Bunout 1989

Methods	Randomised trial comparing supplements to no supplements in hospitalized patients with alcoholic liver disease. Geographical location Santiago, Chile. Paper published 1989.
Participants	Inclusion criteria: Excessive alcohol ingestion for at least 2 years, 2 or more signs of liver failure (jaundice, hepatic encephalopathy, ascites, hepatomegaly, collateral circulation, edema) who had not been in hospital > 3 days. Exclusion criteria: Contraindication for oral or enteral feeding, current upper gastrointestinal bleeding, grade IV hepatic encephalopathy, extrahepatic major organ (cardiac, pulmonary, renal) failure. 40 patients (no details regarding sex, mean age 49).
Interventions	Intervention group received nutritional supplement (casein, maltodextrin, MCT, sunflower oil) to increase intake to 50 kcal/kg and 1.5 gms protein/kg per day; Controls received standard diet containing 35 kcal/kg and 0.8 gm protein/kg per day. All patients received bed rest, sodium restriction prn, vitamins. Duration therapy 3 to 4 weeks.
Outcomes	Mortality, appearance/resolution hepatic encephalopathy, duration hospitalization, bilirubin.
Category of study	Supplement/Medical.
Sample size calculation	Not reported if done.
Full paper or abstract only	Full paper.
Notes	Request for further information sent via e‐mail on September 18, 2011 (dbunout@inta.cl). No response has been received as of March 20, 2012.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Only states "randomly assigned".
Allocation concealment (selection bias)	Unclear risk	No details.
Blinding (performance bias and detection bias) All outcomes	High risk	Not blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Four dropouts accounted for.
Selective reporting (reporting bias)	Low risk	Mortality and morbidity outcomes reported.
Other bias	Unclear risk	Funder of trial not reported.
Intent to treat analysis	High risk	Could not be done.
Baseline imbalance?	Low risk	No imbalance identified.
Early stopping?	Unclear risk	No sample size calculation and unknown why stopped.