Poon 2004

Methods	Randomised trial comparing supplements to no supplements in outpatients with newly diagnosed hepatocellular carcinoma. Geographical location: Hong Kong. Paper published 2004.
Participants	Inclusion criteria: Newly diagnosed unresectable hepatocellular carcinoma eligible for transarterial chemoembolisation, no extrahepatic metastases, no vascular complications (hepatic artery thrombosis, main protal vein thrombosis, arteriovenous shunting), no hepatic encephalopathy, no refractory ascites, no variceal bleed within 3 months, bilirubin < 50 micromol/l, albumin > 2.5 gm%, Karnofsky score > 50. Exclusion criteria: Previous treatment for hepatocellular carcinoma, tumor rupture. 88 patients (78 male/6 female [4 additional dropouts], median age of per protocol population 59).
Interventions	Intervention group received branched chain amino acid supplement (Aminoleban EN®) ‐ 27 gm protein (13 gm amino acids, 13 gm peptide, 1 gm casein), 420 kcal (62.1 gm dextran, 7 gm rice oil), various minerals and vitamins/day); Control group received no supplement. All patients received transarterial chemoembolization (cisplatin/Lipiodol emulsion). Duration of therapy up to one year.
Outcomes	Mortality, appearance ascites/gastrointestinal bleeding/hepatic encephalopathy, infections, quality of life score, bilirubin, body weight, triceps skinfold thickness, midarm circumference. Adverse events not reported by group. Number of readmissions to hospitalization later in study, but these were likely related to underlying disease and not to supplement therapy (so data not used).
Category of study	Supplement/Medical.
Sample size calculation	Calculated need for 44 patients per arm and achieved that number.
Full paper or abstract only	Full report.
Notes	Although longer term mortality also reported, decided to use mortality that occurred by one month after transarterial chemoembolization therapy. Request for further information sent to Dr Poon (poontp@hkucc.hku.hk or poontp@hku.hk) with copy to Dr Fan (stfan@hku.hk) via e‐mail on September 19, 2011. 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 "patients were randomised".
Allocation concealment (selection bias)	Low risk	Consecutively numbered sealed envelopes. Not mentioned whether opaque or not, but we assume so.
Blinding (performance bias and detection bias) All outcomes	High risk	Not blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Three dropouts in treatment group and 1 in control group adequately accounted for.
Selective reporting (reporting bias)	Low risk	Mortality and morbidity outcomes reported.
Other bias	Unclear risk	Funder of trial not reported.
Intent to treat analysis	High risk	Could not be done.
Baseline imbalance?	Low risk	No differences identified.
Early stopping?	Low risk	Achieved planned number.