Eradication efficacy of empiric bismuth quadruple therapy containing amoxicillin in the first-line treatment of Helicobacter pylori in Ningxia, China

Abstract OBJECTIVE: The objective was to evaluate the eradication rate and safety of bismuth quadruple therapy containing amoxicillin in the first-line empiric treatment in with high resistance to Helicobacter pylori ( H. pylori ) in China. METHODS: This was a retrospective study of 874 H.pylori -infected patients who attended the outpatient clinic of the Department of Gastroenterology of the People's Hospital of Ningxia Hui Autonomous Region from June 2021 to October 2022 and met the criteria for exclusion, including Esomeprazole-Bismuth-Amoxicillin-Clarithromycin (EBAC) group, Esomeprazole-Bismuth-Amoxicillin-Levofloxacin (EBAL) group, Esomeprazole-Bismuth-Amoxicillin-Furazolidone (EBAF) group, Esomeprazole-Bismuth-Amoxicillin-Tetracycline (EBAT) group, and the duration of treatment was 14 days. Eradication of H. pylori was determined by a repeat 14-carbon urease breath test (14C-UBT) at weeks 4-6 after the end of treatment. RESULTS: In the intention-to-treat analysis (ITT), the eradication rates of H. pylori in the EBAC, EBAL, EBAF, and EBAT groups were 74.2% (201/271), 75.4% (202/268), 82.9% (126/152), and 74.3% (136/183), respectively; and in the per-protocol (PP) analysis, the PP analysis eradication rates were 83.0% (201/245), 84.9%(202/238), 91.3%(126/138), and 82.4% (136/165), and the differences in the eradication rates of the four groups for ITT and PP analysis were not statistically significant (ITT: P = 0.186; PP: P = 0.086). The incidence rates of adverse event(AE) in the EBAC, EBAL, EBAF and EBAT groups was 13.9% (34/245), 8.4% (20/238), 24.0% (33/138) and 29.7% (49/165), respectively, with a statistically significant difference ( P < 0.001). Conclusion: The efficacy of the amoxicillin-containing regimens in the EBAC, EBAL, EBAT and EBAF groups in Ningxia, China, was similar, and all of them can be used for first-line treatment of H.pylori in this region, and the incidence of adverse effects of furazolidone and tetracycline should be monitored.