| Methods |
Method of randomisation: not stated
Assessor blinding: not reported
Intention to treat: carried out,
Lost to follow‐up: one unable to continue because of illness, 2 died
Timing of intervention: 8 weeks |
| Participants |
Location: not given, presumably University Hospital, Linkoping, Sweden
19 patients
Inclusion criteria: Patients with severe congestive heart failure (NewYork Heart Association functional class III‐IV)
Exclusion criteria: Diabetes mellitus, severe liver or renal insufficiency
Sex: 3 female, 19 male
Age: mean age 72y |
| Interventions |
a: 500 ml oral nutritional supplement (Biosorb 1500 (Pharmacia, Germany)
750 kcal, 30 g protein)
b: 1:10 diluted version of intervention as placebo (7.5 kcal, 3 g protein)
Allocated: 9/13
Assessed: 7/12 |
| Outcomes |
Main outcomes:
Mortality
Morbidity and complications ‐NYHA (New York Heart Association) functional class, complications (renal failure and diabetic coma), malnourished after 8 weeks
Additional outcomes:
Measures of nutritional status ‐ weight, triceps skinfold (mm), arm muscle circumference (cm)
Measures of dietary intake ‐ energy and protein intake |
| Notes |
Request for further details sent 11/5/01 on inpatient or outpatient status, location of trial and further details regarding composition of supplement and how it was provided |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
