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. 2012 May 16;2012(5):CD008344. doi: 10.1002/14651858.CD008344.pub2
Methods Randomised trial comparing supplements (standard or branched chain amino acids) to no supplements in outpatients awaiting liver transplant. Geographical location Dallas, Texas, USA. Paper published 1997.
Participants Inclusion criteria: Malnourished outpatient cirrhotic patients with history of encephalopathy awaiting liver transplantation. Exclusion criteria: None cited. 36 patients (no details regarding sex, age).
Interventions Intervention group received commercial nutritional supplement (Ensure® or Hepatic‐Aid® [0.5 gm/kg/d protein and non‐protein calories]); Controls received standard diet. Duration therapy 64‐143 days.
Outcomes Appearance hepatic encephalopathy. Text indicates no difference in triceps skinfold thickness, midarm circumference, midarm muscle circumference, but no numerical data.
Category of study Supplements/Medical.
Sample size calculation Not reported if done.
Full paper or abstract only Abstract.
Notes Information regarding dropouts and hepatic encephalopathy admissions obtained from author at poster. E‐mail request for more information sent to Dr Hasse on September 17, 2011 (jm.hasse@baylorhealth.edu). See above note regarding response.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Only states "patients were randomised 2:2:1".
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 Unclear risk Large number dropouts for variety of reasons.
Selective reporting (reporting bias) High risk No mortality data.
Other bias Unclear risk Funder of trial not reported.
Intent to treat analysis High risk Could not be done.
Baseline imbalance? Unclear risk No data in abstract.
Early stopping? Unclear risk No sample size calculation and unknown why stopped.