Cognitive-behavioral therapy versus education and...

Cognitive-behavioral therapy versus education and desipramine versus placebo for moderate to severe functional bowel disorders 1 1This study was registered with ClinicalTrials.gov (trial registry no. NCT00006157).

Abstract

BACKGROUND & AIMS: Studies of antidepressants and psychological treatments in functional bowel disorders (FBD) are methodologically limited. The aim of this study was to assess the clinical efficacy and safety of cognitive-behavioral therapy (CBT) against education (EDU) and desipramine (DES) against placebo (PLA) in female patients with moderate to severe FBD (irritable bowel syndrome, functional abdominal pain, painful constipation, and unspecified FBD). We also evaluated the amenability of clinically meaningful subgroups to these treatments. METHODS: This randomized, comparator-controlled, multicenter trial enrolled 431 adults from the University of North Carolina and the University of Toronto with moderate to severe symptoms of FBD. Participants received psychological (CBT vs. EDU) or antidepressant (DES vs. PLA) treatment for 12 weeks. Clinical, physiologic, and psychosocial assessments were performed before and at the end of treatment. RESULTS: The intention-to-treat analysis showed CBT as significantly more effective than EDU (P = 0.0001; responder rate, 70% CBT vs. 37% EDU; number needed to treat [NNT ], 3.1). DES did not show significant benefit over PLA in the intention-to-treat analysis (P = 0.16; responder rate, 60% DES vs. 47% PLA; NNT, 8.1) but did show a statistically significant benefit in the per-protocol analysis (P = 0.01; responder rate, 73% DES vs. 49% PLA; NNT, 5.2), especially when participants with nondetectable blood levels of DES were excluded (P = 0.002). Improvement was best gauged by satisfaction with treatment. Subgroup analyses showed that DES was beneficial over PLA for moderate more than severe symptoms, abuse history, no depression, and diarrhea-predominant symptoms; CBT was beneficial over EDU for all subgroups except for depression. CONCLUSIONS: For female patients with moderate to severe FBD, CBT is effective and DES may be effective when taken adequately. Certain clinical subgroups are more or less amenable to these treatments.

Authors

Drossman DA; Toner BB; Whitehead WE; Diamant NE; Dalton CB; Duncan S; Emmott S; Proffitt V; Akman D; Frusciante K

Journal

Gastroenterology, Vol. 125, No. 1, pp. 19–31

Publisher

Elsevier

Publication Date

July 1, 2003

DOI

10.1016/s0016-5085(03)00669-3

ISSN

0016-5085

Associated Experts

Shrikant Bangdiwala

Professor, Faculty of Health Sciences

Visit profile

Labels

Cognitive-behavioral therapy versus education and desipramine versus placebo for moderate to severe functional bowel disorders 1 1This study was registered with ClinicalTrials.gov (trial registry no. NCT00006157).

Abstract

Authors

Journal

Publisher

Publication Date

DOI

ISSN

Associated Experts

Labels

Fields of Research (FoR)

Sustainable Development Goals (SDG)

Medical Subject Headings (MeSH)

Contact the Experts team