Blitzer 1977.

Methods	Prospective, double‐blind randomised trial Country: USA Dates: 1971–1973 Intention‐to‐treat analysis: no Sample size calculation: not reported
Participants	Demographic characteristics Age (mean): prednisolone group: 47.2 years; control group: 48.4 years Sex: 100% men Inclusion criteria and degree of severity People with alcoholic hepatitis meeting the following criteria after ≥ 5 days in hospital: recent history of heavy alcohol consumption (> 1 pint whiskey per day or alcoholic equivalent); hepatomegaly based on physical examination (palpable > 5 cm below the costal margin) or liver scan or both; total serum bilirubin > 5 mg/100 mL; and ≥ 2 abnormalities of AST > 100 Reitman‐Frankel units/mL, serum albumin concentration < 3 g/100 mL, or prothrombin time > 2 s greater than control value. Liver biopsies: performed whenever possible, but were not required for admission to the study. 14 biopsies proved alcoholic hepatitis. Neither positive PPD skin tests nor active tuberculosis excluded people from randomisation. No positive PPD skin tests, and 1 active tuberculosis continued to receive isoniazid and para‐aminosalicylic acid throughout the study. If serious life‐threatening infection present, patients' entry into study was postponed until it was eradicated. People with history of peptic ulcer, active peptic ulcer disease, or gastrointestinal bleeding were included. Severity of disease: not clearly described; however, participants probably had moderate‐to‐severe alcoholic hepatitis, since they presented people with alcoholic hepatitis who met the described criteria. Exclusion criteria People treated with adrenocorticosteroid in the 6 months prior to admission or who showed evidence of psychotic behaviour precluding their co‐operation Randomisation procedure Random, sealed‐envelope technique Number of participants randomised: 33 Prednisolone group: n = 17 Control group: n = 16
Interventions	Experimental group: oral prednisolone 10 mg 4 times a day for 14 days, 5 mg 4 times a day for 4 days, 2.5 mg 4 times a day for 4 days, and 2.5 mg twice a day for 4 days Control group: placebo tablets; same schedule as prednisolone group Additional interventions to the trial groups: participants encouraged to eat standard hospital 2600‐calorie diet and were offered supplements when caloric intake seemed inadequate. Low‐protein, low‐sodium, and other special diets used as clinical situation dictated. Duration of treatment: 26 days Follow‐up after randomisation: 9 weeks
Outcomes	Mortality Liver biochemistry Liver histology Adverse events
Notes	Quote: "There were no significant differences between them [participants] with respect to mean age, sex, race, duration of hospitalization prior to entry into the study, frequency of histologically proved cirrhosis, or to the histologic severity of the alcoholic hepatitis." Letter sent to authors in March 2000. No answer received. No further attempts were made as the trial was conducted between 1971 and 1973. 1 participant received placebo treatment during trial. At the end of the therapy, due to lack of improvement, the ward physician requested the code be broken. The participant received a 7‐day course of prednisolone. He died 17 days later; his death was included in the mortality data of the control group on an intention‐to‐treat basis. On the 26th day of treatment, 3 participants in control group and 1 in glucocorticosteroid group received the alternative medication on a double‐blind basis. Quote: "Both prednisolone and placebo tablets were kindly supplied by the Upjohn Co., Kalamazoo, Michigan."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients were assigned by random, sealed‐envelope technique to receive either placebo or steroid."
Allocation concealment (selection bias)	Low risk	Quote: "… sealed‐envelope technique to receive either placebo or steroid."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Only the pharmacist was aware of the type of therapy which any individual patient was receiving."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information provided
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "5 participants, who had each received less than 5 days of therapy, were subsequently excluded from analysis. Of these, three had left the hospital against medical advice or withdrew from the study, and in two participants experimental therapy had been stopped following gastrointestinal haemorrhage. One bled after 4 days of therapy from a gastric varix and the other from an unknown site after three days of treatment. On breaking the code at the end of the investigation, it was learned that all five participants had been in the steroid group … Furthermore, the addition of two deaths among the five excluded participants …" 3/17 (9%) people in prednisolone group and 0/16 (0%) people in control group dropped out.
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