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. 2017 Mar 31;2017(3):CD011646. doi: 10.1002/14651858.CD011646.pub2

Depew 1980.

Methods Randomised clinical trial
Participants Country: USA.
 Number randomised: 28.
 Post‐randomisation dropouts: 0 (0%).
 Revised sample size: 28.
 Average age: 49 years.
 Females: 12 (42.9%).
 Inclusion criteria: 1. Alcohol abusers. 2. Clinical diagnosis of severe acute alcoholic hepatitis manifested by hepatomegaly, leucocytosis and a serum bilirubin greater than 5 mg/dL. 3. Spontaneous hepatic encephalopathy in the absence of gastrointestinal haemorrhage, sedation, diuretic usage, or major electrolyte disturbances.
 Exclusion criteria: 1. Severe diabetes. 2. Active tuberculosis. 3. Serious bacterial infection.
Interventions Participants were randomly assigned to two groups.
 Group 1 (n = 15): glucocorticosteroids (prednisolone 40 mg once daily).
 Group 2 (n = 13): placebo.
 Duration: 28 days followed by tapered withdrawal over the ensuing 14 days
Outcomes mortality, adverse events, decompensated cirrhosis.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "all patients fulfilling the criteria who gave informed consent were randomised into two treatment protocols".
 Comment: Further details were not available.
Allocation concealment (selection bias) Unclear risk Comment: this information was not available.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "neither the principal investigator nor the physicians attending the patients were aware of the identity of the coded drugs".
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: Further details were not available.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: there were no post‐randomisation dropouts.
Selective reporting (reporting bias) Low risk Comment: all important outcomes were reported.
For‐profit bias Unclear risk Comment: this information was not available.
Other bias Low risk Comment: there was no other bias.