title: A randomized trial of antioxidant therapy alone or with corticosteroids in acute alcoholic hepatitis.
abstract: OBJECTIVE
  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.
authors.affiliation: Liver Research Group, Institute of Cellular Medicine, Medical School, Newcastle University, Newcastle upon Tyne NE2 4HH, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Stewart
authors.forename: Martin
authors.initials: M
authors.lastname: Prince
authors.forename: Margaret
authors.initials: M
authors.lastname: Bassendine
authors.forename: Mark
authors.initials: M
authors.lastname: Hudson
authors.forename: Oliver
authors.initials: O
authors.lastname: James
authors.forename: David
authors.initials: D
authors.lastname: Jones
authors.forename: Chris
authors.initials: C
authors.lastname: Record
authors.forename: Christopher P
authors.initials: CP
authors.lastname: Day
mesh_terms: D000208:Acute Disease; D000305:Adrenal Cortex Hormones / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000367:Age Factors; D000975:Antioxidants / Q000627:therapeutic use*; D001663:Bilirubin / Q000097:blood; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006519:Hepatitis, Alcoholic / Q000097:blood / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D006801:Humans; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011237:Predictive Value of Tests; D012720:Severity of Illness Index; D016019:Survival Analysis; D017211:Treatment Failure
chemical_list: D000305:Adrenal Cortex Hormones; D000975:Antioxidants; D001663:Bilirubin