Methods | A randomised clinical trial with a cross‐over design Intention to‐treat analysis: not mentioned Sample size calculation was not reported |
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Participants |
Demographic characteristics: no information. Inclusion criteria and degree of severity: non‐infected patients with histologically proven alcoholic hepatitis. All patients had severe hepatic failure (prothrombin time < 50%, or bilirubin > 5.6 mg/dL, or encephalopathy) Number of participants randomised: 23 Glucocorticosteroid group: 12 participants Placebo group: 11 participants |
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Interventions |
Prednisolone group: prednisolone 40 mg daily Control group: placebo 40 mg daily Duration of treatment: Prednisolone group: 1 week of treatment followed by one week of no treatment Control group: 1 week of no treatment followed by one week of treatment After that, both groups received glucocorticosteroids for three weeks. Duration of follow‐up: at discharge from hospital (three months) |
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Outcomes | The trial outcomes were:
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Notes | Country: France. Letter sent to study authors in 2006. No answer received. Only published as abstract |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information |
Selective reporting (reporting bias) | Unclear risk | No information |
For‐profit bias | Unclear risk | Not reported |
Other bias | Unclear risk | No information |