Evidence map›Paper›PMID 32311921›Full record

ArticleMedicine2020

Study on urinary metabolomics of premenstrual dysphoric disorder patients with liver-qi depression syndrome treated with Xiaoyaosan: Study Protocol Clinical Trial (SPIRIT Compliant).

Mengbai Xu, Yanfeng Liu, Yu Guo, Chenyue Liu, Yueyun Liu, Zhiyi Yan, Yajing Hou, Xiaojuan Li, Qingyu Ma, Xuan Zhou and 3 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.9field-weighted citation impact, top 23% 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

9 citing papers in PubMed, 10 citations in OpenAlex.

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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

13 authors at 3 institutions in 1 country.

Mengbai XuSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine.
Yanfeng LiuDongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing.
Yu GuoSchool of Traditional Chinese Medicine, Jinan University, Guangzhou.
Chenyue LiuSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine.
Yueyun LiuSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine.
Zhiyi YanSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine.
Yajing HouSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine.
Xiaojuan LiSchool of Traditional Chinese Medicine, Jinan University, Guangzhou.
Qingyu MaSchool of Traditional Chinese Medicine, Jinan University, Guangzhou.
Xuan ZhouSchool of Traditional Chinese Medicine, Jinan University, Guangzhou.
Liuqing LiuDongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing.
Sheng HuangJiuzhitang Co., Ltd., Changsha, China.
Jiaxu ChenSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine.
Beijing University of Chinese Medicine · CNJinan University · CNDongzhimen Hospital Affiliated to Beijing University of Chinese Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPremenstrual dysphoric disorder (PMDD) is a serious form of premenstrual syndrome with mental symptoms as its main manifestation, which seriously affects women's health and daily life. Some basic research and clinical studies have shown that the Chinese herbal medicine of Xiaoyaosan can relieve the symptoms of mental disorders with few side effects. The aim of this study is to evaluate the clinical efficacy of Xiaoyaosan for treating PMDD with liver-qi depression syndrome. In addition, metabonomics and small molecular marker compounds closely related to the pathogenesis of PMDD are expected to be found, and mechanism of Xiaoyaosan is further explored from the metabolic level. METHODS AND ANALYSIS: This study is a clinical pilot trial. Thirty PMDD patients with liver-qi depression syndrome and thirty healthy participants will be recruited. Study participants will be assigned in a 1:1 ratio to 2 groups: a normal control group and Xiaoyaosan treatment group. The treatment group will receive the Chinese patent medicine of Xiaoyaosan for 3 menstrual cycles. The primary outcome is the syndrome change in the Daily Record of Severity of Problems (DRSP). The secondary outcome is improvement in TCM syndrome, which will be measured with TCM symptom score scale. Urine metabolism profiles of participants by liquid chromatograph-mass spectrometer (LC-MS) method will be measured to explore the mechanism of PMDD pathogenesis and action of Xiaoyaosan on PMDD. DISCUSSION: This trial will evaluate the effectiveness and the therapeutic mechanism from the metabolomics level of Xiaoyaosan in individuals with PMDD. If successful, the outcome of this trial will provide a viable treatment option for PMDD patients and objective evidence on the efficacy of Xiaoyaosan for PMDD. ETHICS AND DISSEMINATION: The trial has been approved by the Institutional Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine (file number: DZMEC-KY-2019-73). Written informed consent will be obtained from all participants. The results of the study will be published in peer-reviewed journals or communicated via yearly reports to funding bodies.

trial registrationChinese Clinical Trial Registry, ChiCTR1900026296.

Indexed as

AdolescentAdultControlled Clinical Trials as TopicDepressionDrugs, Chinese HerbalFemaleHumansLiverMetabolomicsPilot ProjectsPremenstrual Dysphoric DisorderQiYoung AdultDrugs, Chinese Herbalxiaoyaosan

Identifiers

PMID32311921
PMCPMC7220159
OpenAlexW3016413868

What OpenQuestion holds

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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.