Treatment of Functional Dyspepsia With Acupuncture

Study Overview
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Brief Summary
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Functional dyspepsia (FD) is one of the most common chronic gastrointestinal disorders affecting humans. Existing therapies for FD are still far from satisfactory and new therapies are constantly being sought. Acupuncture has been used for the alleviation of functional gastrointestinal symptoms in several non-controlled studies. This study aims to investigate the therapeutic efficacy of acupuncture in patients with FD.

Official Title
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Treatment of Functional Dyspepsia With Acupuncture: A Randomized, Blinded, Sham Acupuncture Controlled Study

Conditions
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Functional Dyspepsia

Intervention / Treatment
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* Other: Acupuncture
* Other: Sham acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: - female and male patients with functional dyspepsia between the ages of ≥18 and ≤70 years. FD will be diagnosed according to the Rome-III criteria. Onset of FD symptoms should begin at least 6 months before clinical presentation and must be fulfilled for the last 3 months and his or her FD symptoms score must be of at least moderate severity. Exclusion criteria: Subjects unable to give informed consent Pregnant or breast-feeding females or women who get pregnant midway Subjects who have received acupuncture treatment before Subjects who have had a previous gastrointestinal surgery except appendectomy and laparoscopic cholecystectomy Any significant past or concurrent disease or disorder which, in the opinion of the investigator, may either put subject at risk in the study, influence the results of the study or influence subject's ability to participate in the study Maintenance treatment with PPIs (proton pump inhibitors) and H2RAs (H2-receptor antagonists) continuously (every day) in the last 6 months prior to entry into the study Treatment with PPIs and H2RAs, prokinetics, antibiotics, prostaglandins or bismuth-containing compounds during the last 2 weeks prior to entry into the study H. pylori eradication treatment within the past 12 months before study start H. pylori positive patients Patients with bleeding diathesis Known or suspected hypersensitivity to acupuncture.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>Patients given acupuncture treatment | Other: Acupuncture<br>* Patients will be stimulated at specific acupuncture points as determined for treatment of the disease by certified acupuncturists<br>|
| Sham Comparator: Sham acupuncture<br>Patients given sham acupuncture treatment | Other: Sham acupuncture<br>* Patients will be given sham acupuncture treatment at dummy acupuncture points<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of symptoms |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life and hospital anxiety & depression scale |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Dyspepsia, Acupuncture, Traditional Chinese Medicine