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

University of Science Ho Chi Minh City50 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

GERD Gastroesophageal Reflux Disease

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in GERD-Q Score

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.

Time frame: Baseline and 4 weeks

Secondary Outcomes

Treatment Response Based on GerdQ

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.

Time frame: Baseline and weekly through 4 weeks

Complete Symptom Resolution Based on GerdQ

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.

Time frame: 4 weeks

Change in Traditional Medicine Symptoms of Liver-Stomach Heat Stagnation Syndrome

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.

Time frame: Baseline and weekly through 4 weeks

Treatment Response Based on Liver-Stomach Stagnated Heat Syndrome Score

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.

Time frame: Baseline and 4 weeks

Adverse Events Associated With Thread-Embedding Acupuncture

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.

Time frame: Throughout the 4-week treatment period