Theodossi 1982

Methods	A randomised controlled trial Analyses were not by intention‐to‐treat method. Sample size calculation was not reported.
Participants	Demographic characteristics: Sex: men/women prednisolone group: 19/8, control group 12/16 Age: not mentioned Inclusion criteria and degree of severity: "patients had to satisfy the following criteria: ‐ a history of alcohol intake of about 80 g or more daily for at least five years, ‐ a serum bilirubin concentration greater than 80 pmol/l (normal up to 20 timol/L), ‐ a serum aspartate transaminase level at least twice the upper limit of normal (normal up to 40 IU/1), ‐ a prothrombin time prolonged by at least nine seconds." "Gastrointestinal bleeding, renal failure, and sepsis did not invalidate entry." Exclusion criteria: "Patients with hepatoma and those with other diseases such as recent myocardial infarction, an accompanying cerebrovascular accident including evidence of subdural hematoma, and active tuberculosis" Randomisation procedure "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..." Number of patients: 60 (55). They were referred from other hospitals because of the severity of their illness (after excluded patients from the analyses because of doubts in initial diagnosis) Prednisolone group: n = 28 (27) Control group: n = 32 (28)
Interventions	Prednisolone group: intravenous methylprednisolone 1 g daily for three days Dose: 1.25 g prednisolone Control group: no intervention Additional treatment: "Patients who were too ill to take the standard hospital diet received a minimum of 2000 calories as intravenous 20% glucose. Encephalopathy was treated with protein restriction (maximum of 20 g/day), lactulose (15 to 30 mL twice daily), and daily magnesium sulphate enemas" Duration of treatment: 3 days Duration of follow‐up: "there was a little difference between the groups in the mean length of stay in hospital (treatment group 24.2 days and control group 28.1 days)"
Outcomes	The trial outcomes were: Mortality Liver biochemistry Adverse events
Notes	Country: UK Letter sent to study authors in March 2000. No answer received "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	Not described
Allocation concealment (selection bias)	Low risk	"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 "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% "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." 1/28 prednisolone and 4/32 control group
Selective reporting (reporting bias)	Low risk	All‐cause mortality, serious adverse events, and liver‐related mortality were reported.
For‐profit bias	Unclear risk	Not reported
Other bias	Low risk	None suspected