Functional bowel disorders Digestive System Bowel disorders
Conditions
Interventions
Group 1: cognitive behaviour therapy (CBT), once a week for 12 weeks
Group 2: desipramine, up to 150 mg/day for 12 weeks
Group 3: combined CBT plus desipramine: CBT once a week and desipramine adminis
Sponsors
The Centre for Addiction and Mental Health (Centre de toxicomanie et de santé mentale) (Canada)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Literate, female patients aged 18 to 65 years 2. Symptoms present at least two days per week for greater than six months 3. Diagnosis of painful functional bowel disorder (later subcategorised using Rome II Criteria as irritable bowel syndrome [IBS], functional abdominal pain syndrome, painful constipation or unspecified functional bowel disorder [FBD]) 4. Moderate (MFBD) or severe (SFBD) functional bowel disorder (FBD) based on the Functional Bowel Disorder Severity Index (FBDSI) that we developed. SFBD is defined as a score more than 110, and MFBD as a score between 36 and 110. Patients with mild symptoms (less than 36) will be excluded, since the proposed treatments would not be cost-effective nor clinically needed.
Exclusion criteria
Exclusion criteria: 1. No evidence for lactose intolerance explaining the symptoms 2. Absence of heart disease, cardiac arrhythmias, glaucoma, urinary retention, pregnancy, alcohol consumption more than 3 oz/day that would preclude participation or prevent data assessment, or systemic or gastrointestinal diseases or previous surgery that would interfere with the interpretation of symptoms or physiology (active thyroid disease, scleroderma, vasculitis, IBD, ischaemic bowel, gastrointestinal bypass or resection, malabsorption syndromes) 3. No history of bipolar disorder requiring hospitalisation, schizophrenia, substance abuse/dependency, or suicide attempts. Other psychiatric disorders may be excluded if they preclude successful participation in the study. 4. Ability and willingness to discontinue anticholinergic medication, calcium channel blockers or 5-hydroxytryptamine (5HT) receptor acting agents for the duration of the study 5. Discontinuance of all antidepressant medications for at least one month 6. Patients who have previously used Desipramine for more than one week 7. Use of an acceptable method of birth control (birth control pill, condoms, foam and barrier, intrauterine device [IUD], sterilisation) throughout the study (if receiving anti- depressant treatment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite measure consisting of: 1. Satisfaction with treatment 2. Global well being 3. Pain ratings 4. Health related quality of life Points two to four above will be measured at pre-treatment, post-treatment, three month follow up and six month follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Four outcomes of composite measure will be analysed separately as secondary variables: 1. Satisfaction with treatment: post-treatment, three month follow up, six month follow up 2. Global well being: pre-treatment, post-treatment, three month follow up, six month follow up 3. Pain ratings: pre-treatment, end of treatment, three month follow up, six month follow up 4. Health related quality of life: post-treatment, three month follow up, six month follow up | — |
Countries
Canada
Outcome results
None listed