Porter 1971.

Methods	Prospective, double‐blind, controlled pilot trial Country: USA Intention‐to‐treat analysis: no Sample size calculation: not reported
Participants	Demographic characteristics Age (mean): prednisolone group: 44.6 (SD 4.4) years; control group: 49.5 (SD 8.9) years; overall range 27–61 years) Sex: prednisolone group: 13 (64%) men; control group: 7 (67%) men Inclusion criteria and degree of severity History of recent heavy alcohol ingestion, serum bilirubin concentration ≥ 5 mg/100 mL, clinical and laboratory deterioration over the first 5 hospital days, striking lack of improvement in the patient's clinical and biochemical status over first 5 hospital days, or rapid marked deterioration in < 24 hours For admission to the study all three absolute criteria were required. In addition, ≥ 2 major criteria or 1 major and ≥ 4 minor criteria had to be met. Major criteria: liver biopsy showing alcoholic hepatitis; hepatic encephalopathy (including asterixis); persistent or progressive azotaemia not explained by another process; and total bilirubin levels > 20 mg/100 mL. Minor criteria: fever not obviously secondary to another process; white blood count > 12,000 not obviously secondary to another process; anorexia or nausea or vomiting; palpable hepatomegaly; palpable splenomegaly; oesophageal varices; spider angiomas, oedema or ascites; palmar erythema; and prothrombin time prolonged ≥ 3 seconds over control. The Australia antigen was absent from the serum of all 16 participants in whom it was sought. Before the trial, a percutaneous needle biopsy of the liver was performed if the prothrombin time was not prolonged >4 seconds over control and there was no clinical bleeding tendency. Exclusion criteria Active gastrointestinal bleeding, pancreatitis, radiological evidence of peptic‐ulcer disease, active or questionably active pulmonary tuberculosis, and potentially life‐threatening bacterial infection Randomisation procedure Number drawn from a pool Number of participants randomised: 23 (20 analysed). 23 accepted to participate, but 3 died within 36 hours of start of therapy, and were excluded from analysis before code was broken, and did not receive adequate medication. Final series consisted of 20 participants Prednisolone group: n = 11 Control group: n = 9
Interventions	Prednisolone group: 6‐methyl‐prednisolone 50 mg (equivalent to prednisolone 50 mg, or hydrocortisone 200 mg) in 3 divided doses, parenterally for the first 10 days. If clinical improvement occurred over this interval and if nausea and vomiting were absent the drug was administered orally, and the dose gradually tapered (decreased every second day by 4 mg for the 11th to the 18th days, by 2 mg for the 19th to 30th days and every third day by 2 mg for the 31st to 45th days). If there was no clinical improvement within 10 days, the initial parenteral dose of 40 mg daily was continued until improvement or death occurred. Control group: placebo (lactose) Additional treatment: early in study only participants with a positive intermediate strength PPD test or a suspicious chest x‐ray were given isoniazid; however, later in study, all participants received isoniazid. Received general supportive care required in hepatic decompensation. Special attention given to fluid and electrolyte balance, prompt treatment of hepatic encephalopathy, and repeated evaluation for infection. Most participants had daily estimation of the caloric and protein intake by a hospital dietitian. People unable to take oral nutrition received glucose ≥ 400 calories/day parenterally Duration of treatment and of follow‐up: 45 days after randomisation
Outcomes	Mortality Liver biochemistry Liver histology Adverse events
Notes	Country: USA Letter sent to study authors in March 2000. No answer received. Quote: "Twenty‐three patients were accepted for studying. However, three died within 36 hours of the start of the therapy Quote: and were excluded from analysis before the code was broken because they did not receive adequate medication." Supported in part by a gastroenterology‐research training grant (AM‐05099) from the National Institute of Arthritis and Metabolic Diseases (a portion of this work was conducted within the Clinical Research Center of the University of Washington, with support by a grant MO1 FR‐37 from the National Institutes of Health.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "the case was randomised into one of the two treatment groups. Both the steroid (6‐methyl prednisolone, or Medrol) and the placebo (lactose) were packaged and coded by number in both parenteral and oral forms (prepared and supplied through the courtesy of the Upjohn Co, Kalamazoo, Mich) and randomisation was achieved by a number drawn from a pool. Neither patients nor physicians knew which form of treatment was used until the study had been completed, when the code was broken."
Allocation concealment (selection bias)	Low risk	Quote: "the case was randomised into one of the two treatment groups. Both the steroid (6‐methyl prednisolone, or Medrol) and the placebo (lactose) were packaged and coded by number in both parenteral and oral forms (prepared and supplied through the courtesy of the Upjohn Co, Kalamazoo, Mich) …"
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Neither patients nor physicians knew which form of treatment was used until the study had been completed, when the code was broken."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "At the conclusion of the study, all needle biopsy and post‐mortem liver specimens were coded and read in blind review by the same observer."
Incomplete outcome data (attrition bias) All outcomes	High risk	13% Quote: "Twenty three patients were accepted for study, three died within 36 hours of the start of therapy and were excluded from analysis before the code was broken because they didn't receive adequate medication. The final series thus consisted of 20 patients."
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