Brown 1990.
Methods | Design: randomised controlled trial. Multi‐centre or single‐centre: single‐centre. Period: not reported. Sample size calculation: not reported. Generation of allocation: random numbers table. Allocation concealment: not reported. Blinded assessment of treatment allocation: not reported. Withdrawals: 3 recruited participants withdrawn (2 deaths, 1 transferred to another unit on day 2). Intention‐to‐treat analysis: not reported. Follow‐up: not reported | |
Participants |
How many enter the study on each arm? 23 participants, 20 analysed (BCAA 4 women and 6 men; control 1 woman and 9 men) How many finish the study on each arm? BCAA group 7; control group 2 Mean age: BCAA group 43 years; control group 33 years (overall 38 years) Mean total burn surface area (TBSA): BCAA 45%; control 49% Inclusion criteria: consecutively thermally injured patients who required PN for > 7 days and > 10% TBSA Exclusion criteria: TBSA < 10%, acute renal failure, liver failure and insulin‐dependent diabetes mellitus; patients who received steroids within 24 hours of the start of parenteral nutrition |
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Interventions | All participants had parenteral nutrition―isocaloric, isonitrogenous and isovolumic (n = 20): Experimental/BCAA group (n = 10): modified amino acid solution with 45% BCAA Control (n = 10): standard amino acid solution with 19% BCAA |
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Outcomes | Death, LOS | |
Notes | Other outcomes (biochemical): C‐reactive protein, albumin, prealbumin, fibronectin, etc | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Generated by random numbers sequence |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Did not address blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 participants excluded after randomisation 3 recruited participants withdrawn (2 deaths, 1 transferred to another unit on day 2) |
Other bias | High risk | No intention‐to‐treat principle applied |