Effects of silymarin MZ-80 on oxidative stress in patients with alcoholic cirrhosis. Results of a randomized, double-blind, placebo-controlled clinical study
Lucena, M.I.; Andrade, R.J.; de la Cruz, J.P.; Rodriguez-Mendizabal, M.; Blanco, E.; Sánchez de la Cuesta, F.
International Journal of Clinical Pharmacology and Therapeutics 40(1): 2-8
2002
ISSN/ISBN: 0946-1965 PMID: 11841050 Document Number: 545661
Background: The role of silymarin in the treatment of liver cirrhosis is controversial. Aim: Clinical outcome, biochemical profile and the antiperoxidative effects of silymarin MZ-80 during 6 months treatment were investigated in patients with alcoholic liver cirrhosis. Methods: Sixty consecutive patients with alcoholic liver cirrhosis were randomized to receive either silymarin MZ-80 (S) (150 mg t.i.d. per day) or placebo (P) for periods of 6 months. Erythrocyte total glutathione (GSH) content, platelet malondialdehyde (MDA) and serum amino-terminal propeptide of procollagen Type III (PIIINP) were determined at baseline and at the end of treatment. Results: Forty-nine patients completed the study (24 S and 25 P). The 2 groups were well-matched for demographic as well as baseline clinical and laboratory parameters. Silymarin increased total GSH at 6 months (4.5+-3.4 to 5.8+-4.0 mumol/g Hb) whereas, in the placebo group, GSH remained unchanged (4.1+-3.9 to 4.4+-4.1 mumol/gHb) (p<0.001), and platelet-derived non-induced MDA decreased by 33% (p<0.015). A parallel decrease in PIIINP values was seen with silymarin (1.82+-1.03 to 1.36+-0.5 U/ml, p<0.033) but not with placebo (1.31+-0.4 to 1.27+-0.6 U/ml). There were no concurrent changes on laboratory indices of the pathology. Conclusions: Silymarin is well-tolerated and produces a small increase in glutathione and a decrease in lipid peroxidation in peripheral blood cells in patients with alcoholic liver cirrhosis. Despite these effects no changes in routine liver tests were observed during the course of therapy.