Problems and challenges in the design of Irritable Bowel Syndrome clinical trials. Focusing on the future with the experience from the past

Abstract

SUMMARY
Irritable Bowel Syndrome (IBS) is a common chronic disorder
that is associated with significant disability and
health costs. Drug development for this disorder is complex
for a variety of reasons. A review of the literature concludes
that there are few studies, which offer convincing
evidence of effectiveness in treating IBS symptoms. Future
trials must be double blind, placebo controlled, use internationally
approved diagnostic criteria and describe the
randomisation method. Clear, well-defined outcome measures
are necessary as well.
Key words: Irritable bowel syndrome, drug development diagnostic
criteria, side effects