMAI%
2 16160 全部字段:HERB% or GINSENG% or LIRIOPE% or PANAX% or OPHIOPOGON%
3 529 全部字段:SCHISANDRA% or SCHIZANDRA%
4 184979 全部字段:DRUG% or MEDICAL% or MEDICINE% or HERB%
5 65003 全部字段:CHINESE
6 42782 #5 and #4
7 53206 #6 or #3 or #2
8 54727 #7 or #1
9 76520 全部字段:HEART% or CARDIAC% or VENTRIC%
10 37086 全部字段:FAIL% or INSUFFICIENCY% or DYSFUNCTION%
11 14149 #10 and #9
12 582 #11 and #8
13 103 #11 and #8 -限定:2011-2013; 人类

CBM Chinese

2013-6-13 20:08
序号 命中文献数 检索表达式
1 17901 主题词:心室功能/全部树/全部副主题词
2 688 主题词:心室功能障碍/全部树/全部副主题词
3 55038 主题词:心力衰竭/全部树/全部副主题词
4 251783 全部字段:心%功能
5 26730 全部字段:心%衰
6 287516 #5 or #4 or #3 or #2 or #1
7 9549 全部字段:生脉 or 生麦 or 参麦 or 参脉
8 3562 全部字段:五味子 or 乌梅子 or 山花椒 or 五梅子
9 6428 全部字段:麦冬 or 红木香 or 地血香
10 480033 全部字段:参
11 432 #10 and #9 and #8
12 9825 #11 or #7
13 573484 全部字段:随机 or 随意 or 任意 or 单盲 or 双盲 or 三盲 or 盲法
14 948 #13 and #12 and #6
15 206 #13 and #12 and #6 -限定:2011-2013; 人类

VIP English

〖检索时间〗2013-06-14 12:07
〖检索范围〗全部期刊
〖起止年代〗2011-2013
〖检索条件〗(任意字段=CHINESE*任意字段=(MEDICINE+MEDICAL+DRUG)*((Years=2011+Years=2012+Years=2013))) 或者 (任意字段=(SHENGMAI+SENGMAI+SHENMAI+SENMAI+HERB+GINSENG+LIRIOPE+SCHISANDRA+SCHIZANDRA+PANAX+OPHIOPOGON)*((Years=2011+Years=2012+Years=2013))) 与 (任意字段=(HEART+CARDIAC+VENTRICLE+VENTRICULAR)*((Years=2011+Years=2012+Years=2013))
〖检索结果〗检中95篇

VIP Chinese

〖检索时间〗2012-6-13 20:34
〖检索范围〗全部期刊
〖起止年代〗2011-2013
〖检索条件〗(任意字段=(心力衰竭+心衰+心功能)*((Years=2011+Years=2012+Years=2013))) 与 (任意字段=(随机+随意+任意+单盲+双盲+三盲+盲法)) 与 ((任意字段=(生脉+生麦+参麦+参脉)*((Years=2011+Years=2012+Years=2013))) 或者 (任意字段=(五味子+乌梅子+山花椒+五梅子)*任意字段=(麦冬+红木香+地血香)*任意字段=参*((Years=2011+Years=2012+Years=2013))))
〖检索结果〗检中212篇

CNKI English

检索时间:2012-6-13 17:51
检索条件:检索条件: 全文=shengmai+sengmai+senmai+shenmai+herb+ginseng+liriope+schisandra+schizandra+panax+ophiopogon+chinese /NEAR 6 medicine+chinese /NEAR 6 medical+chinese /NEAR 6 drug AND 全文=heart failure+heart insufficiency+cardiac failure+cardiac insufficiency+ventricular dysfunction+ventricle dysfunction AND 全文=controlled study+randomized+controlled clinical NOT 主题=animal+dog+rat+mouse+mice+rabbit+cat 并且 发表时间 between (2011-04-01,2013-06-13) (精确匹配)
检索方式:跨库检索; 检索到:247条记录 所属学科:医药卫生科技; 数据库:中国学术期刊网络出版总库,中国博士学位论文全文数据库,中国优秀硕士学位论文全文数据库,中国优秀硕士学位论文全文数据库_增刊,中国重要会议论文全文数据库,中国重要报纸全文数据库,中国年鉴网络出版总库,中国图书全文数据库,中国专利数据库,国家标准全文数据库,中国行业标准全文数据库,国外标准数据库,国家科技成果数据库,德国SPRINGER公司期刊数据库,TAYLOR期刊数据库,Earthscan期刊数据库;

CNKI Chinese

检索时间 2013-6-13 18:48
检索条件: 全文=五味子+乌梅子+山花椒+五梅子 AND 全文=麦冬+红木香+地血香 AND 全文=参 OR 全文=生脉+生麦+参麦+参脉 AND 全文=随机+随意+任意+单盲+双盲+盲法+三盲 AND ( 主题=心功能+心衰 OR 主题=动物+猫+鼠+犬+狗+兔+猴+蛙 ) OR ( 关键词=心功能+心衰 NOT 关键词=动物+猫+鼠+犬+狗+兔+猴+蛙 ) OR 摘要=心功能+心衰 并且 发表时间 between (2011-04-01,2013-06-13) (模糊匹配)
检索方式:跨库检索; 检索到:647条记录 所属学科:医药卫生科技; 数据库:中国学术期刊网络出版总库,中国博士学位论文全文数据库,中国优秀硕士学位论文全文数据库,中国优秀硕士学位论文全文数据库_增刊,中国重要会议论文全文数据库,中国重要报纸全文数据库,中国年鉴网络出版总库,中国图书全文数据库,中国专利数据库,国家标准全文数据库,中国行业标准全文数据库,国外标准数据库,国家科技成果数据库,德国SPRINGER公司期刊数据库,TAYLOR期刊数据库,Earthscan期刊数据库;

What's new

DateEventDescription
20 July 2013New search has been performedChanges to author team.
20 July 2013New citation required but conclusions have not changedSearches were re-run (AMED wasn't searched for the update as access and it is no longer available to the person conducting the searches). We identified four new trials for inclusion. In total, we included 14 trials (13 articles) in this update.

History

Protocol first published: Issue 4, 2004
Review first published: Issue 4, 2007

DateEventDescription
10 January 2011New search has been performed

The inclusion criteria (types of studies and types of outcome measures) have changed, which led to a total of 16 previously included studies being excluded in this update.

Searches were re-run and two additional Chinese databases searched. This identified three new studies. In total, six studies were included in this update.

10 January 2011New citation required but conclusions have not changedNew authors added.
14 July 2008AmendedConverted to new review format.
1 June 2007New citation required and minor changesSubstantive amendment

Contributions of authors

Zhou Qin searched Chinese databases, ascending search results, retrieved articles against inclusion criteria, appraised the quality of included trials, performed data extraction and analysis, drafted the update of review, contacted the trial authors for information, checked and corrected the data.

Qin Wen-Zhe (joint first author) checked and corrected the data, interpreted data, revised the manuscript based on Cochrane Heart Group comments, and developed the final draft of the manuscript.

Liu Shuai-Bin provided clinical suggestions and helped to interpret the review findings.

Zhou Jing searched Chinese databases, ascending search results, retrieved articles against inclusion criteria, appraised the quality of included trials and performed data extraction.

Joey Kwong advised on review methodology, data presentation, style and language.

Chen Jin conceived and designed the review, acted as review guarantor, critical appraised the quality of included trials, performed data extraction and analysed the data.

Declarations of interest

The authors have no known conflicts of interest.

Sources of support

Internal sources

  • Chinese Cochrane Centre, Chinese Centre of Evidence-based Medicine, West China Hospital of Sichuan University, China.

