Background and Aims: Tegaserod is approved for the treatment of constipation-predominant irritable bowel syndrome (C-IBS) in females. The aim of this study was to evaluate the effect of tegaserod on colonic transit time (CTT) and symptoms in male patients with C-IBS.
Methods: Forty-four males with C-IBS (Rome II) were enrolled. After a baseline washout period of 2 weeks, 40 patients were randomized to 6 mg twice daily of tegaserod or placebo for 12 weeks. Daily bowel habits and weekly satisfactory relief of symptoms were recorded. Total and segmental CTT were measured using radiopaque markers at baseline and after treatment.
Results: The mean ± SD for the total colonic, right colonic, left colonic and rectosigmoid transit time (in hours) were 18.96 ± 3.92, 7.74 ± 1.55, 5.64 ± 1.51 and 5.58 ± 2.2 in the tegaserod group compared to 22.47 ± 3.73, 9.69 ± 2.33, 6.6 ± 1.32 and 6.18 ± 2.22 in the placebo group at the end of 12 weeks. There was a statistically significant difference in the total, right and left CTT in the tegaserod group (P < 0.05) at the end of treatment. Global satisfactory relief at the end of 12 weeks was 75% in the tegaserod group and 50% in the placebo group (P > 0.05). Greater stool frequency occurred in the tegaserod group (P > 0.05). There was a significant decrease in the stool consistency at the end of 12 weeks in patients treated with tegaserod (P < 0.05).
Conclusions: Tegaserod causes significant acceleration of CTT in male patients with C-IBS. Although there was a trend towards improvement in bowel symptoms in the treated group, this effect was not statistically significant.