Evidence map›Paper›PMID 29941708›Full record

Trial reportChinese medical journal2018

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial of Qi-Zhi-Wei-Tong Granules on Postprandial Distress Syndrome-Predominant Functional Dyspepsia.

Qing Su, Sheng-Liang Chen, Hua-Hong Wang, Lie-Xin Liang, Ning Dai, Bin Lyu, Jun Zhang, Rong-Quan Wang, Ya-Li Zhang, Yue Yu and 2 more

Erratum issued Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Chinese medical journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02460601 (The Efficacy and Safety of Qizhiweitong Granule on Patients With Functional Dyspepsia in a Multi-center Clinical Study), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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.

NCT02460601 phase4completednot on this map

The Efficacy and Safety of Qizhiweitong Granule on Patients With Functional Dyspepsia in a Multi-center Clinical Study

TypeinterventionalSponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRan2013 to 2015Enrolled400ConditionsFunctional DyspepsiaArmsQizhiweitong granule
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Clinical efficacy ofAmerican journal of translational research · 2021
    Article
  5. Article
  6. Article
  7. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Qing SuDepartment of Gastroenterology, Wuhan Union Hospital of Huazhong University of Science and Technology, Wuhan, Hubei 430000, China.
Sheng-Liang ChenDepartment of Gastroenterology, Renji Hospital of Shanghai Jiaotong University School of Medicine, Shanghai 200127, China.
Hua-Hong WangDepartment of Gastroenterology, Peking University First Hospital, Beijing 100034, China.
Lie-Xin LiangDepartment of Gastroenterology, People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi 530021, China.
Ning DaiDepartment of Gastroenterology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310016, China.
Bin LyuDepartment of Gastroenterology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang 310006, China.
Jun ZhangDepartment of Gastroenterology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi 710004, China.
Rong-Quan WangDepartment of Gastroenterology, The Southwest Hospital of Third Military Medical University, Chongqing 400038, China.
Ya-Li ZhangDepartment of Gastroenterology, The Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong 510515, China.
Yue YuDepartment of Gastroenterology, Anhui Provincial Hospital, Hefei, Anhui 230001, China.
Jin-Song LiuDepartment of Gastroenterology, Wuhan Union Hospital of Huazhong University of Science and Technology, Wuhan, Hubei 430000, China.
Xiao-Hua HouDepartment of Gastroenterology, Wuhan Union Hospital of Huazhong University of Science and Technology, Wuhan, Hubei 430000, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFunctional dyspepsia (FD) is a common upper gastrointestinal disorder worldwide, but the current treatments for FD are still unsatisfactory. The aims of this study were to investigate the efficacy and safety of Qi-Zhi-Wei-Tong granules in patients with postprandial distress syndrome (PDS)-predominant FD.

methodsThe study was conducted as a randomized, double-blinded, multicenter, placebo-controlled design in 197 patients with PDS. All participants received placebo treatment for 1 week. Patients whose total symptom score decreased by <50% after the placebo treatment were recruited into the 4-week treatment period, in which they were randomly assigned to be treated with either Qi-Zhi-Wei-Tong granules or placebo. The patients were then followed for 2 weeks without any treatment. Dyspeptic symptoms were scored at weeks 2 and 4 during the random treatment period and 2 weeks after the treatment. Anxiety and depression symptoms were also scored and compared.

results(1) The total effective rates in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 during the random treatment period and 2 weeks after treatment were all significantly higher than those in the placebo group (38.82% vs. 8.75%, P < 0.001; 69.14% vs. 16.25%, P < 0.001; 77.65% vs. 21.25%, P < 0.001). (2) The total dyspeptic symptoms scores in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 and 2 weeks after treatment were significantly lower than those in the placebo group. (3) The severity and frequency of each dyspeptic symptom at weeks 2 and 4 and the follow-up period were all significantly lower than those in the placebo group. (4) The anxiety scores in the Qi-Zhi-Wei-Tong granules group were significantly lower than those in the placebo group. (5) Qi-Zhi-Wei-Tong granules did not have more adverse effects than the placebo.

conclusionQi-Zhi-Wei-Tong granules offer significant symptomatic improvement in PDS with no more adverse effects than placebo.

trial registrationhttps://clinicaltrials.gov/, NCT02460601.

Indexed as

Drugs, Chinese HerbalAdultDouble-Blind MethodDyspepsiaFemaleHumansMaleMiddle AgedQiTreatment OutcomeDrugs, Chinese HerbalClinical TrialFunctional DyspepsiaPostprandial Distress SyndromeQi-Zhi-Wei-Tong Granules

Identifiers

PMID29941708
PMCPMC6032672

What Socratic holds

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Registered trials

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.