Shumaker 1978.

Methods	Prospective, double‐blind, randomised clinical trial Country: USA Intention‐to‐treat analysis: not mentioned, but presumably used Sample size calculation: not reported.
Participants	Demographic characteristics Age (mean): prednisolone group/control group: 45,5/44,5 Sex: prednisolone group: 25% men; control group: 44% men Inclusion criteria and degree of severity History of recent heavy alcoholic ingestion, serum bilirubin > 5 mg %, hospitalisation for ≥ 5 days without improvement in liver tests; or rapid deterioration of the clinical condition during a 24‐hour period while under observation. In addition, minimum of 2 major criteria or 1 major and 2 minor criteria to be included. Major criteria: liver biopsy showing alcoholic hepatitis (with or without Mallory bodies), hepatic encephalopathy, azotaemia unexplained by another process (blood urea nitrogen > 20 mg % or creatinine > 1.5 mg %), hyperbilirubinaemia (> 20 mg %) and prothrombin time prolonged > 4 seconds over control; and unresponsive to parenteral administration of vitamin K. Minor criteria included fever not obviously secondary to another process, white blood count > 12,000, hepatomegaly (span > 14 cm), splenomegaly, or liver stigmas (spider telangiectasias, palmar erythema, ascites, oedema, etc.) Positive hepatitis B antigen did not exclude them from the study if a percutaneous liver biopsy confirmed alcoholic hepatitis. Exclusion criteria AST > 500 IU/L; active gastrointestinal bleeding; pancreatitis; x‐ray evidence of peptic ulcer disease; active or questionably active tuberculosis; active infection; or severe psychiatric disorder Randomisation procedure Predetermined code provided by the drug manufacturer Number of participants randomised: 27 Prednisolone group: n = 12 Control group: n = 15
Interventions	Prednisolone group: 6‐methylprednisolone 80 mg (equivalent to prednisolone 100 mg) for 4–7 days; medication was then tapered on a flexible schedule with cessation of therapy planned for 4 weeks unless death or complications Control group: placebo Additional interventions to the trial groups: both groups received comparable supportive care required in hepatic decompensation. All participants with positive tuberculin tests were treated with isoniazid 300 mg daily and pyridoxine 50 mg daily. Duration of treatment: 5 weeks; participants were placed on treatment for 4–7 days. Then the medication was tapered on flexible schedule with cessation of therapy planned for 4 weeks unless death or complication intervened. Duration of follow‐up: to hospital discharge
Outcomes	Mortality Liver histology Adverse events
Notes	Letter sent to study authors in March 2000. No answer received Quote: "The patient was then randomised into a predetermined code provided by the drug manufacturer. (Upjohn Co., Kalamazoo, MI, prepared and supplied the medication and placebo."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "The patient was then randomised into a predetermined code provided by the drug manufacturer. Immediately prior to randomisation, patients were stratified into two categories based on the presence or abstinence of criteria permitting liver biopsy" the purpose of this procedure was to provide comparable case material for both steroid and placebo control groups.in the absence of other contradictions, patients with prothrombin times less than four seconds prolonged were placed in the "Biopsy feasible" group (n = 10) whether or not they agreed to a biopsy. All other patients constituted the "Biopsy‐ Disallowed" group (n = 17)."
Allocation concealment (selection bias)	Low risk	Quote: "The patient was then randomised into a predetermined code provided by the drug manufacturer."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind Quote: "80 mg of 6‐methylprednisolone or equivalent number of placebo tablets (or parenteral therapy of the same dosage intravenously if gastrointestinal function precluded oral intake."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Clinical evaluation was carried out by junior staff physicians blinded to treatment status of the patients."
Incomplete outcome data (attrition bias) All outcomes	Low risk	3.7 % Quote: "a steroid treated patient voluntarily withdrew from the study after eight days but was retained for statistical purposes." Prednisolone group: 1/12; control group: 0/15
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