Evidence map›Paper›PMID 26130637›Full record

ArticleJournal of neurogastroenterology and motility2015

Randomized, Controlled, Multi-center Trial: Comparing the Safety and Efficacy of DA-9701 and Itopride Hydrochloride in Patients With Functional Dyspepsia.

Myung-Gyu Choi, Poong-Lyul Rhee, Hyojin Park, Oh Young Lee, Kwang Jae Lee, Suck Chei Choi, Sang Young Seol, Hoon Jai Chun, Jong-Sun Rew, Dong Ho Lee and 8 more

Open access · diamondAbstract read
In one paragraph

Article in Journal of neurogastroenterology and motility, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
3.3field-weighted citation impact, top 9% 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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Non-Chinese herbal medicines for functional dyspepsia.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Prokinetics for functional dyspepsia.The Cochrane database of systematic reviews · 2018
    Pooled it
  3. Trial
  4. Double-Blind, Randomized, Placebo-Controlled Trial of DA-9701 in Parkinson's Disease: PASS-GI Study.Movement disorders : official journal of the Movement Disorder Society · 2020
    Trial
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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

18 authors at 18 institutions in 1 country.

Myung-Gyu ChoiDepartment of Internal Medicine, The Catholic University of Korea, Seoul, Korea.ORCID http://orcid.org/0000-0003-4083-5187
Poong-Lyul RheeSungkyunkwan University School of Medicine, Seoul, Korea.
Hyojin ParkYonsei University College of Medicine, Seoul, Korea.
Oh Young LeeHanyang University College of Medicine, Seoul, Korea.
Kwang Jae LeeAjou University School of Medicine, Suwon, Gyeonggi-do, Korea.
Suck Chei ChoiWonkwang University College of Medicine, Iksan, Jeollabuk-do, Korea.
Sang Young SeolInje University College of Medicine, Busan, Korea.
Hoon Jai ChunKorea University College of Medicine, Seoul, Korea.
Jong-Sun RewChonnam National University College of Medicine, Gwangju, Korea.
Dong Ho LeeSeoul National University College of Medicine, Seoul, Korea.
Geun Am SongPusan National University College of Medicine, Busan, Korea.
Hwoon Yong JungUniversity of Ulsan College of Medicine, Seoul, Korea.
Hyung Yong JeongChungnam National University College of Medicine, Daejeon, Korea.
In Kyung SungKonkuk University College of Medicine, Seoul, Korea.
Joon Seong LeeSoonchunhyang University College of Medicine, Seoul, Korea.
Soo Teik LeeChonbuk National University College of Medicine, Jeonju, Jeollabuk-do, Korea.
Sung Kook KimKyungpook National University College of Medicine, Daegu, Korea.
Yong Woon ShinInha University College of Medicine, Incheon, Korea.
Ajou University · KRCatholic University of Korea · KRChonnam National University · KRChungnam National University · KRHanyang University · KRInha University · KRInje University Busan Paik Hospital · KRJeonbuk National University · KRKonkuk University · KRKorea University · KRKyungpook National University · KRPusan National University · KRSeoul National University · KRSoonchunhyang University · KRSungkyunkwan University · KRUlsan College · KRWonkwang University · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsTherapies of functional dyspepsia (FD) are limited. DA-9701 is a novel prokinetic agent formulated with Pharbitis semen and Corydalis Tuber. We aimed to assess the efficacy of DA-9701 compared with itopride in FD patients.

methodsPatients with FD randomly received either itopride 50 mg or DA-9701 30 mg t.i.d after a 2-week baseline period. After 4 weeks of treatment, 2 primary efficacy endpoints were analyzed: the change from baseline in composite score of the 8 dyspep-tic symptoms and the overall treatment effect. Impact on patients' quality of life was assessed using the Nepean Dyspepsia Index (NDI) questionnaire.

resultsWe randomly assigned 464 patients with 455 having outcome data. The difference of the composite score change of the 8 symptoms between the 2 groups was 0.62, indicating that DA-9701 was not inferior to itopride. The overall treatment effect response rate was not different between the groups. When responder was defined as ≥ 5 of the 7 Likert scale, responder rates were 37% of DA-9701 and 36% of itopride group. Patients receiving DA-9701 experienced similar mean percentage of days with adequate relief during the 4-week treatment period compared with those receiving itopride (56.8% vs 59.1%). Both drugs increased the NDI score of 5 domains without any difference in change of the NDI score between the groups. The safety profile of both drugs was comparable.

conclusionsDA-9701 significantly improves symptoms in patients with FD. DA-9701 showed non-inferior efficacy to itopride with com-parable safety.

Indexed as

Clinical trialDA-9701Functional dyspepsiaItopride

Identifiers

PMID26130637
PMCPMC4496904
OpenAlexW1919447194

What Socratic holds

Textmetadata
LicenceCC BY-NC
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.