Department of Allied Health (Clinical Nutrition), The Royal Melbourne Hospital, Melbourne, Australia.
Department of Critical Care, Melbourne Medical School, The University of Melbourne, Melbourne, Australia.
JPEN J Parenter Enteral Nutr. 2023 Nov;47(8):983-992. doi: 10.1002/jpen.2527. Epub 2023 Jun 25.
Beta-hydroxy-beta-methylbutyrate (HMB) is a nutrition supplement that may attenuate muscle wasting from critical illness. This trial aimed to determine feasibility of administering a blinded nutrition supplement in the intensive care unit (ICU) and continuing it after ICU discharge.
Single-center, parallel-group, blinded, placebo-controlled, randomized feasibility trial. After traumatic injury necessitating admission to ICU, participants were randomized to receive an enteral study supplement of 3 g of HMB (intervention) or placebo daily for 28 days or until hospital discharge. Primary outcome was feasibility of administering the study supplement, quantified as protocol adherence. Secondary outcomes included change in quadriceps muscle thickness, measured weekly until day 28 or hospital discharge by using ultrasound and analyzed by using a linear mixed model.
Fifty randomized participants (intervention, n = 26; placebo, n = 24) showed comparable baseline characteristics. Participants received 862 (84.3%) of the 1022 prescribed supplements during hospitalization with 543 (62.8%) delivered via an enteral feeding tube. The median (IQR) number of study supplements successfully administered per participant was 19.5 (13.0-24.0) in the intervention group and 16.5 (8.5-23.5) in the placebo group. Marked loss of quadriceps muscle thickness occurred in both groups, with the point estimate favoring attenuated muscle loss with the intervention, albeit with wide CIs (mean intervention difference after 28 days, 0.26 cm [95% CI, -0.13 to 0.64]).
A blinded, placebo-controlled, randomized clinical trial of daily enteral HMB supplementation for up to 28 days in hospital is feasible. Any effect of HMB supplementation to attenuate muscle wasting after traumatic injury remains uncertain.
β-羟-β-甲基丁酸（HMB）是一种营养补充剂，可减轻危重病患者的肌肉消耗。本试验旨在确定在重症监护病房（ICU）中给予盲法营养补充剂的可行性，并在 ICU 出院后继续进行。
单中心、平行组、双盲、安慰剂对照、随机可行性试验。因创伤而需要入住 ICU 的患者，随机分为每天接受 3g HMB 的肠内研究补充剂（干预组）或安慰剂组，持续 28 天或直至出院。主要结局是评估研究补充剂的可行性，通过方案依从性来量化。次要结局包括股四头肌厚度的变化，每周通过超声测量一次，直至第 28 天或出院，并通过线性混合模型进行分析。
50 名随机参与者（干预组 n=26；安慰剂组 n=24）具有相似的基线特征。参与者在住院期间接受了 1022 份规定补充剂中的 862 份（84.3%），其中 543 份（62.8%）通过肠内喂养管给予。干预组中每位参与者成功给予的研究补充剂中位数（IQR）为 19.5（13.0-24.0），安慰剂组为 16.5（8.5-23.5）。两组的股四头肌厚度均明显减少，尽管置信区间较宽，但干预组的肌肉损失减少幅度更大（28 天后的平均干预差异，0.26cm[95%CI，-0.13 至 0.64]）。
在医院内进行长达 28 天的每日肠内 HMB 补充的盲法、安慰剂对照、随机临床试验是可行的。HMB 补充对减轻创伤后肌肉消耗的任何作用仍不确定。
