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

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
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
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
Outcomes Mortality
Liver biochemistry
Liver histology
Adverse events
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