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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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GERD

Intervention / Treatment
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* Other: Thread Embedding Acupuncture
* Other: Auricular acupuncture
* Other: Standard treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture + Standard treatment<br>Standard treatment plus thread embedding acupuncture and auricular acupuncture | Other: Thread Embedding Acupuncture<br>* 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.<br>Other: Auricular acupuncture<br>* 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.<br>Other: Standard treatment<br>* Standard treatment, continuously administered over the 4-week intervention period, involves standard doses of proton pump inhibitors, additional antacids as needed, and lifestyle modifications.<br>|
| Active Comparator: Standard treatment<br>Standard treatment | Other: Standard treatment<br>* Standard treatment, continuously administered over the 4-week intervention period, involves standard doses of proton pump inhibitors, additional antacids as needed, and lifestyle modifications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of heartburn resolution | 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 | 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 | 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 | 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 | 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 | 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 |  | Up to 4 weeks |