Mendenhall 1977

Methods	A prospective, randomised clinical trial (three intervention groups) Country: USA Intention‐to‐treat analysis: not mentioned Sample size calculation was not reported.
Participants	Demographic characteristics Age: not reported Sex: not reported; most probably men as they came from V.A. (Veteran Affairs) Medical Centers Inclusion criteria and degree of severity History of daily ethanol ingestion > 100 g/d for ≥ 1 year; Hepatomegaly (> 12 cm) and significant jaundice (bilirubin > 5 mg %) Liver biopsy was obtained in about 70% of participants to confirm the diagnosis Exclusion criteria Not described Randomisation procedure Not described, but mentioned that "regimens were chosen randomly and blinded so that neither physician nor patient was aware of the treatment modality" Number of participants randomised n = 46 29 (n = prednisolone and placebo) + 17 (n = oxandrolone) Prednisolone group: n = 12 (all severe alcoholic hepatitis) Control group: n = 17 (all severe alcoholic hepatitis)
Interventions	Experimental group: "prednisolone 60 mg/d x 5, then decreased over a 16 day period" Dose: 60 mg Placebo group: placebo Dose: unknown Additional treatment: supportive care Duration of treatment: 21 days Duration of follow‐up: at the moment of discharge
Outcomes	The trial outcomes were Mortality Liver biochemistry
Notes	Letter sent to study authors in 2006. No answer received. Only published as an abstract
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	".....regimens were chosen randomly"
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"blinded so that neither physician nor patient was aware of the treatment modality"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	"one additional mortality withdrew from the study on the 8 day" (not mentioned from what group out of 50 participants 17 participants were treated with oxandrolone
Selective reporting (reporting bias)	Low risk	All‐cause mortality was reported
For‐profit bias	Unclear risk	Not reported
Other bias	Low risk	None suspected