gov, the WHO International Clinical Trials Registry Platform, and full text searches were conducted until November 2011. The searches in Chinese Bio-medical
Literature Database, China Network Knowledge Information, Chinese Science Journal Database, Chinese Medical Citation Index, Wanfang Database, and full text searches were conducted until January 2011. Manufacturers and authors were contacted.\n\nSelection criteria\n\nAll randomised clinical trials comparing bezafibrate at any dose or regimen in patients with primary biliary cirrhosis with placebo or no intervention, or with 17DMAG another drug. Any concomitant interventions were allowed if received equally by all treatment groups in a trial.\n\nData collection and analysis\n\nTwo authors extracted data. RevMan Analysis was used for statistical analysis of dichotomous data with risk ratio (RR) or risk difference (RD), and of continuous data with mean difference (MD), both with 95% confidence intervals (CI). Methodological domains were used to assess risk of systematic errors (bias). Trial sequential OICR-9429 order analysis was used to control for random errors (play of chance).\n\nMain results\n\nSix trials with 151 Japanese patients were included. All trials had high risk of bias. Four trials compared bezafibrate plus
UDCA with no intervention plus UDCA (referenced as bezafibrate versus no intervention in the remaining text), and two trials compared bezafibrate with UDCA. No Cediranib clinical trial patient died and no patient developed liver-related complications in any of the included trials. Bezafibrate was without significant effects on the occurrence of adverse events compared with no intervention (5/32 (16%) versus 0/28 (0%)) (RR 5.40, 95% CI 0.69 to 42.32; 3 trials with 60 patients; I-2 = 0%) or with UDCA (2/32 (6%) versus 0/37 (0%)) (RR 6.19, 95% CI 0.31 to 122.05; 2 trials with 69 patients; I-2 = 0%). Bezafibrate significantly decreased
the activity of serum alkaline phosphatases compared with no intervention (MD -186.04 U/L, 95% CI -249.03 to -123.04; 4 trials with 79 patients; I-2 = 34%) and when compared with UDCA (MD -162.90 U/L, 95% CI -199.68 to -126.12; 2 trials with 48 patients; I-2 = 0%). These results were supported by trial sequential analyses. Bezafibrate compared with no intervention significantly decreased plasma immunoglobulin M (MD -164.00 mg/dl, 95% CI -259.47 to -68.53; 3 trials with 50 patients; I-2 = 46%) and serum bilirubin concentration (MD -0.19 mg/dl, 95% CI -0.38 to -0.00; 2 trials with 34 patients; I-2 = 0%). However, the latter two results were not supported by trial sequential analyses. Bezafibrate compared with no intervention had no significant effect on the activity of serum gamma-glutamyltransferase (MD -1.22 U/L, 95% CI -11.97 to 9.52; 4 trials with 79 patients; I-2 = 42%) and serum alanine aminotransferase (MD -5.61 U/L, 95% CI -24.