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. 2018 Nov;97(46):e13245.
doi: 10.1097/MD.0000000000013245.

Modified quadruple therapy versus bismuth-containing quadruple therapy in first-line treatment of Helicobacter pylori infection in Korea; rationale and design of an open-label, multicenter, randomized controlled trial

Hyun Lim  1 , Chang Seok Bang  1   2 , Woon Geon Shin  1 , Jae Ho Choi  2 , Jae Seung Soh  1 , Ho Suk Kang  1 , Young Joo Yang  1   2 , Ji Taek Hong  1 , Suk Pyo Shin  1 , Ki Tae Suk  1 , Jae Jun Lee  2   3 , Gwang Ho Baik  1 , Dong Joon Kim  1
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Modified quadruple therapy versus bismuth-containing quadruple therapy in first-line treatment of Helicobacter pylori infection in Korea; rationale and design of an open-label, multicenter, randomized controlled trial

Hyun Lim et al. Medicine (Baltimore). 2018 Nov.

Abstract

Background: Clarithromycin-containing triple regimen for eradication of Helicobacter pylori is no longer acceptable in Korea due to high clarithromycin resistance. Concomitant therapy or bismuth-containing quadruple therapy is recommended as an alternative regimen. A recent study in Korea has shown that modified quadruple therapy has comparable efficacy and safety to concomitant therapy as a first-line regimen. However, there has been no comparative study of modified quadruple therapy with bismuth-containing quadruple therapy. The aim of this study is to compare the efficacy and safety of modified quadruple therapy with those of bismuth-containing quadruple therapy as a first-line regimen and to present the phenotypic and genotypic antibiotic resistance profile of H pylori.

Methods: This study is an open-label, multicenter, randomized controlled trial. We are recruiting subjects endoscopically diagnosed with H pylori infection from 2 hospitals in Korea. Subjects will be randomly allocated either to modified quadruple therapy (proton-pump inhibitor bid, amoxicillin 1 g bid, metronidazole 500 mg tid, bismuth subcitrate 300 mg qid daily) or bismuth-containing quadruple therapy (proton-pump inhibitor bid, tetracycline 500 mg qid, metronidazole 500 mg tid, bismuth subcitrate 300 mg qid daily) for 14 days. The rate of eradication success and adverse events will be checked at least 4 weeks after the treatment. Antibiotic resistance will be established using both a bacterial culture with agar dilutions and DNA sequencing of the clarithromycin resistance point mutations in the 23S rRNA gene of H pylori.

Conclusion: The results of this study will provide solid evidence for determining the optimal treatment regimen for first-line H pylori eradication in Korea.

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Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Flow chart of the study. ITT = intention-to-treat, n = number, PP = per-protocol.
See this image and copyright information in PMC

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References

    1. Schistosomes, liver flukes and Helicobacter pylori. IARC Working Group on the Evaluation of Carcinogenic Risks to Humans. Lyon, 7-14 June 1994. IARC Monogr Eval Carcinog Risks Hum. 1994;61:1–241. - PMC - PubMed
    1. Kwak HW, Choi IJ, Cho SJ, et al. Characteristics of gastric cancer according to Helicobacter pylori infection status. J Gastroenterol Hepatol 2014;29:1671–7. - PubMed
    1. Correa P. A human model of gastric carcinogenesis. Cancer Res 1988;48:3554–60. - PubMed
    1. Choi IJ, Kook MC, Kim YI, et al. Helicobacter pylori therapy for the prevention of metachronous gastric cancer. N Engl J Med 2018;378:1085–95. - PubMed
    1. Lee YC, Chiang TH, Chou CK, et al. Association between Helicobacter pylori eradication and gastric cancer incidence: a systematic review and meta-analysis. Gastroenterology 2016;150:1113–24. - PubMed

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