Evidence map›Paper›PMID 33108123›Full record

Trial reportClinical and translational gastroenterology2020

An Herbal Formulation of Jiawei Xiaoyao for the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Placebo-Controlled, Clinical Trial.

Guang Chen, Peimin Feng, Shaofeng Wang, Xiangping Ding, Jiaying Xiong, Jianhua Wu, Lihua Wang, Wei Chen, Guixia Chen, Mei Han and 3 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
2.1field-weighted citation impact, top 12% 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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Pooled it
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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 9 institutions in 1 country.

Guang ChenDivision of Gastroenterology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
Peimin FengDivision of Gastroenterology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Shaofeng WangDivision of Gastroenterology, Changsha People's Hospital, Changsha, China.
Xiangping DingDivision of Gastroenterology, Gansu Second Provincial People's Hospital, Gansu, China.
Jiaying XiongDivision of Gastroenterology, Loudi Central Hospital, Hunan, China.
Jianhua WuDivision of Gastroenterology, Hengyang Chinese Medicine Hospital, Hengyang, China.
Lihua WangDivision of Gastroenterology, Harrison International Peace Hospital, Hengshui, China.
Wei ChenDivision of Gastroenterology, Xiang Yang No. 1 People's Hospital, Xiangyang, China.
Guixia ChenGeriatric Department, Luoyang No. 1 Hospital of TCM, Luoyang, China.
Mei HanCenter for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Ting ZouTechnology Center for Drug Research and Evaluation, Chinese Association of Traditional Chinese Medicine, Beijing, China.
Lei LiTechnology Center for Drug Research and Evaluation, Chinese Association of Traditional Chinese Medicine, Beijing, China.
Hongbo DuDivision of Gastroenterology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
Beijing University of Chinese Medicine · CNChinese Pharmaceutical Association · CNDongzhimen Hospital Affiliated to Beijing University of Chinese Medicine · CNChengdu University of Traditional Chinese Medicine · CNGansu Provincial Hospital · CNHarrison International Peace Hospital · CNHengyang Academy of Agricultural Sciences · CNLoudi Central Hospital · CNXiang Yang No.1 People's Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTo investigate the efficacy and safety of an herbal formulation of Jiawei Xiaoyao (JX) on gastrointestinal symptoms in patients with functional dyspepsia (FD) who had previously rejected standard therapies of proton pump inhibitors, H2 blockers, or Helicobacter pylori eradication.

methodsA total of 144 adult men and women with FD according to the Rome III criteria were recruited at 9 sites in China from August 2017 to April 2019. Participants were randomized to receive either a JX pill or placebo (12 g/d, 6 g twice a day) for 4 weeks. The primary end point was the change in the total Gastrointestinal Symptom Score (GIS) from baseline to week 4. The secondary end points included the scores on the Hamilton Depression Scale and the Hamilton Anxiety Scale. The safety outcomes included the results of the complete blood count, the liver function test, the renal function test, urinalysis, the fecal occult blood test, and an electrocardiogram.

resultsData from 141 patients (JX pill, n = 70; placebo, n = 71) were statistically analyzed. The mean ± SD of the GIS for the JX pill group at baseline and 4 weeks was 9.3 ± 3.1 and 3.8 ± 3.0, respectively; the mean ± SD of the GIS for the placebo group at baseline and 4 weeks was 9.5 ± 3.4 and 5.3 ± 4.4, respectively (change from baseline to 4 weeks in the JX pill group vs change from baseline in the control group, -1.3 points; P = 0.013). The JX pill group showed greater improvement in both the Hamilton Depression Scale and Hamilton Anxiety Scale scores from baseline to 4 weeks than the placebo group, but the difference was not significant. The total number of adverse events was 30 in the JX pill group vs 20 in the placebo group (P = 0.240). DISCUSSION: The JX pill was superior to the placebo in terms of improving the GIS in patients with FD but did not significantly improve depression or anxiety symptoms. These findings suggest that the JX pill may have a positive effect on the resolution of gastrointestinal symptoms in patients with FD who are seeking alternative therapies.

Indexed as

AdolescentAdultAgedAnxietyDepressionDouble-Blind MethodDrugs, Chinese HerbalDyspepsiaFemaleHumansMaleMiddle AgedPlacebosTreatment OutcomeYoung AdultDrugs, Chinese Herbalkamisyoyo sanPlacebos

Identifiers

PMID33108123
PMCPMC7544170
OpenAlexW3092352789

What Socratic holds

Textmetadata
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 Socratic graph.