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. 2019 Apr 9;2019(4):CD001511. doi: 10.1002/14651858.CD001511.pub4

Theodossi 1982.

Methods Randomised controlled trial
Country: UK
Intention‐to‐treat analysis: no
Sample size calculation: not reported
Participants Demographic characteristics
Age: not mentioned
Sex: prednisolone group: 19 men/8 women; control group: 12 men/16 women
Inclusion criteria and degree of severity
Patients had to satisfy the following criteria: history of alcohol intake ≥ 80 g/day for ≥ 5 years; serum bilirubin > 80 pmol/L (normal up to 20 µmol/L); serum AST level ≥ 2 × upper limit of normal (normal up to 40 IU/L); prothrombin time prolonged by ≥ 9 seconds. Gastrointestinal bleeding, renal failure, and sepsis did not invalidate entry.
Exclusion criteria
Hepatoma and other diseases such as recent myocardial infarction, accompanying cerebrovascular accident including evidence of subdural haematoma, and active tuberculosis
Randomisation procedure
Random sealed envelope
Number of participants: 60 (55 analysed). Referred from other hospitals because of the severity of their illness. 5 excluded from the analyses because of doubts in initial diagnosis
Prednisolone group: n = 28 (analysed n = 27)
Control group: n = 32 (analysed n = 28)
Interventions Prednisolone group: intravenous methylprednisolone 1 g daily (equivalent to 1.25 g prednisolone) for 3 days
Control group: no intervention
Additional treatment: participants who were too ill to take the standard hospital diet received a ≥ 2000 calories as intravenous 20% glucose. Encephalopathy treated with protein restriction (maximum of 20 g/day), lactulose (15–30 mL twice daily), and daily magnesium sulphate enemas
Duration of treatment: 3 days
Duration of follow‐up: little difference between groups in mean length of stay in hospital (prednisolone group: 24.2 days; control group: 28.1 days)
Outcomes Mortality
Liver biochemistry
Adverse events
Notes Letter sent to study authors in March 2000. No answer received
Quote: "Of the 60 patients who satisfied the entry criteria, one in the treatment group and four in the control group were excluded from the final analysis because subsequent findings in four cases cast doubt on the initial diagnosis, and one patient was later found to have been given corticosteroids at the referring hospital. Thus there were 27 patients in the treatment and 28 in the control group."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Patients … referred from other hospitals because of the severity of their illness. Patients were allocated by random sealed envelope technique to a control or treatment group …"
Allocation concealment (selection bias) Low risk Quote: "Patients were allocated by random sealed envelope technique to a control or treatment group, …"
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not blinded
Quote: "Patients were allocated by random sealed envelope technique to a control or treatment group, the latter receiving intravenous methylprednisolone 1 g daily for three days."
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not described
Incomplete outcome data (attrition bias) 
 All outcomes High risk 8%
Quote: "Of the 60 patients who satisfied the entry criteria, one in the treatment group and four in the control group were excluded from the final analysis because subsequent findings in four cases cast doubt on the initial diagnosis, and one patient was later found to have been given corticosteroids at the referring hospital. Thus, there were 27 patients in the treatment and 28 in the control group."
Prednisolone group: 1/28; control group: 4/32
Selective reporting (reporting bias) Low risk No protocol available. However, all‐cause mortality, serious adverse events, and liver‐related mortality were reported.
Other bias Low risk None suspected