Clinical trial NCT02149914: The Changes of Ryodoraku and HRV After PPI Treatment in GERD Patients
Official title: The Changes of Ryodoraku and HRV After PPI Treatment in GERD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-erosive Reflux Disease
Barrett's Esophagus
Keywords: Ryodoraku
Meridian energy
Heart rate variability
Autonomic Nervous System
GERD
Lead sponsor: Taichung Tzu Chi Hospital
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: gastroesophageal reflux disease questionnaire
timeFrame: four weeks
Secondary outcomes:
measure: Upper gastrointestinal endoscopy
timeFrame: four weeks
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: Taichung Tzu Chi Hospital
Study officials:
affiliation: Taichung Tzu Chi Hospital
name: Mei-Ling Shen, M.D
role: STUDY_CHAIR
References: