Effect of acupuncture on insomnia in menopausal women: a study protocol for a randomized controlled trial
Abstract Background The National Institutes of Health estimates the prevalence of insomnia in menopausal women at 40–50%. Some studies have shown that acupuncture might be effective in treating primary insomnia and insomnia related to depression and stroke. Although there are some programs supportin...
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doaj-c9b7d1ae1b044346b18182fec6bc047c2020-11-25T03:10:56ZengBMCTrials1745-62152019-05-012011810.1186/s13063-019-3374-8Effect of acupuncture on insomnia in menopausal women: a study protocol for a randomized controlled trialShanshan Li0Ping Yin1Xuan Yin2Anna Bogachko3Tingting Liang4Lixing Lao5Shifen Xu6Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese MedicineShanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese MedicineShanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese MedicineShanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese MedicineShanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese MedicineSchool of Chinese Medicine, University of Hong KongShanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese MedicineAbstract Background The National Institutes of Health estimates the prevalence of insomnia in menopausal women at 40–50%. Some studies have shown that acupuncture might be effective in treating primary insomnia and insomnia related to depression and stroke. Although there are some programs supporting insomnia during the menopausal transition, there are few randomized controlled trials (RCT) to provide evidence regarding their effectiveness. We design a RCT of suitable sample size to verify the effectiveness of acupuncture in patients with insomnia during the menopausal transition and to form an optimized acupuncture treatment protocol. Method/Design In this randomized, single-site, single-blind, placebo-controlled trial, 84 eligible patients will be recruited and randomly assigned to either the acupuncture group (n = 42) or the sham control group (n = 42) in a 1:1 ratio. Participants will receive a total of 18 treatment sessions for eight consecutive weeks. Treatments will be given three times per week in the first four weeks, twice a week for the next two weeks, and finally once weekly for the final two weeks. Treatment will utilize eight main acupoints (GV20, GV24, GV29, RN6, RN4, SP6, HT7, EX-HN22) and extra two acupoints based on syndrome differentiation. The primary outcome will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will be measured by sleep parameters recorded in the Actigraphy (SE, TST, SA), Insomnia Severity Index (ISI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), and Menopause Quality of Life (Men-QOL). The primary outcomes will be assessed at baseline, week 4, week 8, and the first and third month after the end of treatment. Discussion If the results confirm that acupuncture is effective and safe for the treatment on insomnia in menopausal women, this positive outcome could provide evidence for clinical application. Trial registration Chinese Clinical Trial Registry, ChiCTR1800018645. Registered on 10 January 2018.http://link.springer.com/article/10.1186/s13063-019-3374-8MenopauseInsomniaAcupunctureClinical trial |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Shanshan Li Ping Yin Xuan Yin Anna Bogachko Tingting Liang Lixing Lao Shifen Xu |
spellingShingle |
Shanshan Li Ping Yin Xuan Yin Anna Bogachko Tingting Liang Lixing Lao Shifen Xu Effect of acupuncture on insomnia in menopausal women: a study protocol for a randomized controlled trial Trials Menopause Insomnia Acupuncture Clinical trial |
author_facet |
Shanshan Li Ping Yin Xuan Yin Anna Bogachko Tingting Liang Lixing Lao Shifen Xu |
author_sort |
Shanshan Li |
title |
Effect of acupuncture on insomnia in menopausal women: a study protocol for a randomized controlled trial |
title_short |
Effect of acupuncture on insomnia in menopausal women: a study protocol for a randomized controlled trial |
title_full |
Effect of acupuncture on insomnia in menopausal women: a study protocol for a randomized controlled trial |
title_fullStr |
Effect of acupuncture on insomnia in menopausal women: a study protocol for a randomized controlled trial |
title_full_unstemmed |
Effect of acupuncture on insomnia in menopausal women: a study protocol for a randomized controlled trial |
title_sort |
effect of acupuncture on insomnia in menopausal women: a study protocol for a randomized controlled trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2019-05-01 |
description |
Abstract Background The National Institutes of Health estimates the prevalence of insomnia in menopausal women at 40–50%. Some studies have shown that acupuncture might be effective in treating primary insomnia and insomnia related to depression and stroke. Although there are some programs supporting insomnia during the menopausal transition, there are few randomized controlled trials (RCT) to provide evidence regarding their effectiveness. We design a RCT of suitable sample size to verify the effectiveness of acupuncture in patients with insomnia during the menopausal transition and to form an optimized acupuncture treatment protocol. Method/Design In this randomized, single-site, single-blind, placebo-controlled trial, 84 eligible patients will be recruited and randomly assigned to either the acupuncture group (n = 42) or the sham control group (n = 42) in a 1:1 ratio. Participants will receive a total of 18 treatment sessions for eight consecutive weeks. Treatments will be given three times per week in the first four weeks, twice a week for the next two weeks, and finally once weekly for the final two weeks. Treatment will utilize eight main acupoints (GV20, GV24, GV29, RN6, RN4, SP6, HT7, EX-HN22) and extra two acupoints based on syndrome differentiation. The primary outcome will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will be measured by sleep parameters recorded in the Actigraphy (SE, TST, SA), Insomnia Severity Index (ISI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), and Menopause Quality of Life (Men-QOL). The primary outcomes will be assessed at baseline, week 4, week 8, and the first and third month after the end of treatment. Discussion If the results confirm that acupuncture is effective and safe for the treatment on insomnia in menopausal women, this positive outcome could provide evidence for clinical application. Trial registration Chinese Clinical Trial Registry, ChiCTR1800018645. Registered on 10 January 2018. |
topic |
Menopause Insomnia Acupuncture Clinical trial |
url |
http://link.springer.com/article/10.1186/s13063-019-3374-8 |
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