The primary aim of this study is to compare the efficacies of clinical treatments for the group of chronic, painful functional bowel disorders (FBD) that predominantly affect women. Secondary aims include 1) determination of demographic, psychosocial, physiologic and symptomatic predictors of clinical improvement and 2) analysis of significant relationships among physiologic markers of FBD, psychosocial status, symptoms and treatment effects. The Principal Investigator and his colleagues propose to compare cognitive-behavioral psychological treatment with antidepressant drug therapy (desipramine) and education/attention placebo in over 300 women. Interrelationships between psychological and physiological factors on the development, clinical expression and treatment of FBD have long been recognized, but this is the first large-scale study designed both to isolate therapeutic effects, and to investigate interactions among physiologic measures, psychologic and sociodemographic factors, severity of symptoms, and therapeutic improvement including quality of life. In the proposed plan of research, at least 300 female patients (aged 18- 65) with FBD (irritable bowel syndrome, painful constipation and/or functional abdominal pain) will be enrolled in clinics at UNC-Chapel Hill and Toronto, Canada. A severity index will determine recruitment into the group of moderate FBD (200 patients) and severe FBD (100 patients). Each group will be randomized into the three treatment arms (cognitive- behavioral treatment, desipramine, and education/attention placebo), treated over a 12-week period, and followed for one year. Outcome measures will include symptoms (standardized abdominal pain, stool form, and frequency) using diary cards, daily functional status (Sickness Impact Profile), depression (HAM-D), and psychological distress (SCL-90), physiological measures (enhanced rectal motility and visceralsensation), and health care use. Multivariate statistical methods with a hierarchical design will be applied to the data to assure maintenance of statistical power over multiple tests of overlapping groups. The results of this study may significantly improve an understanding of this complicated syndrome that lowers the quality of life and economic productivity of large numbers of women. The clinical impact of the study, in providing physicians with scientific evidence of the efficacy of treatments of FBD that are commonly used in practice, may be significant. This study may provide clinicians with predictors of success among types of FBD patients and types of therapy that will improve symptoms and quality of life and reduce the health care costs associated with this common syndrome, while improving patient-physician satisfaction.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
5R01DK049334-07
Application #
6380964
Study Section
Special Emphasis Panel (SRC (04))
Program Officer
Robuck, Patricia R
Project Start
1995-09-30
Project End
2003-08-31
Budget Start
2001-09-01
Budget End
2003-08-31
Support Year
7
Fiscal Year
2001
Total Cost
$666,850
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
078861598
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Weinland, Stephan R; Morris, Carolyn B; Dalton, Christine et al. (2010) Cognitive factors affect treatment response to medical and psychological treatments in functional bowel disorders. Am J Gastroenterol 105:1397-406
Drossman, Douglas A; Morris, Carolyn Blank; Schneck, Susan et al. (2009) International survey of patients with IBS: symptom features and their severity, health status, treatments, and risk taking to achieve clinical benefit. J Clin Gastroenterol 43:541-50
Thiwan, Syed; Drossman, Douglas A; Morris, Carolyn B et al. (2009) Not all side effects associated with tricyclic antidepressant therapy are true side effects. Clin Gastroenterol Hepatol 7:446-51
Dorn, Spencer D; Morris, Carolyn B; Hu, Yuming et al. (2009) Irritable bowel syndrome subtypes defined by Rome II and Rome III criteria are similar. J Clin Gastroenterol 43:214-20
Drossman, Douglas A; Morris, Carolyn; Hu, Yuming et al. (2008) Further characterization of painful constipation (PC): clinical features over one year and comparison with IBS. J Clin Gastroenterol 42:1080-8
Grunkemeier, David M S; Cassara, Joseph E; Dalton, Christine B et al. (2007) The narcotic bowel syndrome: clinical features, pathophysiology, and management. Clin Gastroenterol Hepatol 5:1126-39;quiz 1121-2
Drossman, Douglas; Morris, Carolyn B; Hu, Yuming et al. (2007) Characterization of health related quality of life (HRQOL) for patients with functional bowel disorder (FBD) and its response to treatment. Am J Gastroenterol 102:1442-53
Drossman, Douglas A; Morris, Carolyn B; Hu, Yuming et al. (2005) A prospective assessment of bowel habit in irritable bowel syndrome in women: defining an alternator. Gastroenterology 128:580-9
Drossman, Douglas A; Toner, Brenda B; Whitehead, William E et al. (2003) Cognitive-behavioral therapy versus education and desipramine versus placebo for moderate to severe functional bowel disorders. Gastroenterology 125:19-31
Drossman, D A; Patrick, D L; Whitehead, W E et al. (2000) Further validation of the IBS-QOL: a disease-specific quality-of-life questionnaire. Am J Gastroenterol 95:999-1007

Showing the most recent 10 out of 11 publications