Clinical efficacy of traditional Chinese medicine/herbal decoction combined with ursodeoxycholic acid for primary biliary cirrhosis:a meta-analysis

Objective To systematically evaluate the efficacy of traditional Chinese medicine / herbal decoction combined with ursodeoxycholic acid(UDCA) in the treatment of primary biliary cirrhosis(PBC),and to provide a reference for clinical medication.Methods Literature published before July 31,2014 was searched in databases as follows:Cochrane Library,Pub Med,China National Knowledge Infrastructure(CNKI),Chinese Scientific Journals Full-text Database(VIP),Chinese Biomedical Literature Database(CBM),and Wanfang Data.The randomized controlled trials(RCTs) comparing the efficacy of traditional Chinese medicine / herbal decoction combined with UDCA versus UDCA alone in PBC patients were included in the analysis.The methodological quality of included trials was assessed and the data were extracted,followed by meta-analysis using Rev Man 5.0 software.Results A total of 12 RCTs were included,involving 681 patients with 346 in the test group and 335 in the control group.The results of meta-analysis showed that,after 6 months of treatment,the overall response rate,improvement rate,and biochemical indices of liver function(ALT,ALP,GGT,and TBil) and hepatic fibrosis in the test group were significantly improved compared with those in the control group(all P < 0.05).There were no significant differences between the two groups in the immunological indices such as Ig A,Ig G,anti-mitochondrial antibody(AMA),and AMA M2 subtype(all P > 0.05).Conclusion Traditional Chinese medicine / herbal decoction combined with UDCA markedly improves the indices of hepatocellular necrosis and cholestasis,degree of hepatic fibrosis,and clinical symptoms in PBC patients after 6 months of treatment,but leads to no significant improvement in immunological indices.Due to the limited number of included RCTs and patients through systematic evaluation,and the presence of selection bias and publication bias,more double-blind randomized controlled trials with large sample size,multicenter involvement,and high quality are required to provide convincing evidence.