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. |