Bories 1987

Methods	Randomised controlled trial Country: France, 1979‐1982 Analyses were performed according to intention‐to‐treat method. Sample size calculation was not reported.
Participants	Demographic characteristics Age: prednisolone group: average 41 years old (26 to 68); control group: average 49 years old (30 to 70) Sex: 16 men and 8 women in the treatment group, and 11 men and 10 women in the control group Inclusion criteria and degree of severity Not stated clearly, but the average level of bilirubin was ≥ 147 + 30.78 mmol/L Alcohol consumption: 155 g + 46 g per day in men; 140 g + 32 g per day in women Exclusion criteria 48 patients were excluded due to infections (45 patients), diabetes (2 patients), and tuberculosis (1 patient). Randomisation procedure Random number table Number of participants randomised n = 45 Prednisolone group: n = 24 Control group: n = 21
Interventions	Experimental group: oral prednisolone Dose: 40 mg/d Control group: no intervention Additional interventions to the trial groups: 1500 calories and 50 g of protein/d. Encephalopathy was treated with lactulose and neomycin. In case of infection, participants were treated with antibiotics. Duration of treatment: 1 month Duration of follow‐up: 3 months after randomisation
Outcomes	The trial outcomes were: Mortality Liver histology Adverse events
Notes	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	"By random number table"
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not blinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts
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	None suspected