Effects of silymarin MZ-80 on oxidative stress in patients with alcoholic cirrhosis. Results of a randomized, double-blind, placebo-controlled clinical study

• Published in: International journal of clinical pharmacology and therapeutics Vol. 40; no. 1; p. 2
• Main Authors: Lucena, M I, Andrade, R J, de la Cruz, J P, Rodriguez-Mendizabal, M, Blanco, E, Sánchez de la Cuesta, F
• Format: Journal Article
• Language: English
• Published: Germany 01-01-2002
• Subjects: Adult; Aged; Alcoholism - complications; Alcoholism - drug therapy; Alcoholism - metabolism; Double-Blind Method; Female; Humans; Liver Cirrhosis, Alcoholic - complications; Liver Cirrhosis, Alcoholic - drug therapy; Liver Cirrhosis, Alcoholic - metabolism; Liver Function Tests; Male; Middle Aged; Oxidative Stress - drug effects; Silymarin - pharmacology; Silymarin - therapeutic use
• ISSN: 0946-1965

The role of silymarin in the treatment of liver cirrhosis is controversial.
Clinical outcome,biochemical profile and the antiperoxidative effects of silymarin MZ-80 during 6 months treatment were investigated in patients with alcoholic liver cirrhosis.
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.
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 micromol/g Hb) whereas, in the placebo group, GSH remained unchanged (4.1 +/- 3.9 to 4.4 +/- 4.1 micromol/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.
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.