Treatment of benign chronic gastric ulcer with ranitidine. A randomized, double-blind, and placebo-controlled six week trial.

A randomized, multicenter, double-blind, placebo-controlled study was conducted to determine whether ranitidine 150 mg b.i.d. for 6 weeks would expedite endoscopic healing or relief of symptoms in patients with benign gastric ulcer. Of 203 patients enrolled, 101 received ranitidine and 102 received placebo. Endoscopic evaluations were conducted at baseline and at 2 and 6 weeks. At 6 weeks 68% of the patients treated with ranitidine had healed compared with 53% in the placebo group (p = 0.02). In those patients who had not healed by 6 weeks, ranitidine provided greater relief from pain than placebo. More patients in the placebo group dropped out of the study because of worsening symptoms (13 versus 4, p = 0.04). No differences in laboratory abnormalities or incidence of adverse events were detected between the two study groups. These results indicate that ranitidine 150 mg b.i.d. is superior to placebo in the treatment of benign gastric ulcer.