Evidence map›Paper›PMID 27039086›Full record

Trial reportTrials2016

Effect of acupuncture and its influence on cerebral activity in functional dyspepsia patients: study protocol for a randomized controlled trial.

Seok-Jae Ko, Kyungmo Park, Jieun Kim, Minji Kim, Joo-Hee Kim, Jeungchan Lee, Abdalla Z Mohamed, Inkwon Yeo, Jinsung Kim, Sun-Mi Choi and 3 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02358486 (Effect and Mechanism of Acupuncture on Patients With Functional Dyspepsia), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.9field-weighted citation impact, top 13% 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.

NCT02358486 naunknown statusnot on this map

Effect and Mechanism of Acupuncture on Patients With Functional Dyspepsia: a Protocol for a Randomized, Assessor-blind, Sham-controlled Trial

TypeinterventionalSponsorKyunghee University Medical CenterRan2015 to 2018Enrolled70ConditionsDyspepsiaArmsAcupuncture, Sham acupuncture
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  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

13 authors at 4 institutions in 2 countries.

Seok-Jae KoDepartment of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.
Kyungmo ParkDepartment of Biomedical Engineering, Kyung Hee University, Yongin, Republic of Korea.
Jieun KimDivision of Clinical Research, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
Minji KimDepartment of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.
Joo-Hee KimDivision of Clinical Research, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
Jeungchan LeeDepartment of Biomedical Engineering, Kyung Hee University, Yongin, Republic of Korea.
Abdalla Z MohamedDepartment of Biomedical Engineering, Kyung Hee University, Yongin, Republic of Korea.
Inkwon YeoDepartment of Statistics, Sookmyung Women's University, Seoul, Republic of Korea.
Jinsung KimDepartment of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.
Sun-Mi ChoiDivision of Clinical Research, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
Honggeol KimDepartment of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
Jae-Woo ParkDepartment of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea. pjw2907@khu.ac.kr.
Jun-Hwan LeeDivision of Clinical Research, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea. omdjun@kiom.re.kr.ORCID http://orcid.org/0000-0001-5730-6869
Kyung Hee University · KRHarvard University · USKorea Institute of Oriental Medicine · KRSookmyung Women's University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFunctional dyspepsia (FD) is a prevalent gastric disorder that is difficult to manage due to lack of satisfactory treatments. Acupuncture has been studied with regard to the rising need for treating FD, but the mechanism verifying its efficacy has not yet been fully revealed. The aim of this study is to explore the efficacy and mechanism of acupuncture for FD compared with a sham group. METHODS/

designWe describe a proposal for a randomized, assessor-blind, sham-controlled trial with 70 eligible participants who will be randomly allocated either into an acupuncture or a sham group. Participants in the acupuncture group will receive 10 sessions of real acupuncture treatment and those in the sham group will be treated with identical sessions using a Streitberger needle. Functional magnetic resonance imaging (fMRI) and metabolomics studies will be implemented before and after 4 weeks of treatment to investigate the mechanism of acupuncture. The primary outcome is a proportion of responders with adequate symptom relief and the secondary outcomes include the Nepean Dyspepsia Index - Korean version, Functional Dyspepsia-Related Quality of Life questionnaire, Ways of Coping Questionnaire, Coping Strategies Questionnaire, perception of bodily sensation questionnaire, State-Trait Anxiety Inventory, and the Center for Epidemiological Studies - Depression Scale. The outcomes will be evaluated before and after the treatment. DISCUSSION: This is the first large-scale trial evaluating the efficacy and mechanism of acupuncture with fMRI and metabolomic methods. We will compare real acupuncture with the Streitberger sham needle to verify the specific effect of acupuncture. The results of this trial are expected to be relevant evidences affecting policy and decision-makers associated with routine healthcare.

trial registrationClinicalTrials.gov Identifier: NCT02358486 . Date of Registration: 21 January 2015.

Indexed as

Acupuncture TherapyBrain WavesAdaptation, PsychologicalAdultBrainBrain MappingClinical ProtocolsDyspepsiaFemaleHumansMagnetic Resonance ImagingMaleMetabolomicsMiddle AgedQuality of LifeRemission InductionAcupunctureFunctional dyspepsiaFunctional magnetic resonance imagingMetabolomicsStreitberger needle

Identifiers

PMID27039086
PMCPMC4818864
OpenAlexW2324410445

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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 OpenQuestion graph.