External sources

  • China Medical Board of New York (Grant number: 98-680), USA.

  • Cochrane Complementary Medicine Field, USA.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ding 2012

MethodsRCT
Participants

Ethnicity: Chinese
Participants: 80 patients (40 in Shengmai group, M/F 18/22, age 70.74 ± 6.43 years, duration of heart failure 8.70 ± 6.30 years, old myocardial infarction/hypertensive heart disease/diabetes mellitus/hyperlipidaemia: 12/28/17/13, NYHA class3/4: 30/10;40 in control A group, M/F 15/25, age 72.56 ± 5.64 years, duration of heart failure 8.92 ± 4.68 years, old myocardial infarction/hypertensive heart disease/diabetes mellitus/hyperlipidaemia: 13/27/16/13, NYHA class3/4: 31/9);
Diagnostic criteria: heart failure diagnosis based on Framingham criteria and Guidelines for adult chronic systolic heart function class based on NYHA class, TCM symptom: Guideline for clinical research on the treatment of new Chinese traditional medicine in congestive heart failure.
Inclusion criteria: (1) meet the congestive heart failure (CHF) diagnostic criteria, heart function class in Ⅲ or Ⅳ; (2) coronary heart disease is the primary disease; (3) diagnosed as heart kidney Yang deficiency syndrome in traditional Chinese medicine; (4) concomitant diseases (such as hypertension, hyperglycaemia, hyperlipidaemia, etc.) are under good control and in stable condition; (5) age from 60 to 80 years.

Exclusion criteria: (1) Acute cardiac insufficiency; (2) congestive heart failure was not caused by coronary heart disease; (3) associated with cardiac shock, or fatal arrhythmia, atrioventricular block in Ⅱ degree or above, acute myocardial infarction, uncontrolled hypertension (> 160/90 mmHg (21.3/12 kPa, 1 kPa = 7.5 mmHg)), CHF combined uncontrolled infection; (4) combined with blood system diseases; (5) serious liver or kidney dysfunction; (6) current or past tumour or other deadly diseases that may affect short-term survival; (7) pregnant women, breast-feeding women and psychiatric patients.

Baseline characteristics: comparable (statistical analysis)

InterventionsShengmai group: Shengmai injection (agent: Shanxi, 40 mL + 5% glucose solution 250 mL intravenously daily) + co-intervention
Control group: co-intervention only
Co-intervention: diuretic, cardiotonic, ACEI or adrenergic receptor binder, beta-adrenoceptor blockade, nitrate esters
Treatment duration: seven days
Outcomes

LVEF (%): before treatment: 44.83 ± 4.08 in Shengmai group, 45.89 ± 4.51 in control group; after treatment: 52.37 ± 3.53 in Shengmai group, 50.68 ± 3.87 in control group.

SV(ml/bite): before treatment: 44.46 ± 5.02 in Shengmai group, 46.12 ± 6.38 in control group; after treatment: 56.42 ± 8.51 in Shengmai group, 54.14 ± 8.14 in control group.

CO (L/min): before treatment: 3.61 ± 0.56 in Shengmai group, 3.56 ± 0.47 in control group; after treatment: 4.88 ± 0.82 in Shengmai group, 4.39 ± 0.55 in control group.

Adverse reactions: none
The outcomes were measured at the end of treatment

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

"patients were randomly allocated".
Sequence generation: a computer random number generator.

However, baseline data were not available.

Allocation concealment (selection bias)High riskThe method of concealment is not described.
Blinding (performance bias and detection bias)
All outcomes
High riskThe trial did not answer this question.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information.
Selective reporting (reporting bias)Unclear riskInsufficient information.
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists.

Fang 1987

MethodsRandomized, double-blind, placebo-controlled, cross-over trial
Participants

Ethnicity: Chinese

Participants: 40 patients, M/F 35/5 (20 in Shengmai group, 20 in control group), age: 39 to 80 years, mean age 57.52 ± 10.78 years, stable Angina/old myocardial infarction 9/31. NYHA class 2/3: 37/3

Setting: inpatients

Diagnostic criteria: NYHA class; CHD based on WHO criteria 1979( Rapaport 1979)
Exclusion criteria: not stated
Baseline characteristics: comparable (statistical analysis)

InterventionsShengmai group: Shengmai oral liquid (10 mL twice a day)
Control group: placebo
Treatment duration: 50 days in total = Phase I (20 days) + wash-out period (10 days) + Phase II (20 days)
Outcomes

Heart function improvement (ECG)

In Shengmai group:

HR: before treatment 75.95 ± 10.12, after treatment 75.18 ± 9.22

Contractive pressure (SBP): before treatment 128.9 ± 13.8, after treatment 128.3 ± 12.1

Diastolic blood pressure (DBP): before treatment 79.25 ± 8.01, after treatment 78.75 ± 6.30

Q-Z: before treatment 173.3 ± 15.1, after treatment 161.5 ± 11.6

HI: before treatment 10.55 ± 3.44, after treatment 12.59 ± 3.67

Q-B/B-X: before treatment 0.4482 ± 0.08, after treatment 0.4064 ± 0.06

Adz/dtMax: before treatment 0.6203 ± 0.1933, after treatment 0.4872 ± 0.1758

SV: before treatment 48.33 ± 13.29, after treatment 54.73 ± 12.56

SVI: before treatment 30.58 ± 9.43, after treatment 34.78 ± 8.98

CI: before treatment 2.2638 ± 0.6140, after treatment 2.6140 ± 0.6488

In placebo group:

HR: before treatment 75.83 ± 9.06, after treatment 76.40 ± 9.71

contractive pressure(SBP): before treatment 129.65 ± 12.34, after treatment 129.55 ± 12.55

Diastolic blood pressure (DBP): before treatment 79.30 ± 6.83, after treatment 79.40 ± 6.69

Q-Z: before treatment 169.88 ± 12.75, after treatment 168.40 ± 10.73

HI: before treatment 10.35 ± 3.30, after treatment 10.51 ± 3.26

Q-B/B-X: before treatment 0.4366 ± 0.07, after treatment 0.4262 ± 0.06

Adz/dtMax: before treatment 0.6051 ± 0.2103, after treatment 0.5783 ± 0.2038

SV: before treatment 49.08 ± 12.38, after treatment 49.68 ± 13.19

SVI: before treatment 31.20 ± 9.28, after treatment 31.45 ± 9.25

CI: before treatment 2.3343 ± 0.6400, after treatment 2.3647 ± 0.6203

Adverse reaction: not stated

The outcomes were measured at the end of treatment

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

"patients were randomly allocated by drawing of lots" (pers. communication with trial author).

However, baseline data were not available.

Allocation concealment (selection bias)High riskThe method of concealment is not described.
Blinding (performance bias and detection bias)
All outcomes
Low riskDouble blinding.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information.
Selective reporting (reporting bias)Unclear riskInsufficient information.
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists.

