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

doi:10.1186/s12906-024-04651-7

科研成果详情

题名	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
作者	Wu, Qiqi 1; Wang, Jiawei 2; Fan, Lijuan 3; Qian, Lala 1; Han, Dexiong 4; Hu, Hantong 4,5; Gao, Hong 4,5
发表日期	2024-12-01
发表期刊	BMC Complementary Medicine and Therapies 影响因子和分区
语种	英语
原始文献类型	Article
关键词	Auricular acupressure Drug-dependent Estazolam Estazolam-dependent insomnia Insomnia Randomized controlled trial
摘要	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).
ISSN	2662-7671
卷号	24 期号:1
DOI	10.1186/s12906-024-04651-7
收录类别	SCOPUS
URL	查看原文
PubMed ID	39395964
SCOPUSEID	2-s2.0-85206123455
通讯作者地址	[Hu, Hantong]Department of Acupuncture and Moxibustion,The Third Affiliated Hospital of Zhejiang,Chinese Medical University,Hangzhou city,China ; [Gao, Hong]Department of Acupuncture and Moxibustion,The Third Affiliated Hospital of Zhejiang,Chinese Medical University,Hangzhou city,China
Scopus学科分类	Complementary and Alternative Medicine
SCOPUS_ID	SCOPUS_ID:85206123455
引用统计
文献类型	期刊论文
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/220888
专题	温州医科大学
通讯作者	Hu, Hantong; Gao, Hong
作者单位	1.Department of Acupuncture,Moxibustion and Massage,Wenzhou Central Hospital,Wenzhou city,China; 2.The Third School of Clinical Medicine,Zhejiang Chinese Medical University,Hangzhou city,China; 3.Department of Comprehensive Rehabilitation,Zhejiang Rehabilitation Medical Center,Hangzhou city,China; 4.Department of Acupuncture and Moxibustion,The Third Affiliated Hospital of Zhejiang,Chinese Medical University,Hangzhou city,China; 5.Department of Acupuncture and Moxibustion,The Third Affiliated Hospital of Zhejiang Chinese Medical University,No. 219 Moganshan Road, Xihu District,Hangzhou city,China
推荐引用方式 GB/T 7714	Wu, Qiqi,Wang, Jiawei,Fan, Lijuan,et al. 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[J]. BMC Complementary Medicine and Therapies,2024,24(1).
APA	Wu, Qiqi., Wang, Jiawei., Fan, Lijuan., Qian, Lala., Han, Dexiong., ... & Gao, Hong. (2024). 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. BMC Complementary Medicine and Therapies, 24(1).
MLA	Wu, Qiqi,et al."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".BMC Complementary Medicine and Therapies 24.1(2024).