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.
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.
Rambaldi
Andrea
A
Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Denmark.
Jacobs
Bradly P
BP
Iaquinto
Gaetano
G
Gluud
Christian
C
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
D010919:Placebos; D028321:Plant Preparations