He 2004

MethodsRCT
Participants

Ethnicity: Chinese
Participants: 60 patients (32 in Shengmai group, M/F 18/14, mean age 43 years; 28 in control group, M/F 15/13, mean age 42 years), NYHA class: class 2/class 3/class 4:8/34/18; CHD/hypertensive heart disease/DCM/RHD:21/15/12/12
Setting: inpatients
Diagnostic criteria of heart failure: NYHA class
Exclusion criteria: not stated

Baseline characteristics: not stated

InterventionsShengmai group: Shengmai injection (agent: Huaxi, 20 to 40 mL + 5% glucose solution 250 mL intravenously daily) plus co-intervention
Control group: co-intervention
Co-intervention: cardiotonic, diuretic, vasodilator
Treatment duration: 14 days
Outcomes

Heart function improvement < class 1: 3 in Shengmai group, 7 in control group
Exercise test after treatment: 12 min ± 3min in Shengmai group, 6 ± 3min in control group
Heart rate multiply systolic blood pressure: no difference
The activity of Flow Medicated Dilation of brachial artery:

before treatment: 3.5 ± 3.1 in Shengmai group, 3.6 ± 3.1 in control group
after treatment: 9.6 ± 3.2 in Shengmai group, 4.2 ± 2.8 in control group

Adverse reaction: none

The outcomes were measured at the end of treatment

NotesActivity of flow medicated dilation of brachial artery was assessed blindly.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

"patients were randomly allocated"

Sequence generatIon: drawing of lots (telephone author)

However, the baseline data were not available.

Allocation concealment (selection bias)High riskThe method of concealment is not described.
Blinding (performance bias and detection bias)
All outcomes
Low riskActivity of flow medicated dilation of brachial artery assessed blindly.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information.
Selective reporting (reporting bias)Unclear riskInsufficient information.
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists.

Jiang 1988

MethodsRandomized, double-blind, placebo-controlled, cross-over trial
Participants

Ethnicity: Chinese

Participants: 26 patients, M/F: 23/3 (13 in Shengmai group, 13 in control group), age 23 to 60 years, mean age: 43.8 ± 12.3 years, DCM: 26, NYHA class 2/3: 23/3

Setting: outpatients

Diagnostic criteria: NYHA class; DCM based on WHO criteria 1984(WHO 1984)

Exclusion criteria: not stated

Baseline characteristics: comparable (statistical analysis)

InterventionsShengmai group: Shengmai oral liquid (10 mL twice a day)
Control group: placebo
Treatment duration: 50 days in total = Phase I (20 days) + wash out period (10 days) + Phase II (20 days)
Outcomes

Heart function improvement (M-UCG)

In Shengmai group:

HR (bpm): before treatment 70.7 ± 10.2, after treatment 70.8 ± 10.5

Contractive pressure (SBP) (mmHg): before treatment 120.2 ± 13.1, after treatment 119.5 ± 15.4

DBP (mmHg): before treatment 75.3 ± 5.6, after treatment 76.3 ± 5.1

Left ventricular end-diastolic dimension (Dd) (mm): before treatment 61.5 ± 5.7, after treatment 56.6 ± 6.2

Left ventricular end systolic diameter (Ds) (mm): before treatment 52.9 ± 6.1, after treatment 44.8 ± 6.8

CO (L/min): before treatment 3.97 ± 0.17, after treatment 4.48 ± 0.98

EF (%): before treatment 29.71 ± 5.49, after treatment 29.35 ± 5.30

Left ventricular fractional shortening (ΔD): before treatment 13.96 ± 2.77, after treatment 14.05 ± 2.82

mVcf (cir/s): before treatment 0.440 ± 0.10, after treatment 0. ± 0.142

Exercise test: before treatment 7.22 ± 3.80, after treatment 10.67 ± 4.24

In placebo group:

HR (bpm): before treatment 70.5 ± 10.7,after treatment 69.9 ± 10.8

Contractive pressure (SBP) (mmHg): before treatment 119.4 ± 13.6, after treatment 119.3 ± 13.3

DBP (mmHg): before treatment 75.2 ± 6.1, after treatment 75.1 ± 5.4

Left ventricular end-diastolic dimension (Dd) (mm): before treatment 60.9 ± 6.8, after treatment 61.0 ± 5.9

Left ventricular end-systolic diameter (Ds) (mm): before treatment 52.6 ± 7.1, after treatment 52.5 ± 6.2

CO (L/min): before treatment 3.82 ± 1.2, after treatment 3.80 ± 1.00

EF (%): before treatment 29.15 ± 5.43, after treatment 29.35 ± 5.30

Left ventricular fractional shortening (ΔD): before treatment 13.96 ± 2.77, after treatment 14.05 ± 2.82

mVcf (cir/s): before treatment 0.440 ± 0.10, after treatment 0.439 ± 0.09

Exercise test: before treatment 5.33 ± 3.60, after treatment 5.22 ± 4.01

Adverse reaction: one patient with stomach discomfort, one patient with hypoglycaemia

Outcomes were measured at the end of treatment

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk"patients were randomly allocated by drawing of lots".(contact the author). However, the baseline data were not available.
Allocation concealment (selection bias)High riskThe method of concealment is not described.
Blinding (performance bias and detection bias)
All outcomes
Low riskDouble blinding.
Incomplete outcome data (attrition bias)
All outcomes
High riskTwo missing outcome data in Shengmai group.
Selective reporting (reporting bias)Unclear riskInsufficient information.
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists.

Liu 2007a

MethodsRCT
Participants

Ethnicity: Chinese
Participants: 120 patients: 30 in low-dose group, M/F 15/15, age 40 to 75 years, duration of heart failure 4 to 12 years, CHD/hypertension heart disease/DCM/RDH: 13/11/3/3, NYHA class2/3/4: 7/13/10; 30 in middle-dose group, M/F 17/13, age 39 to 74 years, duration of heart failure 3 to 11 years, CHD/hypertension heart disease/DCM/RDH: 13/10/3/4,NYHA class 2/3/4: 8/13/9 30 in high-dose group, M/F 16/14, age 38 to 75 years, duration of heart failure 5 to 12 years, CHD/hypertension heart disease/DCM/RDH: 12/11/3/4, NYHA class 2/3/4: 8/14/8

30 in control group, M/F 16/14, age 38 to 73 years, duration of heart failure 3 to 10 years, CHD/hypertension heart disease/DCM/RDH: 14/10/2/4, NYHA class 2/3/4: 8/12/10

Setting: inpatients and outpatients

Diagnostic criteria: heart function class based on NYHA class

Exclusion criteria: (1) age > 75, (2) women with pregnancy or in lactation stage; (3) heart failure caused by other organs, such as liver and kidney failure; (4) malignant arrhythmia; (5) diabetes with non controlling serum glucose; (6) acute myocardial infarction; (7) hypertensive patients with non-controlling of blood pressure; (8) patients with treatment discontinued, unable to determine the efficacy

Baseline characteristics: comparable (statistical analysis)

Interventions

Shengmai group: Shengmai injection

(1) in low-dose group (agent: Shanxi, 20 mL + 5% glucose solution 250 mL intravenously daily)

(2) in middle-dose group (agent: Shanxi, 40 mL + 5% glucose solution 250 mL intravenously daily)

(3) in high-dose group (agent: Shanxi, 60 mL + 5% glucose solution 250 mL intravenously daily)

Control group: co-intervention (co-interventions: diuretics, cardiotonics, vasodilators)
Treatment duration: 15 days

Outcomes

Symptoms and sign no improvement or worsening of heart failure: 7 in low-dose group, 2 in middle-dose group, 2 in high-dose group, 14 in control group

Cardiac function and haemorheology changes:

In Shengmai groups:

Low-dose group:

LV (mm): before treatment 59.87 ± 10.09, after treatment 48.63 ± 6.25

CO (L/min): before treatment 2.61 ± 0.60, after treatment 3.92 ± 0.62

LVEF: before treatment 0.36 ± 0.03, after treatment 0.42 ± 0.03

E/A: before treatment 0.88 ± 0.09, after treatment 1.20 ± 0.13

cardiothoracic ration: before treatment 0.50 ± 0.03, after treatment 0.61 ± 0.06

Middle-dose group:

