Article Text

Original article
Sequential therapy for 10 days versus triple therapy for 14 days in the eradication of Helicobacter pylori in the community and hospital populations: a randomised trial
  1. Jyh-Ming Liou1,
  2. Chieh-Chang Chen1,
  3. Chi-Yang Chang2,
  4. Mei-Jyh Chen1,
  5. Chien-Chuan Chen1,
  6. Yu-Jen Fang3,
  7. Ji-Yuh Lee3,
  8. Tsung-Hua Yang3,
  9. Jiing-Chyuan Luo4,
  10. Jeng-Yih Wu5,
  11. Tai-Cherng Liou6,
  12. Wen-Hsiung Chang6,
  13. Yao-Chun Hsu2,
  14. Cheng-Hao Tseng2,
  15. Chun-Chao Chang7,
  16. Ming-Jong Bair8,9,
  17. Tzeng-Ying Liu10,
  18. Chun-Fu Hsieh10,
  19. Feng-Yun Tsao10,
  20. Chia-Tung Shun11,
  21. Jaw-Town Lin1,12,
  22. Yi-Chia Lee1,13,
  23. Ming-Shiang Wu1
  24. for the Taiwan Gastrointestinal Disease and Helicobacter Consortium
  1. 1Departments of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan
  2. 2Department of Internal Medicine, E-DA Hospital and I-Shou University, Kaohsiung County, Taiwan
  3. 3Departments of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, National Taiwan University College of Medicine, Yun-Lin, Taiwan
  4. 4Department of Medicine, National Yang-Ming University, School of Medicine, and Taipei Veterans General Hospital, Taipei, Taiwan
  5. 5Department of Internal Medicine, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
  6. 6Division of Gastroenterology, Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan
  7. 7Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan
  8. 8Division of Gastroenterology, Department of Internal Medicine, Mackay Memorial Hospital, Taitung, Taiwan
  9. 9Department of Nursing, Meiho University, Pingtung, Taiwan
  10. 10Lienchiang County Government and Health Bureau of Lienchiang County, Nangan Hsiang, Lienchiang County, Matsu, Taiwan
  11. 11Department of Pathology, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan
  12. 12School of Medicine, Fu Jen Catholic University, New Taipei City, Taiwan
  13. 13Graduate Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan
  1. Correspondence to Clinical associate professor Yi-Chia Lee, Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, No. 7, Chung-Shan S Road, Taipei 100, Taiwan; yichialee{at}ntu.edu.tw Professor Ming-Shiang Wu, Department of Internal Medicine and Primary Care Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, No. 7, Chung-Shan S Road, Taipei 100, Taiwan; mingshiang{at}ntu.edu.tw

Abstract

Objective Significant heterogeneity was observed in previous trials that assessed the efficacies of sequential therapy for 10 days (S10) versus triple therapy for 14 days (T14) in the first-line treatment of Helicobacter pylori. We aimed to compare the efficacy of S10 and T14 and assess the factors affecting their efficacies.

Design We conducted this open-label randomised multicentre trial in eight hospitals and one community in Taiwan. 1300 adult subjects with H pylori infection naïve to treatment were randomised (1:1) to receive S10 (lansoprazole and amoxicillin for the first 5 days, followed by lansoprazole, clarithromycin and metronidazole for another 5 days) or T14 (lansoprazole, amoxicillin and clarithromycin for 14 days). All drugs were given twice daily. Successful eradication was defined as negative 13C-urea breath test at least 6 weeks after treatment. Our primary outcome was the eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. Antibiotic resistance was determined by agar dilution test.

Results The eradication rates of S10 and T14 were 87.2% (567/650, 95% CI 84.4% to 89.6%) and 85.7% (557/650, 95% CI 82.8% to 88.2%) in the ITT analysis, respectively, and were 91.6% (556/607, 95% CI 89.1% to 93.4%) and 91.0% (548/602, 95% CI 88.5% to 93.1%) in the PP analysis, respectively. There were no differences in compliance or adverse effects. The eradication rates in strains susceptible and resistant to clarithromycin were 90.7% and 62.2%, respectively, for S10, and were 91.5% and 44.4%, respectively, for T14. The efficacy of T14, but not S10, was affected by CYP2C19 polymorphism.

Conclusions S10 was not superior to T14 in areas with low clarithromycin resistance.

Trial registration number NCT01607918.

  • HELICOBACTER PYLORI - TREATMENT
  • ANTIBIOTIC THERAPY

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Supplementary materials

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Footnotes

  • J-ML and C-Chang Chen contributed equally.

    Y-CL and M-SW contributed equally.

  • Contributors The study was conceived by J-ML, C-Chang Chen, Y-CL and M-SW with input from all the other listed contributors from the Taiwan Gastrointestinal Disease and Helicobacter Consortium. J-ML and M-SW designed the study and wrote the protocol. J-ML and Y-CL prepared the statistical analyses. J-ML, Y-CL, C-Chang Chen, M-JC, C-Chang Chen, C-YC, Y-JF, J-YL, T-HY, J-CL, J-YW, T-CL, W-HC, Y-CH, C-CChang, M-JB, C-HT, T-YL, C-FH, J-TL and M-SW recruited patients to the study. C-TS contributed to the histological assessment. J-ML drafted the article, which was critically revised by Y-CL and M-SW. M-SW supervised the hospital setting and Y-CL supervised the community setting in Matsu Island. All authors commented on drafts and approved the final version. All authors had full access to the data and participated in the decision to submit for publication.

  • Funding The study was funded by the National Taiwan University Hospital (103-002516) and the Ministry of Science and Technology, Executive Yuan, ROC, Taiwan (Grant Number: NSC 103-2325-B-002-022, 102-2628-B-002-034-MY3 and NSC 102-2325-B-002-074). The lansoprazole used in the present study was provided for free by the Takeda Company (Taiwan).

  • Disclaimer The funding source had no role in study design, data collection, analysis or interpretation, report writing or the decision to submit this paper for publication.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval The project was approved by the Institutional Review Board of NTUH and collaborative institutions.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Contact with J-ML for data sharing (dtmed046@pchome.com.tw).

  • J-ML and C-Chang Chen contributed equally.

  • Y-CL and M-SW contributed equally.

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