Omeprazole is more effective than cimetidine for the relief of all grades of gastro‐oesophageal reflux disease‐associated heartburn, irrespective of the presence or absence of endoscopic oesophagitis

Abstract

Background: Previous studies have demonstrated greater efficacy for omeprazole compared with cimetidine in patients with endoscopically verified oesophagitis, but excluded the substantial group of gastro‐oesophageal reflux disease (GERD) patients with reflux symptoms but without endoscopic abnormality. This prospective, randomized, double‐blind study compared omeprazole and cimetidine in the treatment of GERD‐associated heartburn both in patients with symptomatic non‐ulcerative oesophagitis and in those with heartburn but without oesophagitis. Methods: A total of 221 patients with heartburn and oesophageal mucosa grade 0 (normal, n = 51), 1 (no macroscopic erosions, n = 52), 2 (isolated erosions, n = 97) or 3 (confluent erosions, n = 21) were randomized to receive 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. Results: There was no correlation between severity of heartburn and endoscopic grade at entry (correlation coefficient = 0.196). After 4 weeks of treatment, the proportion of patients in whom heartburn was controlled (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 between the relief of heartburn in the 47% of patients without unequivocal oesophagitis (endoscopic grade 0 or 1) and in the 53% of patients with erosive oesophagitis (grade 2 or 3) (P = 0.31). Only treatment with omeprazole (P < 0.0001) and lower severity of heartburn at entry (P < 0.01) were significant in predicting heartburn relief. Amongst those patients requiring an additional 4 weeks of treatment with omeprazole, 67% (54/81) reported that their heartburn was controlled after 8 weeks of treatment. Conclusion: We conclude that omeprazole is superior to cimetidine for the relief of all grades of heartburn in GERD, whether or not the patient has unequivocal endoscopic oesophagitis.

Digestive system disorders: gastroesophageal reflux disease

“…20 Another RCT compared the use of omeprazole, 20 mg, versus that of cimetidine, 400 mg (108 people), and found significantly greater symptom relief in those taking omeprazole (66% free of heartburn with omeprazole vs 31% with cimetidine; ARR 34%, 95% CI 21%-46%). 21 Similar results were found when treatment with omeprazole, 20 or 10 mg, was compared with that of cisapride, 40 mg (10 mg 4 times a day). 22 In most trials, symptom relief was about twice as good with omeprazole.…”

Efficacy of Omeprazole for the Treatment of Symptomatic Acid Reflux Disease Without Esophagitis

“…36 In these studies, omeprazole, 20 mg once daily, produced significantly higher rates of symptom resolution, including relief of heartburn, than did ranitidine, 150 mg twice daily, [22][23][24]37,38 or cimetidine, 400 mg 4 times daily. 39 In studies comparing lansoprazole and ranitidine, treatment with lansoprazole, 30 mg once daily, resulted in significantly greater relief of heartburn than did ranitidine, 150 mg twice daily. 25,26 The findings of the present study are consistent with those of a multicenter trial conducted in Scandinavia in a similar patient population in which Lind et al 40 found that omeprazole, 20 mg once daily, was significantly more efficacious than either omeprazole, 10 mg daily, or placebo for the treatment of heartburn in patients with symptomatic GERD without erosive esophagitis.…”

Pathophysiology and Pharmacological Treatment of Gastroesophageal Reflux Disease

“…These drugs are effective in healing reflux esophagitis and relieving related symptoms. Several studies have demonstrated that omeprazole is superior to H 2 blockers or prokinetics in the treatment of reflux esophagitis [4,14,31].…”

“…after 4 weeks of treatment for For severe esophagitis even high doses of H 2 blockers do not appear to be as effective as PPI [50]. In a randomthe relief of all grades of heartburn in GERD, whether or not the patient has unequivocal endoscopic esophagitis ized, double-blinded study on patients with symptomatic, endoscopically confirmed erosive GERD, omeprazole (66 vs. 31%) [4]. Comparable to the H 2 blockers, omeprazole is also superior to therapy with prokinetics in the (20 mg) was superior to cimetidine (400 mg; q.i.d.)…”