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 |