The Changes of Ryodoraku and HRV After PPI Treatment in GERD Patients

Study Overview
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Brief Summary
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Gastroesophageal reflux disease(GERD) mainly related to the reflux of stomach content induced by the dysfunction of lower esophageal sphincter. Proton pump inhibitors (PPI) can effectively block gastric acid secretion but the drug reactions and the degree of improvement in symptoms are sometimes unpredictable. The aim of this study is to investigate the association between the clinical efficacy of PPI in patients with GERD and the personal physical status by Ryodoraku and ANSWatch.

Detailed Description
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Gastroesophageal reflux disease(GERD) is a common disease, mainly related to the reflux of stomach content induced by the dysfunction of lower esophageal sphincter. The common symptoms of GERD are heartburn, acid regurgitation, chest pain and globus hystericus. The methods to treat GERD are changes of lifestyle, pharmacotherapy, antireflux surgery and endoscopy. Proton pump inhibitors (PPI) can effectively block gastric acid secretion and promote the repair of esophagus, but the drug reactions and the degree of improvement in symptoms are sometimes unpredictable. Recently there are many instruments used to analyze personal physical status. Meridian energy analysis device ( Ryodoraku ) is used to assess the energy of meridian system by analysis of resistance of the skin surface, as well as the wrist-worn heart rate monitor (ANSWatch) used to assess the autonomic nervous system by analysis of heart rate variability. Therefore, the aim of this study is to investigate the association between the clinical efficacy of PPI in patients with GERD and the personal physical status by Ryodoraku and ANSWatch. Investigators will recruit 120 patients with GERD in clinic who have to receive PPIs for four weeks and assess each volunteer before and after taking the medication. Assessment methods : 1. ANSWatch to assess the autonomic nervous system, 2. Ryodoraku to assess the energy of meridian system, 3. Upper gastrointestinal endoscopy to assess the grade of reflux esophagitis, 4. gastroesophageal reflux disease questionnaire to assess the severity of GERD. Investigators analysed and compared the database from the assessments between before and after taking the medication. Investigators anticipate to substantiate that the changes of Ryodoraku and ANSWatch are good predictors for the clinical efficacy of PPI in patients with GERD.

Official Title
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The Changes of Ryodoraku and HRV After PPI Treatment in GERD Patients

Conditions
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Non-erosive Reflux Disease, Barrett's Esophagus

Intervention / Treatment
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* Device: Ryodoraku
* Device: ANSWatch
* Device: UGI endoscopy
* Other: GerdQ
* Drug: PPI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female age of 20-75 years patients with GERD who have to receive PPIs for four weeks Exclusion Criteria: Suffering from peptic ulcer, gallstones, cancer, and Barrett's esophagus previously underwent the esophagus, stomach or duodenum surgery Lactating women or pregnant women

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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PPI treatment<br>Patients with GERD would be assessed by ANSWatch. Ryodoraku, UGI endoscopy, and GerdQ before taking PPIs and after taking PPI 20mg tablet by mouth everyday for 4 weeks. | Device: Ryodoraku<br>* Ryodoraku to assess the energy of meridian system for each patient before and after taking the medication<br>* Other names: Me-100;Device: ANSWatch<br>* ANSWatch to assess the autonomic nervous system for each patient before and after taking the medication<br>* Other names: TS-0411;Device: UGI endoscopy<br>* UGI endoscopy to assess the grade of reflux esophagitis for each patient before and after taking the medication<br>* Other names: Fujinon EG590WR;Other: GerdQ<br>* GerdQ to assess the severity of GERD for each patient before and after taking the medication<br>* Other names: Gastroesophageal reflux disease questionnaire;Drug: PPI<br> <br> * Other names: Pariet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastroesophageal reflux disease questionnaire | To assess the severity of GERD | four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper gastrointestinal endoscopy | To assess the grade of reflux esophagitis | four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, Autonomic Nervous System, Ryodoraku, Meridian energy, Heart rate variability