title: Night-time symptoms and their impact on sleep in patients with gastroesophageal reflux disease who have a partial response to proton pump inhibitors: a qualitative patient interview study.
abstract: BACKGROUND
  Limited data exists about night-time symptoms that are generated directly from patients with gastroesophageal reflux disease (GERD) who have a partial response to proton pump inhibitor (PPI) therapy. This information is needed to select an appropriate instrument in studies in this patient population.
  
  
  OBJECTIVE
  The objective of this qualitative interview study was to gain understanding of the night-time symptoms of patients with GERD who had a partial response to PPIs. The specific aims were (i) to evaluate whether GERD symptoms experienced during the night differ from those occurring during the day; and (ii) to understand the impact of night-time symptoms on sleep and next-day functioning.
  
  
  METHODS
  Four US sites participated in this study of patients with GERD who, despite PPI therapy for at least 4 weeks, still experienced both daytime and night-time heartburn and/or regurgitation. Non-responders to PPIs were excluded. Patient statements were coded and grouped by concept.
  
  
  RESULTS
  Twenty-nine patients were enrolled. The predominant and most troublesome symptoms during both the day and night were heartburn and regurgitation. At night-time only, expressions describing regurgitation were more frequent than those describing heartburn (62 vs. 26 %). During the daytime only, expressions describing regurgitation and heartburn occurred with similar frequency (21 vs. 27 %). Patients experienced greater severity of heartburn and regurgitation at night than during the day, and the difference was more pronounced for regurgitation. Patients focused on symptom frequency during the day but on symptom severity at night. Of expressions about the impact of night-time GERD symptoms, 46 % described impact on sleep and 41 % described compensatory behaviors when woken up by symptoms. Next-day impacts of night-time symptoms predominantly included changes in diet (53 %).
  
  
  CONCLUSIONS
  Partial responders to PPI therapy experience similar GERD symptoms at night and during the day. However, regurgitation is more predominant at night than during the day, and at night patients focus more on symptom severity than symptom frequency.
authors.affiliation: AstraZeneca R&D Mölndal, Pepparedsleden 1, SE-431 83, Mölndal, Sweden, anna.ryden@astrazeneca.com.
authors.forename: Anna
authors.initials: A
authors.lastname: Rydén
authors.forename: Mona
authors.initials: M
authors.lastname: Martin
authors.forename: Katarina
authors.initials: K
authors.lastname: Halling
authors.forename: Anna
authors.initials: A
authors.lastname: Niklasson
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D036301:Qualitative Research; D011788:Quality of Life; D012307:Risk Factors; D012720:Severity of Illness Index; D012893:Sleep Wake Disorders / Q000209:etiology*; D016896:Treatment Outcome; D014481:United States
chemical_list: D054328:Proton Pump Inhibitors