Overview
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.
Eligibility
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.
