Depew 1980.
Methods | Randomised, double‐blind, controlled clinical trial Country: USA Dates: 1977–1979 Study approved by the Human Experimentation Committee of the John Wesley County Hospital. Intention‐to‐treat analysis: yes Sample size calculation: reported |
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Participants |
Demographic characteristics Age (mean): prednisolone group: 49.8 (SD 2.1) years; control group: 48.2 (SD 2.3) years Sex: prednisolone group: 10 (67%) men; control group: 6 (43%) men Hepatic encephalopathy: prednisolone group: 100%; control group: 100% Ascites: prednisolone group: 87%; control group: 92% Inclusion criteria and degree of severity Alcohol abusers from lower socioeconomic strata with a clinical diagnosis of severe alcoholic hepatitis manifested by hepatomegaly, leukocytosis, and a serum bilirubin > 5 mg/dL, spontaneous hepatic encephalopathy occurring in absence of gastrointestinal haemorrhage, sedation, diuretic usage, or major electrolyte disturbances. Exclusion criteria Quote: "Severe diabetes, active tuberculosis, and serious bacterial infection prevented participation in the trial" Liver biopsy was not required. Randomisation procedure Unclear as not described (see 'Risk of bias' table) Number of participants randomised: 28 Prednisolone group: n = 15 Control group: n = 13 |
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Interventions |
Prednisolone group: prednisolone 40 mg daily orally Control group: placebo Additional treatment: supportive measures were attention to fluid and electrolyte balance, multiple vitamin supplementation, and parenteral glucose administration when food intake was poor. Encephalopathy treated with catharsis, protein restriction, and oral neomycin Duration of treatment: 28 days followed by tapered withdrawal over the ensuing 14 days Duration of follow‐up: 6 weeks |
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Outcomes | Mortality Liver biochemistry Liver histology Adverse events |
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Notes | Letter sent to authors in March 2000. No answer received. No further attempts were made as the trial was conducted between 1977–1979. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described. Quote: "All patients fulfilling the criteria who gave informed consent were randomised into two treatment protocols" and "… to avoid introducing bias based on the presence of the hepatorenal syndrome, the randomisation procedure was stratified to distinguish those with a serum creatinine greater than 2.5 mg/dL." |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Neither the principal investigators nor the physicians attending the patients were aware of the identity of the coded drugs. Provision was made for breaking the code if serious complications developed which could be related to steroid therapy." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals and dropouts |
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 |