Evidence map›Paper›PMID 23958271›Full record

Trial reportTrials2013

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

Ewan Forrest, Jane Mellor, Louise Stanton, Megan Bowers, Priscilla Ryder, Andrew Austin, Christopher Day, Dermot Gleeson, John O'Grady, Steven Masson and 7 more

Open access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 4 pooled it
6.6field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 4 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Pooled it
  2. Glucocorticosteroids for people with alcoholic hepatitis.The Cochrane database of systematic reviews · 2019
    Pooled it
  3. Glucocorticosteroids for people with alcoholic hepatitis.The Cochrane database of systematic reviews · 2017
    Pooled it
  4. Diagnosis and Treatment of Alcoholic Hepatitis: A Systematic Review.Alcoholism, clinical and experimental research · 2016
    Pooled it
  5. Trial
  6. Trial
  7. Observational
  8. Article
  9. Review
  10. Article
  11. Article
  12. Alcoholic liver disease: Current insights into cellular mechanisms.World journal of biological chemistry · 2021
    Review
  13. Review
  14. Article
  15. Review
  16. Article
  17. Article
  18. Predictors of 90-day mortality in patients with severe alcoholic hepatitis: Experience with 183 patients at a tertiary care center from India.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2018
    Article
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 13 institutions in 1 country.

Ewan ForrestHepatology Section, Imperial College, Norfolk Place, London, Paddington W2 1NY, UK. m.thursz@imperial.ac.uk.
Jane Mellor
Louise Stanton
Megan Bowers
Priscilla Ryder
Andrew Austin
Christopher Day
Dermot Gleeson
John O'Grady
Steven Masson
Anne McCune
David Patch
Paul Richardson
Paul Roderick
Stephen Ryder
Mark Wright
Mark Thursz
Southampton General Hospital · GBGlasgow Royal Infirmary · GBUniversity of Southampton · GBAt Bristol · GBFreeman Hospital · GBImperial College London · GBNewcastle University · GBQueen's Medical Centre · GBRoyal Derby Hospital · GBRoyal Hallamshire Hospital · GBRoyal Liverpool University Hospital · GBThe Royal Free Hospital · GBUniversity of Cambridge · GB

Funding

Cancer Research UK 15956Department of Health 08/14/44Department of Health HTA/08/14/44
6 · The paper itself

Abstract

backgroundAlcoholic 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/

designSTOPAH 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. 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.

trial registrationEudraCT reference number: 2009-013897-42 ISRCTN reference number: ISRCTN88782125.

Indexed as

Research DesignClinical ProtocolsDouble-Blind MethodFatty Liver, AlcoholicGlucocorticoidsHumansKaplan-Meier EstimatePentoxifyllinePrednisoloneRisk FactorsSeverity of Illness IndexTime FactorsTreatment OutcomeUnited KingdomGlucocorticoidsPentoxifyllinePrednisolone

Identifiers

PMID23958271
PMCPMC3766225
OpenAlexW1985808363

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.