GERD
Conditions
Brief summary
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
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.
Interventions
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.
OTHERAuricular 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.
OTHERStandard 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.
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of heartburn resolution | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chang in the Gastroesophageal Reflux disease Questionnaire (GerdQ) score | 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. |
| Chang in the Frequency Scale for the Symptoms of GERD (FSSG) score | 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. |
| The proportion of regurgitation resolution | 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. |
| Changes in the number of antacid packets used | 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. |
| The proportion of side effects of thread embedding acupuncture and auricular acupuncture | Up to 4 weeks | — |
| Chang in the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score | 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. |
Countries
Vietnam
Outcome results
None listed