Mendenhall 1977.
| Methods | Prospective, randomised clinical trial (3 intervention groups) Country: USA Intention‐to‐treat analysis: not mentioned Sample size calculation: not reported |
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| Participants |
Demographic characteristics Age: not reported Sex: not reported; most probably men as they came from V.A. (Veteran Affairs) Medical Centers Inclusion criteria and degree of severity History of daily ethanol ingestion > 100 g/day for ≥ 1 year; hepatomegaly (> 12 cm) and significant jaundice (bilirubin > 5 mg %). Liver biopsy obtained in about 70% of participants to confirm diagnosis Exclusion criteria Not described Randomisation procedure Not described, but mentioned that "regimens were chosen randomly and blinded so that neither physician nor patient was aware of the treatment modality." Number of participants randomised: 46 Prednisolone group: n = 12 (all severe alcoholic hepatitis) Control group: n = 17 (all severe alcoholic hepatitis) Oxandrolone group: n = 17 |
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| Interventions |
Experimental group: prednisolone 60 mg/day × 5, then decreased over a 16‐day period Control group: placebo Experimental group 2: oxandrolone (not included in the review) Additional treatment: supportive care Duration of treatment: 21 days Duration of follow‐up: to discharge |
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| Outcomes | Mortality Liver biochemistry |
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| Notes | Letter sent to study authors in 2006. No answer received. Only published as an abstract |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "… regimens were chosen randomly." |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "blinded so that neither physician nor patient was aware of the treatment modality." |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "one additional mortality withdrew from the study on the 8 day" (not mentioned from what group out of 50 participants 17 participants treated with oxandrolone |
| Selective reporting (reporting bias) | High risk | No protocol available. However, all‐cause mortality was reported. |
| Other bias | Low risk | None suspected |