OBJECTIVES Hepatitis B virus infected over 2 billion people worldwide, and 350 million suffering from chronic HBV infection. The prevalence of chronic HBV infection is high in Asia and most of Africa. Kushenin injection as a new traditional Chinese medicine is now widely used for chronic HBV treatment in China. The objective of this study was to compare the effectiveness between Kushenin and western medicines on patients with chronic HBV. METHODS : Based on a pilot study of patient interview at one hospital setting, we identified key outcome measurements of effectiveness related to Kushenin and western medicine, including ALT recovery rate and negative conversion rate of HBeAg. Consequently, we performed a systematic literature review using computer-based search-engines such as MEDLINE (1966 to 2007), EMBASE (1966 to 2006), OVID (1965 to 2006), the Chinese Biomedical Database (CBM) (1978 to 2006) and CNKI (China National Knowledge Infrastructure) (1994 to 2007). From available data, both interferon and lamivudine were selected as western medicines to compare with Kushenin regimen. A Meta-analysis was performed using a software program of Reviewmanager® 4.2. RESULTS A total of 15 published clinical studies involving 1396 patients met inclusion criteria for the meta-analysis. Comparing to interferon alone regimen, Kushenin showed no significant differences in terms of ALT recovery rate [relative risk, RR=0.96; 95% confidence interval (CIs),0.86-1.09] and negative conversion rate of HBeAg (RR= 0.85; 95%CIs, 0.69-1.05). Meanwhile, kushenin combined with lamivudine showed better effectiveness in term of ALT recovery rate (RR=1.77; 95%CIs,1.38-2.26) and negative conversion rate of HBeAg (RR= 2.58; 95% CIs, 1.81-3.68) compared with lamivudine alone. CONCLUSIONS Integrated Kushenin plus lamivudine showed better clinical outcomes in ALT recovery rate and HBeAg negative conversion rate. Further evidence-based analysis is required due to low quality of randomization procedure in clinical trials and insufficient study patients for treating chronic HBV with kunshenin.