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关于轻度失眠的疗效:一项随机安慰剂对照试验。

Efficacy of on Mild Insomnia: A Randomized Placebo-Controlled Trial.

机构信息

Department of Brain and Cognitive Sciences, Ewha Womans University, Seoul 03760, Korea.

Ewha Brain Institute, Ewha Womans University, Seoul 03760, Korea.

出版信息

Nutrients. 2019 Jul 25;11(8):1719. doi: 10.3390/nu11081719.

DOI:10.3390/nu11081719
PMID:31349690
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6723095/
Abstract

(PS) rhizome, which contains glyceryl-1-monolinoleate as its primary active component, has been shown to improve insomnia in animal models. Based on these findings, we aimed to investigate the safety and efficacy of PS rhizome extract in improving sleep quality in individuals with mild insomnia. Eighty individuals with mild insomnia were enrolled in a four-week, randomized, double-blind, placebo-controlled trial of PS rhizome extract (500 mg/day, = 40, PS group) or placebo ( = 40, placebo group). The primary outcome measure was change in total score on the Athens Insomnia Scale (AIS) to indicate sleep quality. The secondary outcome measures included change in actigraphy data and perfusion levels in the brain regions within the default mode network (DMN), which is known to play a key role in insomnia. The PS group showed greater improvement in the total AIS score with a significant increase in total sleep time, relative to the placebo group. In addition, significant group-by-visit interactions were observed in the perfusion level of the medial prefrontal cortex within the DMN. Findings of the current study provide first evidence that PS rhizome extract could be an effective natural ingredient for improving sleep in mild insomnia using a human model.

摘要

(PS)块茎,其主要活性成分为甘油-1-亚油酸酯,已被证明可改善动物模型中的失眠症。基于这些发现,我们旨在研究 PS 块茎提取物改善轻度失眠个体睡眠质量的安全性和有效性。80 名轻度失眠的个体参加了为期四周、随机、双盲、安慰剂对照的 PS 块茎提取物(500mg/天,n=40,PS 组)或安慰剂(n=40,安慰剂组)试验。主要结局指标是 Athens 失眠量表(AIS)总评分的变化,以表明睡眠质量。次要结局指标包括脑默认模式网络(DMN)内脑区的活动数据和灌注水平的变化,该网络已知在失眠中发挥关键作用。PS 组的 AIS 总分改善更大,总睡眠时间显著增加,与安慰剂组相比。此外,在 DMN 内的前额叶内侧皮质的灌注水平观察到显著的组间访视交互作用。本研究的结果首次提供了证据,表明 PS 块茎提取物可能是一种有效的天然成分,可通过人体模型改善轻度失眠的睡眠。

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