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Cochrane Database of Systematic Reviews

Ursodeoxycholic acid for primary biliary cirrhosis

Information

DOI:
https://doi.org/10.1002/14651858.CD000551.pub3Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 12 December 2012see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:
  1. Cochrane Hepato-Biliary Group

Copyright:
  1. Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • Jelena S Rudic

    Correspondence to: Department of Hepatology, Clinic of Gastroenterology, Clinical Centre of Serbia, Belgrade, Serbia

    [email protected]

    The Cochrane Hepato‐Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

  • Goran Poropat

    Department of Gastroenterology, Clinical Hospital Centre Rijeka, Rijeka, Croatia

  • Miodrag N Krstic

    Clinic of Gastroenterology, Clinical Centre of Serbia, Medical Faculty, University of Belgrade, Belgrade, Serbia

  • Goran Bjelakovic

    The Cochrane Hepato‐Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

    Department of Internal Medicine, Medical Faculty, University of Nis, Nis, Serbia

  • Christian Gluud

    The Cochrane Hepato‐Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

Contributions of authors

JR and GP screened the literature, identified trials with updated information, extracted data, and made the risk of bias judgements.
JR, GB, and CG analysed and interpreted the data and results.
JR drafted the manuscript and performed the meta‐analyses.
GB performed the meta‐regression analyses.
MK, GB, and CG were involved in critical revision of the manuscript for important intellectual content.

Sources of support

Internal sources

  • The Cochrane Hepato‐Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Denmark.

External sources

  • Ministry of Science (Grant No. 41004), Serbia.

  • Clinic of Gastroenterology, Clinical Centre of Serbia, Belgrade, Serbia.

Declarations of interest

None known.

Acknowledgements

We thank the patients who entered the trials and the investigators who conducted them. We also wish to express special thanks to Dr. Albert Pares who kindly responded to our requests for further information on the trial he was involved in. We thank especially Dimitrinka Nikolova, The Cochrane Hepato‐Biliary Group, for expert assistance during the preparation of this review and excellent collaboration. We are very grateful to Sarah Louise Klingenberg, The Cochrane Hepato‐Biliary Group, for her contribution to this review. We thank Janus Jakobsen, The Cochrane Hepato‐Biliary group, for many important linguistic improvements.

Peer reviewer: Janus Jakobsen, Denmark.
Contact editor: Rosa Simonetti, Italy.

Version history

Published

Title

Stage

Authors

Version

2012 Dec 12

Ursodeoxycholic acid for primary biliary cirrhosis

Review

Jelena S Rudic, Goran Poropat, Miodrag N Krstic, Goran Bjelakovic, Christian Gluud

https://doi.org/10.1002/14651858.CD000551.pub3

2008 Jul 16

Ursodeoxycholic acid for primary biliary cirrhosis

Review

Yan Gong, Zhi Bi Huang, Erik Christensen, Christian Gluud

https://doi.org/10.1002/14651858.CD000551.pub2

2001 Oct 23

Ursodeoxycholic acid for primary biliary cirrhosis

Review

Christian Gluud, Erik EC Christensen

https://doi.org/10.1002/14651858.CD000551

Differences between protocol and review

Peer reviewers requested that we included data from the trials after the period in which fair comparisons could be made.

Differences between previous published version of the review and this review

The whole review protocol part was thoroughly updated following the guidelines in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011): text was added or rewritten for greater precision and understanding. Outcomes were rearranged so that they now are patient oriented. An attempt to collect evidence on harm was also made. The statistical approach was also revised. Based on updated domains for bias risk, we judged bias risk domains anew (Higgins 2011). In the present update, only one trial was assessed as having low risk of bias. Minor inaccuracies found in data previously extracted were now corrected. Number of patients who died, were liver transplanted, obtained hepatic encephalopathy or were diagnosed with bleeding varices are now added to the analyses on serious adverse events. New trial data were added to some of the secondary outcome measures. Due to addition of data to the outcome measures on ascites and histology, the result of the effect for ascites changed from significant into insignificant, and the result of the effect for histology changed from insignificant into significant. We performed subgroup analyses using data in the already included trials as well data found in follow‐up publications of the included trials. Results on all‐cause mortality and mortality or liver transplantation as well as the following secondary outcomes ‐ pruritus, serum bilirubin and serum alkaline phosphatases ‐ were analysed with trial sequential analysis. The random‐effects model meta‐regression showed that none of examined covariates (bias risk of the trials, disease severity of patients at entry, ursodeoxycholic acid dosage, and trial duration) were significantly associated with the estimated intervention effect on mortality or mortality or liver transplantation. Summary of Findings tables and grading of the evidence were also performed. We abandoned our Baysian analyses as they did not seem to add new information.

Notes

This is an updated systematic review to the Gong et al (Gong 2008).