title: Symptom profile in partial responders to a proton pump inhibitor compared with treatment-naïve patients with gastroesophageal reflux disease: a post hoc analysis of two study populations.
abstract: BACKGROUND
  Partial response to proton pump inhibitor (PPI) therapy poses a healthcare challenge. This study aimed to compare symptom profiles in partial PPI responders and treatment-naïve patients with gastroesophageal reflux disease (GERD).
  
  
  METHODS
  A post hoc analysis of data from two studies was performed. Partial PPI responders with GERD (n = 580; NCT00703534) had frequent (≥ 3 days/week) heartburn and/or regurgitation despite PPI therapy; patients with no improvement were excluded. Treatment-naïve patients with GERD (diagnosed by endoscopy and pH-metry; n = 203; NCT00291746) had frequent (≥ 3 days/week) upper gastrointestinal symptoms. The Gastrointestinal Symptom Rating Scale (GSRS) was completed by all patients at study entry and by treatment-naïve patients after PPI therapy.
  
  
  RESULTS
  The highest (mean [95% confidence interval]) discomfort scores were reported in the Reflux (heartburn, regurgitation), Indigestion, and Abdominal pain domains of the GSRS, both in partial PPI responders (4.3 [4.2-4.4], 3.7 [3.6-3.8], and 3.4 [3.3-3.5], respectively) and in treatment-naïve patients (3.5 [3.3-3.7], 3.6 [3.4-3.7], and 3.1 [3.0-3.3], respectively). Partial PPI responders reported more discomfort than treatment-naïve patients in the Reflux, Abdominal pain, and Constipation domains (4.3 [4.2-4.4] vs. 3.5 [3.3-3.7], 3.4 [3.3-3.5] vs. 3.1 [3.0-3.3], and 2.5 [2.4-2.6] vs. 2.1 [1.9-2.2], respectively). All GSRS domain scores improved in treatment-naïve patients following PPI therapy.
  
  
  CONCLUSIONS
  Symptom patterns in partial PPI responders were similar to those in treatment-naïve patients with GERD, but partial PPI responders experienced more severe reflux, abdominal pain, and constipation than did treatment-naïve patients.
authors.affiliation: University of Wisconsin School of Medicine and Public Health, Aurora Summit Hospital, 36500 Aurora Drive, Summit WI 53066, USA. nvakil@wisc.edu.
authors.forename: Nimish
authors.initials: N
authors.lastname: Vakil
authors.forename: Anna
authors.initials: A
authors.lastname: Niklasson
authors.forename: Hans
authors.initials: H
authors.lastname: Denison
authors.forename: Anna
authors.initials: A
authors.lastname: Rydén
mesh_terms: D015746:Abdominal Pain / Q000209:etiology / Q000517:prevention & control; D000328:Adult; D000368:Aged; D003248:Constipation / Q000209:etiology / Q000517:prevention & control; D003967:Diarrhea / Q000209:etiology / Q000517:prevention & control; D004415:Dyspepsia / Q000209:etiology / Q000517:prevention & control; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D006356:Heartburn / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D054328:Proton Pump Inhibitors