Ursodeoxycholic Acid Intervention Primary Biliary Cirrhosis The Systematic Of Review

Objective To assess the long-term efficiency and safety of ursodeoxycholic acid (UDCA) treatment for primary biliary cirrhosis (PBC).Methods According to the criterion of internalized papers, PubMed, EMBASE,CBM, VIP, CNKI and WANGFANG databases were chosen for the primary document search.The Cochrane Library (2008, Issue1): The Cochrane Central Register of Controlled Trials and Ovid were chosen for the secondary document search. Published or unpublished articles in related journals, were manually searched and some other articles were searched with Google.The references were investigated, and the data and full texts were traced by E-mail.The search lasted to June, 2008. The quality of the documents was assessed by two reviewers sperately, and checked crossly.Discussion or the third reviewer was invitied when discrepancy happened. Meta-analysis was performed according to the data and its results were assessed by sensitive analysis and bias analysis.Result Ten trials involving 1278 participants with PBC were included.There were 645 participants in treatment group and 633 participants in control group.Meta-analysis showed:1)primary outcomes were not significant different in the incidence of death[PetoOR=0.92,95%confidence interval (0.58,1.44)], liver trans-plantation [PetoOR=0.88,95%CI(0.55,1.39)], death and/or liver transplantation[PetoOR=0.89,95%CI(0.63,1.25)];2) symptoms were not significant different in the pruritus [PetoOR=1.01,95%CI(0.83,1.22)], fatigue [PetoOR=0.91, 95%CI (0.67,1.23)];3)liver biochemistry have significant different in the serum total bilirubin[WMD=-9.28μmol/l, 95%CI (-16.20, -2.53)μmol/l], alkaline phosphatase [WMD=-325.79U/l, 95% CI (-414.55, -237.03) U/l],γ-glutamyltransferase[WMD=-253.09IU/l,95%CI(-273.10,-233.08)IU/l], aspartate transaminase [WMD= -29.56IU/l, 95%CI (-45.93, -13.19)IU/l], alanine transaminase [WMD=-34.21IU/l, 95%CI (-43.02, -25.39) IU/l], IgM [WMD=-1.33g/l,95%CI (-1.43,-1.22)g/l];4) adverse events was no different significant [PetoOR =1.44, 95%CI (0.79,2.61)].Conclusions The analysis of RCTs of UDCA versus placebo or no intervention shows improvement of liver biochemistry, but not improvement of clinical symptoms and survival.Due to risk of selection bias, performance bias and attrition bias, the evidence is not strong enough to judge whether UDCA is better than placebo or not intervention.Our conclusions suggest that larger-scale randomized trials should be performed in future.