Evidence map›Paper›PMID 31146772›Full record

ArticleTrials2019

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

Shanshan Li, Ping Yin, Xuan Yin, Anna Bogachko, Tingting Liang, Lixing Lao, Shifen Xu

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.2field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 3 countries.

Shanshan LiShanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.
Ping YinShanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.
Xuan YinShanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.
Anna BogachkoShanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.
Tingting LiangShanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.
Lixing LaoSchool of Chinese Medicine, University of Hong Kong, Hong Kong, China. lxlao1@hku.hk.
Shifen XuShanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China. xu_teacher2006@126.com.ORCID http://orcid.org/0000-0001-5595-3480
Shanghai University of Traditional Chinese Medicine · CNUniversity of Maryland, Baltimore · US

Funding

Foundation of Shanghai Municipal Commission of Health and Family Planning 201640026Science and Technology Commission of Shanghai Municipality 18401905200Shanghai Hospital Development Center SHDC12016124State Administration of Traditional Chinese Medicine of the People's Republic of China JDZX2015024
6 · The paper itself

Abstract

backgroundThe 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/

designIn 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 registrationChinese Clinical Trial Registry, ChiCTR1800018645 . Registered on 10 January 2018.

Indexed as

Acupuncture TherapyMenopauseRandomized Controlled Trials as TopicAcupuncture PointsFemaleHumansOutcome Assessment, Health CareResearch DesignSeverity of Illness IndexSingle-Blind MethodSleep Initiation and Maintenance DisordersAcupunctureClinical trialInsomniaMenopause

Identifiers

PMID31146772
PMCPMC6543678
OpenAlexW2946981645

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.