Chinese herbal medicine Xiaoyao san (XYS) for chronic hepatitis B (CHB): A meta-analysis of randomized controlled trials

Objective: To assess the beneficial and adverse effects of XYS for CHB. Methods: Seven databases were searched to retrieve RCTs evaluating clinical effectiveness of XYS. Primary outcome measures were negative conversion of serum HBeAg and/or serum HBV-DNA. Secondary outcome measures were serum ALT, AST, and clinical comprehensive effect. All data were analyzed using Review Manager 5.1 software. 9 RCTs were included. Most of the RCTs were of poor methodological quality. Results: Four trails reported XYS plus hepatoprotective drugs showed significant difference on the normalization of AL T (OR: 4.26 11.26, 14.411; P=0.02) and clinical comprehensive effect (OR: 4.55 [2.03, 10.19]; P=0.0002). Four RCTs reported XYS plus antivirus drugs versus antivirus drugs. As compared to antivirus drugs, XYS showed significant beneficial on the reduced amount of serum AL T (MD: -18.65 1-22.29, -15.011; P<;0.00001) and clinical comprehensive effect (OR: 2.56 [1.30, 5.03]; P=0.006). One trail compared XYS plus hepatoprotective and antivirus drugs versus hepatoprotective and antivirus drugs. It showed that the former therapy has significant beneficial on the reduced amount of serum AL T (MD: -40.52 [-45.51, -35.53]; P<;0.00001), AST (MD: -36.70 [-40.83, -32.571; P<;0.00001). Most studies did not mention adverse events. Conclusion: There is no convincing evidence of XYS for CHB because of low methodological quality. Rigorously designed trials are warranted to justify their clinical use.