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A randomized trial of antioxidant therapy alone or with corticosteroids in acute alcoholic hepatitis

Lookup NU author(s): Dr Martin Prince, Professor Margaret Bassendine, Dr Mark Hudson, Emeritus Professor Oliver James, Professor David Jones, Dr Christopher Record, Professor Chris Day

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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. © 2007 European Association for the Study of the Liver.

Publication metadata

Author(s): Stewart S, Prince M, Bassendine M, Hudson M, James O, Jones D, Record C, Day CP

Publication type: Article

Publication status: Published

Journal: Journal of Hepatology

Year: 2007

Volume: 47

Issue: 2

Pages: 277-283

Print publication date: 01/08/2007

ISSN (print): 0168-8278

ISSN (electronic): 1600-0641

Publisher: Elsevier BV

URL: http://dx.doi.org/10.1016/j.jhep.2007.03.027

DOI: 10.1016/j.jhep.2007.03.027

PubMed id: 17532088

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