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Steroids or pentoxifylline for alcoholic hepatitis (STOPAH): study protocol for a randomised controlled trial

Lookup NU author(s): Professor Chris Day, Dr Steven Masson

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Abstract

Background: Alcoholic hepatitis is the most florid presentation of alcohol-related liver disease. In its severe form, defined by a Maddrey's discriminant function (DF) >= 32, the 28-day mortality rate is approximately 35%. A number of potential treatments have been subjected to clinical trials, of which two, corticosteroids and pentoxifylline, may have therapeutic benefit. The role of corticosteroids is controversial as trial results have been inconsistent, whereas the role of pentoxifylline requires confirmation as only one previous placebo-controlled trial has been published. Methods/design: STOPAH is a multicentre, double-blind, factorial (2 x 2) trial in which patients are randomised to one of four groups: 1. Group A: placebo / placebo 2. Group B: placebo / prednisolone 3. Group C: pentoxifylline / placebo 4. Group D: pentoxifylline / prednisolone The trial aims to randomise 1,200 patients with severe alcoholic hepatitis, in order to provide sufficient power to determine whether either of the two interventions is effective. The primary endpoint of the study is mortality at 28 days, with secondary endpoints being mortality at 90 days and 1 year. Discussion: STOPAH aims to be a definitive study to resolve controversy around the existing treatments for alcoholic hepatitis. Eligibility criteria are based on clinical parameters rather than liver biopsy, which are aligned with standard clinical practice in most hospitals. The use of a factorial design will allow two treatments to be evaluated in parallel, with efficient use of patient numbers to achieve high statistical power.


Publication metadata

Author(s): Forrest E, Mellor J, Stanton L, Bowers M, Ryder P, Austin A, Day C, Gleeson D, O'Grady J, Masson S, McCune A, Patch D, Richardson P, Roderick P, Ryder S, Wright M, Thursz M

Publication type: Article

Publication status: Published

Journal: Trials

Year: 2013

Volume: 14

Print publication date: 19/08/2013

Date deposited: 26/02/2014

ISSN (electronic): 1745-6215

Publisher: BioMed Central Ltd

URL: http://dx.doi.org/10.1186/1745-6215-14-262

DOI: 10.1186/1745-6215-14-262


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Funding

Funder referenceFunder name
Imperial NIHR Biomedical Research Centre
08/14/44NIHR-HTA

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