Association of Complete Spontaneous Bowel Movements (CSBM) and Symptom Improvement in Chronic Constipation (CC) Patients (PTS)

Abstract

Purpose: CC is characterized by multiple persistent Sx (hard stools, straining, sensation of incomplete evacuation, abdominal discomfort/bloating); decreased stool frequency is often less significant, but Tx success is often defined by defecation frequency. We evaluated the relationship between an increase in stool frequency via CSBM and Sx measures of efficacy (improvement of stool form, straining, abdominal bloating, bothersomeness of constipation and satisfaction with bowel habits). Methods: Data from two tegaserod double-blind, randomized, placebo-controlled studies were pooled for analysis. Pts daily record of CSBM, stool form (Bristol Stool Form), laxative use and Sx of straining during bowel movement (score 0 = none; 2 = too much straining) were evaluated. Pts answered weekly questions on their satisfaction with bowel habits, bothersomeness of bloating and bothersomeness of constipation using a 5-point scale (0 = not at all, 5 = a very great deal). Responders (primary variable) were pts with an average increase of ≥1CSBM/week during the first 4 weeks compared with baseline. For each secondary variable, improvement from baseline was compared between responders and non-responders, irrespective of Tx. The mean for responders and non-responders were compared using a Cochran-Mantel-Haenszel-test. Results: Data were collected from 2,612 pts (88% female, mean age 47 years). Responders had a greater improvement in stool form and straining than non-responders. Responders had a greater reduction in bothersomeness of constipation and of bloating. Satisfaction with bowel habits was higher in responders vs non-responders. Conclusions: These data demonstrate that response to therapy for chronic constipation is associated with improvement of Sx of stool form, straining, bloating and more generally to satisfaction with bowel habit.Table: No Caption available.