title: Effect of acupuncture and its influence on cerebral activity in functional dyspepsia patients: study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02358486 . Date of Registration: 21 January 2015.
authors.affiliation: Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Seok-Jae
authors.initials: SJ
authors.lastname: Ko
authors.affiliation: Department of Biomedical Engineering, Kyung Hee University, Yongin, Republic of Korea.
authors.forename: Kyungmo
authors.initials: K
authors.lastname: Park
authors.affiliation: Division of Clinical Research, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
authors.forename: Jieun
authors.initials: J
authors.lastname: Kim
authors.affiliation: Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Minji
authors.initials: M
authors.lastname: Kim
authors.affiliation: Division of Clinical Research, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
authors.forename: Joo-Hee
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Department of Biomedical Engineering, Kyung Hee University, Yongin, Republic of Korea.|Athinoula A Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Charlestown, USA.
authors.forename: Jeungchan
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Biomedical Engineering, Kyung Hee University, Yongin, Republic of Korea.
authors.forename: Abdalla Z
authors.initials: AZ
authors.lastname: Mohamed
authors.affiliation: Department of Statistics, Sookmyung Women's University, Seoul, Republic of Korea.
authors.forename: Inkwon
authors.initials: I
authors.lastname: Yeo
authors.affiliation: Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Jinsung
authors.initials: J
authors.lastname: Kim
authors.affiliation: Division of Clinical Research, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
authors.forename: Sun-Mi
authors.initials: SM
authors.lastname: Choi
authors.affiliation: Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Honggeol
authors.initials: H
authors.lastname: Kim
authors.affiliation: Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea. pjw2907@khu.ac.kr.
authors.forename: Jae-Woo
authors.initials: JW
authors.lastname: Park
authors.affiliation: Division of Clinical Research, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea. omdjun@kiom.re.kr.|Korean Medicine Life Science, University of Science & Technology, Campus of Korea Institute of Oriental Medicine, Daejeon, Republic of Korea. omdjun@kiom.re.kr.
authors.forename: Jun-Hwan
authors.identifier: http://orcid.org/0000-0001-5730-6869
authors.initials: JH
authors.lastname: Lee
mesh_terms: D015670:Acupuncture Therapy; D000223:Adaptation, Psychological; D000328:Adult; D001921:Brain / Q000000981:diagnostic imaging / Q000378:metabolism / Q000503:physiopathology*; D001931:Brain Mapping / Q000379:methods; D058256:Brain Waves; D002985:Clinical Protocols; D004415:Dyspepsia / Q000175:diagnosis / Q000378:metabolism / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D055432:Metabolomics; D008875:Middle Aged; D011788:Quality of Life; D012074:Remission Induction; D056910:Republic of Korea; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
keywords: Acupuncture; Functional dyspepsia; Functional magnetic resonance imaging; Metabolomics; Streitberger needle