NIZATIDINE VERSUS PLACEBO IN GASTROESOPHAGEAL REFLUX DISEASE - A 12-WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND-STUDY (REPRINTED FROM AMERICAN JOURNAL OF GASTROENTEROLOGY, VOL 86, PG 1735, 1991)

Two doses of nizatidine (150 mg twice daily and 300 mg at bedtime), an H-2-receptor antagonist, were compared with placebo in a 12-week, mul ticentre, randomised, double-blind, parallel study in 466 patients wit h endoscopically documented gastro-oesophageal reflux disease. Antacid tablets were given concomitantly as needed for pain. Compared with pl acebo, nizatidine 150 mg twice daily was highly effective in rapidly r educing the severity of heartburn, regardless of oesophagitis severity at entry. Significantly greater complete mucosal healing of oesophagi tis occurred after 6 weeks of therapy with nizatidine 150 mg bid (vs n izatidine 300 mg at bedtime or placebo) only in patients with erosive oesophagitis [16/68 (24%) vs 8/65 (12%)] and erosive and ulcerative oe sophagitis combined [21/99 (21%) vs 10/94 (11%)]. At week 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 oesophagitis combined [29/99 (29 %) vs 12/94 (13%)]. These results show that twice-daily therapy with n izatidine 150 mg is very effective at relieving heartburn, and can als o heal erosive and ulcerative oesophagitis. Nizatidine 300 mg at bedti me was not effective at healing oesophagitis, compared with placebo.