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

Author(s): Moreno C, Langlet P, Hittelet A, Lasser L, Degre D, Evrard S, Colle I, Lemmers A, Deviere J, Le Moine O

Affiliation(s): Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Erasme Hospital, Universite Libre de Bruxelles, Brussels, Belgium.

Publication date & source: 2010-08-01, J Hepatol., [Epub ahead of print]

BACKGROUND & AIMS: 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 14days. 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 analysis for protocol violation. The two groups did not differ in baseline characteristics. Survival rates at 1 and 6months in N-acetylcysteine and control groups were 70.2 vs. 83.8% (p=0.26) and 62.4 vs. 67.1% (p=0.60), respectively. Early biological changes, documented infection rate at 1month and incidence of hepatorenal syndrome did not differ between the two groups. CONCLUSIONS: In this study, high doses of intravenous N-acetylcysteine therapy for 14days 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. Copyright (c) 2010 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Page last updated: 2010-10-05

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