Oy. Lee et al., Impact of advertisement and clinic populations in symptoms and perception of irritable bowel syndrome, ALIM PHARM, 13(12), 1999, pp. 1631-1638
Background: This study assessed the impact of recruitment on irritable bowe
l syndrome clinical trials, by determining whether irritable bowel syndrome
patients recruited from advertisement or a specialty clinic differ in clin
ical and physiologic measures.
Methods: We prospectively surveyed 657 irritable bowel syndrome patients wh
o either: (i) were referred from a functional bowel disease clinic (52%); o
r (ii) responded to advertisement for clinical trials (48%), using question
naires about bowel and psychological symptoms, and quality of life. In a su
bset of 42 irritable bowel syndrome patients (29 advertisement and 15 clini
c patients), rectal discomfort thresholds were measured before and after re
petitive sigmoid stimulation.
Results: While the advertisement population more commonly consulted primary
care physicians, the clinic population more commonly consulted gastroenter
ologists. The clinic population reported more prevalent and severe abdomina
l pain, and higher psychological symptom scores, while the advertisement po
pulation had greater quality of life. In the visceral perception studies, b
oth subgroups were hypersensitive to rectal distension.
Conclusion: Compared to the clinic population, the advertisement population
had less severe abdominal pain and psychological symptoms, better quality
of life but similar visceral perception. The differences in clinical self-r
eports may have consequences for enrolment of these different patient popul
ations into clinical trials.