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. 2019 Apr 9;2019(4):CD001511. doi: 10.1002/14651858.CD001511.pub4

Bories 1987.

Methods Randomised controlled trial
Country: France
Dates: 1979–1982
Intention‐to‐treat analysis: yes
Sample size calculation: not reported.
Participants Demographic characteristics
Age (mean): prednisolone group: 41 years (range 26 to 68 years); control group: 49 years (range 30 to 70 years)
Sex: prednisolone group: 16 men and 8 women; control group: 11 men and 10 women
Inclusion criteria and degree of severity
Not stated clearly, but mean level of bilirubin ≥ 147 (SD 30.78) mmol/L
Alcohol consumption: men: 155 (SD 46) g/day; women: 140 (SD 32) g/day
Exclusion criteria
48 excluded due to infections (n = 45), diabetes (n = 2), and tuberculosis (n = 1)
Randomisation procedure
Random number table
Number of participants randomised: 45
Prednisolone group: n = 24
Control group: n = 21
Interventions Experimental group: oral prednisolone 40 mg/day
Control group: no intervention
Additional interventions to the trial groups: 1500 calories and protein 50 g/day. Encephalopathy treated with lactulose and neomycin. In case of infection, participants received antibiotics.
Duration of treatment: 1 month
Duration of follow‐up: 3 months after randomisation
Outcomes 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 Quote: "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 No protocol available. However, all‐cause mortality, serious adverse events, and liver‐related mortality were reported.
Other bias Low risk None suspected