Bories 1987.
Methods | Randomised controlled trial Country: France Dates: 1979–1982 Intention‐to‐treat analysis: yes Sample size calculation: not reported. |
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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 |
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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 |
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Outcomes | Mortality Liver histology Adverse events |
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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 |