Characteristics of patients with irritable bowel syndrome recruited from three sources: implications for clinical trials

Citation
Gf. Longstreth et al., Characteristics of patients with irritable bowel syndrome recruited from three sources: implications for clinical trials, ALIM PHARM, 15(7), 2001, pp. 959-964
Citations number
26
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Pharmacology,"da verificare
Journal title
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
ISSN journal
0269-2813 → ACNP
Volume
15
Issue
7
Year of publication
2001
Pages
959 - 964
Database
ISI
SICI code
0269-2813(200107)15:7<959:COPWIB>2.0.ZU;2-9
Abstract
Background: Variation in the characteristics of irritable bowel syndrome pa tients recruited for clinical trials from different sources could affect th eir response and the generalizability of trial results. Aim: To describe and compare the characteristics of three different groups of irritable bowel syndrome patients recruited into a 'mock clinical trial. ' Methods: We enrolled 245 irritable bowel syndrome patients from three sourc es: (i) 121 from British primary practitioners; (ii) 72 from California new spaper advertisements; and (iii) 52 from a California gastroenterologist's practice. We obtained demographic, clinical, and Hospital Anxiety and Depre ssion (HAD) Scale data. Results:Most patients were young to middle-aged women; the majority reporte d symptoms for > 5 years in all three groups. Subject characteristics varie d among the groups. Typically, primary care patients were anxious, smokers and daily alcohol drinkers who had sought care recently for irritable bowel syndrome and tried antispasmodic drugs. Their symptoms were intermediate i n severity between those of the other two groups. Advertisement subjects we re the oldest, most highly educated, most often depressed, and were least l ikely to have sought care recently for symptoms, which were almost uniforml y only moderate in severity. Gastroenterologist patients tended to be anxio us and had nearly all sought care recently for symptoms, which were the mos t severe and most likely to include all three pain-related Rome I criteria. Conclusion: Recruitment methodology affects important characteristics of an irritable bowel syndrome study group.