Helman 1971.

Methods	Randomised controlled trial Country: USA Intention‐to‐treat analysis: yes Sample size calculation: not reported
Participants	Demographic characteristics Age (mean): 47.8 years (range 30–67 years) Sex: 12 men and 25 women Inclusion criteria and degree of severity Diagnosis of alcoholic hepatitis confirmed by percutaneous needle biopsy. 70% of participants had anaemia on admission attributed to folate deficiency, blood loss, alcoholism, and haemolysis Exclusion criteria Biopsy could not be obtained within the first week of hospitalisation, gastrointestinal bleeding requiring transfusion, or if PPD was positive. Authors reported that participants were classified into three groups, according to clinical severity of their disease. Quote: "Group I were severely ill – manifesting precoma or coma, group 2 were moderately ill, but no evidence of encephalopathy, group 3 were asymptomatic ambulatory patients." Randomisation procedure Random, double‐blind technique. Determined by hospital pharmacist, without informing physicians, nurses, or patients until completion of the study Number of participants randomised: 37, divided in 3 groups according to severity of disease Prednisolone group: n = 20 Control group: n = 17
Interventions	Experimental group: prednisolone 40 mg daily Control group: daily lactose placebo Additional intervention: bed rest, high‐protein (100 g) and high‐calorie diet (3000 kcal) when tolerated and vitamin supplementation including folic acid. Sodium restriction instituted and all participants with ascites and oedema were treated with diuretics. Duration of treatment: 6 weeks: 4 weeks and 2‐week period tapered Duration of follow‐up after randomisation: 4 months
Outcomes	Mortality Liver biochemistry Liver histology Adverse events
Notes	Quote: "tablets 40 mg of prednisolone daily or lactose placebo (provided by Upjohn Co, Kalamazoo, Mich)." Letter sent to authors in March 2000. No answer received
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described. Quote: "patients were selected by a random, double‐blind technique …"
Allocation concealment (selection bias)	Low risk	Quote: "Drug treatment was randomly determined by the hospital pharmacist, without informing physicians, nurses, or patients until completion of the study."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "… The treatment code was broken during the study in only one case because of a medical emergency."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	No withdrawals or dropouts
Selective reporting (reporting bias)	High risk	No protocol available. However, all‐cause mortality and liver‐related mortality were reported.
Other bias	Low risk