It has been proposed that treatments for irritable bowel syndrome (IBS) with constipation should provide rapid symptomatic relief.
There have also been proposals that IBS treatments should be intermittent, and effective upon repeated use.
Dr Tack and colleagues evaluated the efficacy and safety of tegaserod on IBS symptoms.
The team also investigated its impact on quality of life and health economic measures.
The research team assessed women of 18 years of age with IBS with constipation according to the Rome II criteria.
The team undertook a prospective, double blind, placebo controlled, randomized trial.
Women with IBS and constipation either received tegaserod 6 mg twice daily or placebo for 1 month.
|For relief of abdominal discomfort/pain, 31% of responders used tegaserod|
Patients with at least a partial response entered a treatment free interval.
Upon symptom recurrence, the team re-randomized tegaserod treated patients to tegaserod or placebo for an additional month.
Primary efficacy variables were response, or overall IBS symptoms and abdominal discomfort/pain, to first and repeated treatment.
The research team undertook analysis by intention to treat.
The team reported that 2660 patients and 1191 patients were randomized for first and repeated treatment, respectively.
Tegaserod was superior to placebo for each primary efficacy variable.
In the first treatment, there were 34% responders in the tegaserod group vs 24% with placebo for relief of IBS symptoms.
For relief of abdominal discomfort/pain, there were 31% responders in the tegaserod group vs 22% with placebo.
The team observed that repeated treatment occurred in 45% with tegaserod vs 28% with placebo.
Tegaserod was superior to placebo for every secondary efficacy variable.
The secondary efficacy variables included relief of abdominal discomfort/pain, bloating and constipation; stool frequency and consistency.
The research team observed a response to tegaserod was within the first treatment week.
In addition, the noted that tegaserod produced greater satisfaction, work productivity, and improved quality of life than placebo.
Dr Tack's team concludes, “Tegaserod provides rapid and sustained relief of symptoms of irritable bowel syndrome with constipation both during first and repeated treatment.”