Humbert 1988

Methods	Randomised trial comparing supplements (branched‐chain amino acids) to no supplements in outpatients with cirrhosis. Geographical location Barcelona, Spain. Paper published 1988.
Participants	Inclusion criteria: Cirrhosis (almost all of the patients were Childs B or C). Exclusion criteria: None cited. 49 patients (31 men/18 women , mean age 54).
Interventions	Intervention group received nutritional supplement (branched‐chain amino acid‐enriched amino acid supplement [65 gm/d in 300 cc water {2224 kcal, 19.6 gm amino acids with 40% as branched chain‐amino acids}]; Controls did not receive supplement. All participants received 80‐90‐gm protein diet, standard treatment for complications. Duration therapy six months.
Outcomes	Mortality, appearance hepatic encephalopathy, bilirubin, triceps skinfold thickness, midarm muscle circumference.
Category of study	Supplements/Medical.
Sample size calculation	Not reported if done.
Full paper or abstract only	Full report.
Notes	Number of episodes of hepatic encephalopathy were total; for purposes of meta‐analysis, assumed one per patient. Article in Spanish. Unable to find any contact address or e‐mail for Dr Humbert, so no request sent for further information.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Table of random numbers.
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	Two and four dropouts in treatment and control groups accounted for.
Selective reporting (reporting bias)	Low risk	Mortality and morbidity outcomes reported.
Other bias	Unclear risk	Funder not reported.
Intent to treat analysis	Low risk	Although dropouts noted, denominators in paper were all randomised patients.
Baseline imbalance?	Low risk	No differences identified.
Early stopping?	Unclear risk	No sample size calculation and unknown why stopped.