Methods |
Randomised clinical trial |
Participants |
Country: UK.
Number randomised: 60.
Post‐randomisation dropouts: 5 (8.3%).
Revised sample size: 55.
Average age: not stated
Females: 24 (43.6%).
Inclusion criteria: 1. History of alcohol intake of 80 g or more daily for at least 5 years. 2. Serum bilirubin concentration greater than 80 μmol/L. 3. Serum aspartate transferase at least twice the upper limit of normal. 4. Prothrombin time prolonged by at least nine seconds.
Exclusion criteria: 1. Hepatoma. 2. Recent myocardial infarction. 3. Accompanying cerebrovascular accident including evidence of subdural haematoma. 4. Active tuberculosis. |
Interventions |
Participants were randomly assigned to two groups.
Group 1 (n = 27): glucocorticosteroids (methylprednisolone 1 g intravenous daily).
Group 2 (n = 28): no intervention.
Duration: 3 days |
Outcomes |
mortality, adverse events. |
Notes |
Reasons for post‐randomisation dropouts: group 1: 1, Group 2: 4 (previous steroids, doubtful diagnosis). |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Quote: "patients were allocated by random sealed envelope".
Comment: Further details were not available. |
Allocation concealment (selection bias) |
Low risk |
Quote: "random sealed envelopes". |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Quote: "patients were allocated to a control or treatment group". |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Comment: this information was not available. |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Quote: "5 patients were not included in the analysis".
Comment: there were 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. |