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

Gastroesophageal Reflux Disease (GERD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04660019
• Other study ID #: N202004031
• Status: Completed
• Phase: N/A
• Start date: August 10, 2020
• Est. completion date: May 10, 2022

Study information

• Verified date: April 2022
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 10, 2022
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)
• Neurology

Intervention

Other:
• the scalp and ear acupuncture
Some stimulation areas with outstanding effects on certain symptoms are selected for acupuncture
• sham acupuncture
Some stimulation areas with outstanding effects on certain symptoms are selected for acupuncture, and change acupuncture to auricular points sticker.

Locations

Country	Name	City	State
Taiwan	Wanfang Hospital	Taipei	Wenshan District

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (10)

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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Two weeks
Primary	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	Two weeks