Refractory irritable bowel syndrome
Conditions
Interventions
Treatment group:Conventional therapy plus Amitriptyline 12.5-37.5mg/day,p.o. for 4 weeks
Sponsors
Guangzhou First Municipal People's Hospital,Guangzhou Nan Sha Center Hospital Affiliated to Guangzhou Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients from the gastroenterology outpatient of Nansha Center Hospital of Guangzhou First Municipal People's Hospital who conform to the Rome III criteria for irritable bowel syndrome: Subjects must have had recurrent abdominal pain or discomfort for 3 or more days per month in the nearly three months for > 6 months and the following 2 symptoms or more: (1) Improvement of symptoms after a bowel movement; (2) Abnormal frequency of defecation; (3) Stool changes. 2. 18-65 years of age; 3. Failed conventional therapy; 4. Signed informed consent and agreed to enter the study.
Exclusion criteria
Exclusion criteria: 1. Patients with ulcers, erosions, tumors, polyps or other organic disease are found by colonoscopy; 2. Patient with hepatobiliary and pancreatic organic disease are found by laboratories, B ultrasound, X-line; 3. Diabetes, connective tissue diseases, mental illness or other systemic diseases; 4. History of abdominal surgery; 5. Age 65 years; 6. Pregnancy or lactation women; 7.Disabled patients (blind, deaf, dumb, mental retardation, physical disabilities); 8. Patient with severe anxiety and depression, suicidal tendencies; 9. Language impaired; 10. History of hypersensitivity to the amitriptyline ingredients, adrenergic drugs or other chemical structure similar drugs of the investigational drug; 11. Consumption of other antidepressants 2 weeks prior to screening; 12. Participating in other drug trials 2 weeks prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical syndrome;Hamilton Depression Rating Scale;Hamilton Anxiety Rating Scale;Pittsburgh Sleep Quality Index;Irritable Bowel Syndrome-Quality of Life Scale;Stool consistency and frequency;Small Bowel Transit Time;Gastrointestinal hormone;Inflammatory factors;Behaviour;Side effect;Cost-effectivenes; | — |
Countries
China
Contacts
Public ContactLin Jia
Outcome results
None listed