Clinical trial NCT02358486: The Effect and Mechanism of Acupuncture on Functional Dyspepsia
Official title: Effect and Mechanism of Acupuncture on Patients With Functional Dyspepsia: a Protocol for a Randomized, Assessor-blind, Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dyspepsia
Keywords: Functional Dyspepsia
Acupuncture
Functional MRI
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Korea Institute of Oriental Medicine
name: Kyung Hee University Hospital at Gangdong
First posted: 2015-02-09
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of responders
timeFrame: Once in treatment period (4 wks)
Secondary outcomes:
measure: Nepean Dyspepsia Index - Korean version (NDI-K)
timeFrame: treatment (0 wks), After treatment (4 wks)
measure: Functional Dyspepsia-Related Quality of Life (FD-QoL) Questionnaire
timeFrame: Before treatment (0 wks), After treatment (4 wks)
measure: Ways of Coping Question (WCQ)
timeFrame: treatment (0 wks), After treatment (4 wks)
measure: Coping Strategy Questionnaire (CSQ)
timeFrame: Before treatment (0 wks), After treatment (4 wks)
measure: Functional Magnetic Resonance Imaging ; 3.0T MRI system(Achieva, Philips)
timeFrame: Before treatment (0 wks), After treatment (4 wks)
measure: Metabolic profiling of plasma and urine
timeFrame: Time Frame: Before treatment (0 wks), After treatment (4 wks)
measure: The Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Before treatment (0 wks), After treatment (4 wks)
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: Before treatment (0 wks), After treatment (4 wks)
measure: Perception of bodily sensation (PDS)
timeFrame: Before treatment (0 wks)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
state: Gangdong-gu
Study officials:
affiliation: Kyung Hee University Hospital at Gangdong
name: Seok-Jae Ko, KMD, PhD
role: PRINCIPAL_INVESTIGATOR
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