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

University of Medicine and Pharmacy at Ho Chi Minh City

Status: Completed

Conditions: GERD

Treatments: Other: Auricular acupuncture; Other: Standard treatment; Other: Thread Embedding Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06157424

703/HDDD-DHYD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups

Acupuncture + Standard treatment

Experimental group

Description:

Standard treatment plus thread embedding acupuncture and auricular acupuncture

Treatment:

Other: Standard treatment

Other: Thread Embedding Acupuncture

Other: Auricular acupuncture

Standard treatment

Active Comparator group

Description:

Standard treatment

Treatment:

Other: Standard treatment