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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.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods\/design<\/jats:title>\n            <jats:p>STOPAH is a multicentre, double-blind, factorial (2 \u00d7 2) trial in which patients are randomised to one of four groups:<\/jats:p>\n            <jats:p>\n              <jats:list list-type=\"order\">\n                <jats:list-item>\n                  <jats:p>Group A: placebo \/ placebo<\/jats:p>\n                <\/jats:list-item>\n                <jats:list-item>\n                  <jats:p>Group B: placebo \/ prednisolone<\/jats:p>\n                <\/jats:list-item>\n                <jats:list-item>\n                  <jats:p>Group C: pentoxifylline \/ placebo<\/jats:p>\n                <\/jats:list-item>\n                <jats:list-item>\n                  <jats:p>Group D: pentoxifylline \/ prednisolone<\/jats:p>\n                <\/jats:list-item>\n              <\/jats:list>\n            <\/jats:p>\n            <jats:p>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.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Discussion<\/jats:title>\n            <jats:p>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.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Trial registration<\/jats:title>\n            <jats:p>EudraCT reference number: 2009-013897-42<\/jats:p>\n            <jats:p>ISRCTN reference number: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/www.controlled-trials.com\/ISRCTN88782125\/stopah\" ext-link-type=\"uri\">ISRCTN88782125<\/jats:ext-link>\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1186\/1745-6215-14-262","type":"journal-article","created":{"date-parts":[[2013,8,19]],"date-time":"2013-08-19T12:14:37Z","timestamp":1376914477000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":68,"title":["Steroids or pentoxifylline for alcoholic hepatitis (STOPAH): study protocol for a randomised controlled trial"],"prefix":"10.1186","volume":"14","author":[{"given":"Ewan","family":"Forrest","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jane","family":"Mellor","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Louise","family":"Stanton","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Megan","family":"Bowers","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Priscilla","family":"Ryder","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Austin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher","family":"Day","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dermot","family":"Gleeson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"O\u2019Grady","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven","family":"Masson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne","family":"McCune","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Patch","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Richardson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Roderick","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen","family":"Ryder","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Wright","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Thursz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2013,8,19]]},"reference":[{"key":"1468_CR1","volume-title":"Can the NHS afford it? 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