Sequential and concomitant non-bismuth quadruple therapies are ineffective for <i>H. pylori</i> eradication in Palestine. A randomized trial

Abstract

Background: Increasing clarithromycin resistance has undermined the effectiveness of traditional clarithromycin-containing triple eradication therapy of Helicobacter pylori infections. Sequential and concomitant therapies show improved outcome with clarithromycin resistance. Aim: To evaluate the effectiveness of sequential and concomitant 4-drug non-bismuth therapies for eradication of Helicobacter pylori in a prospective, randomized, clinical trial conducted in Palestine. Patients and Methods: Patients who underwent upper endoscopy for a clinical indication and tested positive for rapid urease test were included. Subjects randomly allocated into two groups: One received a modified sequential therapy: esomeprazole 40 mg OD and amoxicillin 1 g BID for 5 days then esomeprazole 40 mg OD, clarithromycin 500 mg BID and tinidazole 500 mg BID for another 5 days. The other group received concomitant therapy in which the same 4 drugs and doses were all given daily for 10 days. Stool antigen was tested 4 weeks after completion of treatment. Results: Five hundred thirty three (533) patients were tested for H. pylori and 180 (34%) were positive; 141 patients were included in the study and 112 patients completed. The overall per protocol eradication rate was (74%; 95% CI = 65.9% - 82.1%). The eradication rates for sequential therapy was, (70.9%; 95% CI = 58.9% - 82.9%) and for concomitant therapy (77.2%; 95% CI = 66.3% - 88.1%). The results intention-to-treat were: sequential 61%, concomitant 57%. Conclusion: Neither sequential nor concomitant therapy achieved an acceptable H. pylori eradiation rate in Palestine.