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. |