About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Transcutaneous Electrical Acustimulation