Background: Xiaochaihu Tang was a compound traditional Chinese herbal medicine recorded in ancient Chinese medical book Shanghanlun, and has been widely used for chronic liver diseases especially in Japan.
Objective: To assess the beneficial effects and safety of Xiaochaihu Tang, for chronic hepatitis B (CHB).
Search strategy: Electronic and manual searches were conducted and the search ended in November 2009.
Inclusion criteria: We included randomized clinical trials testing Xiaochaihu Tang against placebo, non-specific treatment, antivirals, or combined with antivirals against antivirals alone.
Data extraction and analysis: Selection of trials for inclusion, assessment of methodological quality by Jadad score, data extraction and data syntheses were conducted according to the Cochrane Hepato-Biliary Group methods.
Results: Sixteen randomized trials (involving 1 601 CHB patients) with various methodological quality were included. One trial published in English had good quality, while other trials published in Chinese were of poor quality. The pooled results showed that Xiaochaihu Tang combined with antiviral drugs was more effective in serum loss of hepatitis B viral markers and in improving liver function compared with antiviral drugs alone. Xiaochaihu Tang was not different from placebo in terms of viral clearance or improving liver function. However, Xiaochaihu Tang was superior to non-specific treatment in liver function improvement. There were no adverse effects reported in the trials regarding Xiaochaihu Tang, but adverse effects were reported in patients treated by interferon, and severe adverse effects occurred in few cases.
Conclusion: Xiaochaihu Tang in this review appears to be effective in improving liver function and clearance of serum hepatitis B viral markers in patients with chronic hepatitis B. However, due to poor methodological quality in the majority of included trials the potential benefits need to be confirmed in rigorous clinical trials following international standards.