LV (mm): before treatment 60.59 ± 9.26, after treatment 40.13 ± 5.31

CO (L/min): before treatment 2.44 ± 0.79, after treatment 4.86 ± 0.72

LVEF: before treatment 0.36 ± 0.02, after treatment 0.47 ± 0.03

E/A: before treatment 0.87 ± 0.11, after treatment 1.41 ± 0.13

cardiothoracic ratio: before treatment 0.52 ± 0.03, after treatment 0.65 ± 0.06

High-dose group:

LV (mm): before treatment 58.05 ± 8.79, after treatment 39.59 ± 6.25

CO (L/min): before treatment 2.44 ± 0.81, after treatment 4.85 ± 0.77

LVEF: before treatment 0.37 ± 0.03, after treatment 0.46 ± 0.02

E/A: before treatment 0.88 ± 0.13, after treatment 1.44 ± 0.15

cardiothoracic ratio:before treatment 0.52 ± 0.04, after treatment 0.65 ± 0.05

Control group:

LV (mm): before treatment 62.82 ± 7.66, after treatment 55.95 ± 5.96

CO (L/min): before treatment 2.38 ± 0.78, after treatment 3.17 ± 0.62

LVEF: before treatment 0.35 ± 0.02, after treatment 0.38 ± 0.03

E/A: before treatment 0.86 ± 0.11, after treatment 1.00 ± 0.12

cardiothoracic ratio: before treatment 0.51 ± 0.04, after treatment 0.55 ± 0.05

Adverse reaction: 1 patient with little skin hypersensitiveness in control group, 2 patients with mild somnipathy in high-dose group

Outcomes were measured at the end of treatment

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

"patients were randomly allocated by random number table" (telephone author)

However, the baseline data were not available.

Allocation concealment (selection bias)High riskThe method of concealment is not described.
Blinding (performance bias and detection bias)
All outcomes
High riskThe trial did not answer this question.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information.
Selective reporting (reporting bias)Unclear riskInsufficient information.
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists.

Liu 2013

MethodsRCT
Participants

Ethnicity: Chinese;
Participants: 50 patients (25 in Shengmai group, M/F 16/9, age 67 ± 4 years; NYHA class3/4: 17/8; 25 in control group, M/F 17/8, age 67 ± 6, NYHA class 3/4: 16/9);
Diagnostic criteria: Guideline for clinical research on the treatment of new Chinese traditional medicine in congestive heart failure, Reference standard of deficiency syndrome classification in traditional Chinese medicine, heart function class based on NYHA class.

Setting: inpatients

Baseline characteristics: comparable (statistical analysis)

InterventionsShengmai group: Shengmai oral liquid 100 mL (agent: Panax ginseng Ophiopogon 12 g, japonicus 12 g and Schisandra chinensis 6 g po bid) + co-intervention
Control group: co-intervention
Co-interventions: diuretic, digitalis, ACEI, beta-adrenoceptor blockade, nitrate esters
Treatment duration: 14 days.
Outcomes

Heart function improvement < class 1: 4 in Shengmai, 7 in control group

BNP (ng/L):

before treatment: 841.21 ± 413.61 in Shengmai group, 839.67 ± 431.79 in control group; after treatment: 371.18 ± 189.27 in Shengmai group, 567.26 ±162.43 in control group.

With no obvious improvement or even aggravation of TCM (Traditional Chinese Medicine) syndrome: 3 in Shengmai, 11 in control group

Adverse reaction: none
Outcomes were measured at the end of treatment

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk"patients were randomly allocated". Sequence generation: a computer random number generator. However, the baseline data were not available.
Allocation concealment (selection bias)High riskThe method of concealment is not described.
Blinding (performance bias and detection bias)
All outcomes
High riskThe trial did not answer this question.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information.
Selective reporting (reporting bias)Unclear riskInsufficient information.
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists.

Mao 2003a

MethodsRCT
Participants

Ethnicity: Chinese
Participants: 40 patients (10 in Shengmai A1 group, M/F 3/7, age 59.40 ± 6.24 years, duration of heart failure 6.96 ± 6.24 years, CHD/RDH/PHD: 8/1/1, NYHA class2/3: 4/6;10 in Shengmai A2 group, M/F 4/6, age 59.20 ± 6.83 years, duration of heart failure 6.60 ± 6.22 years, CHD/HBP: 9/1, NYHA class2/3: 3/7; 10 in Shengmai A3 group, M/F 6/4, age 58.80 ± 8.09 years, duration of heart failure 6.35 ± 7.32 years, CHD/RDH/PHD: 8/1/1, NYHA class2/3: 3/7;10 in control A group, M/F 4/6, age 60.30 ± 7.07 years, duration of heart failure 6.87 ± 6.22 years, CHD/HBP/PHD: 8/1/1, NYHA class2/3: 3/7)
40 patients (10 in Shengmai B1 group,10 in Shengmai B2 group, 10 in Shengmai B3 group, 10 in control B group)
Setting: inpatients
Diagnostic criteria: heart failure diagnosis based on Framingham and Boston criteria, heart function class based on NYHA class
Inclusion criteria: heart failure; (1) age 41 to 70 years; (2) heart failure class 2-3; not taking digitalis or drugs affecting the metabolization of digoxin within one week; liver and kidney function were normal, normal electrolyte
Exclusion criteria: acute myocardial infarction, acute respiratory insufficiency of PHD, serious mitral stenosis in sinus rhythm, or HCM with obstruction; combined with diabetes, hyperthyroidism

Baseline characteristics: comparable (statistical analysis)

Interventions

Shengmai + co-intervention A versus co-intervention (Part A)

(i) Shengmai A1, A2, A3 groups: Shengmai injection (agent: Yibing, 20, 40, 60 mL intravenously daily ) + co-intervention A
Control group: Co-intervention A
Co-interventions A: digoxin (0.25 mg + 5% glucose solution 40 mL, intravenously daily) + polarized solution 200 mL intravenously daily

Shengmai versus co-intervention B (Part B)
(ii) Shengmai B1, B2, B3 groups: Shengmai injection (agent: Yibing 20, 40, 60 mL intravenously daily) + co-intervention B (placebo)
Control group: co-intervention B (placebo)
Co-interventions B: polarized solution 200 mL intravenously daily

Treatment duration: 14 days

Outcomes

Shengmai + co-intervention A versus co-intervention (Part A)

Heart function improvement < class 1: 1/30 in Shengmai group, 2/20 in control group

Serum TNFα:
before treatment: 1.44 ± 0.8 in Shengmai A1 group, 1.53 ± 0.73 in Shengmai A2 group, 1.52 ± 0.66 in Shengmai A3 group, 1.54 ± 0.68 in control A group
after treatment: 0.71 ± 0.52 in Shengmai A1 group, 0.63 ± 0.29 in Shengmai A2 group, 0.59 ± 0.36 in Shengmai A3 group, 1.2 ± 0.65 in control A group

Serum EDLF:
before treatment: 0.17 ± 0.12 in Shengmai B1 group, 0.15 ± 0.08 in Shengmai B2 group, 0.16 ± 0.09 in Shengmai B3 group, 0.18 ± 0.06 in control B group
after treatment: 0.29 ± 0.14 in Shengmai B1 group, 0.32 ± 0.11 in Shengmai B2 group, 0.37 ± 0.1 in Shengmai B3 group, 0.14 ± 0.06 in control B group

Shengmai + co-intervention A versus co-intervention (Part B)

Heart function improvement <class 1: 1/30 in Shengmai group, 2/20 in control group

Serum TNFα:
before treatment: 1.44 ± 0.8 in Shengmai A1 group, 1.53 ± 0.73 in Shengmai A2 group, 1.52 ± 0.66 in Shengmai A3 group, 1.54 ± 0.68 in control A group
after treatment: 0.71 ± 0.52 in Shengmai A1 group, 0.63 ± 0.29 in Shengmai A2 group, 0.59 ± 0.36 in Shengmai A3 group, 1.2 ± 0.65 in control A group

Serum EDLF:
before treatment: 0.17 ± 0.12 in Shengmai B1 group, 0.15 ± 0.08 in Shengmai B2 group, 0.16 ± 0.09 in Shengmai B3 group, 0.18 ± 0.06 in control B group
after treatment: 0.29 ± 0.14 in Shengmai B1 group, 0.32 ± 0.11 in Shengmai B2 group, 0.37 ± 0.1 in Shengmai B3 group, 0.14 ± 0.06 in control B group

Adverse reaction: not stated

Outcomes were measured at the end of treatment

NotesFunding source: A project of Tanjin Province
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

"patients were randomly allocated"
Sequence generation: a random number table (telephone author)

However, the baseline data were not available.

Allocation concealment (selection bias)High riskThe method of concealment is not described.
Blinding (performance bias and detection bias)
All outcomes
High riskThe trial did not answer this question.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information.
Selective reporting (reporting bias)Unclear riskInsufficient information.
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists.

Su 2012

MethodsRCT
Participants

Ethnicity: Chinese;
Participants: 66 patients (33 in Shengmai group, M/F 17/16, age 65.04 ± 12.61 years, CHD/RHD/HBP/PHD: 20/3/5/5; NYHA class2/3/4: 8/19/6;33 in control group, M/F 15/18, age 66.15 ± 11.74, CHD/RHD/HBP/PHD: 18/2/6/7; NYHA class2/3/4: 6/20/7);
Diagnostic criteria: heart function class based on NYHA class.

Setting: inpatients

Baseline characteristics: comparable (statistical analysis)

InterventionsShengmai group: Shengmai injection (agent: 100 to 180 mL + 5% GS 150 mL "intravenously daily" ) + co-intervention
Control group: co-intervention
Co-interventions: diuretic, digitalis, ACEI/adrenergic receptor binder
Treatment duration: 10 days
Outcomes

Heart function improvement < class 1: 2 in Shengmai, 4 in control group

BNP (ng/L):

before treatment: 1165.35 ± 382.46 in Shengmai group, 1143.28 ± 411.73 in control group; after treatment: 295.62 ± 99.24 in Shengmai group, 510.71 ±110.68 in control group

Adverse reaction: none
Outcomes were measured at the end of treatment

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

"patients were randomly allocated".
Sequence generation: random number table (telephone the author).

However, the baseline data were not available.

Allocation concealment (selection bias)High riskThe method of concealment is not described.
Blinding (performance bias and detection bias)
All outcomes
High riskThe trial did not answer this question.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskinsufficient information.
Selective reporting (reporting bias)Unclear riskinsufficient information.
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists.

Wan 2012

MethodsRCT
Participants

Ethnicity: Chinese;
Participants: 62 patients (33 in Shengmai group, 29 in control group), M/F 28/34, age 62.4 ± 3.8, HBP/CHD/DM: 26/29/32; NYHA class2/3/4: 22/30/10;
Diagnostic criteria: Reference standards for the treatment of left ventricle diastolic heart failure, heart function class based on NYHA class, TCM symptom: Guideline for clinical research on the treatment of new Chinese traditional medicine in congestive heart failure.

Exclusion criteria: serious left ventricular systolic dysfunction in Echocardiography; acute myocardial infarction; serious disease such as liver and renal insufficiency; allergic constitution or be allergic to this drug and various drugs; drug allergies; pregnant or breast-feeding women

Setting: inpatients

Baseline characteristics: comparable (statistical analysis)

InterventionsShengmai group: Shengmai injection (agent: Suzhong. 40 mL + 5% GS 100 mL intravenously daily ) + co-intervention
Control group: co-intervention
Co-interventions: diuretic, ACEI
Treatment duration: 14 days
Outcomes

Heart function improvement < class 1: 2 in Shengmai, 2 in control group

Emas(cm/s):

before treatment: 42.12 ± 10.06 in Shengmai group, 45.29 ± 11.41 in control group;
after treatment: 73.78 ± 12.15 in Shengmai group, 57.88 ± 11.02 in control group.

Amas(cm/s):

before treatment: 72.81 ± 17.54 in Shengmai group, 74.32 ± 18.90 in control group;
after treatment: 50.34 ± 10.77 in Shengmai group, 71.76 ±19.81 in control group.

E/A:

before treatment: 0.69 ± 0.17 in Shengmai group, 0.66 ± 0.41 in control group;
after treatment: 1.37 ± 0.54 in Shengmai group, 0,82 ±0.39 in control group.

DT(ms):

before treatment: 251.20± 32.28 in Shengmai group, 251.90 ± 26.44 in control group;
after treatment: 164.00± 26.59 in Shengmai group, 230.20 ± 31.56 in control group.

IVRT(ms):

before treatment: 112.60 ± 13.82 in Shengmai group, 115.70 ± 13.83 in control group;
after treatment: 83.50 ± 14.38 in Shengmai group, 100.60 ±15.40 in control group.

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

"patients were randomly allocated".

Sequence generation: random number table

However, the baseline data were not available.

Allocation concealment (selection bias)High riskThe method of concealment is not described.
Blinding (performance bias and detection bias)
All outcomes
High riskThe trial did not answer this question.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskinsufficient information.
Selective reporting (reporting bias)Unclear riskinsufficient information.
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists.

Wang 2010a

MethodsRCT, single-blind
Participants

Ethnicity: Chinese
Participants: 74 patients, 38 in Shengmai group, M/F 22/16, age: 60 to 83 years, mean age 71.5 ± 9.4 years, NYHA class 2/3/4: 4/22/12, CHD/hypertensive heart disease/DCM:20/16/2

36 in control group, M/F 21/15, age: 61 to 85 years, mean age 72.3 ± 8.6 years, NYHA class 2/3/4: 3/23/10; CHD/hypertensive heart disease/DCM: 21/13/2

Setting: inpatients

Diagnostic criteria of heart failure: Guideline for diagnosis and treatment of chronic heart failure 2007, NYHA class

Exclusion criteria: acute myocardial infarction, acute inflammation, chronic renal failure, chronic liver disease, chronic bronchitis, and other organic heart disease

Baseline characteristics: comparable (statistical analysis)

InterventionsShengmai group: Shengmai injection (agent: Jiangsu. 60 mL + GS 250ml iv gtt qd) + co-intervention
Control group: co-intervention
Co-interventions: diuretic, digitalis, ACEI/adrenergic receptor binder
Treatment duration: 15 days
Outcomes

Heart function improvement < class 1: 3 in Shengmai, 10 in control group

Hemodynamics

LVEDV (mL):

before treatment: 148.3 ± 35.8 in Shengmai group, 144.8 ± 28.4 in control group
after treatment: 132.6 ± 39.5 in Shengmai group, 136.3 ± 41.6 in control group

LVDSV (mL):

before treatment: 99.2 ± 34.3 in Shengmai group, 99.6 ± 34.3 in control group
after treatment: 65.4 ± 28.4 in Shengmai group, 80.4 ± 14.8 in control group

LVEF (%):

before treatment: 33.2 ± 9.8 in Shengmai group, 32.7 ± 12.4 in control group
after treatment: 54.2 ± 7.6 in Shengmai group, 45.8 ± 10.4 in control group

BNP (ng/L):

before treatment: 908.16 ± 524.13 in Shengmai group, 912.45 ± 559.14 in control group
after treatment: 57.52 ± 85.98 in Shengmai group, 369.93 ± 216.39 in control group

Adverse reaction: none
Outcomes were measured at the end of treatment

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

"patients were randomly allocated"
Sequence generation: random number table (telephone the author)

However, the baseline data were not available.

