Tangkijvanich 2000

Methods	Randomised trial comparing branched chain amino acid supplement to no supplement in outpatients with cirrhosis. Geographical location: Bangkok, Thailand. Abstract published 2000.
Participants	Inclusion criteria: Patients with cirrhosis documented by biopsy and/or "clear cut evidence"; no current hepatic encephalopathy, gastrointestinal bleeding, uncontrolled ascites, spontaneous bacterial peritonitis, hepatocellular carcinoma. Exclusion criteria: Diabetes mellitus, renal failure, severe cardiopulmonary disease. 30 patients (22 male/8 female [1 other dropout], mean age 53).
Interventions	Intervention group received branched‐chain amino acid supplement (Aminoleban EN®) containing 150 gm protein plus 40 gm protein/2000 kcal diet; Control group received standard 80 gram protein/2000 kcal diet. Duration of therapy 4 weeks.
Outcomes	Appearance gastrointestinal bleeding/hepatic encephalopathy, bilirubin, body weight, midarm muscle circumference. Probably no mortality but not explicitly stated. Data regarding infections limited to episodes of spontaneous bacterial peritonitis, but this probably did not include all infections and not used in meta‐analysis. Data regarding duration of stay in hospital/intensive care unit collected but not specifically reported; data regarding septic morbidity, six‐month survival (after transplant), major non‐infectious complications all supposed to be collected similarly not specifically reported (other than noting no difference).
Category of study	Supplements/Medical.
Sample size calculation	Not reported if done.
Full paper or abstract only	Full paper.
Notes	Request for further information sent to senior author (Dr. Willayalertpanya) via e‐mail (wsupeech@pioneer.chula.ac.th) on September 19, 2011. E‐mail address failed and letter sent on September 26, 2011 to Assoc Prof Supeecha Wittayalertpanya, Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand. Response 10/16/11 stated that Dr Tangkijvanich was contacted but that he had no recollection of any details about trial.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Only states "patients were randomised".
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	One dropout from treatment group accounted for.
Selective reporting (reporting bias)	High risk	No mortality data. Other data that were supposed to be collected were not available (see note in Outcomes above.)
Other bias	Unclear risk	Funder of trial not reported. Company acknowledged for supplying supplements, but this alone not sufficient to judge this parameter as inadequate.
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.