title: Randomised clinical trial: the burden of illness of uninvestigated dyspepsia before and after treatment with esomeprazole--results from the STARS II study.
abstract: BACKGROUND
  Patients with dyspepsia often experience troublesome symptoms.
  
  
  OBJECTIVE
  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.
authors.affiliation: Division of Gastroenterology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada. vanzanten@ualberta.ca
authors.forename: S Veldhuyzen
authors.initials: SV
authors.lastname: van Zanten
authors.forename: P
authors.initials: P
authors.lastname: Wahlqvist
authors.forename: N J
authors.initials: NJ
authors.lastname: Talley
authors.forename: K
authors.initials: K
authors.lastname: Halling
authors.forename: N
authors.initials: N
authors.lastname: Vakil
authors.forename: K
authors.initials: K
authors.lastname: Lauritsen
authors.forename: N
authors.initials: N
authors.lastname: Flook
authors.forename: T
authors.initials: T
authors.lastname: Persson
authors.forename: E
authors.initials: E
authors.lastname: Bolling-Sternevald
mesh_terms: D000293:Adolescent; D000328:Adult; D000897:Anti-Ulcer Agents / Q000191:economics / Q000627:therapeutic use*; D017281:Cost of Illness; D004311:Double-Blind Method; D004415:Dyspepsia / Q000188:drug therapy* / Q000191:economics*; D064098:Esomeprazole / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D011788:Quality of Life; D012044:Regression Analysis; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000897:Anti-Ulcer Agents; D064098:Esomeprazole