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Multi-center randomized controlled study to establish the standard third-line regimen for Helicobacter pylori eradication in Japan

  • Original Article—Alimentary Tract
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Abstract

Backgrounds

The present study sought to establish a standard third-line eradication regimen for Helicobacter pylori in Japan.

Methods

Subjects were 204 patients with H. pylori infection in whom the standard Japanese first- and second-line eradication therapies had proven unsuccessful. Patients were randomly assigned to one of the following third-line eradication therapy groups: (1) LA group: lansoprazole (LPZ) 30 mg 4 times a day (qid) + amoxicillin (AMPC) 500 mg qid for two weeks; (2) LAL group: LPZ 30 mg twice a day (bid) + AMPC 750 mg bid + levofloxacin (LVFX) 300 mg bid for one week; (3) LAS group: LPZ 30 mg bid + AMPC 750 mg bid + sitafloxacin (STFX) 100 mg bid for one week. Patients for whom these therapies failed underwent a crossover fourth-line eradication regimen. Drug sensitivity was also tested for AMPC, clarithromycin (CAM), MNZ, LVFX, and STFX.

Results

Drug resistance rates prior to third-line eradication therapy were 86.4 % for CAM, 71.3 % for MNZ, 57.0 % for LVFX, 8.2 % for AMPC, and 7.7 % for STFX. Intention-to-treat analysis of third-line eradication therapy eradication rates showed a significantly higher rate in the LAS group (70.0 %) compared with the LA group (54.3 %; p < 0.05) and the LAL group (43.1 %; p < 0.001). The significantly lower rate in the LAL group than the LAS group was caused by bacterial resistance to LVFX.

Conclusions

The findings suggest that triple therapy with PPI, AMPC, and STFX for one week would be an effective standard third-line eradication regimen for H. pylori in Japan.

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Conflict of interest

Mototsugu Kato received lecture fees from Takeda Pharmaceutical Company. Hideyuki Nomura received lecture fees from Daiichi Sankyo Co. Ltd. and MSD. Takahisa Huruta received research grants from Takeda Pharmaceutical Co., Ltd., AstraZeneca KK, Eisai Co., Ltd., and Daiichi Sankyo Co. Ltd.

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Authors and Affiliations

  1. Department of Gastroenterology, Faculty of Medicine, Oita University, 1-1 Idaigaoka, Hasama-machi, Yuhu, Oita, 879-5593, Japan

    Kazunari Murakami, Masaaki Kodama & Tadayoshi Okimoto

  2. Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Japan

    Takahisa Furuta

  3. Gastroenterological Department, Social Insurance Kyoto Hospital, Kyoto, Japan

    Takashi Ando

  4. Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan

    Takeshi Nakajima

  5. Inui Clinic of Internal Medicine, Takasaki, Japan

    Yoshikatsu Inui

  6. Division of Upper Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan

    Tadayuki Oshima & Toshihiko Tomita

  7. Division of Endoscopy, Hokkaido University Hospital, 1-11, Nishi-5, Kita-14, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan

    Katsuhiro Mabe & Mototsugu Kato

  8. Department of Gastroenterology, Aichi Medical University School of Medicine, Nagakute, Japan

    Makoto Sasaki

  9. Japanese Foundation for Cancer Research Cancer Institute Hospital, Tokyo, Japan

    Takanori Suganuma

  10. Department of Internal Medicine, Shin-Kokura Hospital, Kitakyushu, Japan

    Hideyuki Nomura

  11. Division of Gastroenterology, Department of Internal Medicine, Jichi Medical University, Shimotsuke, Japan

    Kiichi Satoh

  12. National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan

    Shinichiro Hori

  13. National Hospital Organization Kochi National Hospital, Kochi, Japan

    Syuuji Inoue & Takeshi Tomokane

  14. Department of Gastroenterology, Sapporo Hokuyu Hospital, Sapporo, Japan

    Mineo Kudo

  15. Department of Gastroenterology, Kagawa Prefectural Central Hospital, Takamatsu, Japan

    Tomoki Inaba

  16. Department of Internal Medicine, Fukuwatari Municipal Hospital, Okayama, Japan

    Susumu Take

  17. Department of Gastroenterology and Hepatology, The Jikei University Kashiwa Hospital, Kashiwa, Japan

    Toshifumi Ohkusa

  18. Division of Gastroenterology and Hematology, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan

    Shojiro Yamamoto

  19. Department of Gastroenterology and Hepatology, Nihon University, School and Medicine, Tokyo, Japan

    Shigeaki Mizuno

  20. Hitachi General Hospital, Hitachi, Japan

    Toshiro Kamoshida

  21. Ibaraki Prefectual Central Hospital and Cancer Center, Ibaraki, Japan

    Kenji Amagai

  22. Tokyo Medical University, Ibaraki Medical Center, Ibaraki, Japan

    Junichi Iwamoto

  23. Toshiba General Hospital, Tokyo, Japan

    Jun Miwa

  24. Cancer Preventive Medicine, Hokkaido University School of Medicine, Hokkaido, Japan

    Masahiro Asaka

Authors
  1. Kazunari Murakami
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  2. Takahisa Furuta
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  3. Takashi Ando
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  4. Takeshi Nakajima
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  5. Yoshikatsu Inui
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  6. Tadayuki Oshima
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  7. Toshihiko Tomita
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  8. Katsuhiro Mabe
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  9. Makoto Sasaki
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  11. Hideyuki Nomura
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  12. Kiichi Satoh
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  13. Shinichiro Hori
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  14. Syuuji Inoue
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  15. Takeshi Tomokane
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  16. Mineo Kudo
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  17. Tomoki Inaba
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  18. Susumu Take
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  19. Toshifumi Ohkusa
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  20. Shojiro Yamamoto
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  21. Shigeaki Mizuno
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  22. Toshiro Kamoshida
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  23. Kenji Amagai
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  24. Junichi Iwamoto
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  25. Jun Miwa
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  26. Masaaki Kodama
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  27. Tadayoshi Okimoto
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  28. Mototsugu Kato
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  29. Masahiro Asaka
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Consortia

For the Japan GAST Study Group.

Corresponding authors

Correspondence to Kazunari Murakami or Mototsugu Kato.

Additional information

K. Murakami and M. Kato contributed equally to this work.

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Murakami, K., Furuta, T., Ando, T. et al. Multi-center randomized controlled study to establish the standard third-line regimen for Helicobacter pylori eradication in Japan. J Gastroenterol 48, 1128–1135 (2013). https://doi.org/10.1007/s00535-012-0731-8

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  • DOI: https://doi.org/10.1007/s00535-012-0731-8

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