Neuroregulators for the Treatment of Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities.

Procedure steps： n Study One, each participant first completed a questionnaire that included the Gastroesophageal Reflux Disease Questionnaire (GERDQ, PROMIS GERD, DSI \& GSS, RSI), the Brief Esophageal Swallowing Difficulty Scale (BEDQ), the Esophageal Hypersensitivity and Anxiety Scale (EHAS), the Visceral Sensitivity Index (VSI), and the Sleep and Psychosocial Questionnaire (Pittsburgh Sleep Quality Index (PSQI), Taiwanese Depression Questionnaire (TDQ), State-Trait Anxiety Inventory (STAI), Functional Dyspepsia (FD) Questionnaire, Irritable Bowel Syndrome (IBS) Questionnaire, and the Quality of Life Questionnaire (SF-12, Northwest Esophageal Quality of Life Scale (NEQOL)). Completing the questionnaires took approximately 20 to 30 minutes. Afterward, participants were randomly assigned by computer to receive either 12 weeks of treatment with a neuromodulator-tricyclic antidepressants (TCA), or a neuromodulator-selective serotonin reuptake inhibitors (SSRI), or 12 weeks of the control medication-proton pump inhibitors (PPI). Investigators plan to recruit 70 participants for the TCA group, 70 for the SSRI group, and 70 for the PPI group, with each participant having about a 1/3 chance of being assigned to one of these groups. The tricyclic antidepressant (TCA) will be administered as 25 mg enteric-coated tablets (Department of Health Drug Code 047966), taken twice daily. The selective serotonin reuptake inhibitor (SSRI) will be administered as 50 mg enteric-coated tablets (Department of Health Drug Code 021780), taken once daily. The control medication, the proton pump inhibitor (PPI), will be given as 30 mg orally dissolving tablets (Department of Health Drug Code 024273), taken once daily. At the end of the 12-week medication treatment, participants will complete another round of questionnaires to conclude the study.