Methods |
Randomised trial comparing the use of a late‐evening snack of a branched‐chain amino acid‐enriched supplement to no supplement in patients undergoing transarterial chemoembolization for hepatocellular carcinoma. |
Participants |
Patients undergoing transarterial chemoembolisation for hepatocellular carcinoma. |
Interventions |
Experimental group received a commercial supplement (Aminoleban EN ‐ 878.64 kJ energy in 50 gram pack) ingested at night (10 PM) beginning one day before the procedure and lasting for two weeks afterward. The control group did not receive any nutrition therapy. |
Outcomes |
Mortality, duration of hospitalization (for the chemoembolization procedure), lab tests, adverse events, body mass index. |
Category of study |
Supplements/Medical. |
Sample size calculation |
None reported. |
Full paper or abstract only |
Full paper. |
Notes |
Request for further information sent via e‐mail on September 18, 2011 (ichikawa@net.nagasaki‐u.ac.jp and Shige‐ygc@umin.ac.jp). 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 |
"patients were randomly placed into 2 groups". |
Allocation concealment (selection bias) |
Unclear risk |
No details provided. |
Blinding (performance bias and detection bias) All outcomes |
High risk |
No placebo solution provided. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
No dropouts. |
Selective reporting (reporting bias) |
High risk |
Although explicitly stated to be a secondary outcome, no hepatocellular carcinoma recurrence rates provided. No morbidity data reported. |
Other bias |
Unclear risk |
Differences in white and red blood cell, platelet counts and total serum cholesterol between the two groups; funding not reported. |
Intent to treat analysis |
Low risk |
All patients accounted for. |
Baseline imbalance? |
High risk |
Controls had more abnormal hemograms and other laboratory tests. |
Early stopping? |
Unclear risk |
No sample size calculation presented and no explanation regarding why trial stopped when it was. |