title: Randomized controlled trial of silymarin treatment in patients with cirrhosis of the liver.
abstract: Silymarin, the active principle of the milk thistle Silybum marianum, protects experimental animals against various hepatotoxic substances. To determine the effect of silymarin on 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 Non-compliant patients and patients who failed to come to a control were considered as 'drop outs' and were withdrawn from the study.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.(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: 1st Department of Gastroenterology and Hepatology, University of Vienna, Austria.
authors.forename: P
authors.initials: P
authors.lastname: Ferenci
authors.forename: B
authors.initials: B
authors.lastname: Dragosics
authors.forename: H
authors.initials: H
authors.lastname: Dittrich
authors.forename: H
authors.initials: H
authors.lastname: Frank
authors.forename: L
authors.initials: L
authors.lastname: Benda
authors.forename: H
authors.initials: H
authors.lastname: Lochs
authors.forename: S
authors.initials: S
authors.lastname: Meryn
authors.forename: W
authors.initials: W
authors.lastname: Base
authors.forename: B
authors.initials: B
authors.lastname: Schneider
mesh_terms: D000328:Adult; D002423:Cause of Death; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D005419:Flavonoids / Q000627:therapeutic use*; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy*; D008104:Liver Cirrhosis, Alcoholic / Q000188:drug therapy; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011897:Random Allocation; D012838:Silymarin / Q000627:therapeutic use*
chemical_list: D005419:Flavonoids; D012838:Silymarin