Gastroesophageal Reflux Disease (GERD)NCT04660019
Combined Scalp and Ear Acupuncture in Patients With Proton Pump Inhibitor- Dependent Gastroesophageal Reflux Disease
A study testing Scalp and auricular acupuncture and Seed acupressure in people with Gastroesophageal Reflux Disease (GERD) and Neurology, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 (GERD) has increased from 610,000 to over 760,000 in the past three years (2016-2018). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD), Neurology
- What is being tested?
- Scalp and auricular acupuncture and Seed acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Aug 2020to 10 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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 (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).
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 GERD 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). Acupuncture treatment for GERD primarily utilizes body acupuncture, while scalp and auricular acupuncture for GERD treatment remain scarcely discussed.
This research plan intends to use scalp and auricular acupuncture on recurrent, PPI-dependent GERD and further explore what is the mechanism of acupuncture to improve the symptoms in patients with refractory gastroesophageal reflux. We hypothesized that scalp and auricular acupuncture will reduce scores of reflux disease questionnaire and PPI use compared to placebo treatment with seed acupressure (SAP). 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.
- Conditions
- Gastroesophageal Reflux Disease (GERD), Neurology
- Being tested
- Scalp and auricular acupuncture, Seed acupressure
- Keywords
- Acupuncture
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp and auricular acupunctureOther
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.
Seed acupressureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Scalp and auricular acupuncture | Experimental | Three scalp acupoints including GV 20, bilateral GB 15, stomach area and four ear acupoints (Shenmen, thalamus, cardia, stomach). Receives: 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). Receives: Other: Seed acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start10 Aug 2020
- Primary completion30 Nov 2020
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Shun Wu, PHD, Study director, Taipei Municipal Wanfang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660019
- Sponsor's protocol ID
- N202004031
- Status last verified
- Apr 2022
- First submitted
- 2 Dec 2020
- Last updated
- 26 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is just for combined scalp and auricular acupuncture in patients with proton pump inhibitor- dependent gastroesophageal reflux disease.
Publications
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.
PubMed 11051337Scarpellini 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.
PubMed 27075264Gao 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.
PubMed 30945492Sutor 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.
PubMed 786839Wolfe 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.
PubMed 495684Mishina 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.
PubMed 24509233Herisson 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.
PubMed 30150661Shaw 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.
PubMed 18447946Zanella 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.
PubMed 31028972Kattalai 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.
PubMed 27155456
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Scalp and Ear Acupuncture in Patients With Proton Pump Inhibitor- Dependent Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT04660019
- Acronym / sponsor ID
- N202004031
- Conditions
- Gastroesophageal Reflux Disease (GERD), Neurology
- Keywords
- Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 (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).
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 GERD 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). Acupuncture treatment for GERD primarily utilizes body acupuncture, while scalp and auricular acupuncture for GERD treatment remain scarcely discussed.
This research plan intends to use scalp and auricular acupuncture on recurrent, PPI-dependent GERD and further explore what is the mechanism of acupuncture to improve the symptoms in patients with refractory gastroesophageal reflux. We hypothesized that scalp and auricular acupuncture will reduce scores of reflux disease questionnaire and PPI use compared to placebo treatment with seed acupressure (SAP). 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scalp and auricular acupuncture | Experimental | Other: Scalp and auricular acupunctureThree scalp acupoints including GV 20, bilateral GB 15, stomach area and four ear acupoints (Shenmen, thalamus, cardia, stomach). |
| Seed acupressure | Placebo comparator | Other: Seed acupressureThree scalp acupoints including GV 20, bilateral GB 15, stomach area and four ear acupoints (Shenmen, thalamus, cardia, stomach). |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scalp and auricular acupunctureThree 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. | Other | Scalp and auricular acupuncture |
| Seed acupressureThree 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. | Other | Seed acupressure |
Primary outcome
Reflux Diagnostic Questionnaire
Time frame: One month
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.
Analysis of cytokines and GABA concentration in blood
Time frame: Two weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Background: PubMed 11051337Meining 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.
- Background: PubMed 27075264Scarpellini 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.
- Background: PubMed 30945492Gao 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.
- Background: PubMed 786839Sutor 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.
- Background: PubMed 495684Wolfe 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.
- Background: PubMed 24509233Mishina 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.
- Background: PubMed 30150661Herisson 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.
- Background: PubMed 18447946Shaw 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.
- Background: PubMed 31028972Zanella 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.
- Background: PubMed 27155456Kattalai 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.
- Individual participant dataSharing planned: No. The data is just for combined scalp and auricular acupuncture in patients with proton pump inhibitor- dependent gastroesophageal reflux disease.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Shun Wu, PHD study director
Taipei Municipal Wanfang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scalp and auricular acupuncture and Seed acupressure in people with Gastroesophageal Reflux Disease (GERD) and Neurology, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reflux Diagnostic Questionnaire (time frame: One month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04660019, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.