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

Primary Purpose

Gastroesophageal Reflux Disease (GERD), Neurology

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
the scalp and ear acupuncture
sham acupuncture
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD) focused on measuring Acupuncture

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wanfang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

the scalp and ear acupuncture

sham acupuncture

Arm Description

CHIAN HUEI ACUPUNCTURE NEEDLE

Auricular points sticker

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
December 2, 2020
Last Updated
May 10, 2022
Sponsor
Taipei Medical University WanFang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04660019
Brief Title
Combined Scalp and Ear Acupuncture in Patients With Proton Pump Inhibitor- Dependent Gastroesophageal Reflux Disease
Official Title
Combined Scalp and Ear Acupuncture in Patients With Proton Pump Inhibitor- Dependent Gastroesophageal Reflux Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 10, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
May 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University WanFang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease (GERD), Neurology
Keywords
Acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the scalp and ear acupuncture
Arm Type
Experimental
Arm Description
CHIAN HUEI ACUPUNCTURE NEEDLE
Arm Title
sham acupuncture
Arm Type
Placebo Comparator
Arm Description
Auricular points sticker
Intervention Type
Other
Intervention Name(s)
the scalp and ear acupuncture
Intervention Description
Some stimulation areas with outstanding effects on certain symptoms are selected for acupuncture
Intervention Type
Other
Intervention Name(s)
sham acupuncture
Intervention Description
Some stimulation areas with outstanding effects on certain symptoms are selected for acupuncture, and change acupuncture to auricular points sticker.
Primary Outcome Measure Information:
Title
Reflux Diagnostic Questionnaire
Description
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.
Time Frame
Two weeks
Title
Analysis of GABA concentration in blood
Description
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
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Shun Wu, PHD
Organizational Affiliation
Taipei Municipal Wanfang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Wanfang Hospital
City
Taipei
State/Province
Wenshan District
ZIP/Postal Code
116
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data is just for Combined scalp and ear acupuncture in patients with proton pump inhibitor- dependent gastroesophageal reflux disease
Citations:
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11051337
Citation
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Combined Scalp and Ear Acupuncture in Patients With Proton Pump Inhibitor- Dependent Gastroesophageal Reflux Disease

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