Allocation concealment (selection bias)High riskThe method of concealment is not described.
Blinding (performance bias and detection bias)
All outcomes
High riskThe trial did not answer this question.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information.
Selective reporting (reporting bias)Unclear riskInsufficient information.
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists.

Zhai 2009

MethodsRCT, double-blind
Participants

Ethnicity: Chinese
Participants: 60 patients, 30 in Shengmai group, M/F 18/12, age: 50 to 72 years, mean age 62 ± 6 years, duration of heart failure 4 to 12 years, NYHA class 3/4: 17/13, CHD/ hypertensive heart disease/ DCM/ RHD/ other disease:19/3/2/4/2

30 in control group, M/F 16/14, age: 51 to 75 years, mean age 63 ± 6 years, duration of heart failure 2 to 14 years, NYHA class 3/4:18/12; CHD/ hypertensive heart disease/ DCM/ RHD:20/3/2/3

Setting: inpatients.

Diagnostic criteria of heart failure: Guideline for treatment of systolic heart failure, NYHA class

Exclusion criteria: age > 70, heart failure caused by acute myocardial infarction, acute pulmonary edema, congenital heart disease, valvular heart disease, hyperthyroid heart, liver/renal failure

Baseline characteristics: comparable (statistical analysis)

InterventionsShengmai group: Shengmai injection (40 mL + 5% GS250ml iv gtt qd ) + co-intervention
Control group: co-intervention
Co-interventions: diuretic, digitalis, vasodilator, ACEI/adrenergic receptor binder
Treatment duration: 15 days
Outcomes

Heart function improvement < class 1: 4 in Shengmai, 9 in control group
Hemodynamics
CO (L/min):

before treatment: 3.7 ± 1.4 in Shengmai group, 3.6 ± 1.7 in control group
after treatment: 5.0 ± 0.8 in Shengmai group, 4.1 ± 0.7 in control group
SV (mL):

before treatment: 38.2 ± 6.1 in Shengmai group, 43.5 ± 4.6 in control group
after treatment: 69.5 ± 2.8 in Shengmai group, 57.8 ± 3.3 in control group
CI (L/min·m²):

before treatment: 1.80 ± 0.50 in Shengmai group, 1.86 ± 0.36 in control group
after treatment: 3.15 ± 0.20 in Shengmai group, 2.30 ± 0.20 in control group
EF:

before treatment: 0.42 ± 0.03 in Shengmai group, 0.63 ± 0.05 in control group
after treatment: 0.43 ± 0.04 in Shengmai group, 0.51 ± 0.02 in control group
Left ventricular fractional shortening (ΔD) (%):

before treatment: 10.6 ± 3.8 in Shengmai group, 11.8 ± 3.6 in control group
after treatment: 16.0 ± 3.3 in Shengmai group, 14.3 ± 3.1 in control group
ΔT (%):

before treatment: 23.1 ± 12.6 in Shengmai group, 21.8 ± 15.3 in control group
after treatment: 40.2 ± 17.1 in Shengmai group, 31.5 ± 13.7 in control group

QOL:

using "Minnesota Living with Heart Failure Questionnaire"

before treatment: 69.0 ± 20.0 in Shengmai group, 68.0 ± 18.0 in control group
after treatment: 42.0 ± 15.0 in Shengmai group, 48.0 ± 17.0 in control group

Adverse reaction: none
Outcomes were measured at the end of treatment

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

"patients were randomly allocated"
Sequence generation: random number table (telephone the author)

However, the baseline data were not available.

Allocation concealment (selection bias)High riskThe method of concealment is not described.
Blinding (performance bias and detection bias)
All outcomes
High riskThe trial did not answer this question.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information.
Selective reporting (reporting bias)Unclear riskInsufficient information.
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists.

Zhang 2002

MethodsRCT
Participants

Ethnicity: Chinese
Participants: 100 patients, 50 in Shengmai group, M/F 30/20, mean age 58 years, duration of heart failure 4.8 years, NYHA class 2/3/4: 10/35/5; 50 in control group, M/F 29/21, mean age 60 years, duration of heart failure 4.9 years, NYHA class 2/3/4: 10/36/4
Setting: inpatients
Diagnostic criteria: heart function class based NYHA class. WHO/ISFC classification of cardiomyopathy(WHO/ISFC 1980)
Exclusion criteria: CHD, RHD, congenital heart disease

Baseline characteristics: comparable (statistical analysis)

InterventionsShengmai group: Shengmai injection (agent: Huaxi, from three herbs/10 mL: Panax ginseng 1 g, Ophiopogon japonicus 3.12 g and Schisandra chinensis 1.56 g. 60 mL + 5% GS250ml iv gtt qd) + co-intervention
Control group: co-intervention
Co-interventions: oxygen therapy, digoxin 0.125mg daily orally (maintenance therapy); hydrochlorothiazide 25 mg twice daily orally, triamterene 50 mg twice daily orally (to interrupt use); isosorbide dinitrate 5 mg three times daily orally
Treatment duration: 14 days
Outcomes

Heart function improvement < class 1: 8 in Shengmai, 20 in control group
Hemodynamics
CO (L/min):

before treatment: 3.8 ± 1.0 in Shengmai group, 3.7 ± 1.5 in control group
after treatment: 5.1 ± 0.6 in Shengmai group, 4.2 ± 0.3 in control group
SV (mL):

before treatment: 48.9 ± 6.0 in Shengmai group, 45.4 ± 5.3 in control group
after treatment: 70.4 ± 3.2 in Shengmai group, 62.3 ± 3.1 in control group
CI(L/min·m²):

before treatment: 1.9 ± 0.2 in Shengmai group, 1.9 ± 0.2 in control group
after treatment: 3.0 ± 0.2 in Shengmai group, 2.3 ± 0.2 in control group
EF:

before treatment: 0.45 ± 0.01 in Shengmai group, 0.41 ± 0.02 in control group
after treatment: 0.64 ± 0.04 in Shengmai group, 0.51 ± 0.02 in control group
SVR (dyn*sec*cm-5):

before treatment: 2602 ± 689 in Shengmai group, 2660 ± 638 in control group
after treatment: 1886 ± 896 in Shengmai group, 2432 ± 386 in control group
D (%):

before treatment: 10.2 ± 4.1 in Shengmai group, 12.2 ± 3.2 in control group
after treatment: 15.9 ± 3.5 in Shengmai group, 14.0 ± 3.0 in control group
T (%):

before treatment: 23.2 ± 10.3 in Shengmai group, 22.1 ± 16.0 in control group
after treatment: 42.3 ± 23.1 in Shengmai group, 30.6 ± 15.0 in control group

Adverse reaction: not stated
Outcomes were measured at the end of treatment

NotesNational '9·5' Program
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk"patients were randomly allocated"
Sequence generation: a computer random number generator (telephone the author). However, the baseline data were not available.
Allocation concealment (selection bias)High riskThe method of concealment is not described.
Blinding (performance bias and detection bias)
All outcomes
High riskThe trial did not answer this question.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information.
Selective reporting (reporting bias)Unclear riskInsufficient information.
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists.

