Complete resolution of heartburn symptoms and health-related quality of life in patients with gastro-oesophageal reflux disease

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 medic al therapy and HRQL. We evaluated the association between complete resoluti on 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 sympto ms and HRQL scores from three clinical trials (total n=1351) comparing omep razole and ranitidine for acute symptomatic treatment of GERD. Heartburn sy mptoms were measured using patient diaries and/or patient self-report. HRQL was assessed using the Psychological General Well-Being Index (PGWB) in al l three clinical trials and the SF-36 Health Survey in two clinical trials. Resolution of heartburn symptoms was defined as no heartburn reported duri ng the assessment period. Results: We observed statistically significant differences favouring patien ts with no heartburn symptoms on the PGWB total score (P=0.018 to P < 0.000 1) and anxiety (P=0.002 to P < 0.0001), general health (P=0.05 to P < 0.000 1), 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 reporte d 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 signi ficantly better in patients with no heartburn symptoms compared with patien ts 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 ass ociated with improvement in HRQL; the greatest impact was observed on measu res of psychological well-being and physical functioning and well-being. Ef fective treatment of GERD that completely resolves heartburn results in cli nically significant improvement in patient HRQL.