Phlebotonics for venous insufficiency

  • Review
  • Intervention

Authors


Abstract

Background

Chronic venous insufficiency (CVI) is a common condition caused by inadequate blood flow through the veins, usually in the lower limbs. It can result in considerable discomfort with symptoms such as pain, itchiness and tiredness in the legs. Sufferers may also experience swelling and ulcers. Phlebotonics are a class of drugs that are often used to treat CVI.

Objectives

To assess the efficacy of oral or topical phlebotonics.

Search methods

The Cochrane Peripheral Vascular Diseases Group searched their Specialised Register (last search April 2005) and the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 2, 2005) and reference lists of articles. We also contacted pharmaceutical companies.

Selection criteria

Randomised, double blind, placebo-controlled trials (RCTs) assessing the efficacy of rutosides, hidrosmine, diosmine, calcium dobesilate, chromocarbe, centella asiatica, disodium flavodate, french maritime pine bark extract, grape seed extract and aminaftone in CVI patients at any stage of the disease.

Data collection and analysis

Two reviewers independently extracted data and assessed trial quality. The effects of treatment were estimated by relative risk (RR) or by standardised mean differences (SMD) by applying a random effects statistical model. Sensitivity analyses were also performed.

Main results

Fifty-nine RCTs of oral phlebotonics were included, but only 44 trials involving 4413 participants contained quantifiable data for the efficacy analysis: 23 of rutosides, ten of hidrosmine and diosmine, six of calcium dobesilate, two of centella asiatica, one of french maritime pine bark extract, one of aminaftone and one of grape seed extract. No studies evaluating topical phlebotonics, chromocarbe, naftazone or disodium flavodate fulfilled the inclusion criteria.

Outcomes included oedema, venous ulcers, trophic disorders, subjective symptoms (pain, cramps, restless legs, itching, heaviness, swelling and paraesthesias), global assessment measures and side effects. The results of many variables were heterogeneous. Phlebotonics showed some global benefit (i.e. oedema reduction) (relative risk 0.72, 95% confidence interval 0.65 to 0.81). The benefit for the remaining CVI signs and symptoms must be evaluated by phlebotonic group. There were no quantifiable data on quality of life.

Authors' conclusions

There is not enough evidence to globally support the efficacy of phlebotonics for chronic venous insufficiency. There is a suggestion of some efficacy of phlebotonics on oedema but this is of uncertain clinical relevance. Due to the limitations of current evidence, there is a need for further randomised, controlled clinical trials with greater attention paid to methodological quality.

摘要

背景

使用 靜脈張力劑(phlebotonics)來治療靜脈血流不足(venous insufficiency)

慢性靜脈血流不足是因為血液無法適當的流通過靜脈所造成的一種常見疾病,這種症狀通常發生在下肢。通常會引發腿部的疼痛、搔癢和疲勞等不舒服之症狀,患者可能也會有腿部的腫脹和潰瘍等症狀。靜脈張力劑(phlebotonics)則是一種經常使用於治療慢性靜脈血流不足的藥物。

目標

評估口服或局部施用靜脈張力劑的功效。

搜尋策略

我們搜尋Cochrane Peripheral Vascular Diseases Group trials register (2005年4月)、Cochrane Central Register of Controlled Trials (Cochrane Library Issue 2, 2005年)、MEDLINE (1月 1966年 4月 2005年)、EMBASE (1980年1月∼2005年4月)以及文章的參考文獻。我們也與藥廠聯繫。

選擇標準

對於具有任何時期慢性靜脈血流不足的患者,比較rutosides、hidrosmine、diosmine、calcium dobesilate、chromocarbe、centella asiatica、disodium flavodate、french maritime pine bark extract、葡萄籽萃取物和aminaftone等靜脈張力劑之功效的隨機性雙盲安慰劑對照試驗。

