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发酵米胚芽中γ-氨基丁酸对失眠症状患者的安全性和有效性:一项随机双盲试验

Safety and Efficacy of Gamma-Aminobutyric Acid from Fermented Rice Germ in Patients with Insomnia Symptoms: A Randomized, Double-Blind Trial.

作者信息

Byun Jung Ick, Shin Yu Yong, Chung Sung Eun, Shin Won Chul

机构信息

Department of Neurology, Kyung Hee University Hospital at Gangdong, Seoul, Korea.

出版信息

J Clin Neurol. 2018 Jul;14(3):291-295. doi: 10.3988/jcn.2018.14.3.291. Epub 2018 Apr 27.

DOI:10.3988/jcn.2018.14.3.291
PMID:29856155
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6031986/
Abstract

BACKGROUND AND PURPOSE

This study aimed to determine the subjective and objective improvements in sleep quality after treatment with gamma-aminobutyric acid (GABA; 300 mg daily) extracted from unpolished rice germ.

METHODS

This study was a prospective, randomized, double-blind, and placebo-controlled trial. In total, 40 patients who complained of insomnia symptoms were enrolled and randomly assigned to the GABA treatment group (n=30) or the placebo group (n=10). Polysomnography was performed, and sleep questionnaires were administered before treatment and after 4 weeks of treatment.

RESULTS

After 4 weeks of treatment the sleep latency had decreased [13.4±15.7 min at pretreatment vs. 5.7±6.2 min at posttreatment (mean±SD), p=0.001] and the sleep efficacy had increased (79.4±12.9% vs. 86.1±10.5%, p=0.018) only in the GABA treatment group. Adverse events occurred in four subjects (10%).

CONCLUSIONS

This study shows that treatment with unpolished-rice-germ-derived GABA improved not only the subjective sleep quality but also the objective sleep efficacy without severe adverse events.

摘要

背景与目的

本研究旨在确定用糙胚芽提取的γ-氨基丁酸(GABA;每日300毫克)治疗后睡眠质量的主观和客观改善情况。

方法

本研究为前瞻性、随机、双盲、安慰剂对照试验。总共招募了40名主诉失眠症状的患者,并随机分配到GABA治疗组(n = 30)或安慰剂组(n = 10)。在治疗前和治疗4周后进行多导睡眠图检查,并发放睡眠问卷。

结果

仅在GABA治疗组中,治疗4周后睡眠潜伏期缩短[治疗前为13.4±15.7分钟,治疗后为5.7±6.2分钟(均值±标准差),p = 0.001],睡眠效率提高(79.4±12.9%对86.1±10.5%,p = 0.018)。4名受试者(10%)出现不良事件。

结论

本研究表明,用糙胚芽衍生的GABA治疗不仅改善了主观睡眠质量,还提高了客观睡眠效率,且无严重不良事件。

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