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

June 24, 2024 updated by: Taipei Medical University WanFang Hospital
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Wenshan District
      • Taipei, Wenshan District, Taiwan, 116
        • Wanfang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Scalp and auricular acupuncture
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 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.
Placebo Comparator: Seed acupressure
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 seed acupressure treatment on day 1, 5, 9 and 14.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One month
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.
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University WanFang Hospital

Investigators

  • Study Director: Ming-Shun Wu, PHD, Taipei Municipal Wanfang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2020

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

May 10, 2022

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

December 2, 2020

First Posted (Actual)

December 9, 2020

Study Record Updates

Last Update Posted (Actual)

June 26, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N202004031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data is just for combined scalp and auricular acupuncture in patients with proton pump inhibitor- dependent gastroesophageal reflux disease.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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