Efficacy of Tegaserod for Functional Constipation in Chinese Subjects: A Randomized Double Blind Controlled Trial in a Single Center

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: 250 patients were randomized to a double-blinded 8-week treatment of Tegaserod 6mg b.i.d or placebo. Response during weeks 1-4 was defined as an increase in complete spontaneous bowl motion (CSBM)≥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: 109 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 CSBM rate was 29.4% vs 15.7% in the two groups (p=0.016). The response rate was 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 (ps<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.