Evidence map›Paper›PMID 33499921›Full record

ArticleTrials2021

Chinese herbal formula Xuefu Zhuyu for primary dysmenorrhea patients (CheruPDYS): a study protocol for a randomized placebo-controlled trial.

Geng Li, Zhe Zhang, Li Zhou, Shaojun Liao, Jing Sun, Yinghua Liu, Xin Wang, Zehuai Wen

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
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.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.8field-weighted citation impact, top 27% 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, 7 citations in OpenAlex.

  1. Trial
  2. Review
  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

8 authors at 3 institutions in 1 country.

Geng Li *The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.
Zhe Zhang *Liaoning University of Traditional Chinese Medicine, Shenyang, Liaoning, China.
Li ZhouThe Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.
Shaojun LiaoThe Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.
Jing SunDepartment of Obstetrics and Gynecology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, Liaoning, China.
Yinghua LiuDepartment of Obstetrics and Gynecology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, Liaoning, China.
Xin WangDepartment of Obstetrics and Gynecology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, Liaoning, China. tmwxtsy@163.com.
Zehuai WenThe Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China. wenzh@gzucm.edu.cn.ORCID http://orcid.org/0000-0002-1797-2047
Guangzhou University of Chinese Medicine · CNAffiliated Hospital of Liaoning University of Traditional Chinese Medicine · CNLiaoning University of Traditional Chinese Medicine · CN

Funding

The National Key Research and Development Program of China 2018YFC1707407
6 · The paper itself

Abstract

backgroundEpidemiological studies have shown that young women often suffer from primary dysmenorrhea (PD) which is a common cause that affects their routine work and quality of life. Chinese herbal medicine has been widely used for PD in China. A systematic review found that Xuefu Zhuyu (XFZY) has a promising effect on PD management, yet there is a dearth of high-quality evidence in support of this claim. We want to conduct a randomized controlled trial to evaluate the efficacy and safety of XFZY for PD patients.

methodsThis is a protocol for a multicenter, randomized, placebo-controlled trial. A total of 248 participants with PD will be recruited at 6 centers and randomized into two groups-a herbal treatment group and a placebo group. The participants will receive either XFZY or placebo, three times per day, for 3 menstrual cycles, with a 12-week follow-up. The primary outcome will be the mean change in pain intensity as measured by VAS, while the change in menstrual pain duration, the change in peak pain intensity as measured by VAS, the Cox Menstrual Symptom Scale (CMSS), quality of life EQ-5D-5L, cumulative painkiller consumption, and health economics will be included as secondary outcomes. Adverse events will also be reported. DISCUSSION: This protocol describes a multicenter, double-blind, randomized, placebo-controlled trial that investigates the efficacy and safety of XFZY for primary dysmenorrhea. Validated evaluation tools will assess dysmenorrhea severity. We believe that this research will provide important evidence regarding the use of XFZY to treat dysmenorrhea.

trial registrationChinese Clinical Trial Registry ChiCTR1900026819 . Registered on 23 October 2019.

Indexed as

AdolescentAdultAnalgesicsChinaClinical Trials, Phase IV as TopicDouble-Blind MethodDrug Administration ScheduleDrugs, Chinese HerbalDysmenorrheaFemaleHumansMulticenter Studies as TopicPain MeasurementPlacebosQuality of LifeRandomized Controlled Trials as TopicAnalgesicsDrugs, Chinese HerbalPlacebosXue-Fu-Zhu-Yu decoctionChinese herbal medicinePlaceboPrimary dysmenorrheaRandomized controlled trialXuefu Zhuyu Oral Liquid

Identifiers

PMID33499921
PMCPMC7835651
OpenAlexW3123121389

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.