LeCornu 2000

Methods	Randomised trial comparing branched chain amino acid supplement to no supplement in malnourished outpatients with cirrhosis who were awaiting liver transplant at time of entry and who subsequently received a transplant. Geographical location: Birmingham, UK. Paper published 2000.
Participants	Inclusion criteria: Adult patients with end‐stage liver disease on liver transplantation and waiting as outpatients, mid‐arm muscle circumference < 25 percentile. Exclusion criteria: midarm muscle circumference > 25th percentile, fulminant/subacute liver failure (need for urgent transplantation), malignant disease, fluid restriction (< 500 ml/d), regrafts, multiple organ failure, celiac disease. 82 patients (60 male/22 female [1 patient in each of the treatment and control groups subsequently dropped out], median age 51).
Interventions	Intervention group received 500 cc daily of a specially prepared supplement (20 gm protein, 33.5 gm fat, minerals, 750 kcal/day) + usual diet; Control group received the usual diet. Duration of therapy until transplantation (median 77 days in treatment group, 45 days in control group). All patients received postoperative immunosuppression.
Outcomes	Mortality, bilirubin, triceps skinfold thickness, midarm muscle circumference, midarm circumference. Methods section described all of the postoperative information that was to be collected (infections, duration of stay in intensive care unit/hospital, postoperative total complications) but the only mention of it was a terse statement that there were no differences; mild rejection in 14/39 versus 10/32 and severe rejection in 15/39 versus 16/32.
Category of study	Supplements/Surgery.
Sample size calculation	Not reported if done.
Full paper or abstract only	Full paper.
Notes	Request for further information sent to Dr LeCornu via email (kate.lecornu@nnuh.nhs.uk) on September 19, 2011. Subsequent responses in October 4, 2011, provided details about sample size calculation, concealment of allocation, and funding, as well as some outcome data (LOS in hospital and ICU); another response on October 28, 2011, indicated that further information was not available.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Only states "randomisation to either the intervention group or control group".
Allocation concealment (selection bias)	Unclear risk	Sealed envelopes selected by someone other than trial coordinator (but not stated re: opaque, numbered, or if person associated with investigators).
Blinding (performance bias and detection bias) All outcomes	High risk	Not blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	One dropout in each arm accounted for.
Selective reporting (reporting bias)	Low risk	Mortality and morbidity outcomes reported (mostly qualitatively).
Other bias	High risk	Authors have prior publication showing association between malnutrition and poor outcome in transplant patients; industry supplied product.
Intent to treat analysis	High risk	Could not be done.
Baseline imbalance?	Low risk	No differences in per protocol groups.
Early stopping?	Unclear risk	No sample size calculation and unknown why stopped.