Antioxidants versus corticosteroids in the treatment of severe alcoholic hepatitis--a randomised clinical trial

J Hepatol. 2006 Apr;44(4):784-90. doi: 10.1016/j.jhep.2005.11.039. Epub 2005 Dec 20.


Background/aims: Severe alcoholic hepatitis is associated with high morbidity and short-term mortality. Corticosteroids are the only widely used therapy but established contraindications to treatment or the risk of serious side-effects limit their use. The perceived need for alternative treatments together with the theoretical benefits of anti-oxidant therapy triggered the design of a randomised clinical trial comparing these treatment modalities.

Methods: One hundred and one patients were randomized into a clinical trial of corticosteroids or a novel antioxidant cocktail with a primary endpoint of 30-day mortality.

Results: At 30 days there were 16 deaths (30%) in the corticosteroid treated group compared with 22 deaths (46%) in the antioxidant treated group (P=0.05). The odds of dying by 30 days were 2.4 greater for patients on antioxidants (95% confidence interval 1.0-5.6). A diagnosis of sepsis was made more frequently in the AO group (P=0.05), although microbiologically proven episodes of infection occurred more often in the CS group (P<0.01). The survival advantage for corticosteroid treated patients was lost at 1 year of follow-up (P=0.43).

Conclusions: This study has shown that corticosteroids in the form of prednisolone 30 mg daily are superior to a broad antioxidant cocktail in the treatment of severe alcoholic hepatitis.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adrenal Cortex Hormones / therapeutic use*
  • Adult
  • Aged
  • Antioxidants / therapeutic use*
  • Confidence Intervals
  • Female
  • Glucocorticoids / therapeutic use
  • Hepatitis, Alcoholic / complications
  • Hepatitis, Alcoholic / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Odds Ratio
  • Prednisolone / therapeutic use
  • Regression Analysis
  • Sepsis / diagnosis
  • Sepsis / etiology
  • Severity of Illness Index
  • Survival Rate
  • Treatment Outcome


  • Adrenal Cortex Hormones
  • Antioxidants
  • Glucocorticoids
  • Prednisolone