What does is take to convince the Cochrane Hepatobiliary Group?

[Guest guest]

It is really disturbing to me that after all this time (20 years of

research!) no benefit of URSO can be found in primary biliary

cirrhosis by the Cochrane Hepatobiliary Group:

____________________

Yan Gong M.D., M.I.H., Zhibi Huang M.P.H., Christensen M.D., Dr.

Med.Sci., Christian Gluud M.D., Dr. Med.Sci.

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

The American Journal of Gastroenterology (OnlineEarly Articles).

doi:10.1111/j.1572-0241.2007.01235.x

CLINICAL REVIEW

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

Yan Gong, M.D., M.I.H.11The Cochrane Hepato-Biliary Group, Copenhagen

Trial Unit, Center for Clinical Intervention Research, Department

7102, Rigshospitalet, Copenhagen University Hospital, Copenhagen,

Denmark, Zhibi Huang, M.P.H.22Department of Epidemiology, Institute

of Public Health, Copenhagen University, Copenhagen, Denmark,

Christensen, M.D., Dr. Med.Sci.33Clinic of Internal Medicine I, H:S

Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen,

Denmark, and Christian Gluud, M.D., Dr. Med.Sci.11The Cochrane Hepato-

Biliary Group, Copenhagen Trial Unit, Center for Clinical

Intervention Research, Department 7102, Rigshospitalet, Copenhagen

University Hospital, Copenhagen, Denmark1The Cochrane Hepato-Biliary

Group, Copenhagen Trial Unit, Center for Clinical Intervention

Research, Department 7102, Rigshospitalet, Copenhagen University

Hospital, Copenhagen, Denmark; 2Department of Epidemiology, Institute

of Public Health, Copenhagen University, Copenhagen, Denmark; and

3Clinic of Internal Medicine I, H:S Bispebjerg Hospital, Copenhagen

University Hospital, Copenhagen, Denmark

Reprint requests and correspondence: Yan Gong, M.D., M.I.H., The

Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Center for

Clinical Intervention Research, Department 33.44, Rigshospitalet,

Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen,

Denmark.

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.

____________________

Dave

(father of (21); PSC 07/03; UC 08/03)