The Effect and Mechanism of Acupuncture on Functional Dyspepsia
NCT ID: NCT02358486
Last Updated: 2017-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2015-01-31
2018-01-31
Brief Summary
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Detailed Description
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However, the effect and mechanism of acupuncture on FD has not been rigorously evaluated. In the present study, we will investigate whether 10 sessions of acupuncture over 4 weeks, in comparison with sham acupuncture, improve symptoms of FD and activate regions of brain area. We will also perform metabolomics study to find the mechanism of acupuncture to FD. Outcome measures include proportion of responder, Korean version of Nepean Dyspepsia Index, Functional Dyspepsia-Related Quality of Life, Ways of Coping Question, Coping Strategy Questionnaire, Perception of bodily sensation, The State-Trait Anxiety Inventory, Center for Epidemiologic Studies Depression Scale, functional magnetic resonance imaging and metabolomic study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Acupuncture
Participants in this group are given 10 times of real acupuncture treatment for 4 weeks.
Acupuncture
1. Acupuncture rationale 1a) Style of acupuncture: body acupuncture (in accordance with meridian theory)
2. Needling details 2a) Number of needle insertions per subject per session: 13 2b) Acupoints: Basic points - Large Intestine(LI)4, Stomach(ST)36, Liver(LR)3, Pericardium(PC)3, Spleen(SP)4, Stomach(ST)34, Conception Vessel(CV)12, 2c) Depth: 5 \~ 30mm 2d) Response sought: 'De qi' sensation; 2e) Needle stimulation: Manipulation 2f) Retention time: 15 minutes 2g) Needle type: 0.2 X 40 mm, sterilized stainless steel needle, Dongbang Inc., Korea
Sham acupuncture
Participants in this group are given 10 times of sham acupuncture treatment for 4 weeks.
Sham acupuncture
The participants in sham acupuncture group are given sham acupuncture treatment at the same acupoints in the same times and method as acupuncture arm. The sham device would be a Streitberger device.
Interventions
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Acupuncture
1. Acupuncture rationale 1a) Style of acupuncture: body acupuncture (in accordance with meridian theory)
2. Needling details 2a) Number of needle insertions per subject per session: 13 2b) Acupoints: Basic points - Large Intestine(LI)4, Stomach(ST)36, Liver(LR)3, Pericardium(PC)3, Spleen(SP)4, Stomach(ST)34, Conception Vessel(CV)12, 2c) Depth: 5 \~ 30mm 2d) Response sought: 'De qi' sensation; 2e) Needle stimulation: Manipulation 2f) Retention time: 15 minutes 2g) Needle type: 0.2 X 40 mm, sterilized stainless steel needle, Dongbang Inc., Korea
Sham acupuncture
The participants in sham acupuncture group are given sham acupuncture treatment at the same acupoints in the same times and method as acupuncture arm. The sham device would be a Streitberger device.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Aged of 30 - 49
2. Individuals who meet FD and postprandial distress syndrome (PDS) criteria in Rome III
3. Individuals who complain the degree of dyspepsia for more than 40 points of visual analogue scale (VAS; 0, no symptom at all; 100, the most severe symptom one ever had)
4. At least 3 questions show more than 2 points in Gastrointestinal impact scale
5. Individuals who have normal esophagogastroduodenoscopy results within a year and no organic diseases which can explain current symptoms such as peptic ulcer, dysplasia, mucosa-associated, lymphoid tissue lymphoma, esophageal cancer, gastric cancer
6. Individuals who are not supposed to take any other treatments associated with FD during the study
7. Individuals who voluntarily agree with a study protocol and sign a written informed consent
Exclusion Criteria
1. Individuals who have organic diseases such as gastroesophageal reflux disease
2. Individuals who have obvious signs of irritable bowel syndrome
3. Individuals who have alarm symptoms (weight loss, black or tar stool or dysphagia)
4. Individuals who have serious structural disease (disease of heart, lung, liver or kidney) or mental illness
5. Individuals who have had surgery related with the gastrointestinal tract , except for appendectomy more than six months ago
6. Individuals who are pregnant or breastfeeding
7. Individuals who are taking drugs which might affect gastrointestinal tract; minimum wash-out period of 2 weeks is required before participating in the trial
8. Individuals who are HIV-positive
9. Individuals who have a problem of mal-absorption
10. Individuals who have difficulties in attending the trial (eg. paralysis, serious mental illness, dementia, drug addiction, time constraint, severe disorder in vision or hearing, illiteracy, etc.)
11. Individuals who do not want to sign the informed consent
12. Individuals who have other diseases that could interfere acupuncture treatment, e.g. clotting disorders or leukopenia, pace-maker, epilepsy, or anticoagulant therapy
13. Individuals who have metal implants or fragments which might influence fMRI examination
30 Years
49 Years
ALL
No
Sponsors
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Korea Institute of Oriental Medicine
OTHER_GOV
Kyung Hee University Hospital at Gangdong
OTHER
Kyunghee University Medical Center
OTHER
Responsible Party
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Seok-Jae Ko
PhD, Professor, Department of Korean Internal Medicine
Principal Investigators
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Seok-Jae Ko, KMD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kyung Hee University Hospital at Gangdong
Locations
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Kyung Hee University Hospital at Gangdong
Seoul, Gangdong-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. doi: 10.1053/j.gastro.2006.03.008. No abstract available.
Park YC, Kang W, Choi SM, Son CG. Evaluation of manual acupuncture at classical and nondefined points for treatment of functional dyspepsia: a randomized-controlled trial. J Altern Complement Med. 2009 Aug;15(8):879-84. doi: 10.1089/acm.2008.0369.
Park HJ, Kim ST, Yoon DH, Jin SH, Lee SJ, Lee HJ, Lim S. The association between the DRD2 TaqI A polymorphism and smoking cessation in response to acupuncture in Koreans. J Altern Complement Med. 2005 Jun;11(3):401-5. doi: 10.1089/acm.2005.11.401.
Talley NJ, Locke GR 3rd, Herrick LM, Silvernail VM, Prather CM, Lacy BE, DiBaise JK, Howden CW, Brenner DM, Bouras EP, El-Serag HB, Abraham BP, Moayyedi P, Zinsmeister AR. Functional Dyspepsia Treatment Trial (FDTT): a double-blind, randomized, placebo-controlled trial of antidepressants in functional dyspepsia, evaluating symptoms, psychopathology, pathophysiology and pharmacogenetics. Contemp Clin Trials. 2012 May;33(3):523-33. doi: 10.1016/j.cct.2012.02.002. Epub 2012 Feb 10.
Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, Kirsch I, Schyner RN, Nam BH, Nguyen LT, Park M, Rivers AL, McManus C, Kokkotou E, Drossman DA, Goldman P, Lembo AJ. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ. 2008 May 3;336(7651):999-1003. doi: 10.1136/bmj.39524.439618.25. Epub 2008 Apr 3.
Zaslawski CJ, Cobbin D, Lidums E, Petocz P. The impact of site specificity and needle manipulation on changes to pain pressure threshold following manual acupuncture: a controlled study. Complement Ther Med. 2003 Mar;11(1):11-21. doi: 10.1016/s0965-2299(02)00116-4.
Park JW, Ko SJ, Han G, Yeo I, Ryu B, Kim J. The Effects of Banha-sasim-tang on Dyspeptic Symptoms and Gastric Motility in Cases of Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled, and Two-Center Trial. Evid Based Complement Alternat Med. 2013;2013:265035. doi: 10.1155/2013/265035. Epub 2013 Jun 3.
Labus JS, Gupta A, Coveleskie K, Tillisch K, Kilpatrick L, Jarcho J, Feier N, Bueller J, Stains J, Smith S, Suyenobu B, Naliboff B, Mayer EA. Sex differences in emotion-related cognitive processes in irritable bowel syndrome and healthy control subjects. Pain. 2013 Oct;154(10):2088-2099. doi: 10.1016/j.pain.2013.06.024. Epub 2013 Jun 20.
Rodriguez Franco L, Cano Garcia FJ, Blanco Picabia A. [Assessment of chronic pain coping strategies]. Actas Esp Psiquiatr. 2004 Mar-Apr;32(2):82-91. Spanish.
De Giorgi F, Sarnelli G, Cirillo C, Savino IG, Turco F, Nardone G, Rocco A, Cuomo R. Increased severity of dyspeptic symptoms related to mental stress is associated with sympathetic hyperactivity and enhanced endocrine response in patients with postprandial distress syndrome. Neurogastroenterol Motil. 2013 Jan;25(1):31-8.e2-3. doi: 10.1111/nmo.12004. Epub 2012 Aug 21.
Ko SJ, Park K, Kim J, Kim M, Kim JH, Lee J, Mohamed AZ, Yeo I, Kim J, Choi SM, Kim H, Park JW, Lee JH. Effect of acupuncture and its influence on cerebral activity in functional dyspepsia patients: study protocol for a randomized controlled trial. Trials. 2016 Apr 2;17:183. doi: 10.1186/s13063-016-1296-2.
Other Identifiers
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KHNMCOH 2014-08-002
Identifier Type: -
Identifier Source: org_study_id
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