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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
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.
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.
Standard treatment, continuously administered over the 4-week intervention period, involves standard doses of proton pump inhibitors, additional antacids as needed, and lifestyle modifications.
University of Medical Center HCMC - Branch no.3, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Vietnam
The proportion of heartburn resolution
Heartburn resolution is assessed through patient inquiry during each follow-up examination.
Time frame: Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28)
The proportion of regurgitation resolution
Regurgitation resolution is assessed through patient inquiry during each follow-up examination.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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