Evidence map›Paper›PMID 35313933›Full record

ArticleTrials2022

Chinese herbal formula Tongxie Yaofang for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized, multiple-blind, placebo-controlled trial.

Shi-Bing Liang, Mei Han, Hong-Jie Cheng, Qiao-Yan Zhang, Nai-Wei Zhang, Bo-Yi Jia, Nicola Robinson, Jian-Ping Liu

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 24% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Article
  7. 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 2 institutions in 2 countries.

Shi-Bing LiangCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China.
Mei HanCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China.
Hong-Jie ChengFangshan Hospital of Beijing University of Chinese Medicine, Beijing, 102400, China.
Qiao-Yan ZhangFangshan Hospital of Beijing University of Chinese Medicine, Beijing, 102400, China.
Nai-Wei ZhangFangshan Hospital of Beijing University of Chinese Medicine, Beijing, 102400, China.
Bo-Yi JiaFangshan Hospital of Beijing University of Chinese Medicine, Beijing, 102400, China.
Nicola RobinsonCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China.
Jian-Ping LiuCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China. Liujp@bucm.edu.cn.
Beijing University of Chinese Medicine · CNLondon South Bank University · GB

Funding

national natural science foundation of china 81830115
6 · The paper itself

Abstract

introductionDiarrhea-predominant irritable bowel syndrome (IBS-D) is a bowel disease with a high incidence. It significantly reduces the quality of life of patients and affects the patient's daily activities and mental health. No specific therapeutic medications for IBS-D have been found. Published clinical trials suggest that Chinese herbal formula Tongxie Yaofang (TXYF) for IBS-D may be effective. However, high-quality clinical evidence supporting its use in IBS-D is still lacking. This trial aims to evaluate the therapeutic effects and safety of TXYF for IBS-D in adults. METHODS/

designA randomized, multiple-blind, placebo-controlled trial will be conducted. It will consist of an 8-week intervention followed by a 3-month follow-up period. The target sample size is 96 IBS-D patients aged 18 to 65 years. The eligible participants will be randomly allocated to either TXYF or placebo group in a ratio of 1:1. Participants in the experimental group will take TXYF granules, while participants in the control group will be given TXYF placebo granules. The primary outcome will be the degree of IBS symptom severity measured using the scale of IBS symptom severity score. The secondary outcomes include: (a) stool frequency, and (b) stool consistency measured using the Bristol stool scale, (c) quality of life measured using the scale of IBS-quality of life, (d) anxiety measured using the self-rating anxiety scale, (e) depression measured by the self-rating depression scale, and (f) the safety of using TXYF and placebo. Safety monitoring and assessment will be undertaken throughout treatment. DISCUSSION: Chinese herbal formula TXYF consists of four Chinese herbs: Atractylodes macrocephala Koidz., Paeonia lactiflora Pall ., Citrus × aurantium L ., and Radix saposhnikoviae. It has been used for diarrhea for hundreds of years and may have a potential benefit in treating adults with IBS-D, but due to lack of high-quality evidence, we designed a randomized, multiple-blind, placebo-controlled trial to evaluate its therapeutic effects and safety. This trial will provide important data to guide the clinical practice of TXYF for the treatment of IBS-D in adults.

trial registrationISRCTN registry ISRCTN12453166 . Registered on 23 March 2021.

Indexed as

Irritable Bowel SyndromeChinaDiarrheaFecesHumansQuality of LifeRandomized Controlled Trials as TopicChinese herbal medicineIBS-DIrritable bowel syndromeRandomized controlled trialTongxie Yaofang

Identifiers

PMID35313933
PMCPMC8935852
OpenAlexW4220989894

What OpenQuestion holds

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LicenceCC BY
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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.