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 strategy: 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.
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 reviewers. 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.
Reviewer's 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.