OMEPRAZOLE IS MORE EFFECTIVE THAN CIMETIDINE FOR THE RELIEF OF ALL GRADES OF GASTROESOPHAGEAL REFLUX DISEASE-ASSOCIATED HEARTBURN, IRRESPECTIVE OF THE PRESENCE OR ABSENCE OF ENDOSCOPIC ESOPHAGITIS

Background: Previous studies have demonstrated greater efficacy for om eprazole compared with cimetidine in patients with endoscopically veri fied oesophagitis, but excluded the substantial group of gastro-oesoph ageal reflux disease (GERD) patients with reflux symptoms but without endoscopic abnormality. This prospective, randomized, double-blind stu dy compared omeprazole and cimetidine in the treatment of GERD-associa ted heartburn both in patients with symptomatic nonulcerative oesophag itis and in those with heartburn but without oesophagitis. Methods: A total of 221 patients with heartburn and oesophageal mucosa grade 0 (n ormal, n = 51), 1 (no macroscopic erosions, n = 52), 2 (isolated erosi ons, n = 97) or 3 (confluent erosions, n = 21) were randomized to rece ive double-blind either omeprazole 20 mg daily or cimetidine 400 mg q. d.s. for a period of 4 weeks. Those still symptomatic after 4 weeks of treatment received omeprazole 20 mg daily for a further 4 weeks. Resu lts: There was no correlation between severity of heartburn and endosc opic grade at entry (correlation coefficient = 0.196). After 4 weeks o f treatment, the proportion of patients in whom heartburn was controll ed (no more than mild symptoms on no more than 1 day in the previous 7 ) on omeprazole (66%; 74/112) was more than double that on cimetidine (31%; 34/109) (P < 0.0001). There was no significant difference betwee n the relief of heartburn in the 47% of patients without unequivocal o esophagitis (endoscopic grade 0 or 1) and in the 53% of patients with erosive oesophagitis (grade 2 or 3) (P = 0.31). Only treatment with om eprazole (P < 0.0001) and lower severity of heartburn at entry (P < 0. 01) were significant in predicting heartburn relief. Amongst those pat ients requiring an additional 4 weeks of treatment with omeprazole, 67 % (54/81) reported that their heartburn was controlled after 8 weeks o f treatment. Conclusion: We conclude that omeprazole is superior to ci metidine for the relief of all grades of heartburn in GERD, whether or not the patient has unequivocal endoscopic oesophagitis.