irritable bowel syndrome
Conditions
Interventions
Shugan Jieyu capsule group:Shugan Jieyu capsule
Escitalopram oxalate group:Escitalopram oxalate
Paroxetine group:Paroxetine
Sertraline group:Sertraline
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age range from 18 to 75 years old, regardless of gender. (2) Patients with IBS who meet the modified Roman III diagnostic criteria, that is, recurrent abdominal pain and/or abdominal discomfort (may be accompanied by abdominal distension), at least 3 days per month in the past 3 months, with 2 or more of the following: ? related to defecation (refers to abdominal pain and abdominal discomfort just before, during or soon after a bowel movement); ?associated with a change in frequency of stool; ? associated with a change in form (appearence) of stool. Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis. (3) Organic diseases were excluded by colonoscopy, abdominal ultrasound or CT in the past 1 year; and there were no obvious abnormalities in blood routine, liver and kidney function tests in the past 3 month. (4) IBS Symptom Severity score (IBS-SSS) =75 (IBS symptom severity is at least mild degree, indicating symptoms of activity). (5) During 1-week baseline screening period, the worst abdominal pain and/or abdominal discomfort score =3 (using the 0-10 VAS scale) for at least 1 day. (6) In the past 1 year, conventional treatment for IBS accumulated =8 weeks, which was ineffective (i.e. symptoms were reduced by less than 50%, that is, refractory IBS), and/or comorbid anxiety and/or depression which were measured by the Hamilton Anxiety Scale (HAMA =14)) and Hamilton Depression Scale (HAMD=17). (7) The proposed neuromodulator has not been used before. (8) The patient has the ability to cooperate with the relevant contents of the study and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with gastrointestinal and abdominal organic diseases, such as inflammatory bowel disease, celiac disease, intestinal obstruction, peritonitis, peptic ulcer, cholelithiasis with biliary colic, endometriosis, gastrointestinal and abdominal and pelvic malignancies, etc. (2) History of abdominal and pelvic surgery (except appendectomy, cesarean section without complications, endoscopic removal or resection of gastrointestinal polyps for more than 3 months). (3) Subjects with other systemic diseases, including serious diseases of the heart, lungs,liver, kidney and other organs and metabolic diseases, immune diseases; Blood routine test and liver and kidney function tests were abnormal before enrollment. (4) Subjects with diagnosis of anxiety, depression and other mental disorders. (5) A history of drug or alcohol abuse. (6) Pregnant or lactating women, or those who have a family plan recently. (7) Less than 3 months after participating in or completing other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| IBS-SSS scores and changes from baseline;Percentage of patients with significant relief of IBS symptoms for more than 6 weeks during 12 weeks medication;HAMA and HAMD scores;Irritable Bowel Syndrome Quality of Life (IBS-QOL);Efficacy and patient compliance of different neuromodulators; | — |
Countries
China
Contacts
Public ContactFang Xiucai
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed