This multicenter study aims to evaluate whether Transcutaneous Electrical Acustimulation (TEA) is effective in treating Non-Erosive Gastroesophageal Reflux Disease (NERD). NERD is a common condition where patients experience symptoms like heartburn and regurgitation, but no visible damage can be seen in the esophagus during an endoscopy. TEA is a non-invasive treatment that uses a small device to deliver mild electrical stimulation through the skin on specific acupoints. This study will compare the effects of real TEA treatment with a sham (inactive) control. Participants will be randomly assigned to one of two groups: active TEA treatment or sham stimulation. Neither the participants nor the researchers evaluating the outcomes will know which treatment is being given. The main outcome is the improvement of reflux symptoms after 4 weeks of treatment. The results of this study may provide a new non-drug option for patients suffering from NERD.
Age 18-75 years, irrespective of gender
Typical heartburn symptoms for at least 3 months
Heartburn on at least 2 days during the run-in diary period
Endoscopically confirmed NERD (no esophageal erosions, Los Angeles grade N or M) within 12 months
Familiarity with acupuncture points and their functions (e.g., previous acupuncture experience or medical training)
Any esophageal structural or mucosal disease (e.g., Barrett's esophagus, erosive esophagitis LA grade A-D, eosinophilic esophagitis, esophageal stricture, varices, malignancy, or prior chemical/thermal/radiation injury)
Presence of gastric or duodenal ulcers
History of or suspected diagnosis of functional heartburn or functional dyspepsia by Rome IV criteria
Parallel
Transcutaneous Electrical Acustimulation
DeviceTranscutaneous electrical acustimulation delivered via a portable stimulator. Stimulation parameters: 25 Hz pulse frequency, 0.5 ms pulse width, 2 seconds on and 3 seconds off. Current amplitude ranges from 1 to 9.5 mA, adjusted to the maximum level tolerated by the participant. Self-administered at home for 1 hour twice daily (morning and evening, within a flexible time window from 6:00 AM to 9:00 PM) for 4 consecutive weeks.
Title Proportion of 24-Hour Heartburn-Free Days During the 4-Week Treatment Period
Description Heartburn is defined as a sensation of warmth, burning, or acid-burning discomfort in the substernal or epigastric region. Heartburn severity is assessed using a 0-3 scale: 0=none; 1=mild (noticed but does not affect activities); 2=moderate (interferes with daily activities); 3=severe (significantly affects daily life or sleep). A heartburn-free day is defined as a day meeting both of the following criteria: heartburn score = 0 on that day, and no use of rescue antacids on that day. The proportion of heartburn-free days is calculated as (number of heartburn-free days) / (number of valid observation days) during the 4-week treatment period.
Weekly Proportion of 24-Hour Heartburn-Free Days During Treatment
The proportion of heartburn-free days (heartburn score = 0 and no rescue antacid use) calculated separately for each week of the 4-week treatment period.
Title Change from Baseline in GERD-Q Total Score
Description GERD-Q (Gastroesophageal Reflux Disease Questionnaire) is a 6-item patient-reported outcome measure assessing reflux symptoms and their impact. Total score ranges from 0 to 18, with higher scores indicating more severe symptoms.
Title Change from Baseline in GERD-HRQL Total Score
GERD-HRQL (Gastroesophageal Reflux Disease-Health Related Quality of Life) is a validated instrument measuring GERD-specific quality of life. Total score ranges from 0 to 50, with higher scores indicating worse quality of life.
Rescue Medication Use
The proportion of participants requiring rescue antacids during the treatment period, measured as the number of days with rescue medication use and the total amount of rescue medication consumed.
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