Treatment of gastroesophageal reflux disease: defining endpoints that are important to patients.

Patients with gastroesophageal reflux disease (GERD) seek treatment to obtain relief of their symptoms. Symptoms are important to patients because they interfere with activities of daily living and impair quality of life. Clinical trials in GERD have traditionally focused on the healing of erosive esophagitis, and symptom endpoints have been relegated to a secondary role. In primary care, however, patients typically are treated empirically without definition of the presence or absence of esophagitis. Patient-centered endpoints such as complete symptom resolution, patient satisfaction, and improvement in quality of life therefore provide more meaningful results in the broad population of patients with GERD, provided they are coupled with objective data on mucosal healing. This article reviews the importance of patient-centered endpoints in the assessment of the treatment of GERD and concludes that complete resolution of symptoms is the most rigorous endpoint in clinical trials and provides a meaningful endpoint for therapy in clinical practice.