Evidence map›Paper›PMID 32493411›Full record

ArticleTrials2020

Overall adjustment acupuncture for postmenopausal osteoporosis (PMOP): a study protocol for a randomized sham-controlled trial.

Z Q Ren, Y F Wang, G F Ao, H X Chen, M Huang, M X Lai, H D Zhao, R Zhao

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
3.7field-weighted citation impact, top 7% 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

4 citing papers in PubMed, 19 citations in OpenAlex.

  1. Review
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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

8 authors at 4 institutions in 1 country.

Z Q RenNanjing University of Chinese Medicine, No.138 Xianlin Road, Nanjing, 210046, China.
Y F WangSchool of Acupuncture-Tuina and Rehabilitation, Yunnan University of Chinese Medicine, No.1076 Yuhua Road, Chenggong District, Kunming, 650500, Yunnan Province, China.
G F AoThe First Affiliated Hospital of Dali University, No. 32 Jiashibo Road, Dali, 671000, Yunnan Province, China.
H X ChenSchool of Acupuncture-Tuina and Rehabilitation, Yunnan University of Chinese Medicine, No.1076 Yuhua Road, Chenggong District, Kunming, 650500, Yunnan Province, China.
M HuangDepartment of Acupuncture, Kunming Municipal Hospital of Traditional Chinese Medicine, 25 Dongfeng Road, Panlong District, Kunming, 650011, Yunnan Province, China.
M X LaiSchool of Acupuncture-Tuina and Rehabilitation, Yunnan University of Chinese Medicine, No.1076 Yuhua Road, Chenggong District, Kunming, 650500, Yunnan Province, China.
H D ZhaoThe First Affiliated Hospital of Dali University, No. 32 Jiashibo Road, Dali, 671000, Yunnan Province, China.
R ZhaoThe First Affiliated Hospital of Yunnan University of Chinese Medicine, No.120 Guanghua Road, Wuhua District, Kunming, 650032, Yunnan Province, China. kmzhaorong@qq.com.
Dali University · CNYunnan University of Traditional Chinese Medicine · CNKunming Municipal Hospital of Traditional Chinese Medicine · CNYunnan University · CN

Funding

National nature science foundation of China 81560799
6 · The paper itself

Abstract

backgroundOsteoporosis is becoming more prevalent in aging societies worldwide, and the economic burden attributable to osteoporotic fractures is substantial. The medications presently available to treat osteoporosis have side effects. Acupuncture is widely used for treating osteoporotic postmenopausal women because it is non-invasive and has fewer side effects, but the powerful clinical evidence for its efficacy remains insufficient. Our study intends to explore the effect of overall adjustment acupuncture (OA) in the treatment of postmenopausal osteoporosis (PMOP). METHODS/

designThis study is a randomized, sham-controlled, patient- and assessor-blinded trial and aims to evaluate the effect of OA in women with PMOP. We will recruit 104 women aged 45-70 years with a diagnosis of PMOP. Participants will be randomly allocated in a 1:1 ratio to the OA group and the sham acupuncture (SA) group. Both groups will receive real herbal medicine treatment as a basic treatment twice a day for 3 months, the OA group receives real acupuncture treatment and the SA group receives placebo acupuncture treatment (non-penetrating, sham skin-needle therapy, sham cupping). All patients will receive acupuncture treatment twice per week for 3 months. The primary outcome is bone mineral density (BMD) and the secondary outcomes include estradiol (E2), follicle-stimulating hormone (FSH), bone gla protein (BGP), bone alkaline phosphatase (BALP), total antioxidant capacity (TAC), advanced oxidation protein products (AOPP), PPARγ, β-catenin, FoxO3a levels, visual analog pain scale score (VAS), Traditional Chinese medicine (TCM) syndrome scores and quality of daily life score (QOL). Outcome measures will be collected at baseline, middle of the treatment (1.5 months), the end of treatment (3 months). The present protocol followed the SPIRIT guidelines and fulfills the SPIRIT Checklist.

conclusionThis study will be conducted to compare the efficacy of OA versus SA. This trial should help to evaluate whether OA can effectively prevent and treat PMOP by improving the estrogen levels of postmenopausal women. The mechanism is to improve the imbalance of osteogenic differentiation and lipogenesis of bone-marrow cells under oxidative stress.

trial registrationChinese Clinical Trial Registry, ID: ChiCTR1800017581. Registered on 5 August 2018. URL: http://www.chictr.org.cn.

Indexed as

Acupuncture TherapyBone DensityDouble-Blind MethodEstradiolFemaleHumansMulticenter Studies as TopicOsteoporosis, PostmenopausalQuality of LifeRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeEstradiolAcupunctureOsteoporosisPMOPProtocolRandomised controlled trialSham acupuncture

Identifiers

PMID32493411
PMCPMC7268299
OpenAlexW3029344809

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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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.