The Effect and Mechanism of Acupuncture on Functional Dyspepsia

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02358486
• Other study ID #: KHNMCOH 2014-08-002
• Status: Recruiting
• Phase: N/A
• First received: January 21, 2015
• Last updated: August 15, 2017
• Start date: January 2015
• Est. completion date: January 2018

Study information

• Verified date: August 2017
• Source: Kyunghee University Medical Center
• Contact: Seok-Jae Ko, KMD, PhD
• Phone: +82-2-440-6245
• Email: kokokoko119[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Functional dyspepsia (FD) is a functional gastrointestinal disorder without any structural lesion. Due to the lack of satisfactory effect of conventional treatments, many FD patients turn to alternative treatments such as acupuncture. Acupuncture, one of the most sought therapeutic modalities in traditional Korean Medicine, has been commonly used for treating gastrointestinal disorders.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 49 Years

Eligibility

Inclusion criteria

Participants should meet following conditions:

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

Participants who report the followings will be excluded:

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

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Device:
• Acupuncture
Acupuncture rationale 1a) Style of acupuncture: body acupuncture (in accordance with meridian theory) 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.

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul	Gangdong-gu

Sponsors (3)

Lead Sponsor	Collaborator
Kyunghee University Medical Center	Korea Institute of Oriental Medicine, Kyung Hee University Hospital at Gangdong

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (10)

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. — View Citation

Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. Review. — View Citation

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. — View Citation

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):2088-99. doi: 10.1016/j.pain.2013.06.024. Epub 2013 Jun 20. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rodríguez Franco L, Cano García FJ, Blanco Picabia A. [Assessment of chronic pain coping strategies]. Actas Esp Psiquiatr. 2004 Mar-Apr;32(2):82-91. Spanish. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Nepean Dyspepsia Index - Korean version (NDI-K)	The Nepean Dyspepsia Index is a reliable and valid measure of quality of life in FD. The Nepean Dyspepsia Index originally contains 42 items designed to measure impairment of a subjective ability engaged in relevant aspects of their life because of dyspepsia. It was subsequently shortened to 25 items, yielding 5 sub-scales. NDI-K, validated in 2003 by Lee at al., made up of 2 sections which are about symptom-based questions and quality of life. In this trial, symptom-based questions, i.e. questions about period, severity and distressful degree of 15 symptoms, will be evaluated.	treatment (0 wks), After treatment (4 wks)
Secondary	Functional Dyspepsia-Related Quality of Life (FD-QoL) Questionnaire	The FD-QoL scale is a 21-item Likert-type questionnaire that can easily be completed within 5 min. Short administration time and high comprehensibility supports the feasibility of measuring health-related quality of life.	Before treatment (0 wks), After treatment (4 wks)
Secondary	Ways of Coping Question (WCQ)	The Ways of Coping Questionnaire (WCQ) (Folkman & Lazarus, 1988) assessed the parents' coping strategies. It has 66-items, each with a 4-point Likert scale indicating the frequency with which the strategy was used. The measure comprises eight scales representing theoretically different coping strategies: confrontative coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, problem solving, and positive reappraisal.	treatment (0 wks), After treatment (4 wks)
Secondary	Coping Strategy Questionnaire (CSQ)	Coping Strategy questionnaire is one of models for measuring stress and coping to help explain the differences in adjustment found among persons who experience chronic pain. It consists of 48 items, each with a 7-point Likert scale (0:never; 3: sometimes; 6:always) and divide into eight scales of six items each; (1) Catastrophizing, (2) Distractor behaviors, (3) Self-instructions, (4) Ignoring the pain, (5) Reinterpreting the pain, (6) Hoping, (7) Faith and praying, (8) Cognitive distraction.	Before treatment (0 wks), After treatment (4 wks)
Secondary	Functional Magnetic Resonance Imaging ; 3.0T MRI system(Achieva, Philips)	A measure of steady state (REST and PAIN) and blood oxygenation level dependent (BOLD) under the condition of event related design (ACUP) scan run.	Before treatment (0 wks), After treatment (4 wks)
Secondary	Metabolic profiling of plasma and urine	In order to investigate the biological effects of FD and the effect of acupuncture on metabolism, the blood and urine sample will be analyzed using nuclear magnetic resonance (NMR)-based metabolomic techniques to compare the metabolites such as amino acids, organic acids, and blood sugar of FD patients.	Time Frame: Before treatment (0 wks), After treatment (4 wks)
Secondary	The Center for Epidemiologic Studies Depression Scale (CES-D)	The Center for Epidemiological Studies-Depression (CES-D), originally published by Radloff in 1977, is a 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or little of the time, 2 = Moderately or much of the time, 3 = Most or almost all the time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.	Before treatment (0 wks), After treatment (4 wks)
Secondary	The State-Trait Anxiety Inventory (STAI)	The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety (anxiety triggered by a specific event), and trait anxiety (anxiety derived from personal characteristic). Higher scores are positively correlated with higher levels of anxiety.	Before treatment (0 wks), After treatment (4 wks)
Secondary	Perception of bodily sensation (PDS)	This scale is a 10-item questionnaire with 6(1-7) point Likert scale. Patients with higher Perception of bodily sensation (PBS) could have a higher emotional or cognitive intolerance to bodily reactions.	Before treatment (0 wks)