| Methods |
Randomised clinical trial |
| Participants |
Country: USA.
Number randomised: 23.
Post‐randomisation dropouts: 3 (13%).
Revised sample size: 20.
Average age: 47 years.
Females: 7 (35%).
Inclusion criteria: For admission to the study all three absolute criteria should be fulfilled. Also, two or more major criteria or one major and four or more minor criteria. Absolute criteria: 1. History of recent, heavy alcohol ingestion. 2. Serum total bilirubin of 5 mg per 100 mL or more. 3. Clinical and laboratory deterioration over the first 5 hospital days, a striking lack of improvement in the patient's clinical and biochemical status over this same period, or rapid, marked deterioration in less than 24 hours. Major criteria: 1. Liver biopsy showing alcoholic hepatitis. 2. Hepatic encephalopathy, persistent or progressive azotaemia unexplained by another process, with either a blood urea nitrogen over 20 mg or a creatinine over 1.5 mg per 100 mL (or both). 3. Total bilirubin over 20 mg per 100 mL. Minor criteria: 1. Fever not obviously secondary to another process. 2. Anorexia or nausea or vomiting. 3. Palpable hepatomegaly. 4. Palpable splenomegaly. 5. Oesophageal varices. 6. A prothrombin time prolonged three or more seconds over control.
Exclusion criteria: 1. Active gastrointestinal bleeding. 2. Pancreatitis. 3. Radiologic evidence of peptic ulcer disease. 4. Active or questionably active pulmonary tuberculosis. 5. Life‐threatening bacterial infections |
| Interventions |
Participants were randomly assigned to two groups.
Group 1 (n = 11): glucocorticosteroids (6‐methylprednisolone 40 mg thrice daily parenterally).
Group 2 (n = 9): placebo.
Duration: if clinical improvement: for 10 days, then given orally and the dose gradually tapered. If no clinical improvement: 40 mg parenterally till improvement or death |
| Outcomes |
mortality, adverse events. |
| Notes |
Reasons for post‐randomisation dropouts: 3 died. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "randomisation was achieved by a number drawn from a pool". |
| Allocation concealment (selection bias) |
Unclear risk |
Quote: "both the steroid and the placebo were packaged and coded by number in both parenteral and oral forms". |
| 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". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Comment: this information was not available. |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Quote: "3 patients died within 36 hours of the start of therapy and were excluded from analysis before the code was broken".
Comment: there were post‐randomisation dropouts. |
| Selective reporting (reporting bias) |
Low risk |
Comment: all important outcomes were reported. |
| For‐profit bias |
Low risk |
Quote: "gastroenterology‐research training grant from the National Institute of Arthritis and Metabolic Diseases and a grant from the National Institutes of Health". |
| Other bias |
Low risk |
Comment: there was no other bias. |
