title: Impact of regurgitation on health-related quality of life in gastro-oesophageal reflux disease before and after short-term potent acid suppression therapy.
abstract: OBJECTIVE
  Limited data exist on the impact of regurgitation on health-related quality of life (HRQOL) in gastro-oesophageal reflux disease (GORD). We assessed the relationship between regurgitation frequency and HRQOL before and after acid suppression therapy in GORD.
  
  
  METHODS
  We used data from two randomised trials of AZD0865 25-75 mg/day versus esomeprazole 20 or 40 mg/day in non-erosive reflux disease (NERD) (n=1415) or reflux oesophagitis (RO) (n=1460). The Reflux Disease Questionnaire was used to select patients with frequent and intense heartburn for inclusion and to assess treatment response. The Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire was used to assess HRQOL.
  
  
  RESULTS
  At baseline, 93% of patients in both the NERD and RO groups experienced regurgitation. Mean QOLRAD scores were similar for NERD and RO at baseline and at week 4 and disclosed decremental HRQOL with increasing frequency of regurgitation; a clinically relevant difference of >0.5 in mean QOLRAD scores was seen with regurgitation ≥4 days/week versus <4 days/week. The prevalence of frequent, persistent regurgitation (≥4 days/week) at week 4 among heartburn responders (≤1 day/week of mild heartburn) was 28% in NERD and 23% in RO. QOLRAD scores were higher among heartburn responders. There was a similar pattern of impact related to regurgitation frequency in heartburn responders compared with the group as a whole.
  
  
  CONCLUSIONS
  Frequent regurgitation was associated with a clinically relevant, incremental decline in HRQOL beyond that associated with heartburn before and after potent acid suppression in both NERD and RO.
  
  
  BACKGROUND
  NCT00206284 and NCT00206245.
authors.affiliation: Division of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, , Chicago, Illinois, USA.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Kahrilas
authors.forename: Andreas
authors.initials: A
authors.lastname: Jonsson
authors.forename: Hans
authors.initials: H
authors.lastname: Denison
authors.forename: Börje
authors.initials: B
authors.lastname: Wernersson
authors.forename: Nesta
authors.initials: N
authors.lastname: Hughes
authors.forename: Colin W
authors.initials: CW
authors.lastname: Howden
mesh_terms: D000863:Antacids / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D064098:Esomeprazole / Q000627:therapeutic use*; D004942:Esophagitis, Peptic / Q000150:complications / Q000188:drug therapy*; D005500:Follow-Up Studies; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy*; D006356:Heartburn / Q000188:drug therapy / Q000209:etiology; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D011725:Pyridines / Q000627:therapeutic use*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: C514958:AZD0865; D000863:Antacids; D007093:Imidazoles; D054328:Proton Pump Inhibitors; D011725:Pyridines; D064098:Esomeprazole
keywords: Anti-Reflux Therapy; Gastroesophageal Reflux Disease; Oesophageal Reflux; Oesophagitis; Quality of Life