Campra 1973

Methods	A prospective randomised control trial Country: USA, 1971 Analyses were not performed according to intention‐to‐treat method Sample size calculation was not reported
Participants	Demographic characteristics Age: (mean + SD): prednisolone/control group 43.1 + 11.1/42.7 + 8.1 Sex: male (%): prednisolone/control group: 8% (40)/9% (35) Inclusion criteria and degree of severity ".....a clinical diagnosis of severe acute alcoholic liver disease, absence of contraindication to corticosteroids therapy, absence of a prior history of liver disease." Liver biopsy was not required for admission in the trial since some participants had prothrombin time < 50% of normal value. No clear definition of severity criteria used Exclusion criteria Participants with other known illness or illnesses Randomisation procedure "...by using previously prepared sealed envelopes, patients were randomly allocated to one of the two treatment groups" Number of participants randomised "50 patients entered the trial, but 5 were subsequently withdrawn when additional data favoured another diagnosis.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". Prednisolone group: n = 22 (20) Control group: n = 28 (25) Analyses of 45 participants: 20 prednisolone + 25 control
Interventions	Experimental group: oral prednisone Dose: 0.5 mg/kg body weight daily, during 3 weeks; and then 0.25 mg/kg body weight, daily, for additional 3 weeks Control group: no intervention Additional interventions to the trial groups: vitamin supplements, folic acids; "high calorie, high protein diet was given if tolerated .......In patients with encephalopathy, protein intake was reduced to 20 or 40 g..... and neomycin 500 x 4 times daily was given. ...In case of bleeding , vomiting and extreme anorexia, 5% or 10% solutions of dextrose in water was administered." Duration of treatment: 6 weeks Duration of follow‐up: "hospital stay after randomisation ranged between 42 and 92 days, with a mean of 47 days, for group 1; and between 43 and 95 days, with a mean of 48 days, for group 2."
Outcomes	The trial outcomes were: 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	"...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 reads: "they 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	"the trial was not double blind"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	".. 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	"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". 0/22 prednisolone group/control group 0/28
Selective reporting (reporting bias)	Low risk	All‐cause mortality, serious adverse events, and liver‐related mortality were reported
For‐profit bias	Unclear risk	Not reported
Other bias	Low risk	Not suspected