Evidence map›Paper›PMID 34743745›Full record

ArticleTrials2021

Efficacy of Bushen Huatan Decoction combined with Baduanjin in the treatment of polycystic ovary syndrome with insulin resistance (IR-PCOS), kidney deficiency and phlegm dampness: study protocol for a randomized controlled trial.

Haiqing Qian, Wenting Xu, Lijuan Cui, Rong Wang, Jiahui Wang, Mengyu Tang, Minggang Wei, Lihong Wang

Open access · goldFull text readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 16% 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, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Evidence map of traditional Chinese exercises.Frontiers in public health · 2024
    Pooled it
  2. Article
  3. Article
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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 2 institutions in 1 country.

Haiqing Qian *Department of Reproduction, Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Zhangjiagang, Suzhou, Jiangsu, China.ORCID https://orcid.org/0000-0002-7446-7151
Wenting Xu *Department of Reproduction, Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Zhangjiagang, Suzhou, Jiangsu, China.ORCID https://orcid.org/0000-0001-9222-1473
Lijuan CuiDepartment of Pathology, Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Zhangjiagang, Suzhou, Jiangsu, China.ORCID https://orcid.org/0000-0003-2523-800X
Rong WangDepartment of Laboratory Medicine, Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Zhangjiagang, Suzhou, Jiangsu, China.ORCID https://orcid.org/0000-0002-3216-8292
Jiahui WangDepartment of Reproduction, Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Zhangjiagang, Suzhou, Jiangsu, China.ORCID https://orcid.org/0000-0001-6471-0798
Mengyu TangDepartment of Reproduction, Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Zhangjiagang, Suzhou, Jiangsu, China.ORCID https://orcid.org/0000-0002-9810-7142
Minggang WeiThe First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China. weiminggang@suda.edu.cn.ORCID https://orcid.org/0000-0002-1714-6650
Lihong WangDepartment of Reproduction, Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Zhangjiagang, Suzhou, Jiangsu, China. zjgzywlh@njucm.edu.cn.ORCID http://orcid.org/0000-0001-7187-5910
Nanjing University of Chinese Medicine · CNSoochow University · CN

Funding

the 333 Project in Jiangsu Province in 2019 BRA2019140the Medical Scientific Research Project of Jiangsu Provincial Health Commission Z2020020the National Natural Science Foundation of China 82004413the Projects For Science and Technology of Chinese Medicine of Jiangsu Province in 2019 YB201959the Science and Technology Development Plan of Suzhou SYS2020055the Special Funds of the Key Clinical Disease in Diagnosis and Treatment Technology of Suzhou in 2019 LCZX201920the Zhangjiagang Health Talent Project ZJGWSRC202001the Zhangjiagang Health Talent Project ZJGWSRC202007
6 · The paper itself

Abstract

backgroundPolycystic ovary syndrome (PCOS) is a common reproductive endocrine disease in women. Insulin resistance (IR) has emerged as a central contributor to the pathogenesis of this disease. According to traditional Chinese medicine (TCM), kidney deficiency is the main syndrome of PCOS. The deficiency of the kidney cannot vaporize water-dampness, and the retention of water-dampness accumulates into phlegm dampness stagnation, resulting in visceral dysfunction and metabolic disorder. TCM involving syndrome differentiation and treatment is widely used to adjust women's menstrual cycles. Our patented formula Bushen Huatan Decoction (BSHTD) has been proven to be effective in the clinical treatment of IR-PCOS. Baduanjin also plays an important role in improving metabolic syndrome through lifestyle intervention. This study investigates the clinical efficacy of Bushen Huatan Decoction combined with Baduanjin in IR-PCOS, to form a specific TCM-behaviour intervention plan in the treatment of IR-PCOS. METHODS/

designThis is a randomized controlled trial involving 190 participants diagnosed with IR-PCOS. All participants will be randomly allocated into 5 groups: group A will receive metformin; group B, BSHTD; group C, Baduanjin; group D, BSHTD combined with metformin; and group E, BSHTD combined with Baduanjin. One course of treatment lasts 3 months, a total of two courses. The primary outcomes are changes in the homeostatic model assessment of insulin resistance (HOMA-IR) and improvements in the oral glucose tolerance test (OGTT) and insulin-releasing test (INS). The secondary outcomes are improvements in the menstrual cycle, ovulation rate, clinical pregnancy rate, basic serum sex hormone levels, free androgen index (FAI), Ferriman-Gallwey scores, body mass index (BMI) and TCM syndrome scores. The related observation indexes will be collected at baseline, during the process of treatment and at the 6-month follow-up. Simultaneously, close monitoring of possible adverse events will be performed throughout the trial process. DISCUSSION: This trial will investigate the efficacy of the comprehensive intervention program of Bushen Huatan Decoction combined with Baduanjin on the adjustment of the menstrual cycle, improvement of insulin resistance and correction of glucose metabolism disorder in IR-PCOS patients. It is expected to form an alternative treatment of TCM-behaviour intervention therapy for IR-PCOS and promote the Chinese fitness Qigong Baduanjin in the application of lifestyle diseases.

trial registrationChinese Clinical Trial Registry ChiCTR2100043415 . Registered on 15 February 2021.

Indexed as

Insulin ResistanceMetabolic SyndromeMetforminPolycystic Ovary SyndromeFemaleHumansInsulinKidneyPregnancyRandomized Controlled Trials as TopicInsulinMetforminBaduanjinBushen Huatan DecoctionInsulin resistancePolycystic ovary syndrome

Identifiers

PMID34743745
PMCPMC8573899
OpenAlexW3175510901

What OpenQuestion holds

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LicenceCC BY
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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.