Efficacy and safety of auricular acupressure on reduction of estazolam in patients with insomnia: a study protocol for a three-arm, blinded randomized controlled trial.

IF 3.3 2区 医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE
Qiqi Wu, Jiawei Wang, Lijuan Fan, Lala Qian, Dexiong Han, Hantong Hu, Hong Gao
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Abstract

Background: Drug-dependent insomnia refers to insomnia patients taking sedatives and sleeping pills regularly for a long period. Auricular acupressure (AA) has attracted growing attention as a complementary treatment for insomnia. Nevertheless, there is a lack of rigorous studies evaluating AA specifically for estazolam-dependent insomnia. Our proposed trial aims to assess the therapeutic effect of AA on estazolam-dependent insomnia.

Methods: This study is a randomized, single-blinded, three-arm controlled trial. No less than 108 participants will be randomized into one of three groups: AA group, sham auricular acupressure (SAA) group, and conventional dosage reduction group. All treatments will be administered for 4 weeks, with a follow-up period of 1 month. The primary clinical outcomes will be estazolam dosing and reduction rates, serum gamma-aminobutyric acid (GABA) and cortisol (CORT) levels. Secondary outcomes will concern the Pittsburgh sleep quality index (PSQI) and Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ). Both intention-to-treat and per-protocol analyses will be performed, with the significance level determined as 5%.

Discussion: The study results will provide evidence on the efficacy and safety of AA in managing estazolam-dependent insomnia by analyzing its immediate effect, time-effect relationship, and reduction of estazolam use.

Trial registration: Clinicaltrials.gov (identification number: NCT06258226; Registered 5 February 2024, https://clinicaltrials.gov/ct2/show/NCT06258226 ).

耳穴按摩对失眠患者减少艾司唑仑剂量的有效性和安全性:三臂盲法随机对照试验的研究方案。
背景:药物依赖性失眠是指失眠患者长期服用镇静剂和安眠药。耳穴穴位按摩(AA)作为失眠症的一种辅助治疗方法,已引起越来越多的关注。然而,目前还缺乏专门针对艾司唑仑依赖性失眠症的耳穴穴位按摩进行评估的严格研究。我们建议的试验旨在评估艾司唑仑依赖性失眠症的治疗效果:本研究是一项随机、单盲、三臂对照试验。不少于 108 名参与者将被随机分为三组:AA 组、假耳穴穴位按摩 (SAA) 组和常规减量组。所有治疗均持续 4 周,随访 1 个月。主要临床结果为艾司唑仑剂量和减量率、血清γ-氨基丁酸(GABA)和皮质醇(CORT)水平。次要结果包括匹兹堡睡眠质量指数(PSQI)和苯二氮卓类药物戒断症状问卷(BWSQ)。将进行意向治疗分析和按协议分析,显著性水平为 5%:研究结果将通过分析AA的即时效果、时间效应关系和减少伊沙唑仑用量,为AA治疗伊沙唑仑依赖性失眠症的有效性和安全性提供证据:试验注册:Clinicaltrials.gov(识别号:NCT06258226;NCT06258226:NCT06258226试验注册:Clinicaltrials.gov(识别号:NCT06258226;注册日期:2024 年 2 月 5 日,https://clinicaltrials.gov/ct2/show/NCT06258226 )。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BMC Complementary Medicine and Therapies
BMC Complementary Medicine and Therapies INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
6.10
自引率
2.60%
发文量
300
审稿时长
19 weeks
期刊介绍:
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