globus pharyngeus
Conditions
Interventions
Paroxetine treatment group :Paroxetine 20mg/qn,p.o. for 6 weeks
amitriptyline treatment group :amitriptyline 25mg/qn,p.o. for 6 weeks
Conventional therapy group :Conventional therapy for 6 weeks
Sponsors
Guangzhou First Municipal People's Hospital, Guangzhou Nansha Central Hospital Affiliated to Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Outpatients with globus from the department of gastroenterology of Nansha Central Hospital of Guangzhou First Municipal People's Hospital. 1. 18-80 years of age; 2. The diagnosis of globus meets the Rome III criteria for globus; 3. Nasal laryngoscopy, endoscopy and blood biochemical examination are required for all the patients to exclude organic disease of larynx and esophagus(such as parapharyngeal tumors, cysts epiglottis, hypopharynx cancer, esophageal cancer etc.), thyroid disease, connective tissue disease, nerve system diseases and mental illness; 4. At least one week before the study, no use of drugs that can affect esophageal motility, such as Prokinetic drugs, sedatives, stimulants, antidepressants, anticholinergic drugs; 5. Subjectively, it is believed to be able to withstand the esophageal manometry; 6. Signed informed consent and agreed to enter the study. The inclusion of healthy volunteers: 1. Male and female Chinese healthy volunteers; 2. Aged 18 to 65 years old; 3. Body mass index between 19-24kg/?; 4. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, chest x-ray examination, and 12-lead electrocardiogram (ECG); 5. Without depression and anxiety disease assessed by Zung self-assessment Depression Scale (ZSDS) and Zung self-assessment Anxiety Scale (ZSAS); 6. Without the globus symptoms as well as esophageal reflux,heartburn,bloating or other gastrointestinal symptoms; 7. At least one week before the study, no use of drugs that can affect esophageal motility, such as Prokinetic drugs, sedatives, stimulants, antidepressants, anticholinergic drugs; 8. Informed consent was obtained from all healthy volunteers.
Exclusion criteria
Exclusion criteria: The exclusion criteria for globus patient 1. Patients do not meet the diagnostic criteria of globus sensateon; 2. Patients with organic diseases of larynx and esophagus detected by nasal laryngoscopy, endoscopy and blood biochemical examination; 3. Patients accompanying thyroid diseases; 4. Patients accompanying neurological diseases and mental illness; 5. Patients with severe anxiety and depression, suicidal tendencies; 6. Patient with history of abdominal surgery; 7. Patients with history of severe cardiovascular, lung, kidney, liver and digestive tract disease, with abnormal liver and kidney function and other serious body disease; 8. Pregnancy or lactation women; 9. Age 80 years; 10. Patients can't take Paroxetine and amitriptyline, including allergic to paroxetine and amitriptyline, need to take Monoamine oxidase inhibitors class at the same time, recent myocardial infarction, history of prostate disease, urinary retention, epilepsy and glaucoma patients; 11. Blind, deaf, dumb, mental retardation, physical disabilities and Language impaired patients; 12. Participating in other drug trials 2 weeks prior to screening; 13. unable to withstand the esophageal manometry. The exclusion criteria for heathy volunteers: 1. History of gastrointestinal surgery; 2. History of serious cardiovascular disease, pulmonary disease, renal diease, hepatical diease and gut disease; 3. Pregnancy or breast feeding; 4. Use of medications that may affect gastrointestinal motor function and the effect of amitriptyline; 5. History of gut disease or other disease that may affect gut motility; 6. Contraindications to amitriptyline, include hypersensitivity or allergy to any tricyclic drug, concomitant therapy with a monoamine oxidase inhibitor, recent myocardial infarction, myelography within previous 48 hours, history of urinary retention, known glaucoma, history of seizures, or thyroid or liver dysfunction are exclusionary criteria to the use of amitriptyline and to entry into this study; 7. Have participated in other clinical trial during last two weeks; 8. unable to withstand the esophageal manometry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical syndrome;the Glasgow Edinburgh Throat Scale;upper esophageal sphincter (UES) resting pressure;UES residual pressure; | — |
Secondary
| Measure | Time frame |
|---|---|
| esophageal motility;Pittsburgh Sleep Quality Index;Zung self-assessment anxiety scale;Zung self-assessment depression scale;Medical Outcomes Study 36 item Short Form Health Survey;Gastrointestinal hormone; | — |
Countries
China
Contacts
Public ContactLin Jia
Outcome results
None listed