Background: The potential benefit of silymarin (special extract
from the fruits of Silybum marianum) in the treatment
of liver diseases remains a controversial issue. Methods:
For this systematic review electronic databases identified 65
papers for the search terms silymarin, silibinin, silicristin or
milk thistle and clinical trial. Only 19 complied with the criteria
‘double-’ or ‘single-blind’. These publications were
analysed from a clinical point of view and meta-analytic calculations
were performed. Results: The clinical evidence of
a therapeutic effect of silymarin in toxic liver diseases is
scarce. There is no evidence of a favourable influence on
the evolution of viral hepatitis, particularly hepatitis C. In alcoholic
liver disease, comparing with placebo, aspartate
aminotransferase was reduced in the silymarin-treated
groups (p = 0.01) while alkaline phosphatase was not. In
liver cirrhosis, mostly alcoholic, total mortality was 16.1%
with silymarin vs. 20.5% with placebo (n.s.); liver-related
mortality was 10.0% with silymarin vs. 17.3% with placebo
(p = 0.01). Conclusions: Based on the available clinical evidence
it can be concluded - concerning possible risks /
probable benefits - that it is reasonable to employ silymarin
as a supportive element in the therapy of Amanita phalloides
poisoning but also (alcoholic and grade Child ‘A’)
liver cirrhosis. A consistent research programme, consolidating
existing evidence and exploring new potential uses,
would be very welcome.