Background: Hepatitis B is an infectious disease of the liver caused by hepatitis B virus (HBV). There are 350 million people chronically infected with the virus who are at risk of cirrhosis and cancer of liver, and 12 million with chronic hepatitis B are in China. Traditional Chinese Medicine (TCM) has been used to treat chronic hepatitis B for decades and many clinical trials have been conducted in China and needs to be reviewed systematically.

Objectives: To assess efficacy of TCM herbs as a special experimental treatment for chronic hepatitis B compared with placebo, no intervention or Interferon treatment. Criteria for considering studies: Randomized or quasi-randomized controlled trials with a minimum follow-up of 3 mo. The participants are chronic hepatitis B patients (disease course >6mo) with positive HBV markers and damaged liver function. Chinese medicinal herbs are as interventions, while placebo, blank or interferon as control interventions. Outcome measures include viral, biochemical and histological responses, as well as adverse effects.

Search strategy for identification of studies: Electronic search and handsearching will be used to search databases both in and out of Cochrane Collaboration and other relevant journals and proceedings.

Methods of the review: Two reviewers will independently select trials and assess the trials' quality by methodological quality criteria. The extracted data are to be input into RevMan and dichotomous data is presented as relative risk and continuous outcomes as weighted mean difference both with 95% confidence intervals. Meta-analysis will be performed within comparisons where individual trials compare similar treatment and control interventions, while sensitivity analysis is used to test how robust the results are under different methodological quality.

Results: Available in August 2000.

Conclusions: To be given at the 8th Cochrane Colloquium in Cape Town.