title: Enteral nutrition with or without N-acetylcysteine in the treatment of severe acute alcoholic hepatitis: a randomized multicenter controlled trial.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium. christophe.moreno@erasme.ulb.ac.be
authors.forename: Christophe
authors.initials: C
authors.lastname: Moreno
authors.forename: Philippe
authors.initials: P
authors.lastname: Langlet
authors.forename: Axel
authors.initials: A
authors.lastname: Hittelet
authors.forename: Luc
authors.initials: L
authors.lastname: Lasser
authors.forename: Delphine
authors.initials: D
authors.lastname: Degré
authors.forename: Sylvie
authors.initials: S
authors.lastname: Evrard
authors.forename: Isabelle
authors.initials: I
authors.lastname: Colle
authors.forename: Arnaud
authors.initials: A
authors.lastname: Lemmers
authors.forename: Jacques
authors.initials: J
authors.lastname: Devière
authors.forename: Olivier
authors.initials: O
authors.lastname: Le Moine
mesh_terms: D000111:Acetylcysteine / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D003131:Combined Modality Therapy; D004750:Enteral Nutrition; D005260:Female; D016166:Free Radical Scavengers / Q000008:administration & dosage / Q000627:therapeutic use*; D006519:Hepatitis, Alcoholic / Q000188:drug therapy* / Q000628:therapy*; D006530:Hepatorenal Syndrome / Q000517:prevention & control; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D018384:Oxidative Stress / Q000187:drug effects; D016037:Single-Blind Method
chemical_list: D016166:Free Radical Scavengers; D000111:Acetylcysteine