Enteral nutrition with or without N-acetylcysteine in the treatment of severe acute alcoholic hepatitis: A randomized multicenter controlled trial

Background & Alms Severe acute alcoholic hepatitis is associated with a high mortality rate Oxidative stress is involved in the pathogenesis of acute alcoholic hepatitis Previous findings had also suggested that enteral nutritional support might increase survival in patients with severe acute alcoholic hepatitis Therefore the aim of the present study was to evaluate the efficacy of N-acetylcysteine in combination with adequate nutritional support in patients with severe acute alcoholic hepatitis Methods Patients with biopsy-proven acute alcoholic hepatitis and mDF >= 32 were randomized to receive N-acetylcysteine intravenously or a placebo perfusion along with adequate nutritional support for 14 days The primary endpoint was 6-month survival secondary endpoints were biological parameter evolution and infection rate Results Fifty-two patients were randomized in the study (28 into the N-acetylcysteine arm 24 into the control arm) and among them five were excluded from the analysis for protocol violation The two groups did not differ in baseline characteristics Survival rates at 1 and 6 months in N-acetylcysteine and control groups were 702 vs 83 8% (p = 0 26) and 624 vs 67 1% (p = 0 60) respectively Early biological changes documented infection rate at 1 month and incidence of hepatorenal syndrome did not differ between the two groups Conclusions In this study high doses of Intravenous N-acetylcysteine therapy for 14 days conferred neither survival benefits nor early biological improvement in severe acute alcoholic hepatitis patients with adequate nutritional support However these results must be viewed with caution since the study suffered from a lack of power (C) 2010 European Association for the Study of the Liver Published by Elsevier B V All rights reserved