An open-label trial of duloxetine in patients with irritable bowel syndrome and comorbid generalized anxiety disorder

Int J Psychiatry Clin Pract. 2014 Jan;18(1):11-5. doi: 10.3109/13651501.2013.838632. Epub 2013 Sep 20.

Abstract

Objective: Irritable bowel syndrome (IBS) is commonly comorbid with generalized anxiety disorder (GAD). We evaluated whether duloxetine would lead to improvement in symptoms and quality of life in patients with both conditions.

Method: A 12-week, open-label trial of duloxetine was conducted in 13 subjects with IBS and GAD. The primary outcome measure was the Clinical Global Impression (CGI) Scale. Secondary measures included the Hamilton Anxiety Rating Scale, IBS Quality of Life (IBS-QOL) Scale, and IBS Symptom Severity Scale (IBS-SSS).

Results: Repeated measures ANOVA was used to examine the effect of treatment with duloxetine on ratings of anxiety and IBS. Significant improvement was observed on the CGI-Improvement (F = 14.19, df = 1,12, p < 0.001) and Severity scales (F = 16.16, df = 1,12, p < 0.001). Secondary measures revealed significant reduction in symptoms of anxiety (F = 11.66, df = 1,12, p < 0.01), ηp(2) = 0.56, and IBS-SSS (F = 6.05, df = 1,12, p < 0.001), ηp(2) = 0.34, in addition to IBS-QOL improvements (F = 11.66, df = 1,12, p < 0.01), ηp(2) = 0.56.

Conclusion: Results of this pilot study support the efficacious use of duloxetine in comorbid IBS and GAD. Participants reported significant reductions in IBS components, as well as improvement in GAD.

Trial registration: ClinicalTrials.gov NCT00961298.

Publication types

  • Clinical Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Analysis of Variance
  • Anxiety Disorders / drug therapy*
  • Anxiety Disorders / epidemiology
  • Anxiety Disorders / psychology
  • Comorbidity
  • Duloxetine Hydrochloride
  • Female
  • Humans
  • Irritable Bowel Syndrome / drug therapy*
  • Irritable Bowel Syndrome / epidemiology
  • Irritable Bowel Syndrome / psychology
  • Male
  • Middle Aged
  • Outcome Assessment, Health Care / statistics & numerical data
  • Pilot Projects
  • Placebos
  • Quality of Life
  • Serotonin Uptake Inhibitors / administration & dosage
  • Serotonin Uptake Inhibitors / therapeutic use*
  • Severity of Illness Index
  • Single-Blind Method
  • Thiophenes / administration & dosage
  • Thiophenes / therapeutic use*
  • Young Adult

Substances

  • Placebos
  • Serotonin Uptake Inhibitors
  • Thiophenes
  • Duloxetine Hydrochloride

Associated data

  • ClinicalTrials.gov/NCT00961298