Objective To evaluate the effectiveness and safety of kushenin for chronic hepatitis B. Methods We searched The Cochrane Hepato-Bil iary Group Controlled Trials Register (March, 2006), The Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 1, 2006), MEDLINE (1966 to present), EMBASE (1966 to present), OVID (1965 to present), the Chinese Biomedical Database (CBM) (1978 to 2006) and CNKI. Qual ity assessment and data extraction were conducted by two reviewers independently, and disagreement, if any, was resolved by discussion. Meta-analyses were performed for homogeneous studies. Results A total of 56 studies involving 5156 patients met the inclusion criteria. These included 3 randomized controlled trials (RCTs), 7 quasi-RCTs, and 46 other studies that did not report randomization methods. None of the trials enforced allocation concealment and only one trial performed blinding.We conducted subgroup analyses based on the outcome measures and interventions. Compared with interferon,the HBeAg seroconversion rate at 12 months after treatment was lower in patients treated with kushenin (RR=0.72, 95%CI 0.58 to 0.90); compared with lamivudine, a lower HBV DNA seroconversion rate after 12 and 24 weeks of treatment was associated with kushenin (RR=0.48, 95%CI 0.33 to 0.70; RR=0.40, 95%CI 0.26 to 0.63). No significant differences were noted between the kushenin group and the control group for all the other outcome measures. Conclusion Kushenin might be effective in normal izing ALT levels, clearing HBV DNA, achieving virus seroconversion and improving hepatic fibrosis, without any serious adverse effects. However, because the overall effects cannot be pooled for analysis, more evidence is needed to support this finding.