Article type
Year
Abstract
Introduction:
Objectives: To evaluate the efficacy and adverse effects of peroral ursodeoxycholic acid (UDCA) for primary biliary cirrhosis (PBC) patients vs placebo or no intervention following the guidelines of the Cochrane Collaboration.
Methods: Databases, the specialist literature and references of identified studies were searched for double-blind, single-blind or unblinded randomised clinical trials (RCTs) evaluating UDCA for PBC. Data were extracted and meta-analysed.
Results: A total of 16 RCTs fulfilled the inclusion criteria. The methodological quality of the RCTs was generally low. After RCT-termination, a number of trials continued UDCA treated patients on UDCA and offered UDCA to patients in the control arm making the evaluation of long-term effects impossible. Compared to placebo or no intervention, UDCA did not significantly influence mortality (Odds Ratio (OR) =0.83; 95% Confidence Interval (CD 0.49-1.40), liver transplantation (OR=0.79; 95% Cl 0.48-1.28), mortality or liver transplantation (OR=0.83; 95% Cl 0.58-1.17), pruritus (OR=0.94; 95% Cl 0.63-1.39), fatigue (OR=0.76; 95% Cl 0.49-1.17), bleeding varices (OR=0.53; 95% Cl 0.20-1.38), liver histology (OR=0.70; 95% Cl 0.37-1.31). prothrombine time, serum albumin and the prevalence of adverse events. However, UDCA significantly decreased serum bilirubin, liver enzymes, cholesterol and IgM values from about 8-50% compared to control intervention.
Discussion: This review demonstrates that the quality of RCTs requires improvement on fundamental aspects of trial design and report. Furthermore, it calls for a total revaluation of UDCA for PBC. The data supporting UDCA are too weak to recommend general usage of UDCA for PBC. Rather, patients should be included in new RCTs. This work was supported by a grant from The 1991 Pharmacy Foundation in Denmark.
Objectives: To evaluate the efficacy and adverse effects of peroral ursodeoxycholic acid (UDCA) for primary biliary cirrhosis (PBC) patients vs placebo or no intervention following the guidelines of the Cochrane Collaboration.
Methods: Databases, the specialist literature and references of identified studies were searched for double-blind, single-blind or unblinded randomised clinical trials (RCTs) evaluating UDCA for PBC. Data were extracted and meta-analysed.
Results: A total of 16 RCTs fulfilled the inclusion criteria. The methodological quality of the RCTs was generally low. After RCT-termination, a number of trials continued UDCA treated patients on UDCA and offered UDCA to patients in the control arm making the evaluation of long-term effects impossible. Compared to placebo or no intervention, UDCA did not significantly influence mortality (Odds Ratio (OR) =0.83; 95% Confidence Interval (CD 0.49-1.40), liver transplantation (OR=0.79; 95% Cl 0.48-1.28), mortality or liver transplantation (OR=0.83; 95% Cl 0.58-1.17), pruritus (OR=0.94; 95% Cl 0.63-1.39), fatigue (OR=0.76; 95% Cl 0.49-1.17), bleeding varices (OR=0.53; 95% Cl 0.20-1.38), liver histology (OR=0.70; 95% Cl 0.37-1.31). prothrombine time, serum albumin and the prevalence of adverse events. However, UDCA significantly decreased serum bilirubin, liver enzymes, cholesterol and IgM values from about 8-50% compared to control intervention.
Discussion: This review demonstrates that the quality of RCTs requires improvement on fundamental aspects of trial design and report. Furthermore, it calls for a total revaluation of UDCA for PBC. The data supporting UDCA are too weak to recommend general usage of UDCA for PBC. Rather, patients should be included in new RCTs. This work was supported by a grant from The 1991 Pharmacy Foundation in Denmark.