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

NCT04660019 | Completed

• 1 other identifier: N202004031
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 (GERD) has increased from 610,000 to over 760,000 in the past three years (2016-2018). Western medicine mainly uses proton pump inhibitors (PPI) to improve symptoms. For patients who are ineffective in drug treatment, it will be treated by surgical treatment (Laparoscopic Nissen Fundoplication, endoluminal gastroplication).

Conditions

Gastroesophageal Reflux Disease (GERD); Neurology

Keywords

Acupuncture

Outcome Measures

Primary Outcomes (2)

• Reflux Diagnostic Questionnaire

  Reflux Diagnostic Questionnaire (RDQ), scores of symptoms of heartburn, dyspepsia, acid regurgitation, and PPI use. The participants must have four-time acupuncture/acupressure treatment in two weeks, and each acupuncture/acupressure treatment spends one hour. For the first visit, the participants must write RDQ. After one month, 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. The difference in scores will show the effect of treatment. If the first RDQ score is higher than the last RDQ score, it means that the participants' symptom has been improved by acupuncture/acupressure treatment. If the first RDQ score is the same or lower than the last RDQ score, it means the participants' symptom has not been effectively improved by acupuncture/acupressure treatment.

  One month

• Analysis of cytokines and GABA concentration in blood

  The participants must have four-time acupuncture/acupressure treatment in two weeks, and each acupuncture/acupressure treatment spends one hour. Blood samples were collected before the first time acupuncture/acupressure treatment and after the last acupuncture/acupressure treatment. The differences between cytokines and GABA will help us to understand the possible mechanisms of acupuncture.

  Two weeks

Study Arms (2)

Scalp and auricular acupuncture

EXPERIMENTAL

Three scalp acupoints including GV 20, bilateral GB 15, stomach area and four ear acupoints (Shenmen, thalamus, cardia, stomach).

Other: Scalp and auricular acupuncture

Seed acupressure

PLACEBO COMPARATOR

Three scalp acupoints including GV 20, bilateral GB 15, stomach area and four ear acupoints (Shenmen, thalamus, cardia, stomach).

Other: Seed acupressure

Interventions

Scalp and auricular acupuncture OTHER

Three scalp acupoints including Baihui (GV 20), bilateral Toulinqi (GB 15, stomach area) and four ear acupoints (Shenmen, thalamus, cardia, stomach). The study duration was 2 weeks with four sessions of scalp and auricular acupuncture treatment on day 1, 5, 9 and 14.

Scalp and auricular acupuncture

Seed acupressure OTHER

Three scalp acupoints including Baihui (GV 20), bilateral Toulinqi (GB 15, stomach area) and four ear acupoints (Shenmen, thalamus, cardia, stomach). The study duration was 2 weeks with four sessions of seed acupressure treatment on day 1, 5, 9 and 14.

Seed acupressure

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with mild reflux esophagitis (Los Angeles grades A or B) diagnosed by endoscopy received a 4-month standard-dose PPI therapy and reported the symptoms were improved during the treatment.
• After discontinuing PPI, patients experienced rebound symptoms but quickly found relief upon resuming PPI.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Wanfang Hospital

Taipei, Wenshan District, 116, Taiwan

Location

Related Publications (10)

• 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.

  PMID: 11051337 BACKGROUND

• 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.

  PMID: 27075264 BACKGROUND

• 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.

  PMID: 30945492 BACKGROUND

• 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.

  PMID: 786839 BACKGROUND

• 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.

  PMID: 495684 BACKGROUND

• 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.

  PMID: 24509233 BACKGROUND

• 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.

  PMID: 30150661 BACKGROUND

• 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.

  PMID: 18447946 BACKGROUND

• 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.

  PMID: 31028972 BACKGROUND

• 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.

  PMID: 27155456 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Officials

• Ming-Shun Wu, PHD

  Taipei Municipal Wanfang Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 9, 2020
• Study Start: August 10, 2020
• Primary Completion: November 30, 2020
• Study Completion: May 10, 2022
• Last Updated: June 26, 2024

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)