Clinical trial NCT04660019: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease (GERD)
Neurology
Keywords: Acupuncture
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Reflux Diagnostic Questionnaire
timeFrame: One month
measure: Analysis of cytokines and GABA concentration in blood
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wanfang Hospital
state: Wenshan District
Study officials:
affiliation: Taipei Municipal Wanfang Hospital
name: Ming-Shun Wu, PHD
role: STUDY_DIRECTOR
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