Thread-Embedding Acupuncture as an Adjunct to Proton Pump Inhibitor Therapy for Gastroesophageal Reflux Disease

Efficacy and Safety of Thread-Embedding Acupuncture as an Adjunct to Proton Pump Inhibitor Therapy in Patients With Gastroesophageal Reflux Disease and Liver-Stomach Stagnation-Heat Syndrome: A Randomized Controlled Trial

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.

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.