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- Title
Randomised clinical trial: the burden of illness of uninvestigated dyspepsia before and after treatment with esomeprazole - results from the STARS II study.
- Authors
Veldhuyzen van Zanten, S.; Wahlqvist, P.; Talley, N. J.; Halling, K.; Vakil, N.; Lauritsen, K.; Flook, N.; Persson, T.; Bolling‐Sternevald, E.
- Abstract
Aliment Pharmacol Ther 2011; 34: 714-723 Summary Background Patients with dyspepsia often experience troublesome symptoms. Aim To assess the burden of uninvestigated dyspepsia (symptoms, health-related quality of life [HRQL] and work productivity) before and after 8 weeks' esomeprazole treatment. Methods Patients ( n = 1250) with uninvestigated dyspepsia (no endoscopy within 6 months and ≤2 endoscopies within 10 years) underwent a 1-week esomeprazole acid-suppression test before randomisation to 7 weeks' esomeprazole or placebo. The Reflux Disease Questionnaire (RDQ), Quality of Life in Reflux and Dyspepsia (QOLRAD) and Work Productivity and Activity Impairment (WPAI) questionnaires were completed at baseline (1-week off-treatment) and 8 weeks. WPAI results were further analysed among patients who responded to the acid-suppression test. Results The highest baseline symptom score was for the RDQ dyspepsia domain, and the highest disease burden was for QOLRAD vitality and food/drink problems. After 8 weeks, significant improvements vs. placebo were observed for all RDQ and QOLRAD domains. The sub-population of acid-suppression test responders, but not the total WPAI population, had a significant work productivity improvement vs. placebo. Conclusions Uninvestigated dyspepsia is associated with high symptom load and impacts on HRQL and work productivity. Esomeprazole improves HRQL among such patients, and improves work productivity among 1-week acid-suppression trial responders. ClinicalTrials.gov identifier: NCT00251992.
- Subjects
INDIGESTION treatment; RANDOMIZED controlled trials; ESOMEPRAZOLE; QUALITY of life; HEMATEMESIS; DEGLUTITION disorders; WEIGHT loss -- Risk factors
- Publication
Alimentary Pharmacology & Therapeutics, 2011, Vol 34, Issue 7, p714
- ISSN
0269-2813
- Publication type
Article
- DOI
10.1111/j.1365-2036.2011.04789.x