Chinese herbal medicine for atopic eczema

 

Abstract

Background

Traditional Chinese herbal mixtures have been used to treat atopic eczema for many years. Their efficacy has attracted public attention and recently some clinical trials have been undertaken.

Objectives

To assess the effects of Chinese herbal mixtures in the treatment of atopic eczema.

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) ( January 2004), the Cochrane Skin Group Specialised Register (January 2004), MEDLINE (1966 to January 2004), EMBASE (1980 to January 2004), CINHL (1980 to January 2004) and a number of complementary medicine databases. In addition, the cited references of all trials identified and key review articles were searched. Pharmaceutical companies involved in oral traditional Chinese herbs and experts in the field were contacted.

Selection criteria

Randomised controlled trials of Chinese herbal mixtures used in the treatment of atopic eczema.

Data collection and analysis

Two authors independently applied eligibility criteria, assessed the quality of the trials and extracted data. Any discrepancies were discussed to achieve consensus.

Main results

Four randomised controlled trials, with eight weeks for each phase, met the inclusion criteria. The trials randomised 159 participants aged from 1 to 60 years. The withdrawal rates ranged from 7.5 to 22.5% and no trial used intention to treat analysis. Three trials were randomised placebo controlled, two-phase cross-over designs assessing the same Chinese herbal mixture, Zemaphyte. In two of these three trials the reduction in erythema and surface damage was greater on Zemaphyte than on placebo, and participants slept better and expressed a preference for Zemaphyte. One trial also reported that participants itched less. The fourth trial was an open-label design comparing Zemaphyte in herbal form with Zemaphyte as a freeze dried preparation. There was a reduction in erythema and surface damage with both formulations, but no comparison between the two formulations was reported. Some adverse effects were reported in all four trials, but none were regarded as serious.

Authors' conclusions

Chinese herbal mixtures may be effective in the treatment of atopic eczema. However, only four small poorly reported RCTs of the same product, Zemaphyte, were found and the results were heterogeneous. Further well-designed, larger scale trials are required, but Zemaphyte is no longer being manufactured.

 

Plain language summary

Traditional Chinese herbal medicine for eczema

Atopic eczema or dermatitis is one of the most common skin diseases. Chinese herbal mixtures, taken by mouth, have been used for this condition for many years. Recently, four randomised controlled trials have been undertaken to assess the efficacy and safety of this therapy. The review of these trials found that a Chinese herbal mixture, Zemaphyte, can improve erythema (redness), surface damage to the skin, sleep disturbance and itching. However, the trials are small and of poor quality and the side effects of Zemaphyte remain unclear. Well designed studies are needed but Zemaphyte is no longer being manufactured. Some evidence shows that one type of traditional Chinese herbal medicine may be effective for atopic eczema.

 

摘要

背景

中草藥對於異位性皮膚炎之療效

傳統中草藥多年以來一直被使用於異位性皮膚炎的治療。它們的療效受到注意，最近也有一些臨床試驗在進行。

目標

評估中草藥在異位性皮膚炎的療效

搜尋策略

我們搜尋了Cochrane Central Register of Controlled Trials (CENTRAL) (2004年1月), the Cochrane Skin Group Specialised Register (2004年1月), MEDLINE (1966年至2004年1月), EMBASE (1980年至2004年1月), CINHL (1980年2004年1月) 以及一些輔助醫學的醫學資料庫。除此之外我們搜尋了所有試驗的參考資料及重要的回顧文獻，我們也連絡了製造傳統中草藥的藥商以及這個領域的專家。

選擇標準

關於中草藥治療異位性皮膚炎的隨機對照試驗

資料收集與分析

兩位審查員獨立地考核納入條件，評估其品質和資料。任何意見不一的地方藉由討論達成共識。

主要結論

總共有四個隨機對照試驗符合納入條件，這四個臨床試驗的試驗期間皆為8週。共有159位年紀從1到60歲的受試者接受隨機分配。受試者中斷率為7.5% 至22.5% ，以上試驗都沒有使用intention to treat的方式來分析。其中有3個試驗為隨機安慰劑對照試驗，以兩階段交互設計來評估同一個中草藥製劑 (Zemaphyte) 。在其中兩個試驗裡，對於減少紅疹及表面傷害而言，Zemaphyte比安慰劑效果更顯著，使用Zemaphyte的受試者也睡得更好，並且較偏好Zemaphyte的使用。另一個試驗也報告受試者比較不會癢。第四個試驗為一開放標識設計試驗，比較草藥劑型和冷凍乾燥劑型的Zemaphyte。兩種劑型對於減少紅疹和表皮傷害皆有幫助，但是本試驗並沒有報告這兩者之間的比較。以上全部的試驗皆有報告一些副作用，但並沒有發生嚴重的副作用。

作者結論

中草藥對於異位性皮膚炎可能有療效。然而我們只找得到四個小型，設計不良的，都是關於Zemaphyte的隨機對照試驗，而且結論有些出入。更大型而設計完善的試驗是必要的，但Zemaphyte已經不再製造了。

翻譯人

本摘要由馬偕醫院黃政傑翻譯。

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

總結

有部分証據顯示某種傳統中草藥對於異位性皮膚炎可能有療效。異位性皮膚炎或溼疹是最常見的皮膚病之一。口服的中草藥在這方面的治療已經被使用多年。近來有四個隨機對照試驗評估此種治療的效果和安全性。在本次回顧中發現Zemaphyte對於改善皮膚紅疹，降低表皮傷害，改善睡眠品質，降低癢的程度皆有幫助。然而這四個試驗都很小而且設計不良，Zemaphyte的副作用仍然不明。設計良好的試驗是需要的，然而Zemaphyte已經不再製造了。