CLINICAL EFFECTIVENESS AND QUALITY-OF-LIFE WITH RANITIDINE VS PLACEBOIN GASTROESOPHAGEAL REFLUX DISEASE PATIENTS - A CLINICAL-EXPERIENCE NETWORK (CEN) STUDY

Background. Gastroesophageal reflux disease (GERD), often characterize d as heartburn, is a highly common presenting complaint to family phys icians. This study is the first large, prospective, nationwide family practice outpatient evaluation of the effectiveness of the histamine ( H-2)-receptor antagonist ranitidine as medical therapy for this disord er. Methods. This randomized, double-blind, placebo-controlled, parall el group, 6-week study was designed to evaluate the effect of ranitidi ne on clinical outcomes and quality of life in patients with GERD. Eli gible patients included those who were at least 18 years old and had a t least a 3-month history of heartburn or heartburn therapy and a mini mum of 4 days with at least one heartburn episode in the week precedin g the baseline visit. Quality-of-life effects were measured using a ge neral health status instrument and a previously validated heartburn-sp ecific questionnaire. Results. Ranitidine treatment conferred clinical ly and statistically significant reductions in mean heartburn pain sco res within the first 24 hours (P less than or equal to.001) and mean n umber of heartburn episodes within the first 48 hours (P less than or equal to.001). These reductions were maintained throughout the 6-week trial, during both daytime and nighttime. Compared with patients recei ving placebo, patients treated with ranitidine also used significantly fewer doses of antacids (P less than or equal to.003). Further, both ranitidine-treated patients' and their physicians' global assessments of decreases in heartburn severity, as well as clinical improvement on ranitidine, proved superior to those of controls (P<.001). The rate o f adverse events associated with ranitidine and placebo was low and si milar. Ranitidine-treated patients had more favorable scores on the ge neral health status dimensions of physical functioning, bodily pain, a nd vitality (P<.05), and more favorable scores on all dimensions of th e heartburn-specific questionnaire (P<.05). Conclusions. Twice-daily t reatment with ranitidine 150 mg is a valuable therapy for GERD in a ty pical family practice setting. It reduces the frequency and severity o f symptoms within the first 24 to 48 hours of treatment and diminishes the use of nonprescription antacids while improving the quality of li fe as measured by both a general health status instrument and a diseas e-specific instrument.