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

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 decreases in heartburn severity, as well as clinical improvement on ranitidine, proved superior to those of controls (P < or = .001). The rate of adverse events associated with ranitidine and placebo was low and similar. Ranitidine-treated patients had more favorable scores on the general health status dimensions of physical functioning, bodily pain, and vitality (P < .05), and more favorable scores on all dimensions of the heartburn-specific questionnaire (P < .05). CONCLUSIONS: Twice-daily treatment with ranitidine 150 mg is a valuable therapy for GERD in a typical family practice setting. It reduces the frequency and severity of symptoms within the first 24 to 48 hours of treatment and diminishes the use of nonprescription antacids while improving the quality of life as measured by both a general health status instrument and a disease-specific instrument.

Diet and exercise and gemfibrozil therapy for the management of dyslipidemia: a CEN study. Clinical Experience Network.

BACKGROUND: Dyslipidemia constitutes a serious health problem that should be diagnosed and treated by the family physician. Little is known about the efficacy of typical dietary therapy for patients with abnormal cholesterol levels. This study was the first large prospective family practice evaluation of the effectiveness of diet-and-exercise therapy followed by a pharmacologic intervention for those patients who remained dyslipidemic. METHODS: Patients who met standard criteria for cardiovascular disease risk based on lipid analysis were enrolled in a typical 6-week physician-directed diet-and-exercise program. Those patients who were still dyslipidemic after that period were started on 12 weeks of pharmacologic treatment with gemfibrozil. RESULTS: Of the 2992 patients screened, 1193 were eligible for participation in the study. The diet-and-exercise program led to a modest change in lipid values (average decrease in total cholesterol of 4.1%). Only 2% of the patients achieved desirable levels of all lipid values. Seven hundred thirty-nine subjects qualified for further therapy and were treated with gemfibrozil. Seventy patients discontinued drug therapy because of adverse effects. Those who completed 12 weeks of pharmacologic therapy had an additional 5.4% reduction in total cholesterol, 3.9% reduction in low-density lipoprotein cholesterol, 30.6% reduction in triglycerides, and a 17.2% increase in high-density lipoprotein cholesterol. CONCLUSIONS: These findings suggest that in a typical clinical setting, a nonpharmacologic intervention of diet and exercise may not produce the desired overall lipid changes in the majority of dyslipidemic patients.