Evaluation of Levofloxacin-containing Regime in Comparison with Clarithromycin-containing Regime in Eradicating Helicobacter pylori Infection in Kerman

Document Type : Original Article

Authors

1 Gastroenterology and Hepatology Research Center, Institute of Basic and Clinical Physiology Sciences, Kerman University of Medical Sciences, Kerman, Iran

2 Department of Internal Medicine, School of Medicine, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran

3 Department of Medical Basic Sciences, School of Medicine, Bam University of Medical Sciences, Bam, Iran

4 1. Gastroenterology and Hepatology Research Center, Institute of Basic and Clinical Physiology Sciences, Kerman University of Medical Sciences, Kerman, Iran

5 Sepehr Laboratory, Kerman, Iran

Abstract

Background: Helicobacter pylori (H.pylori) is the main known cause of gastritis, gastroduodenal ulcer disease, and gastric cancer. Eradication of H.pylori can be an effective method of treatment for peptic ulcer disease and mucosa‐associated lymphoid tissue lymphoma. This study aimed to compare the effectiveness of levofloxacin versus clarithromycin in the eradication of H.pylori.
Methods: This randomized clinical trial was conducted on 170 cases with H.pylori infection in Kerman. The participants were randomly allocated to two groups. As the first line therapy, ‘A’ group was treated twice a day with clarithromycin (500mg), pantoprazole (40mg) and amoxicillin (1gr) for 14 days and ‘B’ group was treated twice a day with levofloxacin (250mg), pantoprazole (40mg) and amoxicillin (1gr) for 14 days. Stool H.pylori antigen test was performed one month after the end of treatment. To analyze the data, descriptive and analytical methods and SPSS software version 22 were used.
Results: The study cases were comprised of 170 individuals (52.35%female). The mean age of patients in ‘A’ and ‘B’ groups was 42±11.88 and 41±13.75 years, respectively. H.pylori eradication was successful in 61.1% of ‘A’ group and 92.9% of ‘B’ group showing a significant difference (P=0.037). Drug complications were reported in 7.1% of ‘A’ group and 4.7% of ‘B’ group which showed no significant difference between the two groups (P=0.772). The most common drug complication in both groups was abdominal pain (2.3%).
Conclusion: The results of this study indicated that levofloxacin-containing regimen was more effective in eradicating H.pylori than the standard clarithromycin triple therapy.

