Quality of Life in Patients with Irritable Bowel Syndrome (IBS), Assessed Using the IBS–Quality of Life (IBS-QOL) Measure after 4 and 8 Weeks of Treatment with Mebeverine Hydrochloride or Pinaverium Bromide: Results of an International Prospective Observational Cohort Study in Poland, Egypt, Mexico and China
Clinical drug investigation(2014)
摘要
BACKGROUND AND OBJECTIVE:Irritable Bowel Syndrome (IBS) has a substantial impact on health-related quality of life (HR-QoL) but high-quality data pre- and post-treatment using the IBS-Quality of Life (IBS-QOL) measure are limited. The objective of this study was to evaluate the changes from baseline of the IBS-QOL scores, symptom scores and health economic data in IBS patients, after 4 and 8 weeks of treatment with mebeverine hydrochloride or pinaverium bromide.METHODS:This was a prospective observational cohort study in patients with IBS, diagnosed using the Rome III criteria in four countries (Poland, Egypt, Mexico and China).RESULTS:A total of 607 patients were enrolled. At baseline, the IBS-QOL total scores were 52.0 in Poland, 48.9 in Egypt, 51.9 in Mexico, 76.4 in China and 56.4 overall. Increases in IBS-QOL total score were statistically significant at Weeks 4 and 8 overall and in each country (overall: 11.8 at Week 4, 24.3 at Week 8; p < 0.001). Improvements were shown in all IBS-QOL subscales and scores. Symptoms and health economic outcomes were improved. Furthermore, the favourable safety profile of these treatments was confirmed in this study.CONCLUSIONS:This study demonstrated that IBS patients have a substantially reduced HR-QoL and that treatment with mebeverine hydrochloride or pinaverium bromide improved HR-QoL.
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关键词
Irritable Bowel Syndrome
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