Nizatidine versus placebo in gastroesophageal reflux disease: a 12-week, multicenter, randomized, double-blind study.

Two doses of nizatidine (150 mg bid and 300 mg hs), an H2-receptor antagonist, were compared with placebo in a 12-wk, multicenter, randomized, double-blind, parallel study in 466 patients with endoscopically documented gastroesophageal reflux disease. Antacid tablets were given concomitantly as needed for pain. Compared with placebo, nizatidine 150 mg twice daily was highly effective in rapidly reducing the severity of heartburn, regardless of esophagitis severity at entry. Significantly greater complete mucosal healing of esophagitis occurred after 6 wk of therapy with nizatidine 150 mg bid (vs. nizatidine 300 mg hs or placebo) only in patients with erosive esophagitis [16/68 (24%) vs. 8/65 (12%)] and erosive and ulcerative esophagitis combined [21/99 (21%) vs. 10/94 (11%)]. At wk 12, healing with nizatidine 150 mg bid was also significantly greater than placebo in erosive [19/68 (28%) vs. 9/65 (14%)], ulcerative [10/31 (32%) vs. 3/29 (10%)], and erosive and ulcerative esophagitis combined [29/99 (29%) vs. 12/94 (13%)]. These results show that twice-daily therapy with nizatidine 150 mg is very effective at relieving heartburn, and can also heal erosive and ulcerative esophagitis. Nizatidine 300 mg hs was not effective in healing esophagitis, compared with placebo.