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Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: A randomized study

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Abstract

Background

Antimicrobial resistance has decreased eradication rates for Helicobacter pylori infection worldwide. A sequential treatment schedule has been reported to be effective, but studies published to date were performed in Italy. We undertook this study to determine whether these results could be replicated in India.

Methods

A randomized, open-labeled, prospective controlled trial comparing sequential vs. standard triple-drug therapy was carried out at Lokmanya Tilak Municipal General Hospital, Mumbai. Two hundred and thirty-one patients with dyspepsia were randomized to a 10-day sequential regimen (40 mg of pantoprazole, 1 g of amoxicillin, each administered twice daily for the first 5 days, followed by 40 mg of pantoprazole, 500 mg of clarithromycin, and 500 mg of tinidazole, each administered twice daily for the remaining 5 days) or to standard 14-day therapy (40 mg of pantoprazole, 500 mg of clarithromycin, and 1 g of amoxicillin, each administered twice daily).

Results

The eradication rate achieved with the sequential regimen was significantly greater than that obtained with the triple therapy. Per-protocol eradication rate of sequential therapy was 92.4 % (95 % CI 85.8–96.1 %) vs. 81.8 % (95 % CI 73.9–87.8 %) (p = 0.027) for standard drug therapy. Intention-to-treat eradication rates were 88.2 % (95 % CI 80.9–93.0 %) vs. 79.1 % (95 % CI 71.1–85.4 %), p = 0.029, respectively. The incidence of major and minor side effects between therapy groups was not significantly different (14.6 % in the triple therapy group vs. 23.5 % in sequential group, p = 0.12). Follow up was incomplete in 3.3 % and 4.7 % patients in standard and sequential therapy groups, respectively. Sequential therapy includes one additional antibiotic (tinidazole) that is not contained in standard therapy.

Conclusions

Sequential therapy was significantly better than standard therapy for eradicating H. pylori infection.

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References

  1. Megraud F. Epidemiology of Helicobacter pylori. Gastroenterol Clin North Am. 1993;22:73–88.

    PubMed  CAS  Google Scholar 

  2. Malfertheiner P, Megraud F, O'Morain CA, et al. European Helicobacter Study Group. Management of Helicobacter pylori infection—the Maastricht IV/Florence Consensus Report. Gut. 2012;61:646–64.

    Article  PubMed  CAS  Google Scholar 

  3. Miehlke S, Kirsch C, Schneider-Brachert W, et al. A prospective, randomized study of quadruple therapy and high dose dual therapy for treatment of Helicobacter pylori resistant to both metronidazole and clarithromycin. Helicobacter. 2003;8:310–9.

    Article  PubMed  CAS  Google Scholar 

  4. Vakil N, Lanza F, Schwartz H, et al. Seven-day therapy for Helicobacter pylori in the United States. Aliment Pharmacol Ther. 2004;20:99–107.

    Article  PubMed  CAS  Google Scholar 

  5. Malfertheiner P, Megraud F, O'Morain C, et al. Current concepts in the management of Helicobacter pylori infection: the Maastricht III consensus report. Gut. 2007;56:772–81.

    Article  PubMed  CAS  Google Scholar 

  6. Chiba N, Van Zanten SJ, Sinclair P, Ferguson RA, Escobedo S, Grace E. Treating Helicobacter pylori infection in primary care patients with uninvestigated dyspepsia: the Canadian adult dyspepsia empiric treatment-Helicobacter pylori positive (CADET-Hp) randomised controlled trial. BMJ. 2002;324:1012–6.

    Article  PubMed  CAS  Google Scholar 

  7. Zullo A, Rinaldi V, Winn S, et al. A new highly effective short-term therapy schedule for Helicobacter pylori eradication. Aliment Pharmacol Ther. 2000;14:715–8.

    Article  PubMed  CAS  Google Scholar 

  8. De Francesco V, Zullo A, Hassan C, et al. Two new treatment regimens for Helicobacter pylori eradication: a randomised study. Dig Liver Dis. 2001;33:676–9.

    Article  PubMed  Google Scholar 

  9. Zullo A, Vaira D, Vakil N, et al. High eradication rates of Helicobacter pylori with a new sequential treatment. Aliment Pharmacol Ther. 2003;17:719–26.

    Article  PubMed  CAS  Google Scholar 

  10. Vaira D, Zullo A, Vakil N, et al. Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a randomized trial. Ann Intern Med. 2007;146:556–63.

    Article  PubMed  Google Scholar 

  11. Zullo A, De Francesco V, Hassan C, Morini S, Vaira D. The sequential therapy regimen for Helicobacter pylori eradication: a pooled-data analysis. Gut. 2007;56:1353–7.

    Article  PubMed  CAS  Google Scholar 

  12. Chaudhuri S, Chowdhury A, Datta S, et al. Anti-Helicobacter pylori therapy in India: differences in eradication efficiency associated with particular alleles of vacuolating cytotoxin (vacA) gene. J Gastroenterol Hepatol. 2003;18:190–5.

