Acupuncture for Functional Dyspepsia: a Functional Magnetic Resonance Imaging (fMRI) Study

Study Overview
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Brief Summary
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He-Mu-point combination（ST36 and CV12） is one of the most commonly used acupoints combination with synergistic effect for functional dyspepsia(FD). The investigators design the trial to identify the efficacy and explore the central integrated mechanism of puncturing at He-Mu-point combination on FD with functional magnetic resonance imaging (fMRI).

Detailed Description
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105 participants with functional dyspepsia will be allocated into three groups: Low-He point group, Mu point group and He-Mu-point combination group.Every participant will receive 20 sessions of manual acupuncture treatment during 4 weeks. Clinical evaluations will be assessed three times, as measured after randomization, 10 and 20 sessions of treatment.The fMRI scans will be conducted twice, after randomization and treatment completion.

Official Title
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Acupuncture for Functional Dyspepsia: a Functional Magnetic Resonance Imaging (fMRI) Study

Conditions
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Functional Dyspepsia

Intervention / Treatment
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* Other: acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: right handed，age between 18 and 45 years old, college degree or above; match the Rome III criteria on FD; no local organic disease by gastroscope examination; before entering the study, without taking any prokinetic agents at least 15days and participating in other clinical study; signing an informed consent in writing by the participant or the immediate family member. Exclusion Criteria: consciousness, cannot express subjective symptoms and psychiatric participants; participants with advanced cancer or other serious wasting diseases, easy to be infected and bleeding; complicating with severe cardiovascular, hepatic,nephritic,digestive, hematopoietic system diseases; impregnate or lactation female; severe depression and anxiety symptoms; female with serious dysmenorrhea; obvious headache, migraine, history of head injury.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-He point(ST36)<br>Zusanli (ST36, the Low-He point of stomach) is the most important point for gastrointestinal disorder, including functional dyspepsia. Everyone in the group will be punctured at unilateral Zusanli. | Other: acupuncture<br>* Manual acupuncture treatment will be conducted. thirty minutes duration every time, five times per week for one course, a total four courses.<br>* Other names: Manual acupuncture;|
| Experimental: Mu point(CV12)<br>Zhongwan (CV12, the Mu point of stomach) is also good at regulating gastric function. Everyone in the group will be punctured at Zhongwan. | Other: acupuncture<br>* Manual acupuncture treatment will be conducted. thirty minutes duration every time, five times per week for one course, a total four courses.<br>* Other names: Manual acupuncture;|
| Active Comparator: He-Mu-point combination(ST36 and CV12)<br>In traditional Chinese acupuncture theory，synergistic effect can be produced by acupoints combination and the He-Mu-point combination is a classical acupoints combination formula for gastrointestinal diseases. Everyone in the group will be punctured at unilateral Zusanli and Zhongwan. | Other: acupuncture<br>* Manual acupuncture treatment will be conducted. thirty minutes duration every time, five times per week for one course, a total four courses.<br>* Other names: Manual acupuncture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nepean Dyspepsia Index (NDI) |  | 4 weeks after allocation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Rating Anxiety Scale |  | 0 day,2, 4weeks after allocation | 
| Self-Rating Depression Scale |  | 0 day,2, 4weeks after allocation | 
| Leeds dyspepsia questionnaire |  | 0 day,4 weeks after allocation | 
| brain MRI data |  | 0 day,4weeks after allocation | 
| The incidence of adverse events during the 4 weeks |  | 4weeks after allocation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, functional dyspepsia, functional magnetic resonance imaging (fMRI)