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

May 10, 2022 updated by: Taipei Medical University WanFang Hospital
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Wenshan District
      • Taipei, Wenshan District, Taiwan, 116
        • WanFang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: the scalp and ear acupuncture
CHIAN HUEI ACUPUNCTURE NEEDLE
Other: the scalp and ear acupuncture
Some stimulation areas with outstanding effects on certain symptoms are selected for acupuncture
PLACEBO_COMPARATOR: sham acupuncture
Auricular points sticker
Other: sham acupuncture
Some stimulation areas with outstanding effects on certain symptoms are selected for acupuncture, and change acupuncture to auricular points sticker.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reflux Diagnostic Questionnaire
Time Frame: Two weeks

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
Time Frame: Two weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University WanFang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 10, 2020

Primary Completion (ACTUAL)

November 30, 2020

Study Completion (ACTUAL)

May 10, 2022

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

December 2, 2020

First Posted (ACTUAL)

December 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 10, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N202004031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data is just for Combined scalp and ear acupuncture in patients with proton pump inhibitor- dependent gastroesophageal reflux disease

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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