The Effect and Mechanism of Acupuncture on Functional Dyspepsia

NCT02358486 | Unknown DMC

• 1 other identifier: KHNMCOH 2014-08-002
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the effect of acupuncture on functional dyspepsia compared with sham control. The study aims to clarify the mechanism of acupuncture by assessing functional magnetic resonance imaging and metabolomics.

Conditions

Dyspepsia

Keywords

Functional Dyspepsia; Acupuncture; Functional MRI

Outcome Measures

Primary Outcomes (1)

• Proportion of responders

  The proportion of patients who answer "Yes" to more than half of adequate relief questions in the treatment period. Patients are expected to report their response to the acupuncture treatment by answering the following question at each visit: "After the last visit, have you had adequate relief of your stomach pain or discomfort?" Questions will be asked at each visit during treatment period (Twice a week for 4 wks, total 10 times - 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5 wks). Responders are defined as patients reporting adequate relief for at least 50% of the study period (more than 5 times of "Yes" to adequate relief question out of total 10 questions). The proportion of responder will be compared statistically between intervention groups.

  Once in treatment period (4 wks)

Secondary Outcomes (9)

• Nepean Dyspepsia Index - Korean version (NDI-K)

  treatment (0 wks), After treatment (4 wks)

• Functional Dyspepsia-Related Quality of Life (FD-QoL) Questionnaire

  Before treatment (0 wks), After treatment (4 wks)

• Ways of Coping Question (WCQ)

  treatment (0 wks), After treatment (4 wks)

• Coping Strategy Questionnaire (CSQ)

  Before treatment (0 wks), After treatment (4 wks)

• Functional Magnetic Resonance Imaging ; 3.0T MRI system(Achieva, Philips)

  Before treatment (0 wks), After treatment (4 wks)

Study Arms (2)

Acupuncture

EXPERIMENTAL

Participants in this group are given 10 times of real acupuncture treatment for 4 weeks.

Device: Acupuncture

Sham acupuncture

SHAM COMPARATOR

Participants in this group are given 10 times of sham acupuncture treatment for 4 weeks.

Device: Sham acupuncture

Interventions

Acupuncture DEVICE

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

Also known as: Acupuncture treatment

Acupuncture

Sham acupuncture DEVICE

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.

Also known as: Streitberger Device

Sham acupuncture

Eligibility Criteria

• Age: 30 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants should meet following conditions:
• Aged of 30 - 49
• Individuals who meet FD and postprandial distress syndrome (PDS) criteria in Rome III
• 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)
• At least 3 questions show more than 2 points in Gastrointestinal impact scale
• 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
• Individuals who are not supposed to take any other treatments associated with FD during the study
• Individuals who voluntarily agree with a study protocol and sign a written informed consent

You may not qualify if:

• Participants who report the followings will be excluded:
• Individuals who have organic diseases such as gastroesophageal reflux disease
• Individuals who have obvious signs of irritable bowel syndrome
• Individuals who have alarm symptoms (weight loss, black or tar stool or dysphagia)
• Individuals who have serious structural disease (disease of heart, lung, liver or kidney) or mental illness
• Individuals who have had surgery related with the gastrointestinal tract , except for appendectomy more than six months ago
• Individuals who are pregnant or breastfeeding
• Individuals who are taking drugs which might affect gastrointestinal tract; minimum wash-out period of 2 weeks is required before participating in the trial
• Individuals who are HIV-positive
• Individuals who have a problem of mal-absorption
• 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.)
• Individuals who do not want to sign the informed consent
• Individuals who have other diseases that could interfere acupuncture treatment, e.g. clotting disorders or leukopenia, pace-maker, epilepsy, or anticoagulant therapy
• Individuals who have metal implants or fragments which might influence fMRI examination

Sponsors & Collaborators

• Kyunghee University Medical Center: lead
• Korea Institute of Oriental Medicine: collaborator
• Kyung Hee University Hospital at Gangdong: collaborator

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, Gangdong-gu, 130-701, South Korea

RECRUITING

Related Publications (11)

• 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.

  PMID: 16678553 BACKGROUND

• 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.

  PMID: 19678778 BACKGROUND

• 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.

  PMID: 15992222 BACKGROUND

• 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.

  PMID: 22343090 BACKGROUND

• 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.

  PMID: 18390493 BACKGROUND

• 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.

  PMID: 12667970 BACKGROUND

• 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.

  PMID: 23861702 BACKGROUND

• 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.

  PMID: 23791896 BACKGROUND

• 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.

  PMID: 15042468 BACKGROUND

• 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.

  PMID: 22908903 BACKGROUND

• 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.

  PMID: 27039086 DERIVED

MeSH Terms

Conditions

Dyspepsia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Seok-Jae Ko, KMD, PhD

  Kyung Hee University Hospital at Gangdong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seok-Jae Ko, KMD, PhD

CONTACT

+82-2-440-6245; kokokoko119@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor, Department of Korean Internal Medicine

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: February 9, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

KR (1)