As part of a multicenter trial evaluating
ranitidine in the treatment of
gastroesophageal reflux disease, the therapeutic responses of patients with and without abnormal endoscopic findings were evaluated. All patients were randomized to either placebo or
ranitidine (150 mg bid) treatment groups. The treatment interval was 6 wk. Thirty-seven percent of 283 patients enrolled in the trial had normal baseline endoscopy. Compared to the placebo group, 147 evaluable
ranitidine patients with abnormal endoscopy displayed a marked and rapid symptom reduction which was sustained throughout the last 4 wk of
therapy. Despite randomization of endoscopically normal patients, those treated with
ranitidine had significantly more
heartburn at baseline. However, the 89 evaluable
ranitidine-treated patients with normal endoscopy also experienced a marked and rapid reduction in
heartburn at the end of 1 wk. The symptomatic improvement in the endoscopically abnormal
ranitidine patients was significantly greater (p less than 0.05) than that observed in the endoscopically normal
ranitidine group. Since both groups fared better on
ranitidine than placebo, the results of this study indicate that
ranitidine is an effective treatment for patients with
heartburn symptoms and documented esophageal
acid sensitivity whether or not endoscopic parameters for
esophagitis are present.