Combined Scalp and Ear Acupuncture in Patients With Proton Pump Inhibitor- Dependent Gastroesophageal Reflux Disease

Study Overview
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Brief Summary
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According to the statistics of the National Health Insurance Administration Ministry of Health and Welfare, the number of patients about gastroesophageal reflux disease has increased from 610,000 to over 760,000 in the past three years (2016-2018). Western medicine mainly uses proton pump inhibitors to improve symptoms. For patients who are ineffective in drug treatment, it will be treated by surgical treatment (Laparoscopic Nissen Fundoplication, endoluminal gastroplication).

Detailed Description
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According to the statistics of the National Health Insurance Administration Ministry of Health and Welfare, the number of patients about gastroesophageal reflux disease has increased from 610,000 to over 760,000 in the past three years (2016-2018). Western medicine mainly uses proton pump inhibitors to improve symptoms. For patients who are ineffective in drug treatment, it will be treated by surgical treatment (Laparoscopic Nissen Fundoplication, endoluminal gastroplication). However, it is easy to cause problems such as difficulty swallowing or recurrence postoperatively. In recent years, more and more integrated treatment studies of Chinese and Western medicine have found that acupuncture can improve the refractory gastroesophageal reflux disease and can provide patients with another non-surgical treatment. Traditional acupuncture is mainly based on distinguishing diseases (mainly according to Western medicine disease diagnosis, to perform acupoint selection.), dialectics and verification (based on clinical experience, some stimulation areas with outstanding effects on certain symptoms are selected for acupuncture). These methods are used as the standard for acupoint selection. This research plan intends to use scalp and ear acupuncture to identify diseases and select points for verification. Combined with the basics of western medicine, embryology and neurophysiology, the investigators will further explore what is the mechanism of acupuncture to improve the symptoms in patients with refractory gastroesophageal reflux. If this mechanism can be clarified, it will reduce the patient's overuse of drugs and the cost of surgery in the future, which will be a big boon for Taiwanese health and finances of health insurance.

Official Title
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Combined Scalp and Ear Acupuncture in Patients With Proton Pump Inhibitor- Dependent Gastroesophageal Reflux Disease

Conditions
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Neurology, Gastroesophageal Reflux Disease (GERD)

Intervention / Treatment
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* Other: the scalp and ear acupuncture
* Other: sham acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with gastroesophageal reflux symptoms who have had Reflux esophagitis (Reflux esophagitis) diagnosed by endoscopy. After using PPI, the symptoms can be improved, but the symptoms are still repeated, and they need to rely on PPI or antacids for a long time. Exclusion Criteria: Cannot sign consent form Women who are ready to become pregnant or are pregnant. Have a history of fainting during acupuncture treatment. Those using anticoagulants or antiplatelet agents.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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: the scalp and ear acupuncture<br>CHIAN HUEI ACUPUNCTURE NEEDLE | Other: the scalp and ear acupuncture<br>* Some stimulation areas with outstanding effects on certain symptoms are selected for acupuncture<br>|
| Placebo Comparator: sham acupuncture<br>Auricular points sticker | Other: sham acupuncture<br>* Some stimulation areas with outstanding effects on certain symptoms are selected for acupuncture, and change acupuncture to auricular points sticker.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflux Diagnostic Questionnaire | Reflux Diagnostic Questionnaire (RDQ), scores of symptoms of heartburn, retrosternal pain, acid regurgitation, and food regurgitation The participants must have four-time acupuncture in two weeks, and each acupuncture spends one hour. For the first time acupuncture, the participants must write RDQ. Then, in the last acupuncture, the participants must write RDQ again. The total score is 35 in RDQ; in addition, the minimum score is 7, and the maximum score is 35. Comparing with the first acupuncture score and last acupuncture score; moreover, the difference in score will show the effect of acupuncture. If the first RDQ score is higher than the last RDQ score, it means that the participants' symptom has been improved by acupuncture. If the first RDQ score is the same or lower than the last RDQ score, it means the participants' symptom has not been had effective improving by acupuncture. | Two weeks | 
| Analysis of GABA concentration in blood | The participants must have four-time acupuncture in two weeks or four-time, and each acupuncture spends one hour. The participants must have to blood draw before the first time acupuncture and after the last acupuncture. The difference results in GABA will show the effect of acupuncture blood draw-10c.c/each | Two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture