Clinical effectiveness and quality of life with ranitidine vs placebo in gastroesophageal reflux disease patients: a clinical experience network (CEN) study.

作者：David R. Rush, Stelmach Wj, Tom Young, Leonard J. Kirchdoerfer, Jane A. Scott-Lennox, H E Holverson, Seymour M. Sabesin, Timothy Nicholas · 发表于：PubMed · 年份：1995 · 被引用次数：74 · 研究领域：Gastroesophageal reflux and treatments、Migraine and Headache Studies、Eosinophilic Esophagitis

BACKGROUND: Gastroesophageal reflux disease (GERD), often characterized as heartburn, is a highly common presenting complaint to family physicians. This study is the first large, prospective, nationwide family practice outpatient evaluation of the effectiveness of the histamine (H2)-receptor antagonist ranitidine as medical therapy for this disorder. METHODS: This randomized, double-blind, placebo-controlled, parallel group, 6-week study was designed to evaluate the effect of ranitidine on clinical outcomes and quality of life in patients with GERD. Eligible patients included those who were at least 18 years old and had at least a 3-month history of heartburn or heartburn therapy and a minimum of 4 days with at least one heart-burn episode in the week preceding the baseline visit. Quality-of-life effects were measured using a general health status instrument and a previously validated heartburn-specific questionnaire. RESULTS: Ranitidine treatment conferred clinically and statistically significant reductions in mean heartburn pain scores within the first 24 hours (P < or = .001) and mean number of heartburn episodes within the first 48 hours (P < or = .001). These reductions were maintained throughout the 6-week trial, during both daytime and nighttime. Compared with patients receiving placebo, patients treated with ranitidine also used significantly fewer doses of antacids (P < or = .003). Further, both ranitidine-treated patients' and their physicians' global assessments of...