Efficacy of tegaserod for functional constipation in Chinese subjects: A randomized double-blind controlled trial in a single centre

Abstract

Background: Tegaserod has been shown to be effective in chronic constipation in Western population. Aim: We investigated if tegaserod is equally effective in Chinese population. Materials and methods: Two hundred and fifty patients were randomized to a double-blinded 8-week treatment of tegaserod 6 mg b.d. or placebo. Response during weeks 1-4 was defined as an increase in complete spontaneous bowel motion ≥1/week. Secondary efficacy included response during weeks 1-8, individual symptoms and scores, quality of life and global assessment of bowel habits and constipation. Results: One hundred and nine patients from the treatment group and 107 from the placebo group completed the 8-week treatment. Responder rates was 47.7% vs. 29% for the treatment and placebo groups (P = 0.005). The sustained complete spontaneous bowel motion rate was 29.4% vs. 15.7% in the two groups (P = 0.016). The response rates were higher than that reported previously in the Caucasian studies. There was improvement in the scores for stool form scale, bothersomeness of constipation, abdominal distension/bloating and satisfaction of bowel habit (P < 0.05). The mental score was higher in the treatment group (46.8 ± 9 vs. 43.6 ± 10, P = 0.01). Conclusions: Tegaserod is effective in relieving chronic constipation in Chinese population. The efficacy observed may be higher than that in Western population. © 2007 The Authors.