Health-related quality of life outcomes of omeprazole versus ranitidine inpoorly responsive symptomatic gastroesophageal reflux disease

Objective: This study evaluated changes in health-related quality of life ( HRQL) outcomes of once-daily omeprazole compared with ranitidine for the sh ort-term treatment of patients with poorly responsive symptomatic gastroeso phageal reflux disease (GERD), Methods: A double-blind, randomized clinical trial, compared omeprazole versus ranitidine for the treatment of poorly r esponsive GERD, Eligible patients had a history of predominant heartburn sy mptoms with symptomatic heartburn after 6 weeks of ranitidine treatment. Pa tients were randomized to omeprazole 20 mg once daily (n = 156) or ranitidi ne 150 mg twice daily (n = 161) and followed for 8 weeks. Assessments were completed at baseline and after 8 weeks with physician-rated symptoms: Gast rointestinal Symptom Rating Scale (GSRS); Psychological General Well-Being (PGWB) Index; Sleep Scale; Impact: on Daily Activities Scale, and Overall T reatment Effect. Primary HRQL endpoints were the GSRS reflux scale and PGWB total score, Results: No differences between the 2 treatment groups were o bserved in baseline demographic, clinical or HRQL measures, After 8 weeks, omeprazole-treated patients had greater improvement in GSRS reflux scale sc ores (p < 0.0001) and PGWB total scores (p = 0.019) compared with ranitidin e-treated patients, Significant between group differences favoring omeprazo le were also observed in GSRS total scores (p < 0.0001), abdominal pain sca le scores (p = 0.003), and indigestion scale scores (p = 0.003), Impact on Daily Activities (p = 0.001), PGWB positive well-being (p = 0.015), anxiety (p = 0.030), and general health scale scores (p = 0.010), Patient ratings of overall treatment effect demonstrated the significantly (p < 0.0001) gre ater benefits of omeprazole (mean = 5.26) compared with ranitidine treatmen t (mean = 3.83). Conclusions: Omeprazole treatment significantly reduced pe rsistent reflux-related symptoms and normalized psychological well-being co mpared with ranitidine in poorly responsive symptomatic patients with GERD.