Puglionisi 1985

Methods	Randomised trial comparing parenteral nutrition to no parenteral nutrition in patients hospitalised for elective portocaval shunt. Geographical location Rome, Italy. Study published 1995.
Participants	Inclusion criteria: Elective porto‐caval shunt surgery for variceal bleeding. Exclusion criteria: None cited. 20 patients (13 men/7 women, mean age 55).
Interventions	Intervention group received parenteral nutrition (40 gm/l branched chain amino acids X 3 days, then 80 gm/l standard amino acids X 4 days; 16% dextrose [unspecified dose]) postoperatively; Controls received 6% dextrose intravenously. Duration 7 days.
Outcomes	Mortality, appearance encephalopathy.
Category of study	Parenteral nutrition/Surgical (Portocaval shunt).
Sample size calculation	None reported if done.
Full paper or abstract only	Full paper.
Notes	No address or location found for Dr Puglionisi; e‐mail sent to one of co‐authors (Dr Di Cera ‐ enrico@slu.edu) on September 13, 2011. On September 17, 2011, Dr DiCera replied that he was only a medical student at the time and had no information to supply. E‐mail returned to him asking if there was anyone else we could contact on September 17, 2011. Response received on September 18 indicated that Dr DiCera was no longer in Italy and that Dr Puglionisi died 20 years ago.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Only states "20 patients divided into 2 random groups of 10".
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	Funding source not reported.
Intent to treat analysis	Low risk	No dropouts.
Baseline imbalance?	Low risk	No differences identified.
Early stopping?	Unclear risk	No sample size calculation and unknown why stopped.