Efficacy and Safety of Combined Thread Embedding Acupuncture With Auricular Acupuncture for GERD

March 18, 2024 updated by: Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City

Evaluating Efficacy and Safety of Combined Thread Embedding and Auricular Acupuncture in Gastroesophageal Reflux Disease With Liver Qi Invading Stomach Pattern: A Randomized Controlled Trial

Gastroesophageal reflux disease (GERD) is increasingly prevalent today. Proton-pump inhibitors (PPIs) are the primary treatment, yet their effectiveness remains limited. Various acupuncture methods have shown promise in treating GERD. Among these, thread embedding acupuncture (TEA) and auricular acupuncture (AA) offer the advantage of prolonged treatment per intervention, significantly reducing healthcare visits for procedures, particularly beneficial for conditions requiring extended therapy. This has led to the widespread application of TEA and AA in GERD treatment. However, evidence supporting their effectiveness remains inconclusive. In this study, we aim to assess the efficacy and safety of combining TEA with AA for treating GERD. According to traditional medicine, treatment should be pattern-based. Thus, we will focus on patients exhibiting the Liver Qi Invading Stomach pattern, as reports indicate its prevalence among GERD patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with GERD diagnosed through the GerdQ score and presenting the traditional medicine pattern of Liver Qi invading Stomach, meeting the inclusion and not the exclusion criteria, will be included in the study. Upon randomization, participants will be allocated into two groups: the control and intervention groups.

The study spans four weeks. Both groups will receive standard GERD treatment following current guidelines, which include PPIs, additional antacids as required, and lifestyle modifications. The intervention group will receive an additional combination of thread embedding acupuncture therapy (TEA) every other week and auricular acupuncture (AA) weekly.

Patients will undergo weekly follow-up examinations. Symptom assessment, quality of life evaluations using specific questionnaires, and antacid medication usage will be monitored weekly. Adverse effects (AE) related to the treatment will be documented throughout the trial.

Study Type

Interventional

Enrollment (Actual)

66

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

  • Vietnam
      • Ho Chi Minh, Vietnam, 700000
        • University of Medical Center HCMC - Branch no.3, University of Medicine and Pharmacy at Ho Chi Minh City

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men or women aged from 18 to 60 Years
  • GerdQ score of eight or higher
  • Having heartburn and/or regurgitation on two days per week or more
  • Diagnosis of GERD with Liver Qi Invading Stomach Pattern

Exclusion Criteria:

  • Any prior endoscopy-confirmed structural diseases
  • Uncontrolled inflammatory bowel disease, chronic or genetic conditions, alcohol or drug abuse history
  • Alarming symptoms indicating gastric cancer, complicated ulcers, or serious illnesses
  • History of esophageal or gastrointestinal surgery
  • Current use of medications impacting GERD treatment or assessment
  • Recent (within two weeks) Western Medicine or Traditional Medicine treatment for GERD
  • History of hypersensitivity reactions to any components involved in the intervention
  • Pregnancy or breastfeeding
  • Current participation in any other clinical trials

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture + Standard treatment
Standard treatment plus thread embedding acupuncture and auricular acupuncture
Other: Thread Embedding Acupuncture
Thread Embedding Acupuncture is applied at acupoints including CV-12, CV-13, ST-36, PC-6, BL-17, BL-18, BL-21 on both sides of the body every 2 weeks, totaling 2 sessions over 4 weeks of intervention.
Other: Auricular acupuncture
Auricular acupuncture is administered using adhesive patches with small needles (0.25 x 1.3 mm) placed at acupoints TF4, AH6, CO12, CO4, CO2 once a week, totaling 4 sessions over the 4-week intervention period.
Other: Standard treatment
Standard treatment, continuously administered over the 4-week intervention period, involves standard doses of proton pump inhibitors, additional antacids as needed, and lifestyle modifications.
Active Comparator: Standard treatment
Other: Standard treatment
Standard treatment, continuously administered over the 4-week intervention period, involves standard doses of proton pump inhibitors, additional antacids as needed, and lifestyle modifications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of heartburn resolution
Time Frame: Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28)
Heartburn resolution is assessed through patient inquiry during each follow-up examination.
Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of regurgitation resolution
Time Frame: Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28)
Regurgitation resolution is assessed through patient inquiry during each follow-up examination.
Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28)
Chang in the Gastroesophageal Reflux disease Questionnaire (GerdQ) score
Time Frame: Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28)
As per GerdQ, patients were prompted to recall their symptoms and utilization of over-the-counter medications in the past week. It employs a four-point Likert scale (0-3) for scoring, resulting in a total GerdQ score range from 0 to 18. A higher score signifies a more severe condition.
Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28)
Chang in the Frequency Scale for the Symptoms of GERD (FSSG) score
Time Frame: Day 0 and after every two week during 4-week treatment (day 0, day 14, day 28)
The FSSG questionnaire consists of twelve questions categorized into two domains: reflux symptoms and dysmotility symptoms. Using a 5-point Likert scale (0-4), the FSSG yields a total score range of 0 to 48. A higher score suggests a more severe or significant disease.
Day 0 and after every two week during 4-week treatment (day 0, day 14, day 28)
Chang in the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score
Time Frame: Day 0 and after every two week during 4-week treatment (day 0, day 14, day 28)
The GERD-HRQL questionnaire consists of 16 questions utilizing a numerical Likert-type response. Patients assess symptom severity on an ordinal scale ranging from 0 to 5. The total score range for GERD-HRQL spans from 0 to 80, incorporating evaluations for heartburn, regurgitation, and other related aspects. A higher score reflects a more severe disease.
Day 0 and after every two week during 4-week treatment (day 0, day 14, day 28)
Changes in the number of antacid packets used
Time Frame: Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28)
The number of antacid packets used per week will be recorded during each follow-up visit.
Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28)
The proportion of side effects of thread embedding acupuncture and auricular acupuncture
Time Frame: Up to 4 weeks
Up to 4 weeks

Collaborators and Investigators

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

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

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)

December 6, 2023

Primary Completion (Actual)

March 18, 2024

Study Completion (Actual)

March 18, 2024

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Actual)

December 5, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 703/HDDD-DHYD

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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