title: Steroids or pentoxifylline for alcoholic hepatitis (STOPAH): study protocol for a randomised controlled trial.
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
  STOPAH is a multicentre, double-blind, factorial (2 × 2) trial in which patients are randomised to one of four groups:1. Group A: placebo / placebo2. Group B: placebo / prednisolone3. Group C: pentoxifylline / placebo4. Group D: pentoxifylline / prednisoloneThe 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  EudraCT reference number: 2009-013897-42 ISRCTN reference number: ISRCTN88782125.
authors: Hepatology Section, Imperial College, Norfolk Place, London, Paddington W2 1NY, UK. m.thursz@imperial.ac.uk.
authors: Ewan
authors: E
authors: Forrest
authors: Jane
authors: J
authors: Mellor
authors: Louise
authors: L
authors: Stanton
authors: Megan
authors: M
authors: Bowers
authors: Priscilla
authors: P
authors: Ryder
authors: Andrew
authors: A
authors: Austin
authors: Christopher
authors: C
authors: Day
authors: Dermot
authors: D
authors: Gleeson
authors: John
authors: J
authors: O'Grady
authors: Steven
authors: S
authors: Masson
authors: Anne
authors: A
authors: McCune
authors: David
authors: D
authors: Patch
authors: Paul
authors: P
authors: Richardson
authors: Paul
authors: P
authors: Roderick
authors: Stephen
authors: S
authors: Ryder
authors: Mark
authors: M
authors: Wright
authors: Mark
authors: M
authors: Thursz
mesh_terms: D002985:Clinical Protocols; D004311:Double-Blind Method; D005235:Fatty Liver, Alcoholic / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D053208:Kaplan-Meier Estimate; D010431:Pentoxifylline / Q000627:therapeutic use*; D011239:Prednisolone / Q000627:therapeutic use*; D012107:Research Design; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D005938:Glucocorticoids; D011239:Prednisolone; D010431:Pentoxifylline
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