The Effect of Tegaserod on Symptoms and Quality of Life in Korean Women with Irritable Bowel Syndrome with Constipation

ABSTRACT

INTRODUCTION: Tegaserod has been used for treatment of irritable bowel syndrome (IBS) but there is no data regarding its effect on Korean patients. The aim of this study was to evaluate the effect of tegaserod on symptoms and quality of life (QOL) in Korean female IBS patients with constipation and to evaluate the usefulness of the IBS-QOL in clinical study. METHODS: A prospective, open labeled, multicenter study was performed. Female patients fulfilling Rome II criteria for IBS received 6 mg of tegaserod twice a day for 4 weeks. The efficacy on IBS symptoms and QOL was assessed using 7-point scaled symptom questionnaire and IBS-QOL questionnaire, respectively. RESULTS: A total of 81 female patients (range 18-73 years of age) were enrolled in this study. Tegaserod therapy significantly reduced the overall symptom scores after 4 weeks (p <0.01). The improved symptoms included abdominal discomfort or pain, hard or lumpy stool, straining during a bowel movement, feeling of incomplete bowel movement, and abdominal fullness or bloating. The IBS-QOL of responders to tegaserod treatment was also significantly improved after 4 weeks (p <0.01). Furthermore, improvement of symptom scores significantly correlated with improvement of the IBS-QOL scores (r = -0.60, p <0.001). CONCLUSIONS: Tegaserod 6 mg given twice daily improved the QOL as well as the bowel symptoms in Korean female IBS patients with constipation. The IBS-QOL can be used as a reliable end-point in clinical study.