Seven Days of Bismuth-Based Quadruple Therapy Is as Effective for the First-Line Treatment of Clarithromycin-Resistant Confirmed Helicobacter pylori Infection as 14 Days of Bismuth-Based Quadruple Therapy

Abstract

Background/Aims: Point mutations in the 23S ribosomal RNA gene have been associated with Helicobacter pylori (H. pylori) clarithromycin resistance and bismuth-based quadruple therapy (BQT) is one of the options for the treatment of clarithromycin-resistant H. pylori. Current H. pylori treatment guidelines recommend BQT for 10–14 days. This study aims to compare the eradication extents according to 7-day and 14-day BQT treatment for treatment-naïve clarithromycin-resistant confirmed H. pylori infection. Methods: We retrospectively investigated treatment-naïve H. pylori infection cases from March 2019 to December 2020, where patients were treated with BQT. Clarithromycin resistance was identified with a dual-priming oligonucleotide-based multiplex polymerase chain reaction method. We reviewed a total of 126 cases. Fifty-three subjects were treated with a 7-day BQT regimen (7-day group), and 73 subjects were treated with a 14-day BQT regimen (14-day group). We evaluated the total eradication extent of the BQT and compared the eradication extents of the two study groups. Results: Total eradication extent of H. pylori was 83.3% (105/126). The eradication extents of the two groups were as follows: 7-day group (81.1% (43/53)), 14-day group (84.9% (62/73), p = 0.572) by intention-to-treat analysis; 7-day group (95.6% (43/45)), 14-day group (92.5% (62/67), p = 0.518) by per-protocol analysis. The moderate or severe adverse event extents during the eradication were 30.2% (16/53) in the 7-day group and 19.2% (14/73) in the 14-day group (p = 0.152). Conclusions: The 7-day BQT regimen was as effective as the 14-day BQT regimen in the eradication of treatment-naïve clarithromycin-resistant H. pylori infection.

Bismuth-Based Quadruple Therapy as First-Line Treatment for Clarithromycin-resistant Helicobacter pylori Infection: A Prospective Randomized Comparison of 7- and 14-Day Treatment Regimens

“…Previous retrospective studies showed similar eradication results with 80.0 to 100% in both 7-and 14-day BQT treatment in the PP analysis. 18,20,24 Although the number of A2142G mutation was small and a larger number of A2142G mutation data will be required, the results of our study and previous studies suggest that the type of 23S rRNA point mutation conferring clarithromycin resistance may not influence the eradication rate of BQT or outcomes according to treatment duration. Adverse events during HP eradication treatment influence treatment compliance.…”

“…13 Previous retrospective studies of the first-line treatment of HP infections confirmed to be clarithromycin-resistant by the PCR assay showed no significant differences between 7and 14-day BQT treatment. 18,20,24 The eradication rates of 7-and 14-day BQT treatment in those studies were 91.1% to 95.6% and 90.3% to 100% in PP analysis. Our prospective randomized study showed that the eradication rate of 14-day BQT treatment was higher than that of 7-day treatment, but the difference was not statistically significant.…”

“…This study showed that the A2143G mutation was the dominant mutation conferring clarithromycin resistance in this study, coinciding with the known distribution of clarithromycin resistance mutations. 7,20,24,25 Previous retrospective studies showed that eradication rates in A2142G mutation and both (A2142G and A2143G) mutation were 90.6% to 97.5% and 90.0% to 100% without significant differences in the PP analysis. 18,20,24 Our finding was consistent with those studies.…”

“…7,20,24,25 Previous retrospective studies showed that eradication rates in A2142G mutation and both (A2142G and A2143G) mutation were 90.6% to 97.5% and 90.0% to 100% without significant differences in the PP analysis. 18,20,24 Our finding was consistent with those studies. Although eradication rates in A2142G mutation were 100% in both 7-and 14-day BQT treatment in PP analysis of our study.…”

“…The clinical significance criterion was set at 15% assuming an eradication rate of 90% based on the previous prospective studies, 14,16,19,20 and the number of subjects was calculated according to the formula below under the assumption that equivalence between the two groups was tested.…”