Treatment of Helicobacter pylori, Comparison of three Regimens, a double Blind Randomized Trial

Abstract

AIM: To compare the effectiveness of standard triple, sequential, and concomitant therapies for eradication of Helicobacter pylori in a randomized, double-blinded, comparative clinical trial conducted in Palestine. METHODS: Patients who underwent upper endoscopy for a clinical indication and tested positive for rapid urease test (RUT) were included, written consent was signed, and randomly allocated into three groups: Group A received the conventional Triple therapy; Esomeprazole 40 mg OD, Amoxicillin 1g and Clarithromycin 500 mg both given BID for 10 days; Group B received Sequential therapy; Esomeprazole 40 mg OD and Amoxicillin 1g BID for 5 days then Esomeprazole 40 mg OD, Clarithromycin 500 mg BID and Tinidazole 500 mg BID for another 5 days; and Group C received Concomitant therapy; Esomeprazole 40 mg OD, Amoxicillin 1g, Tinidazole 500 mg and Clarithromycin 500 mg all given BID, for 10 days. Stool antigen was done 4 weeks after completion of treatment. Binary logistic regression and X2 test with (P< 0.05) were used as appropriate to compare the eradication rates. RESULTS: Six hundred and seventy three (673) patients were tested by (RUT), of whom 242 patients (36%) had a positive RUT, 203 patients were included in the study and 163 patients completed the study. In Per Protocol analysis, the overall eradication rate was 73%. The eradication rates were 70.2%, 70.9% and 77.2% in Groups, A, B, and C respectively. Although the eradication rate achieved by the concomitant therapy was higher than both sequential and triple therapy, these differences were not statistically significant. CONCLUSION: The eradication rates were low with the three protocols. The three protocols are equal as first line treatment of H. pylori. The sequential and concomitant therapies were not superior to triple therapy. New regimens that are more effective, with a higher eradication rate need to be developed.