Randomized controlled trial of silymarin treatment in patients with cirrhosis of the Liver

Author(s): Dragosics, B., Dittrich, H., Frank, H., Benda, L., Lochs, H., Base, W., Schneider, B.

Journal/Book: J Hepatol. 1989; 9: 105-113.

Abstract: Silymarin, the active principle of the milk thistle Silybum marianum, protects experimental animals against various hepatotoxic substances. To determine the effect of silymarin an the outcome of patients with cirrhosis, a double blind, prospective, randomized study was performed in 170 patients with cirrhosis. 87 patients (alcoholic 46, non-alcoholic 41; 61 male, 26 female; Child A, 47; B, 37; C, 3; mean age 57) received 140 mg silymarin three times daily. 83 patients (alcoholic 45, non-alcoholic 38; 62 male, 21 female; Child A, 42; B, 32; C, 9: mean age 58) received a placebo. Non-comphant patients and patients who failed to come to a control were considered as 'drop outs' and were withdrawn from the study. All patients received the same treatment until the last patient entered had finished 2-years of treatment. The mean observation period was 41 months. There were 10 drop outs in the placebo group and 14 in the treatment group. In the placebo group, 37 (+2 drop outs) patients had died, and in 31 of these, death was related to liver disease. In the treatment group, 24 (+4 drop outs) had died, and in 18 of these, death was related to liver disease. The 4-year survival rate was 58 ± 9% (S.E.) in silymarin-treated patients and 39 ± 9% in the placebo group (P = 0.036). Analysis of subgroups indicated that treatment was effective in patients with alcoholic cirrhosis (P = 0.01) and in patients initially rated 'Child A' (P = 0.03). No side effects of drug treatment were observed. The results of this study suggest that mortality of patients with cirrhosis was reduced by treatment with silymarin. However, as this effect was more pronounced in alcoholic cirrhosis, the interrelation of patterns of alcohol consumption and of drug treatment affecting survival must be adressed by future studies.

Keyword(s): Mariendistel

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