San‐In Group 1997

Methods	Randomised trial comparing supplements to no supplements in outpatients who had had an attempted curative resection for hepatocellular carcinoma 2 to 3 weeks earlier. Geographical location: Izumo, Japan. Paper published 1997.
Participants	Inclusion criteria: Patients 2 to 3 weeks after attempted curative resection for HCC. Exclusion criteria: None cited. 150 patients (109 male/23 female [18 additional dropouts], median age of per protocol population 50 to 70).
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. Duration of therapy 1 year.
Outcomes	Mortality, bilirubin, body weight. Outcomes of ascites and encephalopathy reported as percentages, but not clear what denominators were, so the data could not be used in the meta‐analyses.
Category of study	Supplements/Medical.
Sample size calculation	Not reported if done.
Full paper or abstract only	Full paper.
Notes	No e‐mail address available for corresponding author (Dr N Nagasue); letters sent to two different addresses that were found (N Nagasue, MD, Department of Digestive and General Surgery, Shimane University School of Medicine, Izumo 693‐8501, Japan and N Nagasue, MD, Department of Surgery, Kawasaki Hospital, Higashiyama‐cho 3‐3‐1, Hyogo‐ku, Kobe, Hyogo 652‐0042, Japan) on September 19, 2011. Latter letter returned as being undeliverable and not able to forward. No other response 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)	Unclear risk	No details.
Blinding (performance bias and detection bias) All outcomes	High risk	Eight dropouts in treatment group, 10 dropouts in control group all adequately accounted for.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All dropouts accounted for.
Selective reporting (reporting bias)	Low risk	Outcomes of ascites and encephalopathy reported as percentages, but not clear what denominators were. Thus, while the data could not be used in the meta‐analyses, the outcomes were 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?	Unclear risk	No sample size calculation and unknown why stopped.