title: One-week acid suppression trial in uninvestigated dyspepsia patients with epigastric pain or burning to predict response to 8 weeks' treatment with esomeprazole: a randomized, placebo-controlled study.
abstract: BACKGROUND
  While empiric acid-suppressive therapy for uninvestigated dyspepsia patients with symptoms of epigastric pain or burning is standard practice, it is unknown whether an early response to therapy predicts outcome.
  
  
  OBJECTIVE
  To evaluate whether a 1-w acid suppression trial is effective for predicting 8-w response in such patients.
  
  
  METHODS
  Helicobacter pylori-negative patients (aged 18-50 years) in primary care with uninvestigated epigastric pain or burning were randomized to esomeprazole 40 mg q.d.s. or b.d. for 1w, followed by esomeprazole 40 mg q.d.s. or placebo for 7w. Each day, patients rated the severity of their symptoms.
  
  
  RESULTS
  Based on the last 3d, 1-w response rates were 39% (231 of 588) and 43% (258 of 596) with esomeprazole 40 mg q.d.s. and b.d., respectively. Based on the last 7d, response rates at 4w were 38% (283 of 738) and 25% (93 of 380) for esomeprazole and placebo, respectively, and 47% (339 of 716) and 34% (124 of 368), respectively, at 8w (both P < 0.001 vs. placebo). The sensitivity and specificity of esomeprazole treatment were 58% and 70%, respectively, at 8w.
  
  
  CONCLUSIONS
  A 1-w acid suppression trial is of limited clinical value for predicting 8-w response in patients with symptoms of epigastric pain or burning. Esomeprazole provides greater symptom control than placebo at 4w and 8w.
authors: Dalhousie University, Halifax, Canada.
authors: S V
authors: SV
authors: van Zanten
authors: N
authors: N
authors: Flook
authors: N J
authors: NJ
authors: Talley
authors: N
authors: N
authors: Vakil
authors: K
authors: K
authors: Lauritsen
authors: E
authors: E
authors: Bolling-Sternevald
authors: T
authors: T
authors: Persson
authors: E
authors: E
authors: Björck
authors: L-E
authors: LE
authors: Svedberg
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004415:Dyspepsia / Q000188:drug therapy*; D064098:Esomeprazole / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006356:Heartburn / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000897:Anti-Ulcer Agents; D010919:Placebos; D064098:Esomeprazole