Document Detail

Enteral nutrition with or without N-acetylcysteine in the treatment of severe acute alcoholic hepatitis: a randomized multicenter controlled trial.
MedLine Citation:
PMID:  20801542     Owner:  NLM     Status:  MEDLINE    
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 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 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 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.
Christophe Moreno; Philippe Langlet; Axel Hittelet; Luc Lasser; Delphine Degré; Sylvie Evrard; Isabelle Colle; Arnaud Lemmers; Jacques Devière; Olivier Le Moine
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2010-08-01
Journal Detail:
Title:  Journal of hepatology     Volume:  53     ISSN:  1600-0641     ISO Abbreviation:  J. Hepatol.     Publication Date:  2010 Dec 
Date Detail:
Created Date:  2010-11-02     Completed Date:  2011-02-24     Revised Date:  2012-08-24    
Medline Journal Info:
Nlm Unique ID:  8503886     Medline TA:  J Hepatol     Country:  England    
Other Details:
Languages:  eng     Pagination:  1117-22     Citation Subset:  IM    
Copyright Information:
Copyright © 2010 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.
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MeSH Terms
Acetylcysteine / administration & dosage,  therapeutic use*
Combined Modality Therapy
Enteral Nutrition*
Free Radical Scavengers / administration & dosage,  therapeutic use*
Hepatitis, Alcoholic / drug therapy*,  therapy*
Hepatorenal Syndrome / prevention & control
Kaplan-Meier Estimate
Middle Aged
Oxidative Stress / drug effects
Single-Blind Method
Reg. No./Substance:
0/Free Radical Scavengers; 616-91-1/Acetylcysteine

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