Does timing of colon procedures affect outcomes in D-IBS trials?
Background: Sigmoidoscopy/colonoscopy is usually performed
prior to enrollment into clinical trials of irritable bowel syndrome
(IBS). Two main reasons are to rule out alternative diagnoses and to
ensure that colitis is not present. However, the possible impact of a
recent versus remote colon procedure on symptoms in IBS trials has
not been evaluated. The aim of this study was to evaluate the effect
of timing of colon procedures on symptoms in IBS trials.
Methods: Post hoc analyses were conducted using placebo patients
with diarrhea-predominant IBS in a phase 2 trial. Pain, frequency,
consistency, and urgency were analyzed using repeated measures
models during the first 7 days of treatment and over the entire 12-
week treatment period.
Results: Fifty-two placebo patients were grouped by whether they
had a colon exam performed between screening and randomization
(Group 1) or had a normal colon procedure during the 3 years prior
to screening for this trial (Group 2). Average screening symptom
scores were comparable between the two groups. Evaluation of
various symptoms showed that there were no consistent significant
differences between the two groups in pain, frequency, consistency,
Conclusions: After the required 3-day post-procedure recovery period,
there was no evidence that colonoscopy timing affected subsequent