Zhao 2006

  1. a

    Angiotensin converting enzyme inhibitors = ACEIs; M/F = Male/female; CHD = coronary heart disease; RHD = rheumatic heart disease; PHD = pulmonary heart disease; DCM = dilated cardiomyopathy; HCM = hypertrophic cardiomyopathy; HR = heart rate; QOL = quality of life; EF = ejection fraction; CO = cardiac output; SV = stroke volume; CI = cardiac index; LVEDV = left ventricular end-diastolic volume; LVESV = left ventricular end-systolic volume; HI = heather index; PaO2 = oxygen partial pressure; PaCO2 = carbon dioxide partial pressure; kPa = blood pressure measure unit, 1kPa = 7.6 mmHg; po = by mouth; NYHA = New York Heart Association; WHO = World Health Organization.

MethodsStratified random according to age
Participants

Ethnicity: Chinese
Participants: 40 patients, M/F 14/26, age 41 to 70 years, mean age 61.38 ± 8.47 years, duration of heart failure 0.5 to 30 years. 35 CHD, 3 RHD, 2 PHD, heart function class 2/3: 18/22; (10 in low-dose group, 10 in middle-dose group, 10 in high-dose group, 10 in control group)
Setting: inpatients
Diagnostic criteria: heart failure diagnosis based on Framingham criteria, heart function class based on NYHA Class and SAS criteria.

Inclusion criteria: (1) age from 40 to 70 years; (2) hear class 2˜3; (3) no digitalis used in the last week and no high salt diet; (4) blood electrolytes, liver, kidney no obvious abnormalities
Exclusion criteria: (1) age >70 or < 40 years, (2) AMI, hypertrophic obstructive cardiomyopathy, high blood pressure 3 class. (3) combined with diabetes, hyperthyreosis

Baseline characteristics: comparable (statistical analysis), specific data on baseline characters were provided

Interventions

Shengmai group: Shengmai injection

(1) in low-dose group: (agent: Huaxi, 20 mL + 5% glucose solution 100 mL + 0.25 g KCL + R-I 1uintravenously daily)

(2) in middle-dose group:(agent: Huaxi, 40 mL + 5% glucose solution 100 mL + 0.25 g KCL + R-I 1uintravenously daily)

(3) in high-dose group:(agent: Huaxi, 60 mL + 5% glucose solution 100 mL + 0.25 g KCL + R-I 1uintravenously daily)

Control group: 5% glucose solution 100 mL + 0.25 g KCL + R-I 1uintravenously daily

Treatment duration: seven days

Outcomes

Symptoms and sign no improvement or worsening of heart failure: 5 in low-dose group, 2 in middle-dose group, 0 in high-dose group, 8 in control group

Urinary volume change is significant in different groups

Adverse reaction: 2 patients with dry mouth and restlessness in high-dose group

The outcomes were measured at the end of treatment

NotesFunding source: A project of State Administration of Traditional Chinese Medicine
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Stratified random". Sequence generation: random number table (telephone the author).
Allocation concealment (selection bias)High riskInsufficient information to permit judgement.
Blinding (performance bias and detection bias)
All outcomes
High riskThe trial did not answer this question.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information.
Selective reporting (reporting bias)Unclear riskInsufficient information.
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists.

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Bu 2007Not a RCT ("Allocation by the sequence of enrolled in the hospital").
Cen 1999Not a RCT (confirmed by contacting author by telephone).
Chen 2000Not a RCT or quasi-RCT (confirmed by contacting author by telephone)
Chen 2003Not a RCT. Randomisation methods are not mentioned in the paper. We could not contact the study authors.
Chen 2008Not a RCT (confirmed by contacting to the author by telephone. "Allocated by the sequence of medical record number").
Chen 2010The randomisation methods are not mentioned in the paper. We could not contact the authors for details.
Chen 2012The author refused to answer our questions.
Chen 2013There were many contradictions in their data.
Cheng 2001Not a RCT ("allocated by the hospital number").
Cheng 2007Not a RCT (confirmed by contacting the author by telephone).
Dai 2011The randomisation methods are not mentioned in the paper. We could not contact the authors for details.
Deng 1992Not a RCT ("Patients were allocated by the sequence of enrolled in the trial").
Ding 2005Shengmai group used not only Shengmai but other medicine.
Dou 2010We could not contact the authors for details.
Duan 2010The randomisation methods were not mentioned in the paper. We could not contact the authors for details.
Fan 2004We could not contact the author for details.
Feng 2002Not a RCT or quasi-RCT.
Feng 2003Not a RCT. Randomization methods are not mentioned in the paper.
Feng 2012Not a RCT or quasi-RCT ("Patients were allocated casually).
Gao 2001Not a RCT (confirmed by contacting the author by telephone).
Gong 2006Not a RCT (confirmed by contacting the author by telephone).
Gu 2004Not a RCT (confirmed by contacting the author by telephone).
Gu 2008Not a RCT (confirmed by contacting the author by telephone).
He 2001Not a RCT ("allocation by the hospital number").
Hong 2005Not a RCT ("allocation by sequence of visiting the hospital").
Hong 2009The number of patients in tables (treatment group 23, control group 27) was not accordance with that in the text treatment group 24, control group 26). Though we contacted the author, we failed to obtain the outcome data on detail.
Hou 2012Not a RCT ("allocation by sequence of visiting the hospital").
Hu 1997Not a RCT (confirmed by contacting the author by telephone).
Hu 1998Not a RCT (confirmed by contacting the author by telephone).
Hu 2005aNot a RCT (confirmed by contacting the author by telephone).
Hu 2005bNot a RCT ("allocation by sequence of visiting the hospital").
Hui 2007Not a RCT (confirmed by contacting the author by telephone).
Jiang 2005

Shengmai in this study was not used to treat heart failure but to improve symptoms in patients after

coronary artery bypass grafting.

