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一项针对中老年成年人进行为期四周口服γ-氨基丁酸(GABA)及其对疼痛和睡眠影响的试点及可行性随机对照试验方案。

Protocol for a pilot and feasibility randomized-controlled trial of four weeks of oral γ-aminobutyric acid (GABA) intake and its effect on pain and sleep in middle-to-older aged adults.

作者信息

Montesino-Goicolea Soamy, Nin Olga, Gonzalez Barbara M, Sawczuk Nathalie J, Nodarse Chavier Laffitte, Valdes-Hernandez Pedro Antonio, Jackson Elijah, Huo Zhiguang, Somerville Jessie Elise T, Porges Eric C, Smith Cameron, Fillingim Roger B, Cruz-Almeida Yenisel

机构信息

Pain Research & Intervention Center of Excellence, University of Florida, Gainesville, FL, USA.

Department of Community Dentistry & Behavioral Science, College of Dentistry, University of Florida, Gainesville, FL, USA.

出版信息

Contemp Clin Trials Commun. 2023 Jan 20;32:101066. doi: 10.1016/j.conctc.2023.101066. eCollection 2023 Apr.

DOI:10.1016/j.conctc.2023.101066
PMID:36712186
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9876833/
Abstract

Approximately 1.71 billion people globally live with musculoskeletal pain conditions, including low back pain, knee pain, and neck pain Cieza et al. (2020). In the US, an estimated 20.4% of U.S. adult had chronic pain and 8.0% of U.S. adults had high-impact chronic pain, with higher prevalence associated with advancing age Dahlhamer et al. (2018). On the other hand, between 50 and 70 million US adults have a sleep disorder (American Sleep Association). Although the link between sleep and pain is widely established, the neurobiological mechanisms underlying this relationship have yet to be fully elucidated, specifically within an aged population. As currently available sleep and chronic pain therapies are only partially effective, novel treatment approaches are urgently needed. Given the potential mechanistic role of γ-aminobutyric acid (GABA) in both conditions, and the availability of GABA supplements over the counter, the present proposal will determine the feasibility and acceptability of oral GABA administration in middle-to-older aged adults with chronic pain and sleep disorders as well as characterize the potential neurobiological mechanisms involved in both conditions. Results from the present investigation using a parallel, double-blinded, placebo-controlled study will provide novel preliminary information needed for future translational pain and sleep research.

摘要

全球约有17.1亿人患有肌肉骨骼疼痛疾病,包括腰痛、膝关节痛和颈痛(西埃扎等人,2020年)。在美国,估计20.4%的美国成年人患有慢性疼痛,8.0%的美国成年人患有高影响慢性疼痛,患病率随着年龄增长而升高(达尔哈默等人,2018年)。另一方面,美国有5000万至7000万成年人患有睡眠障碍(美国睡眠协会)。虽然睡眠与疼痛之间的联系已被广泛证实,但这种关系背后的神经生物学机制尚未完全阐明,特别是在老年人群中。由于目前可用的睡眠和慢性疼痛疗法仅部分有效,迫切需要新的治疗方法。鉴于γ-氨基丁酸(GABA)在这两种情况下的潜在机制作用,以及非处方GABA补充剂的可用性,本提议将确定口服GABA对患有慢性疼痛和睡眠障碍的中老年成年人的可行性和可接受性,并描述这两种情况下潜在的神经生物学机制。本研究采用平行、双盲、安慰剂对照研究的结果将为未来的转化性疼痛和睡眠研究提供所需的新的初步信息。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f40/9876833/a0f8a0788d0b/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f40/9876833/a873d0bf97b0/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f40/9876833/a0f8a0788d0b/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f40/9876833/a873d0bf97b0/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f40/9876833/a0f8a0788d0b/gr2.jpg

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