Randomized Controlled Trial of Omeprazole Plus Amoxicillin vs. Triple Therapy for Eradication of Helicobacter pylori

Abstract

Our previous study and many others have shown that triple therapy with colloidal bismuth subcitrate, metronidazole, and tetracycline is effective in the treatment of Helicobacter pylori infecton. The combination of omeprazole and amoxicillin has also been claimed to be effective, with earlier symptom relief and less side effects. To compare the efficacy of the two regimens, a randomized controlled study was performed. From January to April 1994, 97 successive patients with endoscopically proven peptic ulcer and positive mucosal urease test results entered the study. Forty eight (48) patients were randomized to receive omeprazole 20 mg twice a day and amoxicillin 500 mg four times a day for 14 days (group O). The other 49 patients were assigned to take colloidal bismuth subcitrate 120 mg, tetracycline 250 mg, and metronidazole 250 mg each four times a day for 14 days (group T). Upper endoscopy was performed again at least 28 days after completion of treatment. There were 30 cases in group O aand 34 cases in group T who did not tank the medications as instructions as instructed or who effused to receive the second endoscopy after completion of treatment, and were excluded for data analysis. Mucosal urease became negative in 72.2% of patients in group O, comparable to 80.0% in group T (P＞0.1). Ulcers healed in 77.8% in group O and 73.3% in group T. For group O, 2 patients had diarrhea during treatment and one complained of constipation. For group T, 2 patients complained of diarrhea, and one complained of headache and backache. In conclusion, omeprazole plus amoxicillin is as effective as triple therapy for the eradication of H pylori. The 20 to 30% drug resistance rate demands more effective treatment in the future.