Combined Scalp and Ear Acupuncture in Patients With Proton Pump Inhibitor- Dependent Gastroesophageal Reflux Disease
- Conditions
- NeurologyGastroesophageal Reflux Disease (GERD)
- Interventions
- Other: Scalp and auricular acupunctureOther: Seed acupressure
- Registration Number
- NCT04660019
- Lead Sponsor
- Taipei Medical University WanFang Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Scalp and auricular acupuncture Scalp and auricular acupuncture Three scalp acupoints including GV 20, bilateral GB 15, stomach area and four ear acupoints (Shenmen, thalamus, cardia, stomach). Seed acupressure Seed acupressure Three scalp acupoints including GV 20, bilateral GB 15, stomach area and four ear acupoints (Shenmen, thalamus, cardia, stomach).
- Primary Outcome Measures
Name Time Method Analysis of cytokines and GABA concentration in blood 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.
Reflux Diagnostic Questionnaire 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Wanfang Hospital
🇨🇳Taipei, Wenshan District, Taiwan