title: Acid-suppressive therapy with esomeprazole for relief of unexplained chest pain in primary care: a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  High-quality data regarding the efficacy of acid-suppressive treatment for unexplained chest pain are lacking. The aim of this study was to evaluate the efficacy of esomeprazole in primary-care treatment of patients with unexplained chest pain stratified for frequency of reflux/regurgitation symptoms.
  
  
  METHODS
  Patients with a ≥ 2-week history of unexplained chest pain (unrelated to gastroesophageal reflux) who had at least moderate pain on ≥ 2 of the last 7 days were stratified by heartburn/regurgitation frequency (≤ 1 day/week (stratum 1) vs. ≥ 2 days/week (stratum 2)) and randomized to 4 weeks of double-blind treatment with twice-daily esomeprazole 40 mg or placebo. Chest pain relief during the last 7 days of treatment (≤ 1 day with minimal symptoms assessed daily using a 7-point scale) was analyzed by stratum in keeping with the predetermined analysis plan.
  
  
  RESULTS
  Overall, 599 patients (esomeprazole: 297, placebo: 302) were randomized. In stratum 1, more esomeprazole than placebo recipients achieved chest pain relief (38.7% vs. 25.5%; P=0.018); no between-treatment difference was observed in stratum 2 (27.2% vs. 24.2%; P=0.54). However, esomeprazole was superior to placebo in a post-hoc analysis of the whole study population (combined strata; 33.1% vs. 24.9%; P=0.035).
  
  
  CONCLUSIONS
  A 4-week course of high-dose esomeprazole provided statistically significant relief of unexplained chest pain in primary-care patients who experienced infrequent or no heartburn/regurgitation, but there was no such significant reduction in patients with more frequent reflux symptoms.
authors.affiliation: University of Alberta, Edmonton, Alberta, Canada. nflook@shaw.ca
authors.forename: Nigel W
authors.initials: NW
authors.lastname: Flook
authors.forename: Paul
authors.initials: P
authors.lastname: Moayyedi
authors.forename: John
authors.initials: J
authors.lastname: Dent
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Talley
authors.forename: Tore
authors.initials: T
authors.lastname: Persson
authors.forename: Björn W
authors.initials: BW
authors.lastname: Karlson
authors.forename: Magnus
authors.initials: M
authors.lastname: Ruth
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000863:Antacids / Q000627:therapeutic use*; D002637:Chest Pain / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D064098:Esomeprazole / Q000627:therapeutic use*; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications; D006356:Heartburn / Q000150:complications; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011320:Primary Health Care; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000863:Antacids; D064098:Esomeprazole