An interventional study of Scalp and auricular acupuncture and Seed acupressure in Gastroesophageal Reflux Disease (GERD) and Neurology, sponsored by Taipei Medical University WanFang Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-26.
Sponsored by Taipei Medical University WanFang Hospital · Not applicable, Interventional, and Treatment
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).
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.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 48 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
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Exclusion Criteria:
Three scalp acupoints including GV 20, bilateral GB 15, stomach area and four ear acupoints (Shenmen, thalamus, cardia, stomach).
Other: Scalp and auricular acupuncture
Three scalp acupoints including GV 20, bilateral GB 15, stomach area and four ear acupoints (Shenmen, thalamus, cardia, stomach).
Other: Seed acupressure
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.
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.
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.
Time frame: 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.
Time frame: Two weeks
Plan to share: No — The data is just for combined scalp and auricular acupuncture in patients with proton pump inhibitor- dependent gastroesophageal reflux disease.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Taipei Medical University WanFang Hospital