Evidence map›Paper›PMID 33350782›Full record

Trial reportMedicine2020

Study on the clinical mechanism of Tong-Xie-An-Chang Decoction in the treatment of diarrheal irritable bowel syndrome based on single-cell sequencing technology.

Xiang Tan, Xing-Jie Zhao, Jun-Xiang Li, Chun-E Xie, Wen-Jing Pei, Lei Shi, Fu-Shun Kou, Ya-Li Yuan, Xiao-Xuan Xue

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. 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

9 authors.

Xiang TanGrauate school, Beijing University of Chinese Medicine, No. 11, North Third Ring East Road, Chaoyang District.ORCID 0000-0001-6552-9907
Xing-Jie ZhaoGatroenterology Department, Dongfang Hospital, Beijing University of Chinese Medicine, No. 6, 1st Section, Fangxingyuan, Fangzhuang, Fengtai District.
Jun-Xiang LiGatroenterology Department, Dongfang Hospital, Beijing University of Chinese Medicine, No. 6, 1st Section, Fangxingyuan, Fangzhuang, Fengtai District.
Chun-E XieGatroenterology Department, Dongfang Hospital, Beijing University of Chinese Medicine, No. 6, 1st Section, Fangxingyuan, Fangzhuang, Fengtai District.
Wen-Jing PeiGatroenterology Department, Dongfang Hospital, Beijing University of Chinese Medicine, No. 6, 1st Section, Fangxingyuan, Fangzhuang, Fengtai District.
Lei ShiSchool of life sciences, Beijing University of Chinese Medicine, No. 11, North Third Ring East Road, Chaoyang District, Beijing, P. R. China.
Fu-Shun KouGrauate school, Beijing University of Chinese Medicine, No. 11, North Third Ring East Road, Chaoyang District.
Ya-Li YuanGrauate school, Beijing University of Chinese Medicine, No. 11, North Third Ring East Road, Chaoyang District.
Xiao-Xuan XueGatroenterology Department, Dongfang Hospital, Beijing University of Chinese Medicine, No. 6, 1st Section, Fangxingyuan, Fangzhuang, Fengtai District.

Funding

Basic Scientific Research Service fee Project of Beijing University of Chinese Medicine in 2019: Young teacher Project( 2019-JYB-JS-124Chinese Medicine Inheritance and Innovation "One Hundred Million" Talent Project Qihuang Scholar to Li JXFundamental Research Funds for the Central Universities 2020-JYB-ZDGG-136Scientific Research and Innovation team Project 2019-JYB-TD004
6 · The paper itself

Abstract

backgroundDiarrhea-predominant irritable bowel syndrome (IBS-D) is a kind of functional gastrointestinal disorder with obscure pathogenesis, and exploration about differential gene expression and cell heterogeneity of T lymphocytes in peripheral blood in IBS-D patients still remains unknown. Clinicians tend to use symptomatic treatment, but the efficacy is unstable and symptoms are prone to relapse. Traditional Chinese Medicine (TCM) is used frequently in IBS-D with stable and lower adverse effects. Tong-Xie-An-Chang Decoction (TXACD) has been proven to be effective in the treatment of IBS-D. However, the underlying therapeutic mechanism remains unclear. This trial aims to evaluate the clinical efficacy and safety of TXACD in IBS-D and elucidate the gene-level mechanism of IBS-D and therapeutic targets of TXACD based on single-cell sequencing technology. METHODS/

designThis is a randomized controlled, double-blind, double-simulation clinical trial in which 72 eligible participants with IBS-D and TCM syndrome of liver depression and spleen deficiency will be randomly allocated in the ratio of 1:1 to two groups: the experimental group and the control group. The experimental group receives Tong-Xie-An-Chang Decoction (TXACD) and Pinaverium bromide tablets placebo; the control group receives pinaverium bromide tablets and TXACD placebo. Each group will be treated for 4 weeks. The primary outcome: the rate of IBS-Symptom Severity Score (IBS-SSS). The secondary outcomes: TCM syndrome score, adequate relief and IBS-Quality of Life Questionnaire (IBS-QOL). Mechanistic outcome is the single-cell sequencing profiling of the T lymphocytes in peripheral blood from IBS-D participants before and after the treatment and healthy individuals. DISCUSSION: This trial will prove the efficacy and safety of TXACD with high-quality evidence and provide a comprehensive perspective on the molecular mechanism of IBS-D by single-cell sequencing profiling, which makes us pinpoint specific biomarkers of IBS-D and therapeutic targets of TXACD.

Indexed as

DiarrheaDrugs, Chinese HerbalIrritable Bowel SyndromeQuality of LifeAdultComplex MixturesDouble-Blind MethodDrug MonitoringFemaleGene Expression ProfilingHumansMaleMedicine, Chinese TraditionalPlant ExtractsSymptom AssessmentT-LymphocytesComplex MixturesDrugs, Chinese HerbalPlant Extracts

Identifiers

PMID33350782
PMCPMC7769325

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.