Thursz 2015.

Methods	Randomised clinical trial
Participants	Country: UK. Number randomised: 1103. Post‐randomisation dropouts: 11 (0.99%). Revised sample size: 1092. Average age: 49 years. Females: 407 (37.2%). Inclusion criteria: 1. Clinical diagnosis of alcoholic hepatitis (history of recent excess alcohol consumption and the absence of other causes of liver disease). 2. Age of 18 years or older. 3. An average alcohol consumption of more than 80 g per day for men and more than 60 g per day for women. 4. A serum bilirubin level greater than 80 μmol per litre (4.7 mg per dL). 5. A discriminant function of 32 or higher. Exclusion criteria: 1. Jaundice for more than 3 months. 2. Cessation of alcohol consumption for more than 2 months before randomisation. 3. The presence of other causes of liver disease. 4. A serum aspartate aminotransferase level greater than 500 IU per litre or serum alanine transaminase level greater than 300 IU per litre. 5. Previous entry into the study within the preceding 6 months.
Interventions	Participants were randomly assigned to four groups. Group 1 (n = 273): glucocorticosteroids (prednisolone 40 mg once daily) plus pentoxifylline 400 mg thrice daily. Group 2 (n = 272): placebo plus placebo. Group 3 (n = 274): glucocorticosteroids (prednisolone 40 mg one daily) plus placebo. Group 4 (n = 273): pentoxifylline 400 thrice daily plus placebo. Duration: 28 days
Outcomes	mortality, adverse events, decompensated cirrhosis.
Notes	Reasons for post‐randomisation dropouts: group 1 (Combination group): 1 (incorrect randomisation). Group 2 (placebo‐placebo): 4 (incorrect randomisation). Group 3 (prednisolone/placebo): 3 (1 incorrect randomisation, 2 no usage of data). Group 4 (Pentoxifylline/placebo): 3 (1 incorrect randomisation, 2 no usage of data).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "A Web‐based computer system (Tenalea, Forms‐ Vision) was used to enrol eligible patients and randomly assign them to study groups".
Allocation concealment (selection bias)	Low risk	Quote: "Randomization was performed with a block size of four, with stratification according to geographic area and risk category".
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "STOPAH was a multicenter, randomised, double‐blind trial".
Blinding of outcome assessment (detection bias) All outcomes	Low risk	This information was not available.
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: there were post‐randomisation dropouts. 5 not considered for the analysis
Selective reporting (reporting bias)	Low risk	Comment: all important outcomes were reported.
For‐profit bias	Low risk	Quote: "Supported by a grant (08 14 44) from the National Institute for Health Research (NIHR) Health Technology Assessment program".
Other bias	Low risk	Comment: there was no other bias.