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. 2012 May 16;2012(5):CD008344. doi: 10.1002/14651858.CD008344.pub2
Methods Randomised trial comparing the use of postoperative branched chain amino acid supplement to no supplement in patients who underwent surgery for an attempted curative resection for hepatocellular carcinoma. Geographical location: Hong Kong. Paper published 1999.
Participants Inclusion criteria: Patients with cirrhosis undergoing attempted curative resection of hepatocellular carcinoma. Exclusion criteria: Palliative resection, benign nodular hyperplasia, adenoma. 44 patients (37 male/7 female [4 other dropouts], median age 52).
Interventions Intervention group received branched chain amino acid supplement (Aminoleban EN®) ‐ 3 packs/day (? 50 gm packs); Control group received isocaloric, isonitrogenous diet. Duration of therapy 12 weeks.
Outcomes Mortality, appearance gastrointestinal bleeding/hepatic encephalopathy, infections, duration hospitalization postoperative total complications (total number, not number of patients with complications)/intra‐abdominal complications/wound infections/pneumonia/major complications (not predefined outcome). Paper indicates that serum bilirubin better in treatment group, but no usable numerical data. Paper indicated that there were no differences in body weight, triceps skinfold thickness, midarm circumference, but no numerical data.
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 Drs Meng and Lau via e‐mail (mengcs@ha.org.hk and josephlau@cuhk.edu.hk) 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) Low risk Computer‐generated sequence.
Allocation concealment (selection bias) Unclear risk Closed envelopes, but not stated if opaque, serially numbered.
Blinding (performance bias and detection bias) All outcomes High risk Not blinded.
Incomplete outcome data (attrition bias) All outcomes Low risk Four dropouts from treatment group, 2 dropouts from control group accounted for.
Selective reporting (reporting bias) Low risk Mortality and morbidity outcomes reported.
Other bias High risk Funded by industry.
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.