Main Article Content
Effect of tegaserod on quality of life and symptom relief in women with irritable bowel syndrome with constipation in South Africa
Abstract
Background: Tegaserod is a promotility agent with proven efficacy and safety in patients with irritable bowel syndrome with constipation (IBS-C).
AIM: Assess tegaserod's effect on quality of life (QOL) and symptom relief in South African patients.
Methods: Women >18 years old meeting Rome II criteria for IBS-C were enrolled in a prospective, open-label, multi-center study in South Africa, consisting of a 2-week treatment-free baseline period, followed by a 4-week tegaserod 6 mg b.i.d. treatment period. QOL was assessed using the IBS-QOL questionnaire, at –2 weeks, baseline and 4 weeks; symptom relief was evaluated with daily diaries and weekly assessments of overall symptom relief.
Results: Of the 242 women enrolled, 210 completed the study visits and questionnaires. Compared with baseline, tegaserod significantly improved overall QOL and domains at Week 4 (p values<0.001). Overall symptom relief was reported by 68.7% of patients. At Week 4 tegaserod significantly improved number of bowel movements, stool form, straining, sense of incomplete evacuation, abdominal pain and bloating (p values<0.001). Significant improvements were observed at Week 1 and sustained throughout the study.
Conclusions: Tegaserod significantly improves QOL and relieves the multiple symptoms associated with IBS-C. Symptom improvement was observed early and was sustained through study end.
South African Gastroenterology Review Vol. 4(1) 2006: 11-15
AIM: Assess tegaserod's effect on quality of life (QOL) and symptom relief in South African patients.
Methods: Women >18 years old meeting Rome II criteria for IBS-C were enrolled in a prospective, open-label, multi-center study in South Africa, consisting of a 2-week treatment-free baseline period, followed by a 4-week tegaserod 6 mg b.i.d. treatment period. QOL was assessed using the IBS-QOL questionnaire, at –2 weeks, baseline and 4 weeks; symptom relief was evaluated with daily diaries and weekly assessments of overall symptom relief.
Results: Of the 242 women enrolled, 210 completed the study visits and questionnaires. Compared with baseline, tegaserod significantly improved overall QOL and domains at Week 4 (p values<0.001). Overall symptom relief was reported by 68.7% of patients. At Week 4 tegaserod significantly improved number of bowel movements, stool form, straining, sense of incomplete evacuation, abdominal pain and bloating (p values<0.001). Significant improvements were observed at Week 1 and sustained throughout the study.
Conclusions: Tegaserod significantly improves QOL and relieves the multiple symptoms associated with IBS-C. Symptom improvement was observed early and was sustained through study end.
South African Gastroenterology Review Vol. 4(1) 2006: 11-15
