Clinical Drug Investigation · 2014 · 52 citations · 9 references
MedicinePharmacologyPharmacotherapyClinical PharmacologyGastroenterologyGastrointestinal PharmacotherapyFunctional Gastrointestinal DisordersHealth-related Quality Of LifeHealth-related Quality Of Life MeasurementIrritable Bowel SyndromeQuality Of LifeQuality Of Life AssessmentGastrointestinal Symptom BurdenGastrointestinal Symptom ScoringHealth Outcomes AnalysisIrritable Bowel Syndrome PharmacotherapyIrritable Bowel Syndrome TreatmentProspective Cohort DataRome CriteriaSymptom Survey Scores
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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