Williams 1985.
Methods | Randomised clinical trial, unknown country. | |
Participants | 64 hospitalised adults with acute alcoholic hepatitis, at nutritional risk defined by trialist Male:Female = 31:33 Mean age = 49 years Exclusion criteria: hepatocellular carcinoma |
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Interventions | Experimental group: 2 litres daily of liquid diet providing, regardless of encephalopathy, approximately 2000 nonprotein kcal and 10 g nitrogen as 65 g of conventional protein administered enterally for 3 weeks (n = 21) Control group: No intervention (n = 22) Co‐intervention: The control diet yielded < 22 mol sodium, 1800 ‐ 2400 kcal and 70 ‐ 100 g protein. The adults receiving only the control diet were given vitamin K i.v. (10 mg x 3) and were subsequently managed with protein restriction (to 40 or 60 g) if indicated for control of encephalopathy, and by intravenous infusion of 5 ‐ 20% dextrose solutions if temporarily unable to take food orally. |
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Outcomes | Mortality, complications, hepatic function (prothrombin time), indices of malnutrition and nitrogen balance | |
Study dates | Not stated | |
Notes | "The authors were not contacted since dr. Calvey died several years ago and no additional data was available" (Koretz 2012). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
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 | Unclear risk | The number of participants with incomplete data was not reported. |
Selective reporting (reporting bias) | Low risk | The trial reported mortality and complications. |
For‐profit bias | Low risk | The trial was supported by the Joint Research Committee of King's College Hospital and Medical School. |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |