Bonkovsky 1991a.
Methods | Randomised clinical trial, USA | |
Participants | 39 hospitalised adults with alcoholic hepatitis due to 1. prolonged ethanol intake; 2. laboratory studies; 3. time of cessation of alcohol intake 5 ‐ 14 days before entry to the study, at nutritional risk according to the trialist
Male:Female = 19:20 Mean age = 42 years Exclusion criteria: recent severe gastro‐intestinal bleeding, severe ascites, severe degree of encephalophathy, renal insufficiency, acute pancreatitis, haemodynamic instability, advanced pulmonary disease, diabetes mellitus, active malignancy |
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Interventions | The trial consisted of 4 groups. Groups 1 and 3, and groups 2 and 4 could be compared. Experimental group: parenteral nutritional supplementation 2 L (3.5 amino acids, 5% dextrose) for 21 days(n = 9) Control group: no intervention(n = 12) Co‐intervention: standard therapy (nutritionally adequate diets) in all groups and Oxandrolone in groups 2 and 4 |
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Outcomes | Laboratory measurements, complications | |
Study dates | August 1986 to November 1988 | |
Notes | We here report group 1 (control) versus group 3 (experimental). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random‐numbers table |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data were reported for all participants for all outcomes. |
Selective reporting (reporting bias) | Unclear risk | No protocol could be obtained, and the trial did not report on serious adverse events or mortality. |
For‐profit bias | High risk | The trial was funded by Miles Laboratories. |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |