title: Milk thistle for alcoholic and/or hepatitis B or C virus liver diseases.
abstract: BACKGROUND
  Alcohol and hepatotoxic viruses cause the majority of liver diseases. Randomised clinical trials have assessed whether extracts of milk thistle, Silybum marianum (L) Gaertneri, have any effect in patients with alcoholic and/or hepatitis B or C virus liver diseases.
  
  
  OBJECTIVE
  To assess the beneficial and harmful effects of milk thistle or milk thistle constituents versus placebo or no intervention in patients with alcoholic liver disease and/or viral liver diseases (hepatitis B and hepatitis C).
  
  
  METHODS
  The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and full text searches were combined (July 2007). Manufacturers and researchers in the field were contacted.
  
  
  METHODS
  Only randomised clinical trials in patients with alcoholic and/or hepatitis B or C virus liver diseases (acute and chronic) were included. Interventions encompassed milk thistle at any dose or duration versus placebo or no intervention. The trials could be double blind, single blind, or unblinded. The trials could be unpublished or published and no language limitations were applied.
  
  
  METHODS
  The primary outcome measure was mortality. Binary outcomes are reported as relative risks (RR) with 95% confidence interval (CI). Subgroup analyses were performed with regard to methodological quality.
  
  
  RESULTS
  Eighteen randomised clinical trials assessed milk thistle in 1088 patients with alcoholic and/or hepatitis B or C virus liver diseases. The methodological quality was low: only 28.6% of the trials reported high methodological quality characteristics. Milk thistle versus placebo or no intervention had no significant effect on mortality (RR 0.78, 95% CI 0.53 to 1.15), complications of liver disease (RR 0.95, 95% CI 0.83 to 1.09), or liver histology. Liver-related mortality was significantly reduced by milk thistle in all trials (RR 0.50, 95% CI 0.29 to 0.88), but not in high-quality trials (RR 0.57, 95% CI 0.28 to 1.19). Milk thistle was not associated with a significantly increased risk of adverse events (RR 0.83, 95% CI 0.46 to 1.50).
  
  
  CONCLUSIONS
  Our results question the beneficial effects of milk thistle for patients with alcoholic and/or hepatitis B or C virus liver diseases and highlight the lack of high-quality evidence to support this intervention. Adequately conducted and reported randomised clinical trials on milk thistle versus placebo are needed.
authors.affiliation: Copenhagen Trial Unit, Centre for Clinical Intervention Research, Cochrane Hepato-Biliary Group, Rigshospitalet, Dept. 3344, Blegdamsvej 9, Copenhagen, Denmark, DK-2100. arambaldi@hotmail.com
authors.forename: A
authors.initials: A
authors.lastname: Rambaldi
authors.forename: B P
authors.initials: BP
authors.lastname: Jacobs
authors.forename: C
authors.initials: C
authors.lastname: Gluud
mesh_terms: D006509:Hepatitis B / Q000188:drug therapy* / Q000401:mortality; D006526:Hepatitis C / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy / Q000401:mortality; D008104:Liver Cirrhosis, Alcoholic / Q000188:drug therapy* / Q000401:mortality; D020944:Silybum marianum; D008517:Phytotherapy / Q000379:methods*; D016032:Randomized Controlled Trials as Topic