DeLedinghen 1997

Methods	Randomised trial comparing enteral nutrition to no enteral nutrition in patients hospitalized with variceal bleeding associated with cirrhosis. Geographical location: Poitiers, France. Paper published 1997.
Participants	Inclusion criteria: Patients admitted for active variceal bleeding which had been stabilized associated with cirrhosis. Exclusion criteria: Hepatocellular carcinoma, hepatorenal syndrome, severe hepatic encephalopathy, age > 80 years. 22 hospitalized patients (17 male/5 female, mean age 56).
Interventions	Intervention group received enteral nutrition through nasogastric tube (commercial formulation [Dripac Sondalis, Sopharga, France] with 1665 kcal and 71 gm protein/day until second sclerotherapy) + standard feeding; Control group given oral diet (nothing by mouth X 3 days, low‐Na milk on day 4, mixed warm low‐Na diet on day 5, 1800 kcal low Na diet from day 6 on). Mean duration of therapy 8.5 days.
Outcomes	Mortality, gastrointestinal bleeding, infections, duration of hospitalization, bilirubin, body weight, triceps skinfold thickness, midarm muscle circumference, nitrogen balance.
Category of study	Enteral nutrition/Medical.
Sample size calculation	Not reported if done.
Full paper or abstract only	Full paper.
Notes	Request for information sent via e‐mail on September 16, 2011 (victor.deledinghen@chu‐bordeaux.fr). 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 patients".
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	No dropouts.
Selective reporting (reporting bias)	Low risk	Mortality and morbidity outcomes reported.
Other bias	Unclear risk	Fund source not reported.
Intent to treat analysis	Low risk	No dropouts.
Baseline imbalance?	Low risk	No imbalance identified.
Early stopping?	Unclear risk	No sample size calculation and unknown why stopped.