title: Complete resolution of heartburn symptoms and health-related quality of life in patients with gastro-oesophageal reflux disease.
abstract: BACKGROUND
  Medical treatments for gastro-oesophageal reflux disease (GERD) vary in their ability to completely resolve heartburn and other symptoms. Although GERD reduces health-related quality of life (HRQL) little is known about the relationship between resolution of heartburn symptoms with medical therapy and HRQL. We evaluated the association between complete resolution of heartburn symptoms and functioning and well-being in three samples of patients with GERD.
  
  
  METHODS
  We analysed baseline and follow-up assessments of heartburn symptoms and HRQL scores from three clinical trials (total n=1351) comparing omeprazole and ranitidine for acute symptomatic treatment of GERD. Heartburn symptoms were measured using patient diaries and/or patient self-report. HRQL was assessed using the Psychological General Well-Being Index (PGWB) in all three clinical trials and the SF-36 Health Survey in two clinical trials. Resolution of heartburn symptoms was defined as no heartburn reported during the assessment period.
  
  
  RESULTS
  We observed statistically significant differences favouring patients with no heartburn symptoms on the PGWB total score (P=0.018 to P < 0.0001) and anxiety (P=0.002 to P < 0.0001), general health (P=0.05 to P < 0. 0001), positive well-being (P=0.028 to P < 0.0001) and vitality (P=0. 05 to P < 0.0001) sub-scale scores at 4-14 weeks. Patients with no heartburn reported better SF-36 pain (P=0.005 to P < 0.0001) and general health perceptions (P=0.032 to P < 0.0001) compared with patients still experiencing heartburn symptoms at 4-24 weeks. SF-36 physical component summary scores were significantly better in patients with no heartburn symptoms compared with patients with heartburn symptoms at 4-24 weeks (P=0.013 to P=0.009), while mental component summary scores were only significantly different at 24 weeks (P=0.0005) in one of the two studies where the SF-36 was utilized.
  
  
  CONCLUSIONS
  Complete resolution of heartburn symptoms was consistently associated with improvement in HRQL; the greatest impact was observed on measures of psychological well-being and physical functioning and well-being. Effective treatment of GERD that completely resolves heartburn results in clinically significant improvement in patient HRQL.
authors.affiliation: Center for Health Outcomes Research, MEDTAP International, Bethesda, MD 20814, USA. Revicki@Medtap.com
authors.forename: D A
authors.initials: DA
authors.lastname: Revicki
authors.forename: J A
authors.initials: JA
authors.lastname: Crawley
authors.forename: M W
authors.initials: MW
authors.lastname: Zodet
authors.forename: D S
authors.initials: DS
authors.lastname: Levine
authors.forename: B O
authors.initials: BO
authors.lastname: Joelsson
mesh_terms: D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006356:Heartburn / Q000188:drug therapy*; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009853:Omeprazole / Q000627:therapeutic use*; D011788:Quality of Life / Q000523:psychology*; D016032:Randomized Controlled Trials as Topic; D011899:Ranitidine / Q000627:therapeutic use*
chemical_list: D000897:Anti-Ulcer Agents; D006635:Histamine H2 Antagonists; D011899:Ranitidine; D009853:Omeprazole