Clinical Review
The American Journal of Gastroenterology (2005) 100, 2583–2591; doi:10.1111/j.1572-0241.2005.00262.x
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
Andrea Rambaldi MD1, Bradly P Jacobs MD, MPH2, Gaetano Iaquinto MD3 and Christian Gluud MD, Dr Med Sci1
- 1Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark;
- 2Osher Center for Integrative Medicine and Department of Medicine, University of California, San Francisco, California;
- 3Gastroenterology and Digestive Endoscopy Service, San G. Moscati Hospital, Avellino, Italy
Correspondence: Christian Gluud, MD, Dr Med Sci, The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Department 7102, H:S Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark, DK-2100
Received 26 February 2005; Revised 0000; Accepted 14 June 2005.
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.
