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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04660019
Recruitment Status : Enrolling by invitation
First Posted : December 9, 2020
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University WanFang Hospital

Study Description
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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).

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease (GERD) Neurology Other: the scalp and ear acupuncture Other: sham acupuncture Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Combined Scalp and Ear Acupuncture in Patients With Proton Pump Inhibitor- Dependent Gastroesophageal Reflux Disease
Actual Study Start Date : August 10, 2020
Actual Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture GERD

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04660019


Locations
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Taiwan
Wanfang Hospital
Taipei, Wenshan District, Taiwan, 116
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
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Study Director: Ming-Shun Wu, PHD Taipei Municipal Wanfang Hospital
More Information
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Publications:

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Responsible Party: Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT04660019    
Other Study ID Numbers: N202004031
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data is just for Combined scalp and ear acupuncture in patients with proton pump inhibitor- dependent gastroesophageal reflux disease

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Medical University WanFang Hospital:
Acupuncture
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases