Evidence map›Paper›PMID 32131886›Full record

ArticleTrials2020

A multicenter randomized trial of personalized acupuncture, fixed acupuncture, letrozole, and placebo letrozole on live birth in infertile women with polycystic ovary syndrome.

Shiya Huang, Min Hu, Ernest Hung Yu Ng, Elisabet Stener-Victorin, Yanhua Zheng, Qidan Wen, Cong Wang, Maohua Lai, Juan Li, Xingcheng Gao and 12 more

Registry-linked trialOpen 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. It is linked to trial NCT03625531 (A Multicenter Randomized Trial of Personalized Acupuncture, Fixed Acupuncture, Letrozole and Placebo on Live Birth for Infertility in Women With Polycystic Ovary Syndrome), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
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.

NCT03625531 phase3completednot on this map

A Multicenter Randomized Trial of Personalized Acupuncture, Fixed Acupuncture, Letrozole and Placebo on Live Birth for Infertility in Women With Polycystic Ovary Syndrome

TypeinterventionalSponsorHongxia MaRan2018 to 2025Enrolled1,103ConditionsPolycystic Ovary SyndromeArmsAcupuncture, Letrozole, Placebo letrozole
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Article
  6. Review
  7. Article
  8. Review
  9. The Application of Complementary and Alternative Medicine in Polycystic Ovary Syndrome Infertility.Evidence-based complementary and alternative medicine : eCAM · 2022
    Review
  10. Research Trends of Acupuncture Therapy on Polycystic Ovary Syndrome: A Bibliometric Analysis.Evidence-based complementary and alternative medicine : eCAM · 2022
    Review
  11. Article
  12. The Challenges of Ethical Review in Clinical Research of Traditional Chinese Medicine.Evidence-based complementary and alternative medicine : eCAM · 2021
    Review
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

22 authors at 11 institutions in 3 countries.

Shiya HuangDepartment of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Min HuDepartment of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Ernest Hung Yu NgDepartment of Obstetrics and Gynecology, University of Hong Kong, Hong Kong, Special Administrative Region, China.
Elisabet Stener-VictorinInstitute of Integration of Traditional Chinese Medicine and Western Medicine, Guangzhou Medical University, Guangzhou, Guangdong, China.
Yanhua ZhengDepartment of Traditional Chinese Medicine, Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Qidan WenDepartment of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Cong WangDepartment of Traditional Therapy, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, China.
Maohua LaiDepartment of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Juan LiDepartment of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Xingcheng GaoDepartment of Urology, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Xinhua WangDepartment of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Zhenxing HuDepartment of Gynecology, Xuzhou Maternity and Child Health Care Hospital, Xuzhou, Jiangsu, China.
Tian XiaCenter for Reproductive Medicine, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.
Rongkui HuDepartment of Reproductive Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.
Jianping LiuInstitute of Integration of Traditional Chinese Medicine and Western Medicine, Guangzhou Medical University, Guangzhou, Guangdong, China.
Xiaohui WenDepartment of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Shuna LiDepartment of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Kewei QuanDepartment of Obstetrics and Gynecology, Dongguan Hospital of Traditional Chinese Medicine, Dongguan, Guangdong, China.
Xingyan LiangDepartment of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Hongcai ShangInstitute of Integration of Traditional Chinese Medicine and Western Medicine, Guangzhou Medical University, Guangzhou, Guangdong, China.
Hongxia MaDepartment of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China. doctorhongxia@126.com.ORCID http://orcid.org/0000-0002-4477-613X
Jie QiaoDepartment of Obstetrics and Gynecology, Third Hospital, Peking University, Beijing, China. jie.qiao@263.net.
First Affiliated Hospital of Guangzhou Medical University · CNBeijing University of Chinese Medicine · CNDongguan People’s Hospital · CNFirst Teaching Hospital of Tianjin University of Traditional Chinese Medicine · CNGuangdong Provincial Hospital of Traditional Chinese Medicine · CNKarolinska Institutet · SEMaternal and Child Health Hospital of Xuzhou · CNNanjing University of Chinese Medicine · CNPeking University · CNSecond Affiliated Hospital of Guangzhou Medical University · CNUniversity of Hong Kong · HK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTraditional Chinese medicine (TCM) usually involves syndrome differentiation and treatment. Acupuncture, one form of TCM, requires the selection of appropriate acupoints and needling techniques, but many clinical trials on acupuncture have used fixed acupuncture protocols without accounting for individual patient differences. We have designed a multicenter randomized controlled trial (RCT) to evaluate whether personalized or fixed acupuncture increases the likelihood of live births in infertile women with polycystic ovary syndrome (PCOS) compared with letrozole or placebo letrozole. We hypothesize that letrozole is more effective than personalized acupuncture, which in turn is more effective than fixed acupuncture, and that placebo letrozole is the least effective intervention. Moreover, we hypothesize that personalized acupuncture is more likely to reduce the miscarriage rate and the risk of pregnancy complications compared with letrozole. METHODS/

designThe study is designed as an assessor-blinded RCT. A total of 1100 infertile women with PCOS will be recruited from 28 hospitals and randomly allocated to 4 groups: personalized acupuncture, fixed acupuncture, letrozole, or placebo letrozole. They will receive treatment for 16 weeks, and the primary outcome is live birth. Secondary outcomes include ovulation rate, conception rate, pregnancy rate, pregnancy loss rate, changes in hormonal and metabolic parameters, and changes in quality of life scores. Adverse events will be recorded throughout the trial. All statistical analyses will be performed using IBM SPSS Statistics version 21.0 software (IBM Corp., Armonk, NY, USA), and a P value < 0.05 will be considered statistically significant. DISCUSSION: This study will be the first multicenter RCT to compare the effect of personalized or fixed acupuncture with letrozole or placebo letrozole on live birth in infertile women with PCOS. The findings will inform whether personalized acupuncture therapy can be considered an alternative treatment to improve the live birth rate in infertile women with PCOS.

trial registrationClinicalTrials.gov, NCT03625531. Registered on July 13, 2018. Chinese Clinical Trial Registry, ChiCTR1800017304. Registered on July 23, 2018.

Indexed as

OvulationOvulation InductionAbortion, SpontaneousAcupuncture TherapyAromatase InhibitorsFemaleHumansInfertility, FemaleLetrozoleLive BirthMulticenter Studies as TopicPolycystic Ovary SyndromePregnancyPregnancy RateQuality of LifeRandomized Controlled Trials as TopicAromatase InhibitorsLetrozoleAcupunctureFixed protocolLetrozolePersonalized protocolPolycystic ovary syndrome

Identifiers

PMID32131886
PMCPMC7057514
OpenAlexW3010366810

What OpenQuestion holds

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Registered trials

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.