A Randomized Trial of Antioxidant Therapy Alone or With Corticosteroids in Acute Alcoholic Hepatitis

J Hepatol. 2007 Aug;47(2):277-83. doi: 10.1016/j.jhep.2007.03.027. Epub 2007 May 4.

Abstract

Background/aims: Oxidative stress is putatively involved in the pathogenesis of alcohol-induced liver injury. This trial was devised to determine whether antioxidant therapy, alone or as an adjunct to corticosteroids, improved survival in patients with acute alcoholic hepatitis.

Methods: Patients with a severe alcoholic hepatitis were stratified by sex and steroid use, and then randomized. The active group received N-acetylcysteine for one week, and vitamins A-E, biotin, selenium, zinc, manganese, copper, magnesium, folic acid and Coenzyme Q daily for 6 months. The trial was double blinded and placebo controlled. The primary end-point was mortality within 6 months.

Results: Thirty-six (20 male, 16 female; mean discriminant function (DF) 86.6) received active drug, and 34 (18 male, 16 female; mean DF 76.4) received placebo. 180-day survival was not significantly different between patients receiving drug and placebo (52.8% vs. 55.8%, p=0.699). This was not affected by stratification for steroid use or sex. The only predictors of survival in multivariate analysis were initial bilirubin (p=0.017), white cell count (p=0.016) and age (p=0.037). Treatment allocation did not affect survival in multivariate analysis (p=0.830).

Conclusions: Antioxidant therapy, alone or in combination with corticosteroids, does not improve 6-month survival in severe alcoholic hepatitis.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acute Disease
  • Adrenal Cortex Hormones / adverse effects
  • Adrenal Cortex Hormones / therapeutic use*
  • Adult
  • Age Factors
  • Antioxidants / therapeutic use*
  • Bilirubin / blood
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Hepatitis, Alcoholic / blood
  • Hepatitis, Alcoholic / drug therapy*
  • Hepatitis, Alcoholic / mortality
  • Hepatitis, Alcoholic / physiopathology
  • Humans
  • Leukocyte Count
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Predictive Value of Tests
  • Severity of Illness Index
  • Survival Analysis
  • Treatment Failure

Substances

  • Adrenal Cortex Hormones
  • Antioxidants
  • Bilirubin