Gastroesophageal reflux disease
Conditions
Interventions
Experimental group:TEA treatment
Control group:Non-acupoint TEA treatment
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Willing to sign the informed consent; 2. Meet the diagnosis of gastroesophageal reflux disease: have typical symptoms such as heartburn and reflux, meet the diagnosis of GERDQ questionnaire or the diagnosis of proton pump inhibitor is effective for 2 weeks, or those with atypical symptoms but 24-hour esophageal PH+ impedance monitoring confirmed reflux; 3. Aged 18 to 75 years, gender is not limited; 4. The course of disease is more than 6 months; 5. According to the manometry of esophageal motility disorder (4th edition of Chicago classification) diagnosed as invalid esophageal motility.
Exclusion criteria
Exclusion criteria: 1. Autoimmune diseases that affect gastrointestinal motility, such as scleroderma, dermatomyositis, and central or peripheral nervous system lesions, after cardiac radiofrequency ablation, etc.; 2. High-resolution esophageal manometry excludes diffuse esophageal spasm, achalasia, and EGJ outflow tract obstruction; 3. Gastroscopy to rule out organic diseases of the stomach and esophagus (such as polyps, ulcers, esophageal cancer, etc.); 4. Diaphragmatic hernia is greater than or equal to 3 cm; 5. History of gastric or esophageal surgery, including patients after endoscopic or laparoscopic fundoplication; 6. Serious comorbidities (such as uncontrolled hypertension, gastrointestinal bleeding, severe heart and lung, liver and kidney, hematopoietic system diseases, etc.); 7. Alcoholism cannot be stopped during the study period (equivalent to ethanol >=40g/day for males, >=20g/day for females); 8. Those who are allergic to medical electrodes; 9. Pregnant and lactating patients or patients who do not rule out the possibility of pregnancy; 10. Familiar with acupuncture treatment, acupoint selection or meridian; 11. The researcher believes that the participant is not suitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety index;Distal systolic integral (DCI);Lower esophageal sphincter (LES); | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptoms of patients with gastroesophageal reflux disease (GERDQ);Quality of life in patients with gastroesophageal reflux disease (GERD-HRQL);Emergency use of PPI; Changes of electrogastrogram combined with liquid nutritional meal before and after treatment;Changes of autonomic nerve function before and after treatment; Changes of gastrointestinal hormones (ghrelin, VIP, IL-13, IL-23, IL-6); | — |
Countries
China
Contacts
Public ContactNing Beifang
Outcome results
None listed