title: High-dose esomeprazole for treatment of symptomatic refractory gastroesophageal reflux disease--a prospective pH-metry/impedance-controlled study.
abstract: OBJECTIVE
  Combined pH-metry/multichannel intraluminal impedance (pH/MII) measurement enables to measure gastroesophageal reflux despite ongoing proton pump inhibitor therapy. The aim of our study was to evaluate the influence of an escalating medical anti-reflux therapy with 40 mg esomeprazole, 80 mg esomeprazole and 80 mg esomeprazole plus baclofen for the treatment of refractory pathological reflux as determined by pH/MII.
  
  
  METHODS
  Symptomatic patients under 40 mg esomeprazole were screened by pH/MII. Patients with normal values in pH/MII were excluded; all others received 2 x 40 mg esomeprazole for another 4 weeks. Thereafter, the treatment effect was controlled by pH/MII. In the case of persistent pathological reflux, therapy was further escalated by adding baclofen and controlled after 3 months by pH/MII.
  
  
  RESULTS
  45/138 (32.6%) patients showed pathological pH/MII despite ongoing therapy with 40 mg esomeprazole. In these, a significant reduction in liquid/mixed reflux events was observed after administering 2 x 40 mg (mean: 118.3 vs. mean: 66.6; p < 0.001), and pH/MII turned to normal in 32/45 (71.1%). Baclofen was additionally administered to 7/13 patients, which did not lead to a remarkable reduction in reflux events.
  
  
  CONCLUSIONS
  In patients with abnormal pH/MII and persistent symptoms under 40 mg esomeprazole, we observed a significant reduction in liquid/mixed reflux events after increasing proton pump inhibitor dose up to 80 mg esomeprazole. Further escalation of therapy with baclofen has shown inconclusive results.
authors.affiliation: Second Medical Department, Technical University of Munich, Munich, Germany.
authors.forename: Monther
authors.initials: M
authors.lastname: Bajbouj
authors.forename: Valentin
authors.initials: V
authors.lastname: Becker
authors.forename: Veit
authors.initials: V
authors.lastname: Phillip
authors.forename: Dirk
authors.initials: D
authors.lastname: Wilhelm
authors.forename: Roland M
authors.initials: RM
authors.lastname: Schmid
authors.forename: Alexander
authors.initials: A
authors.lastname: Meining
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001418:Baclofen / Q000008:administration & dosage; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D017097:Electric Impedance; D064098:Esomeprazole / Q000008:administration & dosage*; D049630:Esophageal Sphincter, Lower; D050782:Esophageal pH Monitoring; D005260:Female; D018755:GABA Agonists / Q000008:administration & dosage; D005764:Gastroesophageal Reflux / Q000150:complications / Q000175:diagnosis* / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018755:GABA Agonists; D054328:Proton Pump Inhibitors; D001418:Baclofen; D064098:Esomeprazole