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

Aliment Pharmacol Ther. 2007 Feb 15;25(4):463-9. doi: 10.1111/j.1365-2036.2006.03230.x.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • China
  • Chronic Disease
  • Constipation / drug therapy*
  • Double-Blind Method
  • Female
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Indoles / therapeutic use*
  • Male
  • Middle Aged
  • Treatment Outcome

Substances

  • Gastrointestinal Agents
  • Indoles
  • tegaserod