Ramond 1992.

Methods	Randomised, double‐blind trial Country: France Dates: March 1987 to June 1990 Intention‐to‐treat analysis: yes Study approved by hospital ethics committees
Participants	Demographic characteristics 124 people with alcohol dependence were admitted to 2 centres. Age (mean): prednisolone group: 48.1 (SD 1.3) years; control group: 48.2 (SD 1.6) years Sex: prednisolone group: 10 men; control group: 9 men Randomisation procedure Computer‐generated random code Inclusion criteria and degree of severity Biopsy‐confirmed alcoholic hepatitis (characterised by hyaline necrosis and infiltration of polymorphonuclear leukocytes) and spontaneous hepatic encephalopathy or a MDF > 32 (or both) 8 people died before inclusion in the trial. Exclusion criteria Gastrointestinal bleeding or bacterial infection excluded unless they could be effectively treated within 48 hours; presence of hepatitis B surface antigen; presence of HIV antibodies; refusal of liver biopsy; non‐alcoholic hepatitis at histology Number of participants randomised: 65 (4 excluded) (see 'Notes') Prednisolone group: n = 33 (32 analysed) Control group: n = 32 (29 analysed)
Interventions	Prednisolone group: prednisolone (Solupred) 40 mg (prednisolone 40 mg equivalent methylprednisolone 32 mg) given in single dose of 2 tablets each morning for 28 days. If participant was unable to take oral medication, received intravenous infusions of prednisolone (Hydrocortancyl) Control group: single dose of 2 tablets Additional treatment: provided with 3000 kcal containing 1 g protein/kg. Participants with hepatic encephalopathy received lactulose therapy. Ascites managed with sodium restriction or by adding spironolactone to the treatment regimen. Received B complex multivitamins, folic acid, and antacids daily Duration of treatment: 28 days Duration of follow‐up: 8 weeks
Outcomes	Mortality Liver biochemistry Adverse events
Notes	Letter sent to study authors in March 2000. No answer received. Trial stopped at the first interim analysis after inclusion of 61 out of the planned 130 participants. Authors used an alpha error < 0.025. This is too high a value to prevent early stopping at a random high. Quote: "Drug therapy was interrupted by the attending physician if there was severe bacterial infection or gastrointestinal bleeding, or if a corticosteroid‐related complication was suspected … in patients with such complications the remaining tablets of the study drug were replaced with placebo tablets provided by the pharmacist (the only person who knew which regimen the patient had received first). The principal investigator and their associates were not aware of randomisation procedure or of the medication that the patients were receiving throughout the trial." Quote: "65 patients were randomly assigned, but 4 were excluded – one patient assigned to receive prednisolone was found to have anguilluliasis and her treatment was stopped one day after her inclusion in the study. Three patients assigned to placebo were found not to have satisfied the inclusion criteria. These 4 patients were alive at the end of treatment." Prednisolone tablets and placebo were provided by Laboratoire Houdé (Paris).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "a random code was prepared by computer for each participating centre … There was a different code prepared for men and women in each center, so that within each group of six patients (male and female), three patients received prednisolone and three received placebo."
Allocation concealment (selection bias)	Low risk	Quote: "a random code was prepared by computer for each participating centre. Random sequences of drug or placebo were prepared by the pharmacist at each hospital."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "a random code was prepared by computer for each participating centre. Random sequences of drug or placebo were prepared by the pharmacist at each hospital." Quote: "prednisolone (Solupred) in 20 mg tablets and identical placebo were provided by the pharmacists at each hospital."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information provided
Incomplete outcome data (attrition bias) All outcomes	Low risk	1.5% 1 woman left the hospital and then "she was re hospitalised 56 days after enrolment and left again the following day. She was the only patient lost to follow up." Prednisolone group: 1/33; control group: 0/32
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	Not suspected