A comparative study of 14‐day dual therapy (esomeprazole and amoxicillin four times daily) and triple plus bismuth therapy for first‐line Helicobacter pylori infection eradication: A randomized trial

Abstract

Background Favorable outcomes in treating H pylori infection using “dual therapy (proton pump inhibitor and amoxicillin four times daily)” have attracted widespread attention. However, there are few reports, and the study results lack agreement. This study aimed to compare the eradication rate, safety, and compliance of naïve‐treatment patients with H pylori infection on “dual therapy” with those on “triple plus bismuth (TPB) therapy.” Methods This is a non‐inferior randomized controlled trial conducted on 760 patients with H pylori infection. The participants were randomly assigned to two eradication groups: dual therapy (esomeprazole 20 mg and amoxicillin 750 mg four times daily) and TPB therapy (esomeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and bismuth potassium citrate 220 mg twice daily) for 14 days. Safety and compliance were assessed within 3 days after eradication. Urea breath test was performed about 8 weeks after eradication to evaluate outcome. Antibiotic resistance and CYP2C19 polymorphism were determined. Results Compared with TPB therapy, dual therapy had significantly higher eradication rates in intention‐to‐treat (87.1% vs 80.5%, rate difference 6.6%), modified intention‐to‐treat (90.9% vs 85.5%, 5.5%) and per‐protocol (92.4% vs 87.8%, 4.7%) analyses, respectively. Adverse reactions in dual therapy group were significantly lower than TPB therapy group (17.6% vs 25.5%, P = .008), and dual therapy group had better compliance (96.3% vs 92.3%, P = .019). Antibiotic resistance and poor compliance were also associated with treatment failure. Conclusions Dual therapy (esomeprazole and amoxicillin four times daily) was non‐inferior to, and even superior to TPB therapy as first‐line H pylori eradication.

Antibiotic Resistance of Helicobacter Pylori and Influencing Factors in Yangzhou, China: a Cross-sectional Study

“…In addition, high-dose dual therapy is becoming familiar to doctors for great e cacy and lower side effects. The study conducted by Song et al reported that dual therapy (esomeprazole and amoxicillin four times daily) was non-inferior to, and even superior to triple plus bismuth therapy as rst-line H. pylori eradication treatment [39]. However, the ndings are not yet consistent and remains to be con rmed with further studies.…”

PPI‐amoxicillin dual therapy four times daily is superior to guidelines recommended regimens in the Helicobacter pylori eradication therapy within Asia: A systematic review and meta‐analysis

“…The current systematic reviews and meta-analyses showed that PPI-amoxicillin DT is not superior to other regimens, [16][17][18][19][20] however, several recent studies have shown that the PPI-amoxicillin DT administered four-times daily can obtain a high eradication rate, [5][6][7] deeming it as not just a combination of two drugs but also as a method with a pathophysiological basis to achieve satisfactory efficacy. Three main factors have been speculated to affect the efficacy of DT.…”

“…Six studies involving H. pylori first-line therapy encompassed 1999 patients. [5][6][7][23][24][25] In the ITT analysis, the eradication rate of the S6), (90.8% vs 88.2%, OR: 1.24, 95% CI: 0.77-2.00, p = 0.37, PP analysis) (Figure S7).…”

“…4 In recent years, proton-pump inhibitor (PPI) and amoxicillin dual therapy (DT) have gained increasing attention worldwide because of its good eradication efficacy in several studies. [5][6][7] Unge et al first used PPI and amoxicillin DT to eradicate H. pylori in 1989, 8 and then, many investigators carried out clinical studies and used PPI and amoxicillin at different dosages, frequencies, and durations to explore the eradication efficacy of DT, but a consistent and satisfactory eradication rate has not yet been attained. 9,10 With the in-depth study on the pharmacokinetics, pharmacodynamics, and pharmacogenomics of PPI and amoxicillin, the pathophysiological mechanisms of DT have been elucidated.…”

“…pylori to amoxicillin are maintained at a low level 4 . In recent years, proton‐pump inhibitor (PPI) and amoxicillin dual therapy (DT) have gained increasing attention worldwide because of its good eradication efficacy in several studies 5‐7 . Unge et al first used PPI and amoxicillin DT to eradicate H .…”