Hybrid, High-Dose Dual and Bismuth Quadruple Therapies for First-Line Treatment of Helicobacter pylori Infection in Taiwan: A Multicenter, Open-Label, Randomized Trial

Abstract

The study aimed to compare the efficacies and safety of 14-day hybrid therapy, 14-day high-dose dual therapy, and 10-day bismuth quadruple therapy in the first-line treatment of Helicobacter pylori infections. METHODS:In this multicenter, open-label, randomized trial, we recruited adult H. pylori-infected patients from 9 centers in Taiwan. Subjects were randomly assigned (1:1:1) to 14-day hybrid therapy, 14-day high-dose dual therapy, or 10-day bismuth quadruple therapy. Eradication status was determined by the 13 C-urea breath test. The primary outcome was the eradication rate of H. pylori assessed in the intention-to-treat population.

10-Day versus 14-day bismuth quadruple therapy for first-line eradication of Helicobacter pylori infection: a randomised, open-label, non-inferiority trial

“…Female sex is a factor of eradication failure with concomitant therapy or sequential therapy, 25 but not of 10-day bismuth quadruple therapy. 7 , 8 , 9 In this study, sex-based analyses confirmed that the efficacy of 10-day bismuth quadruple therapy was non-inferior to that of 14-day therapy in male sex. However, the issue regarding whether 10-day therapy is non-inferior in female sex is inconclusive because our study was not designed to test this hypothesis.…”

“… 28 The prevalence rates of primary antibiotic resistance to metronidazole, tetracycline, and clarithromycin are about 35%, 0%, and 20% in Taiwan, respectively. 9 , 29 , 30 It is justifiable to suggest 10-day bismuth quadruple therapy for first-line H. pylori eradication because it achieves adequate efficacy in geographic regions without high-level metronidazole resistance and its results are similar to estimated results. 22 Nevertheless, the efficacy of 10-day standard bismuth quadruple therapy may not be applicable to geographic regions where the prevalence of metronidazole-resistant H. pylori is >40%.…”

“… 5 Sequential therapy extending from 10 days to 14 days potentially had better eradication efficacy. 6 Nevertheless, previous studies found that 10-day standard bismuth quadruple therapy achieved high efficacy for first-line H. pylori eradication, as determined by intention-to-treat (ITT) analyses (≥90%) and per-protocol (PP) analyses (≥95%) 7 , 8 , 9 ; thus, extending bismuth quadruple therapy from 10 days to 14 days might have a limited effect on the eradication rate. However, females have higher antibiotic resistance rates in H. pylori infection than males do.…”

It Is Time for a Paradigm Shift in Design, Execution, and Publishing of Comparative Helicobacter pylori Treatment Trials

“…The recent comparative study of 3 different Helicobacter pylori treatment regimens currently in use in Taiwan is representative of the approach to the investigation of H. pylori therapy that has evolved over 3 decades (1). The cure rates with 2 of the regimens (14-day hybrid therapy and 10-day bismuth quadruple therapy) were approximately 90%, whereas of a 14-day high-dose amoxicillin (750 mg q.i.d.)…”

Thinking of the Long Puzzling Issue of Several Suboptimal Treatments of Helicobacter pylori Infection

“…Hsu et al (1) concluded that 14-day hybrid therapy and 10-day bismuth quadruple therapy as the first-line treatments of Helicobacter pylori infection (H. pylori-I) can theoretically achieve an optimal eradication rate of $90% in several global areas. However, for example, another study by Hsu et al (2) signifies that 14-day hybrid first-line therapy achieves a suboptimal eradication rate (,90%) when the incidence of clarithromycinresistant strains is high (2).…”