High-dose dual therapy is effective in the treatment of Helicobacter pylori

Abstract

Background: Mongolia has the world’s highest gastric cancer mortality rate and Helicobacter pylori are known as the carcinogen of gastric cancer. Successful eradication therapy plays a major role in reducing the mortality rate. H.pylori is the main carcinogen of gastric cancer. The clarithromycin-based triple treatment rate declined to 72.7% in Mongolia. The Maastricht VI guidelines recommended bismuth-containing quadruple therapy and other selective therapies as a first choice in cases of high resistance (>15%) based on the prevalence of clarithromycin resistance in the region if H. pylori culture is impossible. High-dose dual therapy, an alternative to selective treatment, is relatively new and less studied in our country, so it is necessary to study the results and side effects of treatment. Aim: We aimed to study the efÏcacy of high-dose dual therapy with fewer side effects, and compare it with bismuth-based quadruple treatment. Materials and Methods: We included 96 patients with documented H. pylori infections. Before enrollment, the status of H. pylori infection was confirmed by urease breath test, H. pylori stool antigen test and histology. All participants underwent upper GI endoscopy. Patients with positive results in at least two tests were eligible for enrollment. Eligible H. pylori-infected patients were randomly assigned to the high-dose dual therapy (n=96): 40 mg esomeprazole (KRKA.dd. Novo Mesto, Slovenia) three times a day, 1 g amoxicillin (Sandoz, Novartis, Switzerland) three times a day for 14 days, L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475(BioGaia, Sweden) once daily for 1 month. Cure rates were assessed using a urease breath test for H. pylori 28 days after the termination of treatment. Results: All subjects treated were included in the ITT analysis for H. pylori eradication. A total of 90 patients completed the study. According to ITT analysis cure rates for high-dose dual therapy were 87.5%, and Per-protocol analysis results for therapy were 93.3% (n=84, 95%CI, 90.2-96.4, р<0.001). Overall, 2 patients (2.1%)complained of side effects. The side effects were diarrhea. After H.pylori eradication treatment, abdominal pain decreased by 29.4%( p=0.002) and heartburn decreased by 46.6% (p=0.01). Conclusion: The 14-day esomeprazole and amoxicillin-containing high-dose dual therapy is effective in the first-line treatment of H.pylori.