Chinese medicinal herbs for asymptomatic carriers of hepatitis B virus infection

  • Review
  • Intervention

Authors


Abstract

Background

About 350 million people are chronically infected carriers of hepatitis B virus and are at a higher risk of serious illness and death from cirrhosis of the liver and liver cancer. Chinese medicinal herbs have been used widely for more than 2000 years to treat chronic liver disease.

Objectives

To assess whether Chinese medicinal herbs are effective and safe for treating asymptomatic carriers of hepatitis B virus.

Search methods

The trials registers of The Cochrane Hepato-Biliary Group, The Cochrane Library, and The Cochrane Complementary Medicine Field were searched in combination with MEDLINE, EMBASE, and handsearches of Chinese journals and conference proceedings (October 2000).

Selection criteria

Randomised or quasi-randomised trials (minimum follow-up three months) in asymptomatic carriers of hepatitis B virus. Chinese medicinal herbs (single herb or compound of herbs) compared with placebo, no intervention, general non-specific treatment, or interferon treatment. Trials of Chinese medicinal herbs plus interferon versus interferon alone were also included.

Data collection and analysis

Data were extracted independently by two authors. Analysis was performed by intention-to-treat where possible. Pre-specified subgroup analyses were: ethnic origin, age at time of infection, and single herb or compound of herbs.

Main results

Three randomised clinical trials (307 patients) that followed patients for three months or more after the end of treatment were included. The methodological quality was poor. The herbal compound 'Jianpi Wenshen recipe' had significant effects on viral markers compared to interferon: relative risk 2.40 (95% CI 1.01 to 5.72) for clearance of serum HBsAg, 2.03 (95% CI 0.98 to 4.20) for clearance of HBeAg, and 2.54 (95% CI 1.13 to 5.70) for seroconversion of HBeAg to anti-HBe. Phyllanthus amarus and Astragalus membranaceus showed no significant antiviral effect compared with placebo. Analysis of pooling eight randomised clinical trials with less than three months follow-up did not show a significant benefit of Chinese medicinal herbs on viral markers. Data on long-term clinical outcomes and quality of life were lacking.

Authors' conclusions

Based on one low quality trial, the medicinal herb 'Jianpi Wenshen recipe' may have an antiviral activity in asymptomatic carriers of hepatitis B virus. However, rigorous randomised, double-blind, placebo-controlled trials are needed before herbs should be used for this condition.

摘要

背景

以中草藥治療無症狀B型肝炎帶原者

大約有3億5千萬的人是慢性B型肝炎帶原者,該患病罹患嚴重疾病與因肝硬化和肝癌而死亡的風險較高。 2000多年以來中草藥已被廣泛用於治療慢性肝病。

目標

評估是否中草藥對治療無症狀B型肝炎帶原者的有效性和安全性。

搜尋策略

搜尋The trials registers of The Cochrane HepatoBiliary Group、The Cochrane Library和 The Cochrane Complementary Medicine Field,合併MEDLINE、EMBASE與人工搜尋中文期刊及研討會摘要手冊 (2000年10月).

選擇標準

無症狀B型肝炎帶原者的隨機或半隨機臨床試驗(至少追蹤3個月)。中草藥(單一草藥或複方中草藥)分別與安慰劑、無處置、一般非特異性治療或干擾素治療作比較。中草藥加干擾素對比單獨用干擾素的試驗也被納入。

資料收集與分析

兩位回顧作者獨立提取數據。若可能,數據分析以治療意向進行分析。預先設定的亞組分析有種族(血統)、被感染時年齡以及是單一中草藥或是複方中草藥。

主要結論

共收納3項隨機臨床試驗(307位病人)在治療結束後追蹤3個月或以上。研究方法品質較差。比起干擾素治療,草藥複方Jianpi wenshen recipe對病毒標誌物具有顯著作用:清除血清中HBsAg的relative risk(RR)2.40 (95% CI 1.01 5.72),清除HBeAg RR 2.03 (95% CI 0.98 – 4.20),HBeAg血清轉化成antiHBe RR2. 54 (95% CI 1.13 – 5.70) 。 與安慰劑相比,Phyllanthus amarus和Astragalus membranaceus沒有顯著的抗病毒療效。對於追蹤3個月以下的8項隨機臨床試驗進行合併分析,沒有顯示中草藥對病毒標誌物沒有顯著的好處。 缺乏長期臨床療效和生活品質的資料。

作者結論

根據一項品質較差的試驗,草藥 ‘Jianpi Wenshen recipe’可以抵抗無症狀B型肝炎帶原者體中病毒的活動。但若要將中草藥用在這些病人,需要嚴謹的隨機、雙盲、安慰劑對照試驗。

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

中草藥治療無症狀B型肝炎帶原者的療效仍有待觀察。中草藥被用於治療肝病已有一段時間。本回顧共收納了3項隨機臨床試驗。 由於研究方法品質量差,現有試驗數量少,目前中草藥如草藥複方Jianpi wenshen recipe和Astragalus membranaceus治療無症狀B型肝炎帶原者的證據仍顯不足。需要更好研究設計方法品質及更大型比較草藥和安慰劑的隨機試驗。

Plain language summary

Firm evidence for effect of Chinese medicinal herbs for asymptomatic hepatitis B virus carriers is still awaited

Chinese medicinal herbs have a long history in the treatment of liver diseases. Three randomised clinical trials were included. Due to their poor methodologic quality and the existing small number of trials, there is currently insufficient evidence for treating asymptomatic hepatitis B virus carriers with Chinese medicinal herbs like the herbal compound 'Jianpi Wenshen recipe', Phyllanthus amarus and Astragalus membranaceus. Methodologically better and larger randomised trials are needed comparing medicinal herbs versus placebo.