• John F Johanson, Dan Morton, Joseph Geenen, and Ryuji Ueno.
• University of Illinois College of Medicine, Rockford, Illinois, USA.
• Am. J. Gastroenterol. 2008 Jan 1;103(1):170-7.

ObjectivesTo assess the efficacy and safety of lubiprostone in adults with chronic constipation.MethodsThis multicenter, parallel-group, double-blind controlled trial enrolled 242 patients with constipation and randomized them to receive oral lubiprostone 24 mcg or placebo twice daily for 4 wk. The primary efficacy end point was the number of spontaneous bowel movements (SBMs; those occurring without use of constipation relieving medications) after 1 wk of double-blind treatment. Other evaluations included SBMs at weeks 2, 3, and 4; bowel movement (BM) characteristics (i.e., consistency and straining); constipation severity; abdominal bloating/discomfort; global treatment effectiveness ratings; and safety assessments.ResultsThe 120 lubiprostone-treated patients reported a greater mean number of SBMs at week 1 compared with the 122 placebo-treated patients (5.69 vs 3.46, P= 0.0001), with a greater frequency of SBMs also reported at weeks 2, 3, and 4 (PConclusionsIn patients with chronic constipation, treatment with lubiprostone produces a BM in the majority of individuals within 24-48 h of initial dosing and improves the frequency as well as other characteristics associated with BMs with short-term (i.e., 4 wk) treatment. The most commonly reported adverse event was mild to moderate nausea, which resulted in treatment discontinuation in 5% of treated patients.

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