Efficacy of omeprazole versus ranitidine for symptomatic treatment of poorly responsive acid reflux disease - a prospective, controlled trial

Background: H-2-receptor antagonists are widely used in patients with gastr o-oesophageal reflux disease (GERD) and are frequently continued when sympt oms persist. Aim: To compare the efficacy of omeprazole 20 mg once daily with that of ra nitidine 150 mg twice daily in relieving GERD symptoms, in patients who rem ained symptomatic following a 6-week course of ranitidine therapy. Methods: Patients with heartburn on at least 4 days/week but who did not ha ve endoscopy to assess oesophageal mucosa could participate. This two-phase , prospective trial included a 6-week open-label phase (phase I), followed by an 8-week double-blind phase (phase II). Patients still symptomatic foll owing treatment with ranitidine 150 mg twice daily (phase I) were randomize d to double-blind treatment (phase II) with either omeprazole 20 mg once da ily or ranitidine 150 mg twice daily. The primary efficacy variable was the proportion of patients with heartburn resolution during weeks 4 and 8 of p hase II. Results: Of the 533 patients with GERD who received ranitidine in phase I, 348 patients (65%) were still symptomatic. A total of 317 patients (59%) we re randomized to double-blind treatment (phase II). At week 8, a significan tly (P < 0.0004) greater proportion of omeprazole-treated patients (70%) ex perienced no more than mild heartburn compared with ranitidine-treated pati ents (49%). Complete resolution of heartburn also occurred in a significant ly (P < 0.00001) greater proportion of omeprazole-treated patients (46% vs. 16% of the ranitidine group at week 8). Conclusions: After 6 weeks of ranitidine treatment, the majority of patient s with GERD were still experiencing moderate to severe heartburn. Omeprazol e was significantly more effective than ranitidine in resolving heartburn i n this group of patients.