BACKGROUND:Tegaserod is a promotility agent with proven efficacy and safety in patients with irritable bowel syndrome with constipation. AIM: To assess tegaserod's effect on work productivity and daily activity. METHODS:Women, 18-65 years old and meeting Rome II criteria for irritable bowel syndrome with constipation, were randomized to a double-blind, placebo-controlled, multicentre study of tegaserod 6 mg b.d. or placebo. Productivity loss and daily activity impairment because of irritable bowel syndrome were measured with the Work Productivity and Activity Impairment questionnaire for irritable bowel syndrome, modified to exclude diarrhoea as a symptom. Assessments were made at baseline, weeks 2 and 4. RESULTS:A total of 2660 women were randomized and, of these, 1675 [tegaserod (n = 1363), placebo (n = 312)] were employed and completed Work Productivity and Activity Impairment for irritable bowel syndrome questionnaires. Compared with placebo, tegaserod significantly reduced work and daily activity impairment at weeks 2 and 4. Tegaserod reduced absenteeism by 2.6% (P = 0.004), presenteeism by 5.4% (P < 0.0001), overall work productivity loss by 6.3% (P < 0.0001), and activity impairment by 5.8% (P < 0.0001) at week 4 (vs. baseline). Assuming a 40-h workweek, tegaserod reduced work productivity loss by 2.5 h/week. CONCLUSIONS:Tegaserod significantly reduced work productivity loss and daily activity impairment at 2 weeks, and this benefit was maintained at 4 weeks.
RCT Entities:
BACKGROUND:Tegaserod is a promotility agent with proven efficacy and safety in patients with irritable bowel syndrome with constipation. AIM: To assess tegaserod's effect on work productivity and daily activity. METHODS:Women, 18-65 years old and meeting Rome II criteria for irritable bowel syndrome with constipation, were randomized to a double-blind, placebo-controlled, multicentre study of tegaserod 6 mg b.d. or placebo. Productivity loss and daily activity impairment because of irritable bowel syndrome were measured with the Work Productivity and Activity Impairment questionnaire for irritable bowel syndrome, modified to exclude diarrhoea as a symptom. Assessments were made at baseline, weeks 2 and 4. RESULTS: A total of 2660 women were randomized and, of these, 1675 [tegaserod (n = 1363), placebo (n = 312)] were employed and completed Work Productivity and Activity Impairment for irritable bowel syndrome questionnaires. Compared with placebo, tegaserod significantly reduced work and daily activity impairment at weeks 2 and 4. Tegaserod reduced absenteeism by 2.6% (P = 0.004), presenteeism by 5.4% (P < 0.0001), overall work productivity loss by 6.3% (P < 0.0001), and activity impairment by 5.8% (P < 0.0001) at week 4 (vs. baseline). Assuming a 40-h workweek, tegaserod reduced work productivity loss by 2.5 h/week. CONCLUSIONS:Tegaserod significantly reduced work productivity loss and daily activity impairment at 2 weeks, and this benefit was maintained at 4 weeks.
Authors: Adil E Bharucha; Marie G Gantz; Satish S Rao; Ann C Lowry; Heidi Chua; Tennekoon Karunaratne; Jennifer Wu; Frank A Hamilton; William E Whitehead Journal: Contemp Clin Trials Date: 2021-06-15 Impact factor: 2.261
Authors: R Spiller; Q Aziz; F Creed; A Emmanuel; L Houghton; P Hungin; R Jones; D Kumar; G Rubin; N Trudgill; P Whorwell Journal: Gut Date: 2007-05-08 Impact factor: 23.059