Randomised clinical trial: the burden of illness of uninvestigated dyspepsia before and after treatment with esomeprazole- results from the STARS II study
Alimentary Pharmacology and Therapeutics, 08/18/2011
Clinical Article
van Zanten SV et al. – Uninvestigated dyspepsia is associated with high symptom load and impacts on health–related quality of life(HRQL) and work productivity. Esomeprazole improves HRQL among such patients, and improves work productivity among 1–week acid–suppression trial responders.
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.
- 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.
- 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.
- Sub-population of acid-suppression test responders, but not the total WPAI population, had a significant work productivity improvement vs. placebo.
