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

Am J Gastroenterol. 2005 Nov;100(11):2583-91. doi: 10.1111/j.1572-0241.2005.00262.x.


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.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Cause of Death
  • Double-Blind Method
  • Hepatitis B / drug therapy*
  • Hepatitis C / drug therapy*
  • Hepatitis, Alcoholic / drug therapy*
  • Humans
  • Milk Thistle*
  • Phytotherapy*
  • Placebos
  • Plant Preparations / therapeutic use*
  • Randomized Controlled Trials as Topic* / standards
  • Research Design / standards
  • Time Factors
  • Treatment Outcome


  • Placebos
  • Plant Preparations