Antioxidants versus corticosteroids in the treatment of severe alcoholic hepatitis--a randomised clinical trial.
OBJECTIVE
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.
Institute of Liver Studies, King's College Hospital, Denmark Hill, London SE5 9RS, UK.
Martin
M
Phillips
Howard
H
Curtis
Bernard
B
Portmann
Nora
N
Donaldson
Adrian
A
Bomford
John
J
O'Grady
D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000975:Antioxidants / Q000627:therapeutic use*; D016001:Confidence Intervals; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D006519:Hepatitis, Alcoholic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011239:Prednisolone / Q000627:therapeutic use; D012044:Regression Analysis; D018805:Sepsis / Q000175:diagnosis / Q000209:etiology; D012720:Severity of Illness Index; D015996:Survival Rate; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D000975:Antioxidants; D005938:Glucocorticoids; D011239:Prednisolone