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
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD) focused on measuring Acupuncture
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.
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
NCT ID
NCT04660019
First Posted
December 2, 2020
Last Updated
May 10, 2022
Sponsor
Taipei Medical University WanFang Hospital
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:
PubMed Identifier
11051337
Citation
Meining A, Classen M. The role of diet and lifestyle measures in the pathogenesis and treatment of gastroesophageal reflux disease. Am J Gastroenterol. 2000 Oct;95(10):2692-7. doi: 10.1111/j.1572-0241.2000.03175.x.
Results Reference
background
PubMed Identifier
27075264
Citation
Scarpellini E, Ang D, Pauwels A, De Santis A, Vanuytsel T, Tack J. Management of refractory typical GERD symptoms. Nat Rev Gastroenterol Hepatol. 2016 May;13(5):281-94. doi: 10.1038/nrgastro.2016.50. Epub 2016 Apr 14.
Results Reference
background
PubMed Identifier
30945492
Citation
Gao DX, Bai XH. [Clinical trial of acupuncture treatment of gastroesophageal reflux cough by needling dorsal segment of the Governor Vessel]. Zhen Ci Yan Jiu. 2019 Feb 25;44(2):140-3. doi: 10.13702/j.1000-0607.170761. Chinese.
Results Reference
background
PubMed Identifier
786839
Citation
Sutor AH, Jesdinsky-Buscher C. [Changes in hemostasis during epilespy treatment using dipropyl acetate. Extended study]. Fortschr Med. 1976 Mar 11;94(8):411-4. German.
Results Reference
background
PubMed Identifier
495684
Citation
Wolfe JM, Owens DA. Evidence for separable binocular processes differentially affected by artificially induced anisometropia. Am J Optom Physiol Opt. 1979 May;56(5):279-84. doi: 10.1097/00006324-197905000-00001.
Results Reference
background
PubMed Identifier
24509233
Citation
Mishina Y, Snider TN. Neural crest cell signaling pathways critical to cranial bone development and pathology. Exp Cell Res. 2014 Jul 15;325(2):138-47. doi: 10.1016/j.yexcr.2014.01.019. Epub 2014 Feb 6.
Results Reference
background
PubMed Identifier
30150661
Citation
Herisson F, Frodermann V, Courties G, Rohde D, Sun Y, Vandoorne K, Wojtkiewicz GR, Masson GS, Vinegoni C, Kim J, Kim DE, Weissleder R, Swirski FK, Moskowitz MA, Nahrendorf M. Direct vascular channels connect skull bone marrow and the brain surface enabling myeloid cell migration. Nat Neurosci. 2018 Sep;21(9):1209-1217. doi: 10.1038/s41593-018-0213-2. Epub 2018 Aug 27.
Results Reference
background
PubMed Identifier
18447946
Citation
Shaw M, Dent J, Beebe T, Junghard O, Wiklund I, Lind T, Johnsson F. The Reflux Disease Questionnaire: a measure for assessment of treatment response in clinical trials. Health Qual Life Outcomes. 2008 Apr 30;6:31. doi: 10.1186/1477-7525-6-31.
Results Reference
background
PubMed Identifier
31028972
Citation
Zanella AK, Gutierres JM, Stigger F. Effects of Scalp Acupuncture on Functional Deficits Induced by Early Sensorimotor Restriction. J Acupunct Meridian Stud. 2019 Jun;12(3):77-83. doi: 10.1016/j.jams.2019.03.002. Epub 2019 Apr 24.
Results Reference
background
PubMed Identifier
27155456
Citation
Kattalai Kailasam V, Anand P, Melyan Z. Establishing an animal model for National Acupuncture Detoxification Association (NADA) auricular acupuncture protocol. Neurosci Lett. 2016 Jun 15;624:29-33. doi: 10.1016/j.neulet.2016.05.001. Epub 2016 May 4.
Results Reference
background
Learn more about this trial
Combined Scalp and Ear Acupuncture in Patients With Proton Pump Inhibitor- Dependent Gastroesophageal Reflux Disease
We'll reach out to this number within 24 hrs