Keywords


  1. Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG clinical guideline: Treatment of helicobacter pylori Infection. Am J Gastroenterol. 2017; 112(2):212-39. doi: 10.1038/ajg.2016.563.
  2. Fischbach W, Malfertheiner P, Lynen Jansen P, Bolten W, Bornschein J, Buderus S, et al. Verantwortlich für die DGVS. S2k-Leitlinie Helicobacter pylori und gastroduodenale Ulkuskrankheit [S2k-guideline Helicobacter pylori and gastroduodenal ulcer disease]. Z Gastroenterol. 2016; 54(4):327-63. German. doi: 10.1055/s-0042-102967.
  3. McColl KE. Clinical practice. Helicobacter pylori infection. N Engl J Med. 2010; 362(17):1597-604. doi: 10.1056/NEJMcp1001110.
  4. NIH Consensus Conference. Helicobacter pylori in peptic ulcer disease. NIH Consensus Development Panel on Helicobacter pylori in Peptic Ulcer Disease. JAMA. 1994; 272(1):65-9. PMID: 8007082.
  5. Kasper DL, Fauci AS, Hauser SL, Longo DL, Jameson JL, Loscalzo J. Harrison's principles of internal medicine. 17th ed. Internal Medicine Journal. 2015‎‏; 38(12):932. doi: 10.1111/j.1445-5994.2008.01837.x.
  6. Hsu PI, Lai KH, Hsu PN, Lo GH, Yu HC, Chen WC, et al. Helicobacter pylori infection and the risk of gastric malignancy. Am J Gastroenterol. 2007; 102(4):725-30. doi: 10.1111/j.1572-0241.2006.01109.x.
  7. Ford AC, Delaney BC, Forman D, Moayyedi P. Eradication therapy in Helicobacter pylori positive peptic ulcer disease: Systematic review and economic analysis. Am J Gastroenterol. 2004; 99(9):1833-55. doi: 10.1111/j.1572-0241.2004.40014.x.
  8. Ables AZ, Simon I, Melton ER. Update on Helicobacter pylori treatment. Am Fam Physician. 2007; 75(3):351-8. PMID: 17304866.
  9. Chen LT, Lin JT, Tai JJ, Chen GH, Yeh HZ, Yang SS, et al. Long-term results of anti-Helicobacter pylori therapy in early-stage gastric high-grade transformed MALT lymphoma. J Natl Cancer Inst. 2005; 97(18):1345-53. doi: 10.1093/jnci/dji277.
  10. Morgner A, Bayerdörffer E, Neubauer A, Stolte M. Malignant tumors of the stomach. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori. Gastroenterol Clin North Am. 2000; 29(3):593-607. doi: 10.1016/s0889-8553(05)70132-1.
  11. Adamek RJ, Suerbaum S, Pfaffenbach B, Opferkuch W. Primary and acquired Helicobacter pylori resistance to clarithromycin, metronidazole, and amoxicillin--influence on treatment outcome. Am J Gastroenterol. 1998; 93(3):386-9. doi: 10.1111/j.1572-0241.1998.00386.x.
  12. Massarrat S, Saberi-Firoozi M, Soleimani A, Himmelmann GW, Hitzges M, Keshavarz H. Peptic ulcer disease, irritable bowel syndrome and constipation in two populations in Iran. Eur J Gastroenterol Hepatol. 1995; 7(5):427-33. PMID: 7614105.
  13. Mégraud F. H pylori antibiotic resistance: prevalence, importance, and advances in testing. Gut. 2004; 53(9):1374-84. doi: 10.1136/gut.2003.022111.
  14. Collins J, Ali-Ibrahim A, Smoot DT. Antibiotic therapy for Helicobacter pylori. Med Clin North Am. 2006; 90(6):1125-40. doi: 10.1016/j.mcna.2006.07.002. 
  15. Mohammadi M, Attaran B, Malekzadeh R, Graham DY. Furazolidone, an Underutilized Drug for H. pylori Eradication: Lessons from Iran. Dig Dis Sci. 2017; 62(8):1890-6. doi: 10.1007/s10620-017-4628-5.
  16. Walsh JH, Peterson WL. The treatment of Helicobacter pylori infection in the management of peptic ulcer disease. N Engl J Med. 1995; 333(15):984-91. doi: 10.1056/NEJM199510123331508.
  17. Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, et al. European Helicobacter and microbiota study group and consensus panel. management of Helicobacter pylori infection-the maastricht V/florence consensus report. Gut. 2017; 66(1):6-30. doi: 10.1136/gutjnl-2016-312288.
  18. Chung JW, Lee GH, Han JH, Jeong JY, Choi KS, Kim DH, et al. The trends of one-week first-line and second-line eradication therapy for Helicobacter pylori infection in Korea. Hepatogastroenterology. 2011; 58(105):246-50. PMID: 21510323.
  19. Gisbert JP, Calvet X. Review article: The effectiveness of standard triple therapy for Helicobacter pylori has not changed over the last decade, but it is not good enough. Aliment Pharmacol Ther. 2011; 34(11-12):1255-68. doi: 10.1111/j.1365-2036.2011.04887.x.
  20. Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut. 2010; 59(8):1143-53. doi: 10.1136/gut.2009.192757.
  21. Graham DY. Antibiotic resistance in Helicobacter pylori: Implications for therapy. Gastroenterology. 1998; 115(5):1272-7. doi: 10.1016/s0016-5085(98)70100-3.
  22. Vakil N, Vaira D. Non-invasive tests for the diagnosis of H. pylori infection. Rev Gastroenterol Disord. 2004; 4(1):1-6.PMID: 15029105.
  23. De Francesco V, Zullo A, Hassan C, Faleo D, Ierardi E, Panella C, et al. Two new treatment regimens for Helicobacter pylori eradication: A randomised study. Dig Liver Dis. 2001; 33(8):676-9. doi: 10.1016/s1590-8658(01)80044-x.
  24. Lee H, Hong SN, Min BH, Lee JH, Rhee PL, Lee YC, et al. Comparison of efficacy and safety of levofloxacin-containing versus standard sequential therapy in eradication of Helicobacter pylori infection in Korea. Dig Liver Dis. 2015; 47(2):114-8. doi: 10.1016/j.dld.2014.10.014.
  25. Hung IF, Chan P, Leung S, Chan FS, Hsu A, But D, et al. Clarithromycin-amoxycillin-containing triple therapy: a valid empirical first-line treatment for Helicobacter pylori eradication in Hong Kong? Helicobacter. 2009; 14(6):505-11. doi: 10.1111/j.1523-5378.2009.00722.x.
  26. Saad RJ, Schoenfeld P, Kim HM, Chey WD. Levofloxacin-based triple therapy versus bismuth-based quadruple therapy for persistent Helicobacter pylori infection: A meta-analysis. Am J Gastroenterol. 2006;101(3):488-96. doi: 10.1111/j.1572-0241.2006.00637.x.
  27. Gopal R, Elamurugan TP, Kate V, Jagdish S, Basu D. Standard triple versus levofloxacin based regimen for eradication of Helicobacter pylori. World J Gastrointest Pharmacol Ther. 2013; 4(2):23-7. doi: 10.4292/wjgpt.v4.i2.23.
  28. Goudarzi M, Heidary M, Azad M, Fazeli M, Goudarzi H. Evaluation of antimicrobial susceptibility and integron carriage in Helicobacter pylori isolates from patients. Gastroenterol Hepatol Bed Bench. 2016;9(1):47-52. PMID: 28224028; PMCID: PMC5310800.
  29. Haji-Aghamohammadi AA, Bastani A, Miroliaee A, Oveisi S, Safarnezhad S. Comparison of levofloxacin versus clarithromycin efficacy in the eradication of Helicobacter pylori infection. Caspian J Intern Med. 2016; 7(4):267-71. PMID: 27999644.
  30. Khademi F, Poursina F, Hosseini E, Akbari M, Safaei HG. Helicobacter pylori in Iran: A systematic review on the antibiotic resistance. Iran J Basic Med Sci. 2015; 18(1):2-7. PMID: 25810869.
  31. Gisbert JP, Calvet X. Update on non-bismuth quadruple (concomitant) therapy for eradication of Helicobacter pylori. Clin Exp Gastroenterol. 2012; 5:23-34. doi: 10.2147/CEG.S25419.
  32. Treiber G, Wittig J, Ammon S, Walker S, van Doorn LJ, Klotz U. Clinical outcome and influencing factors of a new short-term quadruple therapy for Helicobacter pylori eradication: A randomized controlled trial (MACLOR study). Arch Intern Med. 2002; 162(2):153-60. doi: 10.1001/archinte.162.2.153.
  33. Okada M, Oki K, Shirotani T, Seo M, Okabe N, Maeda K, et al. A new quadruple therapy for the eradication of Helicobacter pylori. Effect of pretreatment with omeprazole on the cure rate. J Gastroenterol. 1998; 33(5):640-5. doi: 10.1007/s005350050150.
  34. Kongchayanun C, Mahachai V, Pornthisarn B, Amornsawadwattana S, Vilaichone RK. Efficacy of 10-day and 5-day concomitant therapy for Helicobacter pylori eradication in Thai patients with non-ulcer dyspepsia. Gastroenterology. 2011; 140‌(5):879-83. doi: 10.1016/S0016-5085(11)63653-6.
  35. Moradniani M, Mirbeik-Sabzevari Z, Jaferian S, Shafiezadeh S, Ehsani Ardakani MJ, Mirzaee Roozbahany M, et al. Levofloxacin based vs clarithromycin based sequential therapy in helicobacter pylori eradication; a randomized clinical trial. Gastroenterol Hepatol Bed Bench. 2018; 11(1):19-26. PMID: 29564061.
  36. Fakheri H, Bari Z, Taghvaei T, Hosseini V, Maleki I, Valizadeh SM, Kazemi A. The efficacy of levofloxacin-based triple therapy for helicobacter pylori eradication after failure with clarithromycin-containing regimens. Govaresh. 2018; 22:261-65.
  37. Tirgar Fakheri S, Sadough A, Fakheri H. Comparing Clarithromycin- and Levofloxacin-Containing Triple Therapies for First Line Helicobacter pylori Eradication in Mazandran Province, Iran . J Mazandaran Univ Med Sci. 2019; 29(176):1-9.
  38. Tariq H, Patel H, Kamal MU, Abbas N, Ameen M, Azam S, Kumar K, Ravi M, Vootla V, Shaikh D, Amanchi V, Hussain AN, Makker J. Reevaluation of the Efficacy of First Line Regimen for Helicobacter pylori. Clin Exp Gastroenterol. 2020; 13:25-33. doi: 10.2147/CEG.S239343.