refractory globus sensation
Conditions
Interventions
Paroxetine treatment group:Paroxetine 20mg/day, p.o. for 4 weeks
Sponsors
Guangzhou First Municipal People's Hospital, Guangzhou Nan Sha Center Hospital Affiliated to Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Outpatients with refractory globus sensateon from the department of gastroenterology of Nansha Central Hospital of Guangzhou First Municipal People's Hospital. 1. To be aged 18-80 years old; 2. The diagnosis of globus meets the Rome III criteria for globus, including all of the follows: 2.1. Persistent or intermittent, nonpainful sensation of a lump or foreign body in the throat; 2.2. Occurrence of the sensation between meals; 2.3. Absence of dysphagia or odynophagia; 2.4. Absence of evidence that gastroesophageal reflux is the cause of the symptom; 2.5. Absence of histopathology-based esophageal motility disorders. Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis. 3. The criteria for refractory globus sensateon is: After explanation, reassurance and 3 months gastroenterology conventional therapy, Symptoms Score is still over 50 points by visual analogue scale (VAS); 4. 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; 5. Signed informed consent and agreed to enter the study.
Exclusion criteria
Exclusion criteria: 1. Patients do not meet the diagnostic criteria of refractory 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. Younger than 18 years or elder than 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical syndrome;Throat Scale (GETS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Rating Scale;Hamilton Depression Rating Scale;Pittsburgh Sleep Quality Index;the MOS 36 items Short Form Health Survey;Gastrointestinal hormone;Side effect; | — |
Countries
China
Contacts
Public ContactLin Jia
Outcome results
None listed