Mendenhall 1984.

Methods	Co‐operative, multicentre, randomised clinical trial (3 intervention groups) Country: USA Dates: 1980–1983 Intention‐to‐treat analysis: yes Sample size calculation: reported
Participants	Demographic characteristics Age (mean): prednisolone group: 51.5 (SD 8.2) years; control group 50.4 (SD 9.2) years Sex: 100% men Inclusion criteria and degree of severity Men hospitalised at 6 Veterans Administration Medical Centers in whom diagnosis of moderate or severe alcoholic hepatitis was based on conventional clinical and laboratory changes of this disease. Histological confirmation not required, so severely ill people not excluded. Severity classified by degree of jaundice (bilirubin) and coagulopathy (prothrombin time) Exclusion criteria Conditions that contradicted corticosteroid therapy: severe infections, active peptic ulcer disease, or insulin‐dependent diabetes mellitus, or if they had taken corticosteroids within the preceding 3 months; positive test for hepatitis B surface antigen; clinical or historical evidence of recent parenteral drug abuse, intractable congestive heart failure, neoplasms that commonly metastasise to the liver, or non‐alcoholic liver diseases Randomisation procedure Assignment made by Coordinating Center (Hines, Ill) was balanced within each hospital, and according to disease severity Number of participants randomised: 178 (prednisolone and placebo) + 85 (n = oxandrolone) Prednisolone group: n = 90 (moderate 46, severe 44) Control group: n = 88 (moderate 45, severe 43) Oxandrolone group: 85
Interventions	132 participants with moderate disease and 131 with severe disease were randomly assigned to 1 of 3 treatments: prednisolone, oxandrolone, or placebo Experimental group: prednisolone Dose: 60 mg/day for 4 days; 40 mg/day for 4 days; 30 mg/day for 4 days; 20 mg/day for 4 days; 10 mg/day for 7 days; 5 mg/day for 7 final days Control group: placebo Experimental group 2: oxandrolone (not included in the review) Duration of treatment: 30 days When possible, participants were evaluated monthly at outpatient clinics. If alcoholic hepatitis recurred and required rehospitalisation, the person was reassigned to the same therapy for 30 days with his permission. Duration of follow‐up after randomisation: 1 year (350 days for prednisolone group)
Outcomes	Mortality Liver complications Liver biochemistry Adverse events
Notes	Matching placebos prepared by Upjohn Company and G.D. Searle and Company.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Treatment assignment was made by the Coordinating Center (Hines, Ill.). The random assignment of treatments was balanced within each hospital, as well as according to disease severity."
Allocation concealment (selection bias)	Low risk	Quote: "Treatment assignment were made by the Coordinating Center (Hines, Ill)."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Medication was packed into unit dose kits at the Veterans Administration Center Pharmacy(Albuquerque, N.M.). The patient, physician and the local hospital pharmacy had no knowledge of the specific medication in use."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	4.5% Quote: "Ten patients withdrew from the study before completing treatment (5 given placebo, 3 prednisolone). However, these patients were included in the outcome assessment." Prednisolone group: 3/90; control group: 5/88 Quote: "324 days … 37 patients were lost to follow‐up: 13 given placebo, 11 prednisolone."
Selective reporting (reporting bias)	High risk	No protocol available. However, all‐cause mortality and liver‐related mortality were reported.
Other bias	Low risk	None suspected