Premium
A randomized controlled trial of ursodeoxycholic acid in patients with alcohol‐induced cirrhosis and jaundice
Author(s) -
Pelletier Gilles,
Roulot Dominique,
Davion Thierry,
Masliah Claude,
Causse Xavier,
Oberti Frédéric,
Raabe JeanJacques,
Van Lemmens Claire,
Labadie Hélène,
Serfaty Lawrence
Publication year - 2003
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1053/jhep.2003.50118
Subject(s) - ursodeoxycholic acid , medicine , gastroenterology , jaundice , placebo , cirrhosis , randomization , bilirubin , hepatology , primary biliary cirrhosis , alcoholic liver disease , randomized controlled trial , alternative medicine , pathology
The aim of our multicenter study was to assess the efficacy of ursodeoxycholic acid (UDCA) on the survival of patients with alcohol‐induced cirrhosis and jaundice. We included patients with histologically proven alcohol‐induced cirrhosis and serum bilirubin >50 μmol/L. After randomization, patients received either UDCA (13‐15 mg/kg/d) or a placebo for 6 months. Two hundred twenty‐six patients (113 in each group) were included in 24 centers. There were 139 men and 87 women, mean age of 50.3 years. Seventy‐four percent had associated alcohol‐induced hepatitis, and 24% received a corticosteroid therapy. At inclusion, the 2 groups were comparable for the main clinical and biologic parameters, but serum bilirubin was higher in the UDCA group than in the placebo group (163 μmol/L vs. 145 μmol/L, P < .03). The percentage of patients lost at follow‐up or who resumed their alcoholism during the study was comparable in the 2 groups. During the study, 55 patients died, 35 in the UDCA group and 20 in the placebo group. In the intention to treat analysis, the probability of survival at 6 months (Kaplan‐Meier method) was lower in the UDCA than in the P group (69% vs. 82%, respectively; P = .04, log‐rank test). After adjustment on the bilirubin level at entry (Cox model), the independent predictive value of the treatment group did not reach the statistical level (RR = 1.64, CI 0.85‐2.85; P = .077). In conclusion, UDCA administered at the dose recommended in primary biliary cirrhosis has no beneficial effect on the 6‐month survival of patients with severe alcohol‐induced cirrhosis. An inappropriate dosage of UDCA cannot be excluded as an explanation for the lack of therapeutic benefit.