title: A randomized, double-blind, placebo-controlled trial of tegaserod in female patients suffering from irritable bowel syndrome with constipation.
abstract: BACKGROUND
  Irritable bowel syndrome is a common functional gastrointestinal disorder which affects up to 20% of the population, with a predominance in females.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of tegaserod in female patients with irritable bowel syndrome characterized by symptoms of abdominal pain/discomfort and constipation.
  
  
  METHODS
  In a randomized, double-blind, multicentre study, 1519 women received either tegaserod, 6 mg b.d. (n = 767), or placebo (n = 752) for 12 weeks, preceded by a 4-week baseline period without treatment and followed by a 4-week open withdrawal period. The primary efficacy evaluation was the patient's symptomatic response as measured by the Subject's Global Assessment of Relief. Other efficacy variables included abdominal pain/discomfort, bowel habits and bloating.
  
  
  RESULTS
  Tegaserod produced significant (P < 0.05) improvements in the Subject's Global Assessment of Relief and other efficacy variables. These improvements were seen within the first week, and were maintained throughout the treatment period. After withdrawal of treatment, the symptoms rapidly returned. Overall, tegaserod was well tolerated. Diarrhoea was the most frequent adverse event; however, this led to discontinuation in only 1.6% of tegaserod-treated patients.
  
  
  CONCLUSIONS
  Tegaserod, 6 mg b.d., produced rapid and sustained improvement of symptoms in female irritable bowel syndrome patients and was well tolerated.
authors.affiliation: Charles City Research, Towson, MD, USA.
authors.forename: J
authors.initials: J
authors.lastname: Novick
authors.forename: P
authors.initials: P
authors.lastname: Miner
authors.forename: R
authors.initials: R
authors.lastname: Krause
authors.forename: K
authors.initials: K
authors.lastname: Glebas
authors.forename: H
authors.initials: H
authors.lastname: Bliesath
authors.forename: G
authors.initials: G
authors.lastname: Ligozio
authors.forename: P
authors.initials: P
authors.lastname: Rüegg
authors.forename: M
authors.initials: M
authors.lastname: Lefkowitz
mesh_terms: D000328:Adult; D003109:Colonic Diseases, Functional / Q000150:complications / Q000188:drug therapy*; D003248:Constipation / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D017366:Serotonin Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D005765:Gastrointestinal Agents; D007211:Indoles; D017366:Serotonin Receptor Agonists; C105050:tegaserod