Department of Acupuncture, Moxibustion and Massage, Wenzhou Central Hospital, Wenzhou city, P.R. China.
The Third School of Clinical Medicine, Zhejiang Chinese Medical University, Hangzhou city, P.R. China.
BMC Complement Med Ther. 2024 Oct 12;24(1):367. doi: 10.1186/s12906-024-04651-7.
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.
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%.
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.
Clinicaltrials.gov (identification number: NCT06258226; Registered 5 February 2024, https://clinicaltrials.gov/ct2/show/NCT06258226 ).
药物性失眠是指失眠患者长期规律服用镇静催眠药物。耳穴压豆（AA）作为一种治疗失眠的辅助手段，受到越来越多的关注。然而，目前缺乏专门针对艾司唑仑依赖型失眠的 AA 治疗的严格研究。本研究旨在评估 AA 对艾司唑仑依赖型失眠的治疗效果。
这是一项随机、单盲、三臂对照试验。不少于 108 名参与者将随机分为三组：AA 组、假耳穴压豆（SAA）组和常规剂量减少组。所有治疗将持续 4 周，随访期为 1 个月。主要临床结局将是艾司唑仑剂量和减少率、血清γ-氨基丁酸（GABA）和皮质醇（CORT）水平。次要结局将涉及匹兹堡睡眠质量指数（PSQI）和苯二氮䓬戒断症状问卷（BWSQ）。将进行意向治疗和方案分析，显著性水平定为 5%。
通过分析 AA 的即刻效应、时效关系和艾司唑仑使用减少情况，本研究结果将为 AA 治疗艾司唑仑依赖型失眠的疗效和安全性提供证据。
Clinicaltrials.gov（注册号：NCT06258226；注册日期：2024 年 2 月 5 日，https://clinicaltrials.gov/ct2/show/NCT06258226）。
