Campra 1973.

Methods	Prospective randomised control trial Country: USA Date: 1971 Intention‐to‐treat analysis: no Sample size calculation: not reported
Participants	Demographic characteristics Age (mean): prednisolone group 43.1 (SD 11.1) years; control group 42.7 (SD 8.1) years Sex: prednisolone group: 40 (8%) men; control group: 35 (9%) men Inclusion criteria and degree of severity Clinical diagnosis of severe acute alcoholic liver disease, absence of contraindication to corticosteroids therapy, no history of liver disease. Liver biopsy not required for inclusion since some participants had prothrombin time < 50% of normal value. Severity of disease: no clear definition Exclusion criteria People with other known illness or illnesses Randomisation procedure Previously prepared sealed envelopes Number of participants randomised: 50 participants entered trial, but 5 subsequently withdrawn when additional data favoured another diagnosis. 45 analysed (see 'Risk of bias' table). Prednisolone group: n = 20 Control group: n = 25
Interventions	Experimental group: oral prednisone 0.5 mg/kg bodyweight daily for 3 weeks; then 0.25 mg/kg bodyweight daily for 3 weeks Control group: no intervention Additional interventions to the trial groups: vitamin supplements, folic acids; high calorie, high protein diet if tolerated. In people with encephalopathy, protein intake was reduced to 20 g or 40 g and neomycin 500 mg 4 times daily was given. In case of bleeding, vomiting, and extreme anorexia, people received 5% or 10% dextrose solutions. Duration of treatment: 6 weeks Duration of follow‐up: hospital stay after randomisation: prednisolone group: 42–92 days, mean 47 days; control group: 43–95 days, mean 48 days
Outcomes	Mortality Liver biochemistry Liver histology Adverse events
Notes	Letter sent to authors in March 2000. AG Redeker answered in January 2001 (see the 'Risk of bias' table)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "… using previously prepared sealed envelopes, patients were randomly allocated to one of the two treatment groups."
Allocation concealment (selection bias)	Low risk	Information obtained through personal communication with the authors in 2001 read: "they [envelopes] were never in the possession of the investigators, but were kept by the department secretary who opened them upon request." However, the publication reads: "using previously prepared sealed envelopes, patients were randomly allocated to one of the two treatment groups."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "the trial was not double blind."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "… all statistical analyses and interpretation were done under supervision of Dr. John Weiner of the Department of Biostatics, University of Southern California School of Medicine."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "50 patients entered the trial, but five were subsequently withdrawn when additional data favoured another diagnosis. In one case (group 2), jaundice proved to be caused by hepatitis B … the patient died … 2 of these patients were in group 2, one patient in group 1; all survived. The fifth patient was removed from the trial when peptic ulcer was diagnosed after 15 days of prednisolone therapy." Total: prednisolone group: n = 22; control group: n = 28
Selective reporting (reporting bias)	Low risk	No protocol available. However, all‐cause mortality, serious adverse events, and liver‐related mortality were reported.
Other bias	Low risk	Not suspected