GERD, Gastroesophageal Reflux Disease
Conditions
Keywords
Liver-Stomach constraint-heat, Traditional medicine, Acupoint catgut embedding, Thread-embedding acupuncture, Omeprazole
Brief summary
This study aims to evaluate the effectiveness of thread-embedding acupuncture combined with omeprazole in patients with gastroesophageal reflux disease (GERD) presenting with the traditional medicine pattern of Liver-Stomach constraint-heat. Participants will receive either thread-embedding acupuncture combined with omeprazole or the comparator treatment according to the study protocol. Clinical outcomes will be assessed to determine the effectiveness and safety of the intervention.
Interventions
PROCEDUREThread-Embedding Acupuncture
Participants will receive acupoint catgut embedding in addition to standard treatment with omeprazole. Acupoint catgut embedding will be performed twice during the 4-week treatment period, at 2-week intervals. Sterile chromic catgut 3/0 will be embedded at Zhongwan (CV12), Shangwan (CV13), Xiawan (CV10), Zusanli (ST36), Tianshu (ST25), and Taichong (LR3) according to the standardized procedure. Participants will be monitored for 30 minutes after each procedure for adverse events.
Sponsors
University of Science Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants were not blinded because the thread-embedding acupuncture intervention could not be concealed. The investigator responsible for post-intervention outcome assessment and data analysis was blinded to treatment allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18 to 60 years. * Diagnosed with gastroesophageal reflux disease (GERD) with a GerdQ score ≥8 and typical heartburn and/or regurgitation occurring at least 2 days per week, and considered eligible for proton pump inhibitor therapy according to the ACG 2013 guideline. * Meets the diagnostic criteria for Liver-Stomach Heat Stagnation Syndrome according to the 2017 expert consensus on traditional medicine syndrome differentiation for GERD. * No previous diagnosis of GERD within the past 8 weeks. * Voluntarily agrees to participate in the study and provides written informed consent.
Exclusion criteria
* Presence of alarm symptoms, including dysphagia, odynophagia, palpable lymph nodes or mass, unintentional weight loss, family history of gastrointestinal malignancy, gastrointestinal bleeding, anemia, or persistent nausea/vomiting. * Structural gastrointestinal disease confirmed by endoscopy, including esophageal malignancy or other significant organic lesions. * Current use of medications that may influence GERD assessment or treatment, including glucocorticoids, NSAIDs, bisphosphonates, prostaglandins, oral contraceptives, antifungal agents, or sedative medications. * Use of proton pump inhibitors, H2-receptor antagonists, or prokinetic agents within the previous 14 days. * History of hypersensitivity to proton pump inhibitors or absorbable catgut/thread material. * Skin inflammation, infection, or other dermatologic disease at or around the intended thread-embedding sites. * Current pregnancy or breastfeeding. * Currently participating in another interventional clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in GERD-Q Score | Baseline and 4 weeks | Gastroesophageal reflux disease symptoms will be assessed using the Gastroesophageal Reflux Disease Questionnaire (GerdQ). The total GerdQ score ranges from 0 to 18, with higher scores indicating more severe gastroesophageal reflux disease symptoms. Change in the total GerdQ score from baseline to 4 weeks will be assessed between the two study groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Response Based on GerdQ | Baseline and weekly through 4 weeks | Treatment response will be defined as a reduction of at least 2 points in the total Gastroesophageal Reflux Disease Questionnaire (GerdQ) score from baseline. The total GerdQ score ranges from 0 to 18, with higher scores indicating more severe gastroesophageal reflux disease symptoms. The proportion of participants achieving treatment response will be compared between the two study groups. |
| Complete Symptom Resolution Based on GerdQ | 4 weeks | Complete resolution of typical gastroesophageal reflux disease (GERD) symptoms will be assessed using the Gastroesophageal Reflux Disease Questionnaire (GerdQ). The total GerdQ score ranges from 0 to 18, with higher scores indicating more severe GERD symptoms. Complete symptom resolution will be defined as a score of 0 for both the heartburn and regurgitation items of the GerdQ. The proportion of participants achieving complete symptom resolution at 4 weeks will be compared between the two study groups. |
| Change in Traditional Medicine Symptoms of Liver-Stomach Heat Stagnation Syndrome | Baseline and weekly through 4 weeks | Traditional medicine symptoms of Liver-Stomach Stagnated Heat syndrome will be assessed using a syndrome symptom score comprising two main symptoms (burning sensation and acid regurgitation) and six secondary symptoms (retrosternal pain, epigastric burning pain, epigastric fullness, belching or food regurgitation, irritability, and rapid hunger). Each main symptom is rated as absent, mild, moderate, or severe and scored 0, 2, 4, or 6 points, respectively. Each secondary symptom is rated as absent, mild, moderate, or severe and scored 0, 1, 2, or 3 points, respectively. The total score ranges from 0 to 30, with higher scores indicating greater syndrome severity. Change in the total syndrome score from baseline through 4 weeks will be compared between the two study groups. |
| Treatment Response Based on Liver-Stomach Stagnated Heat Syndrome Score | Baseline and 4 weeks | Treatment response for Liver-Stomach Stagnated Heat syndrome will be assessed using the percentage reduction in the total syndrome score from baseline. The efficacy index will be calculated as \[(baseline score - post-treatment score) / baseline score\] × 100. Clinical cure is defined as an efficacy index of at least 95%, markedly effective as 70% to less than 95%, effective as 30% to less than 70%, and ineffective as less than 30%. The proportion of participants classified as clinically cured, markedly effective, effective, or ineffective at 4 weeks will be compared between the two study groups. |
| Adverse Events Associated With Thread-Embedding Acupuncture | Throughout the 4-week treatment period | Adverse events associated with thread-embedding acupuncture will be monitored throughout the 4-week treatment period. Events of interest include local pain, bleeding, bruising, swelling, infection, allergic reactions, and other treatment-related complications. The number and proportion of participants experiencing at least one adverse event will be recorded and compared between the two study groups. |
Countries
Vietnam
Contacts
CONTACTMinh-Anh Nguyen Ngo Le, MD, PhD
PRINCIPAL_INVESTIGATORMinh-Anh Nguyen Ngo Le, MD,PhD
University of Medicine and Pharmacy at Ho Chi Minh City
PRINCIPAL_INVESTIGATORMinh-Anh Nguyen Ngo Le, MD, PhD
University of Medicine and Pharmacy at Ho Chi Minh City
Outcome results
None listed