Mendenhall 1984.
| Methods | Randomised clinical trial | |
| Participants | Country: USA. Number randomised: 178. Post‐randomisation dropouts: 0 (0%). Revised sample size: 178. Average age: 51 years. Females: 0 (0%). Inclusion criteria: Diagnosis of moderate or severe alcoholic hepatitis based on conventional clinical and laboratory changes. Exclusion criteria: 1. Positive test for HBsAg. 2. Clinical or historical evidence of recent parenteral drug abuse. 3. Intractable congestive heart failure. 4. Neoplasms that commonly metastasise to the liver. 5. NAFLD. 6. Severe infections. 7. Active peptic ulcer disease. 8. Insulin‐dependent diabetes mellitus. 9. Corticosteroids within the preceding 3 months. | |
| Interventions | Participants were randomly assigned to three groups.
Group 1 (n = 90): glucocorticosteroids (prednisolone 60 mg tapered to 5 mg in 1 month).
Group 2 (n = 88): placebo. Group 3 (n=85): anabolic steroids (oxandrolone 80 mg). Duration: 30 days treatment |
|
| Outcomes | mortality. | |
| Notes | 3 groups | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Treatment assignments were made by the Coordinating Center. The random assignment of tretment was balanced within each hospital, as well as according to disease severity". |
| Allocation concealment (selection bias) | Unclear risk | Comment: Further details were not available. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The patient, physician and the local hospital pharmacy had no knowledge of the specific medication in use". |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: this information was not available. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: " Ten patients withdrew from the study before completing treatment, however they were included in the outcome analysis. If patients were lost to follow up after hospital‐discharge the VABIRL System was used to determine their status and the date of death". Comment: presumably ITT analysis. |
| Selective reporting (reporting bias) | Low risk | Quote: "Not precisely specified". Comment: all important outcomes were reported. |
| For‐profit bias | Unclear risk | Quote: "Supported by Cooperative Studies program of VAMRS. Matching placebos were prepared for each of these medications by Upjohn Company and G.D. Searle and Company". |
| Other bias | Low risk | Comment: there was no other bias. |