Clinical Review | Published:

Milk Thistle for Alcoholic and/or Hepatitis B or C Liver Diseases—A Systematic Cochrane Hepato-Biliary Group Review with Meta-Analyses of Randomized Clinical Trials

The American Journal of Gastroenterology volume 100, pages 25832591 (2005) | Download Citation

Subjects

Abstract

OBJECTIVES:

Our objectives were to assess the beneficial and harmful effects of milk thistle (MT) or MT constituents versus placebo or no intervention in patients with alcoholic liver disease and/or hepatitis B and/or C liver diseases.

METHODS:

Randomized clinical trials studying patients with alcoholic and/or hepatitis B or C liver diseases were included (December 2003). The randomized clinical trials were evaluated by components of methodological quality.

RESULTS:

Thirteen randomized clinical trials assessed MT in 915 patients with alcoholic and/or hepatitis B or C liver diseases. The methodological quality was low: only 23% of the trials reported adequate allocation concealment and only 46% were considered double blind. MT versus placebo or no intervention for a median duration of 6 months had no significant effects on all-cause mortality (relative risk (RR) 0.78, 95% confidence interval (CI) 0.53–1.15), complications of liver disease, or liver histology. Liver-related mortality was significantly reduced by MT in all trials (RR 0.50, 95% CI 0.29–0.88), but not in high-quality trials (RR 0.57, 95% CI 0.28–1.19). MT was not associated with a significantly increased risk of adverse events.

CONCLUSIONS:

Based on high-quality trials, MT does not seem to significantly influence the course of patients with alcoholic and/or hepatitis B or C liver diseases. MT could potentially affect liver injury. Adequately conducted randomized clinical trials on MT versus placebo may be needed.

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Acknowledgements

We are indebted to N. Salas for the expert technical computer assistance and to D. Nikolova and S.L. Klingenberg for expert assistance with the retrieval of publications. Special thanks to F. Lirussi, M.I. Lucena, and A. Parés for providing us with more information on the trials they were involved in. We thank the Cochrane Collaboration and the Cochrane Hepato-Biliary Group for assistance.This review will be published as a Cochrane Review in The Cochrane Library. Cochrane Reviews are regularly updated as new evidence emerges and in response to comments and criticisms. The Cochrane Library should therefore be consulted for the most recent version.

B.P.J. is author of a report and of a meta-analysis on milk thistle for liver diseases. The other authors have no known conflicts of interest.

This study was supported by The 1991 Pharmacy Foundation, Denmark; Copenhagen Hospital Corporation's Research Grant on Getting Research into Practice (GRIP), Denmark; The Danish Medical Research Council's Grant on Getting Research into Practice (GRIP), Denmark.

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Affiliations

  1. Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

    • Andrea Rambaldi
    •  & Christian Gluud
  2. Osher Center for Integrative Medicine and Department of Medicine, University of California, San Francisco, California

    • Bradly P Jacobs
  3. Gastroenterology and Digestive Endoscopy Service, San G. Moscati Hospital, Avellino, Italy

    • Gaetano Iaquinto

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Correspondence to Christian Gluud.

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DOI

https://doi.org/10.1111/j.1572-0241.2005.00262.x

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