Clinical trial NCT02638870: Colonoscopy-related Pain Predicts the Treatment Response of Amitriptyline in Patients With Irritable Bowel Syndrome
Official title: Colonoscopy-related Pain Predicts the Treatment Response of Amitriptyline in Patients With Irritable Bowel Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Irritable Bowel Syndrome
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-12-23
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with IBS according to the Rome III criteria were recruited in the outpatient clinic at Samsung Medical Center. Inclusion criteria were age 18-75 years and no evidence of inflammatory bowel disease or malignancy on colonoscopy.

Brief summary: Irritable bowel syndrome (IBS) is a functional bowel disorder with recurrent abdominal pain and disordered defecation and is one of the most common gastrointestinal problems. In practice, IBS was frequently diagnosed as an exclusion diagnosis for patients with recurrent abdominal pain without an organic cause. Visceral hypersensitivity is the major contributing factor of abdominal pain in IBS. Accordingly, tricyclic antidepressants (TCAs) are widely used for IBS, especially if abdominal pain is a prominent symptom. Indeed, meta-analysis also exhibits the clinically significant efficacy of low dose TCAs in IBS. Nevertheless, over 40% of IBS patients receiving TCAs had no improvement in symptoms after treatment. Theoretically, if TCAs are used for IBS patients with hypersensitivity, its efficacy could be increased.

Although rectal distension test might be used to identify hypersensitive patients with IBS, it has been used only for clinical research because it is painful for the patient. On the contrary, colonoscopy is frequently performed in IBS patients to rule out organic disease and for the purpose of colorectal cancer screening. In a study by Kim and colleagues, IBS patients reported higher pain score after colonoscopy than non-IBS patients. This has prompted the hypothesis that pain scoring during/after colonoscopy could also segregate IBS patients with visceral hypersensitivity showing better treatment response of TCA than those without.

The aims of the present study were to evaluate the colonoscopy-related pain perception and the treatment response of amitriptyline in IBS patients and to investigate the predictive values of the colonoscopy-related pain scale in identifying IBS patients with a response to amitriptyline treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with IBS according to the Rome III criteria

Exclusion Criteria:

* Inflammatory bowel disease or malignancy on colonoscopy.
* Previous abdominal surgery other than appendectomy or cesarean delivery,
* Major psychiatric disorders or Beck Depression Inventory-II score of ≥19
* Significant cardiopulmonary diseases or any malignancies
* Taking pain modulators including selective serotonin reuptake inhibitors (SSRI) or tricyclic antidepressants
* Polypectomy during colonoscopy.

Primary outcomes:
measure: treatment response of abdominal pain/discomfort
timeFrame: After the intervention period of 4 weeks, the treatment response was determined.
Secondary outcomes:
measure: treatment responses of urgency of defecation
timeFrame: After the intervention period of 4 weeks, the treatment response was determined.
measure: treatment responses of bloating
timeFrame: After the intervention period of 4 weeks, the treatment response was determined.
measure: treatment responses of overall IBS symptoms scores
timeFrame: After the intervention period of 4 weeks, the treatment response was determined.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Study officials:
affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Poong-Lyul Rhee, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: