title: Gastric pH and Therapeutic Responses to Exsomeprazole in Patients With Functional Dyspepsia: Potential Clinical Implications.
abstract: BACKGROUND
  Therapy for functional dyspepsia remains a challenge. This study aimed to evaluate esomeprazole (E) versus placebo (P) regarding (1) the effectiveness in providing relief of abdominal pain or discomfort during 16 weeks of therapy in patients with functional dyspepsia having moderate or severe symptoms; (2) the effects on gastric acid suppression and (3) the relationship between symptom relief and gastric pH.
  
  
  METHODS
  Enrolled patients were randomized to E (n = 38) or P (n = 35) in a double-blind, placebo-controlled trial. Outcomes were measured at four 4-week intervals. Drug dose titrated at each visit, based on relief of abdominal symptoms. The 24-hour gastric pH was monitored at baseline, 4 and 8 weeks.
  
  
  RESULTS
  After 4 weeks, 71% of E patients (40mg) reported satisfactory symptom relief versus 34% of P patients (P < 0.001). When the dose for nonresponders (NR) was titrated to 40mg twice daily, the E relief rate increased to 82% versus 56% in P group (P < 0.05). During the next 4 weeks, with dose decreased by half in responders, E response rate declined to 69% versus 48% in P group (P < 0.10). When the dose was increased for NR during the last 4 weeks, E rate increased to 83% versus 57% in P group (P < 0.05). At 4 and 8 weeks for E responders and NR, patients׳ pH >4 value increased significantly compared to baseline.
  
  
  CONCLUSIONS
  (1) Though E 40mg once daily is superior to P, some patients benefit from 40mg twice daily; (2) E, 40mg once daily, profoundly inhibits gastric acid secretion; (3) intragastric pH monitoring before and after therapy may help address the relationship between symptomatic relief and gastric acid secretion and (4) some patients respond to monitored titrated placebo therapy.
authors.affiliation: Medical University of Lublin, Lublin, Poland.
authors.forename: Marek
authors.initials: M
authors.lastname: Majewski
authors.affiliation: Internal Medicine Department, Texas Tech University Health Sciences Center of El Paso, El Paso, Texas.
authors.forename: Irene
authors.initials: I
authors.lastname: Sarosiek
authors.affiliation: Internal Medicine Department, Texas Tech University Health Sciences Center of El Paso, El Paso, Texas.
authors.forename: Chad J
authors.initials: CJ
authors.lastname: Cooper
authors.affiliation: Medical University of Lublin, Lublin, Poland.
authors.forename: Grzegorz
authors.initials: G
authors.lastname: Wallner
authors.affiliation: Internal Medicine Department, Texas Tech University Health Sciences Center of El Paso, El Paso, Texas.
authors.forename: Richard W
authors.initials: RW
authors.lastname: McCallum
authors.affiliation: Department of Psychiatry, University of Missouri School of Medicine, Kansas City, Missouri. Electronic address: edlavitchs@umkc.edu.
authors.forename: Stanley A
authors.initials: SA
authors.lastname: Edlavitch
authors.affiliation: Internal Medicine Department, Texas Tech University Health Sciences Center of El Paso, El Paso, Texas. Electronic address: jerzy.sarosiek@ttuhsc.edu.
authors.forename: Jerzy
authors.initials: J
authors.lastname: Sarosiek
mesh_terms: D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D004415:Dyspepsia / Q000188:drug therapy*; D064098:Esomeprazole / Q000494:pharmacology / Q000627:therapeutic use*; D050782:Esophageal pH Monitoring; D005260:Female; D005750:Gastric Juice / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D054328:Proton Pump Inhibitors; D064098:Esomeprazole
keywords: Esomeprazole; Functional dyspepsia; Gastric pH; Proton pump inhibitors