Clinical trial NCT06157424: Efficacy and Safety of Combined Thread Embedding Acupuncture With Auricular Acupuncture for GERD
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GERD
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The proportion of heartburn resolution
timeFrame: Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28)
Secondary outcomes:
measure: The proportion of regurgitation resolution
timeFrame: Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28)
measure: Chang in the Gastroesophageal Reflux disease Questionnaire (GerdQ) score
timeFrame: Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28)
measure: Chang in the Frequency Scale for the Symptoms of GERD (FSSG) score
timeFrame: Day 0 and after every two week during 4-week treatment (day 0, day 14, day 28)
measure: Chang in the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score
timeFrame: Day 0 and after every two week during 4-week treatment (day 0, day 14, day 28)
measure: Changes in the number of antacid packets used
timeFrame: Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28)
measure: The proportion of side effects of thread embedding acupuncture and auricular acupuncture
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Ho Chi Minh
country: Vietnam
facility: University of Medical Center HCMC - Branch no.3, University of Medicine and Pharmacy at Ho Chi Minh City
Study officials:
References:
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