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棕榈酰乙醇胺治疗睡眠障碍。一项双盲、随机、安慰剂对照的干预性研究。

Palmitoylethanolamide for sleep disturbance. A double-blind, randomised, placebo-controlled interventional study.

作者信息

Rao Amanda, Ebelt Phillippa, Mallard Alistair, Briskey David

机构信息

RDC Clinical, Brisbane, 4006 Australia.

University of Sydney, School of Medicine, Sydney, Australia.

出版信息

Sleep Sci Pract. 2021;5(1):12. doi: 10.1186/s41606-021-00065-3. Epub 2021 Sep 10.

Abstract

BACKGROUND

Sleep is essential for wellbeing, yet sleep disturbance is a common problem linked to a wide range of health conditions. Palmitoylethanolamide (PEA) is an endogenous fatty acid amide proposed to promote better sleep via potential interaction with the endocannabinoid system.

METHODS

This double-blind, randomised study on 103 adults compared the efficacy and tolerability of 8 weeks of daily supplemented PEA formulation (350 mg Levagen + ®) to a placebo. Sleep quality and quantity were measured using wrist actigraphy, a sleep diary and questionnaires.

RESULTS

At week 8, PEA supplementation reduced sleep onset latency, time to feel completely awake and improved cognition on waking. After 8 weeks, both groups improved their sleep quality and quantity scores similarly. There was no difference between groups at baseline or week 8 for sleep quantity or quality as measured from actigraphy or sleep diaries.

CONCLUSION

These findings support PEA as a potential sleeping aid capable of reducing sleep onset time and improving cognition on waking.

TRIAL REGISTRATION

Australian New Zealand Clinical Trials Registry ACTRN12618001339246. Registered 9 August 2018.

摘要

背景

睡眠对健康至关重要,但睡眠障碍是一个与多种健康状况相关的常见问题。棕榈酰乙醇胺(PEA)是一种内源性脂肪酸酰胺,通过与内源性大麻素系统的潜在相互作用,有望改善睡眠。

方法

这项针对103名成年人的双盲随机研究,比较了每日补充8周PEA制剂(350毫克Levagen + ®)与安慰剂的疗效和耐受性。使用手腕活动记录仪、睡眠日记和问卷来测量睡眠质量和睡眠时间。

结果

在第8周时,补充PEA可缩短入睡潜伏期、完全清醒所需时间,并改善醒来时的认知能力。8周后,两组的睡眠质量和睡眠时间得分改善程度相似。从活动记录仪或睡眠日记测量的睡眠量或质量来看,两组在基线或第8周时没有差异。

结论

这些发现支持PEA作为一种潜在的睡眠辅助剂,能够缩短入睡时间并改善醒来时的认知能力。

试验注册

澳大利亚新西兰临床试验注册中心ACTRN12618001339246。于2018年8月9日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e064/8428962/f99df70d5c47/41606_2021_65_Fig1_HTML.jpg

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