Effects of silymarin MZ-80 on oxidative stress in patients with alcoholic cirrhosis. Results of a randomized, double-blind, placebo-controlled clinical study.
BACKGROUND
The role of silymarin in the treatment of liver cirrhosis is controversial.


OBJECTIVE
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 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.


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.
Lucena
M I
MI
Clinical Pharmacology Service, University Hospital, School of Medicine, Málaga, Spain. lucena@uma.es
Andrade
R J
RJ
de la Cruz
J P
JP
Rodriguez-Mendizabal
M
M
Blanco
E
E
Sánchez  de la Cuesta
F
F
D000328:Adult; D000368:Aged; D000437:Alcoholism / Q000150:complications / Q000188:drug therapy / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008104:Liver Cirrhosis, Alcoholic / Q000150:complications / Q000188:drug therapy / Q000378:metabolism*; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D018384:Oxidative Stress / Q000187:drug effects*; D012838:Silymarin / Q000494:pharmacology* / Q000627:therapeutic use
D012838:Silymarin