Efficacy of manual acupuncture versus placebo acupuncture for generalized anxiety disorder (GAD) in perimenopause women: study protocol for a randomized controlled trial

Abstract Background Generalized anxiety disorder (GAD) is common among perimenopausal women. Acupuncture may be an effective treatment for GAD, but evidence is limited. The pathogenesis of GAD is not yet clear, but it is related to the hypothalamic-pituitary-adrenal axis and its excretion, cortisol...

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Autores principales:	Xin Liu, Xiaoyan Xie, Yingjia Li, Meichen Li, Yuting Wang, Nanbu Wang, Lixing Zhuang, Muxi Liao
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Generalized anxiety disorder Acupuncture Protocol Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/63602c9f907c4de29d0604791bb9b636
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spelling	oai:doaj.org-article:63602c9f907c4de29d0604791bb9b6362021-11-28T12:28:17ZEfficacy of manual acupuncture versus placebo acupuncture for generalized anxiety disorder (GAD) in perimenopause women: study protocol for a randomized controlled trial10.1186/s13063-021-05756-x1745-6215https://doaj.org/article/63602c9f907c4de29d0604791bb9b6362021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05756-xhttps://doaj.org/toc/1745-6215Abstract Background Generalized anxiety disorder (GAD) is common among perimenopausal women. Acupuncture may be an effective treatment for GAD, but evidence is limited. The pathogenesis of GAD is not yet clear, but it is related to the hypothalamic-pituitary-adrenal axis and its excretion, cortisol (CORT), and adrenocorticotropic hormone (ACTH). The object of this study is to evaluate the efficacy of manual acupuncture (MA) versus placebo acupuncture (PA) for perimenopausal women with GAD. Methods This study is a single-center, randomized, single-blind clinical trial that will be conducted in the First Affiliated Hospital of Guangzhou University of Chinese Medicine. A total of 112 eligible GAD patients will be randomly assigned (1:1) to receive MA (n=56) or PA (n=56) three times per week for 4 weeks. The primary outcome measure will be the HAMA score. The secondary outcome measures will be the GAD-7 and PSQI scores and the levels of CORT and ACTH. The evaluation will be executed at baseline, 2 weeks, the end of the treatment, and a follow-up 3-month period. All main analyses will be carried out based on the intention-to-treat (ITT) principle. Discussion This study intends to compare the efficacy between MA and PA in the treatment of perimenopausal women with GAD and to further study the mechanisms underlying the effect. Trial registration Chinese Clinical Trial Registry ChiCTR2100046604 . Registered on 22 May 2021.Xin LiuXiaoyan XieYingjia LiMeichen LiYuting WangNanbu WangLixing ZhuangMuxi LiaoBMCarticleGeneralized anxiety disorderAcupunctureProtocolMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Generalized anxiety disorder Acupuncture Protocol Medicine (General) R5-920
spellingShingle	Generalized anxiety disorder Acupuncture Protocol Medicine (General) R5-920 Xin Liu Xiaoyan Xie Yingjia Li Meichen Li Yuting Wang Nanbu Wang Lixing Zhuang Muxi Liao Efficacy of manual acupuncture versus placebo acupuncture for generalized anxiety disorder (GAD) in perimenopause women: study protocol for a randomized controlled trial
description	Abstract Background Generalized anxiety disorder (GAD) is common among perimenopausal women. Acupuncture may be an effective treatment for GAD, but evidence is limited. The pathogenesis of GAD is not yet clear, but it is related to the hypothalamic-pituitary-adrenal axis and its excretion, cortisol (CORT), and adrenocorticotropic hormone (ACTH). The object of this study is to evaluate the efficacy of manual acupuncture (MA) versus placebo acupuncture (PA) for perimenopausal women with GAD. Methods This study is a single-center, randomized, single-blind clinical trial that will be conducted in the First Affiliated Hospital of Guangzhou University of Chinese Medicine. A total of 112 eligible GAD patients will be randomly assigned (1:1) to receive MA (n=56) or PA (n=56) three times per week for 4 weeks. The primary outcome measure will be the HAMA score. The secondary outcome measures will be the GAD-7 and PSQI scores and the levels of CORT and ACTH. The evaluation will be executed at baseline, 2 weeks, the end of the treatment, and a follow-up 3-month period. All main analyses will be carried out based on the intention-to-treat (ITT) principle. Discussion This study intends to compare the efficacy between MA and PA in the treatment of perimenopausal women with GAD and to further study the mechanisms underlying the effect. Trial registration Chinese Clinical Trial Registry ChiCTR2100046604 . Registered on 22 May 2021.
format	article
author	Xin Liu Xiaoyan Xie Yingjia Li Meichen Li Yuting Wang Nanbu Wang Lixing Zhuang Muxi Liao
author_facet	Xin Liu Xiaoyan Xie Yingjia Li Meichen Li Yuting Wang Nanbu Wang Lixing Zhuang Muxi Liao
author_sort	Xin Liu
title	Efficacy of manual acupuncture versus placebo acupuncture for generalized anxiety disorder (GAD) in perimenopause women: study protocol for a randomized controlled trial
title_short	Efficacy of manual acupuncture versus placebo acupuncture for generalized anxiety disorder (GAD) in perimenopause women: study protocol for a randomized controlled trial
title_full	Efficacy of manual acupuncture versus placebo acupuncture for generalized anxiety disorder (GAD) in perimenopause women: study protocol for a randomized controlled trial
title_fullStr	Efficacy of manual acupuncture versus placebo acupuncture for generalized anxiety disorder (GAD) in perimenopause women: study protocol for a randomized controlled trial
title_full_unstemmed	Efficacy of manual acupuncture versus placebo acupuncture for generalized anxiety disorder (GAD) in perimenopause women: study protocol for a randomized controlled trial
title_sort	efficacy of manual acupuncture versus placebo acupuncture for generalized anxiety disorder (gad) in perimenopause women: study protocol for a randomized controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/63602c9f907c4de29d0604791bb9b636
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Efficacy of manual acupuncture versus placebo acupuncture for generalized anxiety disorder (GAD) in perimenopause women: study protocol for a randomized controlled trial

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