Jiang 2010The randomisation methods were not mentioned in the paper. We could not contact the authors for details.
Kong 2010The randomisation methods were not mentioned in the paper. We could not contact the authors for details.
Li 1998aNot a RCT (confirmed by contacting the author by telephone).
Li 1998bNot a RCT. The randomisation methods were not mentioned in the paper. We could not contact the authors for details).
Li 2003aNot a RCT.
Li 2003bNot a RCT (confirmed by contacting the author by telephone).
Li 2004Not a RCT ("allocation by the sequence of visiting the hospital").
Li 2006aNot a RCT. The randomisation methods were not mentioned in the paper. We could not contact the authors of this article.
Li 2008Not a RCT. The randomisation methods were not mentioned in the paper. We could not contact the authors of this article.
Li 2009aThe randomisation methods were not mentioned in the paper. We could not contact the authors for details.
Li 2009bNot a RCT (confirmed by contacting the author by telephone. "Allocated by the sequence of medical record number").
Li 2009cNot a RCT (confirmed by contacting the author by telephone. "Allocated by the sequence of entering hospital").
Li 2012aNot a RCT (confirmed by contacting the author by telephone. "Allocated by the sequence of entering hospital").
Li 2012bNot a RCT (confirmed by contacting the author by telephone. "Allocated by the sequence of entering hospital").
Liang 2006Not a RCT (confirmed by contacting the author by telephone).
Liao 1996Not a RCT. The randomisation methods were not mentioned in the paper. We could not contact the authors for details.
Liu 1999Shengmai plus Chinese drug plus usual treatment versus usual treatment.
Liu 2007bShengmai versus dobutamine.
Liu 2009There were no outcomes of interest.
Liu 2010There were no outcomes of interest.
Lu 2005Before-and-after study.
Lu 2008Not a RCT (confirmed by contacting the author by telephone. "Allocated by the sequence of entering hospital").
Lu 2009Not a RCT (confirmed by contacting to the author by telephone. "Allocated by the sequence of entering hospital").
Lu 2012Not a RCT (confirmed by contacting to the author by telephone. "Allocated by the sequence of entering hospital").
Ma 2003Not a RCT (confirmed by contacting to the author by telephone).
Ma 2006Not a RCT ("allocation by sequence of visiting the hospital").
Ma 2008Shengmai group used not only Shengmai but other Western medicine.
Mao 1998Not a RCT (confirmed by contacting the author by telephone).
Mao 2003bThere were no outcomes of interest.
Mao 2006aThere were no outcomes of interest.
Mao 2006bThere were no outcomes of interest.
Miao 2005There were no outcomes of interest.
Mo 1996Shengmai versus another drug.
Ni 2004Not a RCT. The randomisation methods were not mentioned in the paper. We could not contact the authors of this article.
Ni 2007Outcome only reported 28 patients in the Shengmai group.
Ni 2012Not a RCT (confirmed by contacting the author by telephone. "Allocated casually".
Peng 2007Combination of Metoprolol and Shengmai capsule.
Peng 2012The randomisation methods were not mentioned in the paper. We could not contact the authors for details.
Qiao 2007Components of Shengmai were more than our intervention specifications.
Qiu 1999Outcome reported from 27 patients, but only 20 patients were included at entry in the control group.
Qiu 2007Shengmai versus captopril.
Shao 2006Not a RCT (confirmed by contacting the author by telephone).
Shen 2006Not a RCT (confirmed by contacting the author by telephone).
Shi 2006Not a RCT (confirmed by contacting to the author by telephone. "Allocated by the sequence of entering hospital").
Shi 2006aThere were no outcomes of interest.
Shi 2006bOutcome reported 21 patients in the control group, but there were only 20 patients included in the study.
Song 2013The randomisation methods were not mentioned in the paper. We could not contact the authors for details.
Su 2008Shengmai versus another Chinese drug.
Sun 1998Not a RCT. The randomisation methods were not mentioned in the paper. We could not contact the authors for details.
Sun 1998bNot a RCT (confirmed by contacting to the author by telephone. "Allocated by the sequence of entering hospital").
Sun 1999Not a RCT or quasi-RCT (confirmed by contacting the author by telephone).
Tang 2001Not a RCT. The randomisation methods were not mentioned in the paper. We could not contact the authors for details).
Tang 2005Not a RCT (confirmed by contacting the author by telephone).
Wan 2004The outcome data did not match the description.
Wan 2007Not a RCT (confirmed by contacting the author by telephone).
Wang 1994Before-and-after study.
Wang 1997Not a RCT. The randomisation methods were not mentioned in the paper. We could not contact the authors of this article for details.
Wang 2002Outcomes reported from 40 patients, but 50 patients were included in study
Wang 2003Outcome reported from 51 patients, but only 50 patients were included at entry in the Shengmai group.
Wang 2004aNo full text article available. We could not obtain any substantial publications to assess these studies for eligibility.
Wang 2004bNot a RCT (we contacted the author: "allocation by the sequence of visiting the hospital").
Wang 2005aNot a RCT (confirmed by contacting the author by telephone).
Wang 2005bNot a RCT (confirmed by contacting the author by telephone).
Wang 2005cNot a RCT. The randomisation methods were not mentioned in the paper. We could not contact the authors of this article for details.
Wang 2006aNot a RCT ("Allocation by sequence of visiting the hospital").
Wang 2006bNot a RCT (confirmed by contacting the author by telephone).
Wang 2008aNot a RCT (confirmed by contacting the author by telephone).
Wang 2008bShengmai injection versus polarized solution.
Wang 2009Not a RCT (confirmed by contacting the author by telephone. "Allocated by the sequence of medical record number").
Wang 2010bNot a RCT (confirmed by contacting to the author by telephone. "Allocated by the sequence of entering hospital").
Wang 2010cThe randomisation methods were not mentioned in the paper. We could not contact the authors the details.
Wu 2009aNot a RCT (confirmed by contacting the author by telephone. "Allocated by the sequence of medical record number").
Wu 2009bThe randomisation methods were not mentioned in the paper. We could not contact the authors for details.
Wu 2011Not a RCT (confirmed by contacting the author by telephone. "Allocated by the sequence of entering hospital").
Xiao 2004Not a RCT or quasi-RCT,
Xin 2012The randomisation methods were not mentioned in the paper. We could not contact the authors for details.
Xu 2009The randomisation methods were not mentioned in the paper. We could not contact the authors for details.
Xu 2011Not a RCT (confirmed by contacting the author by telephone. "Allocated by the sequence of entering hospital").
Yan 2005No outcomes of interest.
Yang 2001Not a RCT or quasi-RCT (confirmed by contacting the author by telephone).
Yang 2005Not a RCT or quasi-RCT (confirmed by contacting the author by telephone).
Yang 2006aNot a RCT or quasi-RCT (confirmed by contacting the author by telephone).
Yang 2006bNot a RCT ("Allocation by clinic record number").
Yang 2010Not a RCT (confirmed by contacting the author by telephone. "Allocated by the sequence of entering hospital").
Ye 2011The randomisation methods were not mentioned in the paper. We could not contact the authors for details.
Yu 2005Not a RCT. The randomisation methods were not mentioned in the paper. We could not contact the authors of this article for details.
Yuan 2011The randomisation methods were not mentioned in the paper. We could not contact the authors for details.
Zhan 2007Shengmai was used to treat chronic pulmonary heart disease without heart failure.
Zhang 1990Before-and-after study.
Zhang 2004aOnly reported the outcomes in Shengmai grou p and did not report the outcomes in co n trol group.
Zhang 2004bNot a RCT or quasi-RCT (confirmed by contacting the author by telephone).
Zhang 2006The treatment drug in this study was Shenmai which is only a partial component of Shengmai.
Zhang 2007aNot a RCT or quasi-RCT (confirmed by contacting the author by telephone).
Zhang 2008We could not contact the author of this article for details.
Zhang 2008aWe could not contact the author of this article for details.
Zhang 2008bNo outcomes of interest reported.
Zhang 2008cNot a RCT ("Allocated by the sequence of entering hospital").
Zhang 2009aNot a RCT ("Allocated by the sequence of entering hospital").
Zhang 2009bSome data in table 2 were wrong. By contacting the author, we could not obtain details of the outcome data.
Zhang 2011The randomisation methods were not mentioned in the paper. We could not contact the authors for details.
Zhao 1998aNot a RCT or quasi-RCT (confirmed by contacting the author by telephone).
Zhao 1998bNot a RCT or quasi-RCT (confirmed by contacting the author by telephone).
Zhao 2000Not a RCT or quasi-RCT (confirmed by contacting the author by telephone).
Zhao 2004No full text article was available. We could not obtain any substantial publications to assess this study for eligibility.
Zhao 2005Disease was low blood pressure.
Zhao 2007Shengmai versus epinephrine.
Zhao 2008Not a RCT ("Allocated by the sequence of entering hospital").
Zhao 2011The author said he forgot how he conducted the allocation and then he refused to answer the phone.
Zheng 1996A descriptive study.
Zheng 2005Not a RCT (confirmed by contacting the author by telephone).
Zhong 2005Not a RCT (confirmed by contacting the author by telephone).
Zhong 2007The intervention included other drugs besides Shengmai.
Zhou 2006aPatients with acute myocardial infraction and without heart failure.
Zhou 2006bNot a RCT (confirmed by contacting the author by telephone).
Zhou 2009The randomisation methods were not mentioned in the paper. We could not contact the authors for details.
Zhu 2004No description of randomisation methods. We could not contact the authors for details.
Zou 2011Not a RCT (confirmed by contacting the author by telephone). "Allocated by the sequence of entering hospital").

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