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. 2017 Nov 2;2017(11):CD001511. doi: 10.1002/14651858.CD001511.pub3
Methods A randomised clinical trial with a cross‐over design
Intention to‐treat analysis: not mentioned
Sample size calculation was not reported
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
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)
Outcomes The trial outcomes were:
  • Mortality

  • Liver biochemistry

Notes Country: France.
Letter sent to study authors in 2006. No answer received.
Only published as abstract
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