title: 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.
abstract: OBJECTIVE
  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.
authors.affiliation: Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Denmark.
authors.forename: Andrea
authors.initials: A
authors.lastname: Rambaldi
authors.forename: Bradly P
authors.initials: BP
authors.lastname: Jacobs
authors.forename: Gaetano
authors.initials: G
authors.lastname: Iaquinto
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
mesh_terms: D002423:Cause of Death; D004311:Double-Blind Method; D006509:Hepatitis B / Q000188:drug therapy*; D006526:Hepatitis C / Q000188:drug therapy*; D006519:Hepatitis, Alcoholic / Q000188:drug therapy*; D006801:Humans; D020944:Silybum marianum; D008517:Phytotherapy; D010919:Placebos; D028321:Plant Preparations / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic / Q000592:standards; D012107:Research Design / Q000592:standards; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010919:Placebos; D028321:Plant Preparations