NCT02638870

Colonoscopy-related Pain Predicts the Treatment Response of Amitriptyline in Patients With Irritable Bowel Syndrome

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 118 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Amitriptyline	This was a prospective, observational study conducted at Samsung Medical Center, Seoul, Korea. Enrolled IBS patients underwent colonoscopy and colonoscopy-related pain score was evaluated. After colonoscopy, all patients received 5 mg amitriptyline once daily at bedtime for the first week and 10 mg for the subsequent 3 weeks. After the intervention period of 4 weeks, the treatment response was determined.

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-08-01
• Completion: 2016-10-01
• First posted: 2015-12-23
• Last updated: 2015-12-24

Locations

1 site across 1 country: South Korea