title: Double blind cross-over placebo controlled study of omeprazole in the treatment of patients with reflux symptoms and physiological levels of acid reflux--the "sensitive oesophagus".
abstract: BACKGROUND
  At least 10-15% of patients with reflux symptoms have a normal endoscopy and physiological levels of acid reflux on pH monitoring. Such patients with 50% or more of symptoms associated with acid reflux episodes have "a positive symptom index" (SI), and it has been proposed that this defines the "sensitive oesophagus".
  
  
  OBJECTIVE
  To test the response to omeprazole 20 mg twice daily for four weeks of patients with normal levels of acid reflux using a randomised, placebo controlled, double blind, cross-over design.
  
  
  METHODS
  Eighteen patients with normal levels of reflux, 12 of whom had a positive SI.
  
  
  METHODS
  Response was measured by symptomatic assessment and the SF-36 quality of life (QOL) questionnaire.
  
  
  RESULTS
  Patients with a positive SI showed the following improvements on omeprazole compared with placebo: decrease in symptom frequency (p < 0.01), severity (p < 0.01) and consumption of antacids (p < 0.01). In the group with a negative SI only one patient clearly improved. The QOL parameters for bodily pain (65.6 v 53.4, p = 0.03) and vitality (60.6 v 48.8, p = 0.049) were significantly better on omeprazole than placebo for the group overall.
  
  
  CONCLUSIONS
  Omeprazole improves symptoms in 11 of 18 patients with normal endoscopy and pH monitoring, particularly those with a positive SI. This supports the theory that such patients have an oesophagus which is "sensitive" to acid reflux and are part of the GORD spectrum.
authors.affiliation: Department of Medicine, Queen's University, Belfast.
authors.forename: R G
authors.initials: RG
authors.lastname: Watson
authors.forename: T C
authors.initials: TC
authors.lastname: Tham
authors.forename: B T
authors.initials: BT
authors.lastname: Johnston
authors.forename: N I
authors.initials: NI
authors.lastname: McDougall
mesh_terms: D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004947:Esophagus / Q000503:physiopathology*; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D011788:Quality of Life
chemical_list: D000897:Anti-Ulcer Agents; D009853:Omeprazole