資料收集與分析

有2名審閱者分別獨立的萃取數據和評估試驗品質。在隨機效應統計模式下,治療功效的評估是以相對風險(RR值)或是標準平均差異(SMD值)來表示。也會進行靈敏度分析。

主要結論

有59個口服靜脈張力劑的隨機性對照試驗被納入,但只有含有4413名受試者的44個試驗有可計量的數據可以進行功效分析。有23個試驗使用rutosides、10個試驗使 hidrosmine和diosmine、6個試驗使用calcium dobesilate、2個試驗使用centella asiatica、1個試驗使用 aminaftone,還有1個試驗使用葡萄籽萃取物。沒有局部使用 phlebotonics、chromocarbe、naftazone或disodium flavodate的研究滿足納入標準。評估成果包括了水腫、靜脈潰瘍、營養失調、主觀症狀(疼痛、痙攣、腿不寧症、發癢、沉重、腫脹和感覺異常)、整體評估檢測、和副作用。這些不同的結果相當具有異質性。使用靜脈張力劑產生一些全面性的好處(例如減少水腫)(RR值為0.72,95% CI值介於0.65至0.81間)。使用靜脈張力劑對慢性靜脈血流不足者尚餘有之症狀也應該要加以評估,對於生活品質改善並沒有可計量的數據。

作者結論

並沒有足夠的證據可以全面性的支持使用靜脈張力劑來治療慢性靜脈血流不足。有一個推論認為靜脈張力劑對於水腫症狀來說具有功效,但是目前還無法確認臨床上的相關性。因為現有證據的限制,必須要更進一步的進行隨基性對照臨床試驗並且更專注於方法學品質的控制。

翻譯人

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

對於腿部靜脈血液循環不佳的人來說,可以使用藥物來促進血液循環。靜脈血流不足這種現象可能是天生的,也有可能是後天引起、受到外傷後引起或是因為血塊而引起。當血液無法順利移流至腿部以上,時很可能會引起腿部腫脹、脹大並且感覺腿部沉重、刺痛、痙攣、疼痛、靜脈曲張和皮膚色素沉澱。如果嚴重的時候,也可能會產生潰瘍和皮膚的破壞。有時會鼓勵患者穿著壓力襪或是使用繃帶來協助血液的流動,並藉由手術來治療靜脈的狀況。由植物提取的天然黃酮萃取物之類的藥物和類似的合成藥物,可能可以有效改善血液流動。本回顧在比較這些藥物和非主動性治療的隨機性對照臨床試驗,這些試驗一般來說會為期1至3個月以上,由13個研究得到的證據(有1245名受試者)指出這些藥物可以降低腫脹(水腫)。有些證據則發現這些藥物對於皮膚營養疾病和腿部不安等症狀有所幫助,但目前仍不明瞭這些發現和整體臨床狀態的關連。在這些研究所提出的資訊中也顯示腸道疾病是最常被提到的副作用。

Plain language summary

Drugs to improve blood flow for people who have poor blood circulation in the veins of their legs.

Insufficient blood flow in the veins of the legs can be something a person is born with the likelihood of developing or may occur after trauma or a blood clot. Poor movement of the blood up the legs may be sufficient to cause swelling and puffiness, and feelings of heaviness, tingling, cramps, pain, varicose veins and skin pigmentation. If severe, ulcers and skin
wasting can develop. People are encouraged to wear compression stockings or bandages to help movement of the blood and the veins can be treated by surgery. Drugs such as natural flavonoids extracted from plants and similar synthetic products may be effective in improving blood flow. This review looked at the evidence from randomised controlled clinical trials comparing these drugs to an inactive treatment, generally over one to three months.

There was evidence from thirteen studies (involving 1245 people), that these drugs reduce puffiness (oedema). Some evidence was found for benefit on skin trophic disorders and restless legs but how relevant these findings are to overall clinical state is not clear. Gastrointestinal disorders were the most frequently reported adverse events in the studies that provided this information.

Ancillary