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Effect of acupuncture and its influence on cerebral activity in functional dyspepsia patients- study protocol for a randomized controlled trial831.24 kB
Published VersionCC BY V4.0, Open Access
Journal article
Effect of acupuncture and its influence on cerebral activity in functional dyspepsia patients: study protocol for a randomized controlled trial
Trials, Vol.17(1), pp.1-12
2016
PMID: 27039086
Abstract
Background: Functional 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/design: We 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.
Details
- Title
- Effect of acupuncture and its influence on cerebral activity in functional dyspepsia patients: study protocol for a randomized controlled trial
- Authors
- Seok-Jae Ko (Author) - Kyung Hee UniversityKyoungok Park (Author) - Kyung Hee UniversityJieun Kim (Author) - Korea Institute of Oriental MedicineMinji Kim (Author) - Kyung Hee UniversityJoo-Hee Kim (Author) - Korea Institute of Oriental MedicineJeungchan Lee (Author) - Kyung Hee UniversityAbdalla Z Mohamed (Author) - Kyung Hee UniversityInkwon Yeo (Author) - Sookmyung Women's UniversityJinsung Kim (Author) - Kyung Hee UniversitySun-Mi Choi (Author) - Korea Institute of Oriental MedicineHonggeol Kim (Author) - Kyung Hee UniversityJae-Woo Park (Author) - Kyung Hee UniversityJun-Hwan Lee (Author) - Korea Institute of Oriental Medicine
- Publication details
- Trials, Vol.17(1), pp.1-12
- Publisher
- BioMed Central Ltd.
- Date published
- 2016
- DOI
- 10.1186/s13063-016-1296-2
- ISSN
- 1745-6215
- PMID
- 27039086
- Copyright note
- © 2016 Ko et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
- Organisation Unit
- University of the Sunshine Coast, Queensland; Thompson Institute
- Language
- English
- Record Identifier
- 99522404302621
- Output Type
- Journal article
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