Paroxetine - Controlled Release in the Treatment of Irritable Bowel Syndrome (IBS)
Status:
Completed
Trial end date:
2002-12-01
Target enrollment:
Participant gender:
Summary
Irritable bowel syndrome (IBS) is an extremely common disorder in the U.S population,
affecting somewhere between 9-22% based on community based studies. IBS has a chronic
relapsing course and overlaps with other functional gastrointestinal disorders. It accounts
for high direct medical expenses and indirect costs including a significant degree of
absenteeism. Most studies have suggested that there is a slight predominance among women,
especially those that have suffered some form of physical or sexual trauma. It has been
estimated that up to 25-40% of patients seen by gastroenterologists' are affected by IBS, and
that 70-90% of these patients may have a psychiatric comorbidity, most commonly major
depression and panic disorder, but also including schizophrenia, double depression, dysthymia
and alcohol abuse.
Abdominal pain and disturbance of bowel habits characterize the symptoms of IBS in the
absence of demonstrable structural pathology. The diagnosis of IBS relies upon clinical
criteria alone, as there is no "gold standard" in laboratory findings. The diagnosis is
dependent upon identifying characteristic symptoms, and then differentiating IBS from other
structural bowel disorders. Previously, the diagnosis of IBS was based upon a consortium
recommendation that examined and defined diagnostic criteria for over 100 functional
gastrointestinal disorders. These criteria became the most definitive in the area of
functional disorders and are referred to as the Rome Criteria. During the time since this
consensus, these criteria have been modified, and in 1999 became the foundation for the
second set of diagnostic criteria by consensus, now referred to as the Rome II criteria. The
revised Rome II criteria include only the first part of the original criteria, but now
require the presence of two out of three symptoms relating abdominal pain to bowel symptoms.
We designed our study and a Randomized, double-blind, parallel-group, flexible-dose,
placebo-controlled 12-week study.