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Effect of Electroacupuncture Versus Cognitive Behavioral Therapy for Perimenopausal Insomnia: Protocol for a Noninferiority Randomized Controlled Trial.

作者信息

Wang Huixian, Yu Xintong, Hu Jing, Zheng Yanting, Hu Jia, Sun Xuqiu, Ren Ying, Chen Yunfei

机构信息

Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Acupuncture Anesthesia Clinical Research Institute, Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

出版信息

JMIR Res Protoc. 2023 Nov 9;12:e51767. doi: 10.2196/51767.


DOI:10.2196/51767
PMID:37943587
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10667986/
Abstract

BACKGROUND: Perimenopausal insomnia (PMI) has a high global incidence, which is common in middle-aged women and is more severe than nonmenopausal insomnia. Effective treatments with fewer side effects and more consistent repeatable results are needed. Acupuncture, a therapy based on traditional Chinese medicine, is safe and may be effective for PMI. It is widely accepted in Western countries, and evidence supports the use of acupuncture as a main or supplementary therapy. Cognitive behavioral therapy is also used to improve sleep quality. It has structured sessions and has been recommended as a first-line treatment for insomnia (cognitive behavioral therapy for insomnia [CBT-I]) by the American Association of Physicians. However, few randomized controlled trials have been conducted to compare the effectiveness of these 2 therapies. This study will be performed in perimenopausal women with insomnia to determine the efficacy of electroacupuncture (EA) versus CBT-I. OBJECTIVE: This study aimed to compare the preliminary effectiveness and safety of EA and CBT-I for PMI through a randomized controlled noninferiority study design. METHODS: This study is designed as an assessor-blinded, noninferiority, randomized controlled trial. A total of 160 eligible participants with PMI will be randomly divided into 2 groups to receive either EA or CBT-I. Participants in the EA group will receive electroacupuncture for 8 weeks. The intervention will be delivered 3 times weekly for a total of 12 sessions and 2 times weekly for the next 4 weeks. Meanwhile, participants in the control group will undergo CBT-I (once a week) for 8 weeks. Treatment will use 7 main acupoints (GV20, DU24, EX-HN3, EX-HN18, EX-CA1, RN6, and RN4) and an extra 4 acupoints based on syndrome differentiation. The primary outcome is the Insomnia Severity Index. The secondary outcome measures are the Pittsburgh Sleep Quality Index; Menopause-Specific Quality of Life; Menopause Rating Scale; Hamilton Depression Scale; Hamilton Anxiety Scale; hot flash score; and the level of estradiol, follicle-stimulating hormone, and luteinizing hormone in serum. Sleep architecture will be assessed using polysomnograms. RESULTS: Participants are currently being recruited. The first participant was enrolled in January 2023, marking the initiation of the recruitment phase. The recruitment process is expected to continue until January 2025, at which point data collection will commence. CONCLUSIONS: This trial represents a pioneering effort to investigate the efficacy and safety of EA and CBT-I as interventions for PMI. It is noteworthy that this study is conducted solely within a single center and involves Chinese participants, which is a limitation. Nonetheless, the findings of this study are expected to contribute valuable insights for clinicians engaged in the management of PMI. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2300070981; https://www.chictr.org.cn/showprojEN.html?proj=194561. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51767.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ebd2/10667986/5a1eac495d5d/resprot_v12i1e51767_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ebd2/10667986/5a1eac495d5d/resprot_v12i1e51767_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ebd2/10667986/5a1eac495d5d/resprot_v12i1e51767_fig1.jpg

相似文献

[1]
Effect of Electroacupuncture Versus Cognitive Behavioral Therapy for Perimenopausal Insomnia: Protocol for a Noninferiority Randomized Controlled Trial.

JMIR Res Protoc. 2023-11-9

[2]
Effect of acupuncture on insomnia in menopausal women: a study protocol for a randomized controlled trial.

Trials. 2019-5-30

[3]
Electroacupuncture versus Sham Acupuncture for Perimenopausal Insomnia: A Randomized Controlled Clinical Trial.

Nat Sci Sleep. 2020-12-22

[4]
Effect of acupuncture on insomnia following stroke: study protocol for a randomized controlled trial.

Trials. 2016-11-16

[5]
Effects of the Prolong Life With Nine Turn-Method Qigong on Fatigue, Insomnia, Anxiety, and Gastrointestinal Disorders in Patients With Chronic Fatigue Syndrome: Protocol for a Randomized Controlled Trial.

JMIR Res Protoc. 2024-2-26

[6]
Effect of Electroacupuncture on Insomnia in Patients With Depression: A Randomized Clinical Trial.

JAMA Netw Open. 2022-7-1

[7]
Telephone-Based Cognitive Behavioral Therapy for Insomnia in Perimenopausal and Postmenopausal Women With Vasomotor Symptoms: A MsFLASH Randomized Clinical Trial.

JAMA Intern Med. 2016-7-1

[8]
Efficacy and safety of electroacupuncture combined with Suanzaoren decoction for insomnia following stroke: study protocol for a randomized controlled trial.

Trials. 2021-7-24

[9]
Effect of acupuncture and its influence on cerebral activity in perimenopausal insomniacs: study protocol for a randomized controlled trial.

Trials. 2017-8-14

[10]
Electroacupuncture Plus Auricular Acupressure on Chemotherapy-Related Insomnia in Patients With Breast Cancer (EACRI): Study Protocol for a Randomized, Sham-Controlled Trial.

Integr Cancer Ther. 2021

本文引用的文献

[1]
Acupuncture for comorbid depression and insomnia in perimenopause: A feasibility patient-assessor-blinded, randomized, and sham-controlled clinical trial.

Front Public Health. 2023

[2]
Psychometric properties and validity of the Menopause Rating Scale in postmenopausal Portuguese women.

Menopause. 2023-2-1

[3]
Behavioral interventions for improving sleep outcomes in menopausal women: a systematic review and meta-analysis.

Menopause. 2022-10-1

[4]
The association between sleep deprivation and arterial pressure variations: a systematic literature review.

Sleep Med X. 2022-1-26

[5]
The Role of Acupuncture in Treating Perimenopausal Insomnia: An Overview and Quality Assessment of Systematic Reviews and Meta-Analyses.

Neuropsychiatr Dis Treat. 2021-11-11

[6]
Acupuncture: A Promising Approach for Comorbid Depression and Insomnia in Perimenopause.

Nat Sci Sleep. 2021-10-12

[7]
Comparative Utility of Acupuncture and Western Medication in the Management of Perimenopausal Insomnia: A Systematic Review and Meta-Analysis.

Evid Based Complement Alternat Med. 2021-4-26

[8]
Pharmacological Management of Insomnia.

Neurotherapeutics. 2021-1

[9]
Electroacupuncture versus Sham Acupuncture for Perimenopausal Insomnia: A Randomized Controlled Clinical Trial.

Nat Sci Sleep. 2020-12-22

[10]
Adherence to a Healthy Sleep Pattern and Incident Heart Failure: A Prospective Study of 408 802 UK Biobank Participants.

Circulation. 2021-1-5

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