Maddrey 1978.

Methods	Randomised, double‐blind clinical trial with parallel‐group design (3 groups) Country: USA Intention‐to‐treat analysis: no Sample size calculation: not reported
Participants	Demographic characteristics Age (mean): prednisolone group: 40 (SD 8.5) years; control group: 42.3 (SD 11.1) years Sex: prednisolone group: 12 (50%) men; control group: 23 (74%) men Inclusion criteria and degree of severity History of long‐standing and recent alcoholism referred to Liver Service (The Johns Hopkins Hospital). Percutaneous liver biopsy performed unless precluded by coagulation abnormalities. Alcoholic hepatitis defined histologically as an inflammatory hepatic disease with cell swelling and hydropic change, cell necrosis, and polymorphonuclear leukocytic infiltration. Exclusion criteria Active gastrointestinal haemorrhage, pancreatitis, history of peptic ulcer, active infection, presence of hepatitis B infection, or history of previous viral hepatitis. MDF. People had wedged hepatic venous pressure determination. Randomisation procedure Random drug sequences Number of participants randomised: 57 Participants randomised into 3 groups based on apparent severity of disease. Group A (moderately ill), serum bilirubin > 3 mg/dL; hepatomegaly; and clotting factors adequate to allow liver biopsy Group B (more severely ill), hyperbilirubinaemia and hepatomegaly as in A with additional presence of ascites or hepatic encephalopathy (or both), but coagulation studies adequate for liver biopsy Group C (severely ill), hyperbilirubinaemia and hepatomegaly as in A and B, with or without ascites or hepatic encephalopathy (or both), but coagulation abnormalities precluded liver biopsy. Prednisolone group: n = 25 Control group: n = 32
Interventions	Experimental group: prednisolone 40 mg/day orally; 8 × 5‐mg tablets every morning Control group: identical placebo tablets Additional interventions to the trial groups: offered 3000 calorie diet. Protein 1–1.5 g/kg provided for people with no evidence of hepatic encephalopathy. In people with encephalopathy, protein restriction to ≤ 20 g/day and lactulose therapy. Ascites managed with sodium restriction alone or with the addition of spironolactone in people who did not respond with diuresis in 5 days. All participants initially received thiamine 100 mg intramuscularly. B‐complex multivitamins and folic acid given daily Duration of treatment: 28–32 days Follow‐up: until discharge
Outcomes	Early mortality Complications of therapy Liver function and haematological tests Wedged hepatic venous pressure Factors associated with a fatal outcome Discriminant function analysis
Notes	Study supported by Research Grant AA00201 from the National Institute of Alcohol Abuse and Alcoholism of the National Institutes of Health, and by Grant RR‐35 from the Clinical Research Centers Program, United States Public Health Service. Prednisolone and placebo tablets provided by the Division of Steroid Research, The Upjohn Company, Kalamazoo, Mich. However, no further details were provided. Letter sent to authors in March 2000. No answer received. No further attempts made.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients were randomised for treatment within three groups based on apparent severity of disease. Random drug sequences were arranged within each group."
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Prednisolone (5 mg) or identical placebo tablets were given in a single dose of 8 pills each morning for 28 to 32 days. (Prednisolone (5 mg) and identical placebo tablets were provided by the Division of Steroid Research, The Upjohn Company, Kalamazoo, Mich.). The investigators were not aware of which regimen the patient was receiving until the completion of the study."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	3.5% dropped out or were withdrawn. Quote: "Two additional patients were removed from the study after randomisation. One patient who was randomised to the placebo group bled from oesophageal varices before receiving the study drug. He subsequently stopped bleeding and survived. Another patient had an episode of upper gastrointestinal haemorrhage presumably from oesophageal varices after receiving prednisolone for 9 days and the drug was stopped." Prednisolone group: 1/25; control group: 1/32
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