J A DiPalma

Dr J A DiPalma, University of South Alabama Digestive Health Centre, Mobile, AL, USA; gastro@usouthal.edu

STUDY DESIGN

Design:

randomised placebo-controlled trial.

Allocation:

unclear allocation concealment.*

Blinding:

blinded (not clear who were blinded).*

STUDY QUESTION

Setting:

50 centres in the US.

Patients:

306 patients with chronic constipation over the past 3 months (<3 satisfactory stools per wk without laxative use, and ⩾1 of the following Rome criteria: straining, lumpy or hard stools, or sensation of incomplete evacuation in >25% of defecations) and during a 14-day observation period (<3 satisfactory bowel movements per wk). Exclusion criteria were prior or current treatment with or sensitivity to study medication; use of medications affecting bowel function; irritable bowel syndrome; pregnancy or …