    Article  PubMed  CAS  Google Scholar 

  13. Valooran GJ, Kate V, Jagdish S, et al. Sequential therapy versus standard triple drug therapy for eradication of Helicobacter pylori in patients with perforated duodenal ulcer following simple closure. Scand J Gastroenterol. 2011;46:1045–50.

    Article  PubMed  CAS  Google Scholar 

  14. Francavilla R, Lionetti E, Castellaneta SP, et al. Improved efficacy of 10-day sequential treatment for Helicobacter pylori eradication in children: a randomized trial. Gastroenterology. 2005;129:1414–9.

    Article  PubMed  CAS  Google Scholar 

  15. Hassan C, De Francesco V, Zullo A, et al. Sequential treatment for Helicobacter pylori eradication in duodenal ulcer patients: improving the cost of pharmacotherapy. Aliment Pharmacol Ther. 2003;18:641–6.

    Article  PubMed  CAS  Google Scholar 

  16. Amarapurkar D, Makesar M, Amarapurkar A, Das HS. Helicobacter pylori eradication: efficacy of conventional therapy in India. Trop Doct. 2004;34:101–2.

    PubMed  Google Scholar 

  17. Kumar D, Ahuja V, Dhar A, et al. Randomized trial of a quadruple-drug regimen and a triple-drug regimen for eradication of Helicobacter pylori: long-term follow-up study. Indian J Gastroenterol. 2001;20:191–4.

    PubMed  CAS  Google Scholar 

  18. Thyagarajan SP, Ray P, Das BK, et al. Geographical difference in antimicrobial resistance pattern of Helicobacter pylori clinical isolates from Indian patients: multicentric study. J Gastroenterol Hepatol. 2003;18:1373–8.

    Article  PubMed  CAS  Google Scholar 

  19. Datta S, Chattopadhyay S, Patra R, et al. Most Helicobacter pylori strains of Kolkata in India are resistant to metronidazole but susceptible to other drugs commonly used for eradication and ulcer therapy. Aliment Pharmacol Ther. 2005;22:51–7.

    Article  PubMed  CAS  Google Scholar 

  20. Ramakrishna BS. Helicobacter pylori infection in India: the case against eradication. Indian J Gastroenterol. 2006;25:25–8.

    PubMed  CAS  Google Scholar 

  21. Moayyedi P, Soo S, Deeks J, et al. Eradication of Helicobacter pylori for non-ulcer dyspepsia. Cochrane Database Syst Rev. 2005;1, CD002096.

    PubMed  Google Scholar 

  22. Talley NJ, Vakil N. Guidelines for the management of dyspepsia. Am J Gastroenterol. 2005;100:2324–37.

    Article  PubMed  Google Scholar 

  23. Bhasin DK, Sharma BC, Ray P, Pathak CM, Singh K. Comparison of seven and fourteen days of lansoprazole, clarithromycin, and amoxicillin therapy for eradication of Helicobacter pylori: a report from India. Helicobacter. 2000;5:84–7.

    Article  PubMed  CAS  Google Scholar 

  24. Bhatia V, Ahuja V, Das B, Bal C, Sharma MP. Use of imidazole-based eradication regimens for Helicobacter pylori should be abandoned in North India regardless of in vitro antibiotic sensitivity. J Gastroenterol Hepatol. 2004;19:619–25.

    Article  PubMed  CAS  Google Scholar 

  25. Bapat MR, Abraham P, Bhandarkar PV, Phadke AY, Joshi AS. Acquisition of Helicobacter pylori infection and reinfection after its eradication are uncommon in Indian adults. Indian J Gastroenterol. 2000;19:172–4.

    PubMed  CAS  Google Scholar 

  26. Nanivadekar SA, Sawant PD, Patel HD, Shroff CP, Popat UR, Bhatt PP. Association or peptic ulcer with Helicobacter pylori and the recurrence rate. A three year follow up study. J Assoc Physicians India. 1990;38 Suppl 1:703–6.

    PubMed  Google Scholar 

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Authors and Affiliations

  1. Department of Gastroenterology, Lokmanya Tilak Municipal General Hospital, Sion, Mumbai, 400 022, India

    Mukesh Nasa, Ajay Choksey, Aniruddha Phadke & Prabha Sawant

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  1. Mukesh Nasa
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  2. Ajay Choksey
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  3. Aniruddha Phadke
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  4. Prabha Sawant
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Correspondence to Mukesh Nasa.

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Nasa, M., Choksey, A., Phadke, A. et al. Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: A randomized study. Indian J Gastroenterol 32, 392–396 (2013). https://doi.org/10.1007/s12664-013-0357-7

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  • DOI: https://doi.org/10.1007/s12664-013-0357-7

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