UDCA for PBC: Systematic Review & Analysis

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Ursodeoxycholic Acid for Patients With Primary Biliary Cirrhosis: An

Updated Systematic Review and Meta-Analysis of Randomized Clinical

Trials Using Bayesian Approach as Sensitivity Analyses

Authors: Gong, Yan1; Huang, Zhibi2; Christensen, 3; Gluud, Christian1

Source: The American Journal of Gastroenterology, August 2007

Abstract:

OBJECTIVES:?Ursodeoxycholic acid (UDCA) is used for primary biliary

cirrhosis (PBC), but the beneficial effects remain controversial.

METHODS:?We performed an updated systematic review to evaluate the

benefits and harms of UDCA in patients with PBC. We included

randomized clinical trials evaluating UDCA versus placebo or no

intervention in patients with PBC. The primary outcomes, mortality and

mortality or liver transplantation, were reported as relative risk

(RR) with 95% confidence interval (CI). Meta-regression was used to

investigate the associations between UDCA effects and the trial's risk

of bias, UDCA dose, duration, and PBC severity at trial entry. We used

Bayesian meta-analytic approaches as sensitivity analyses.

RESULTS:?Sixteen randomized clinical trials (1,447 patients)

evaluating UDCA versus placebo or no intervention were identified.

Over half of the trials had high risk of bias. Comparing with placebo

or no intervention, UDCA did not significantly affect mortality (RR

0.97, 95% CI 0.67-1.42) and mortality or liver transplantation (RR

0.92, 95% CI 0.71-1.21). The findings were supported by the Bayesian

meta-analyses. Meta-regression analyses suggested that UDCA effects

seem to be associated with patient's disease severity and trial

duration. UDCA did not improve pruritus, fatigue, autoimmune

conditions, liver histology, or portal pressure. UDCA seemed to

improve biochemical variables, such as serum bilirubin, and ascites

and jaundice, but the findings were based on few trials with sparse

data. The use of UDCA was significantly associated with adverse

events, mainly weight gain.

CONCLUSIONS:?This updated systematic review did not demonstrate any

benefit of UDCA on mortality and mortality or liver transplantation in

patients with PBC.

(Am J Gastroenterol 2007;102:1799-1807)