Skip to main content
. 2017 Mar 31;2017(3):CD011646. doi: 10.1002/14651858.CD011646.pub2

Theodossi 1982.

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.