Kearns 1992

Methods	Randomised trial comparing enteral nutrition to no enteral nutrition in patients hospitalised with alcoholic liver disease. Geographical location: San Jose, California, USA. Paper published 1992.
Participants	Inclusion criteria: Clinical diagnosis of alcoholic liver disease, bilirubin > 51 micromol/l, one of the following: albumin < 3gm%, PT > 4 secs above control, ascites on examination. Exclusion criteria: None cited. 31 hospitalized patients (21 male/10 female, mean age 44).
Interventions	Intervention group received enteral nutrition through nasoduodenal tube (commercial formulation [Isocal HCN, Mead Johnson] with 167 kj/kg, 1.5 gm/kg protein/day) + regular diet. Control group given regular diet. Duration of therapy 28 days.
Outcomes	Mortality, appearance/resolution hepatic encephalopathy, bilirubin, serious/non‐serious adverse events, body weight, nitrogen balance. Appearance/resolution of ascites and gastrointestinal bleeding noted to be comparable, but no numerical data. Anmthrometic measurements noted not to be different, but no numerical data. Duration hospitalization provided as mean, but no standard deviation or standard error.
Category of study	Enteral nutrition/Medical.
Sample size calculation	Planned to enrol 25 patients in each arm, but did not achieve those numbers.
Full paper or abstract only	Full paper.
Notes	31 patients described and 6 dropouts; unclear if original randomisation included 37, or if only 25 completed trial; for purposes of analysis, assumed 31 patients reported. Morlality data estimated from Kaplan‐Meier curve. Request for further information sent via e‐mail on September 16, 2011 (pj.kearns@med.stanford.edu). 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	High risk	Six dropouts (3 from each group, but unclear reasons).
Selective reporting (reporting bias)	Low risk	Mortality and morbidity outcomes reported.
Other bias	High risk	Partial funding by industry.
Intent to treat analysis	High risk	Could not be done.
Baseline imbalance?	Low risk	No differences identified.
Early stopping?	High risk	Stopped after 31 patients completed trial without any preplanned intention to do so.