Levofloxacin-containing versus Clarithromycin-containing Therapy for Helicobacter pylori Eradication: A Prospective Randomized Controlled Clinical Trial

Sebghatollahi, Vahid; Soheilipour, Maryam; Khodadoostan, Mahsa; Shavakhi, Alireza; Shavakhi, Ahmad

Levofloxacin-containing versus Clarithromycin-containing Therapy for Helicobacter pylori Eradication: A Prospective Randomized Controlled Clinical Trial

Document Type : Original Article

Authors

¹ Department of Internal Medicine, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran

² Department of Internal Medicine, Shahrekord University of Medical Sciences, Shahrekord, Iran

Abstract

Background: This study evaluated the clinical efficacy and tolerability of a 14-day course of bismuth-based quadruple therapy including tinidazole and levofloxacin in compare to a 14-day bismuth-based quadruple therapy including clarithromycin as first-line treatment for Helicobacter pylori infection in Iranian adults. Materials and Methods: The study was a prospective, parallel group, randomized controlled, clinical trial that conducted on 150 patients with H. pylori infection. Patients were randomly assigned to the two groups as follows: first group received pantoprazole 40 mg, bismuth subcitrate 240 mg, amoxicillin 1 g, and clarithromycin 500 mg (PBAC group), and other group received pantoprazole 40 mg, bismuth subcitrate 240 mg, amoxicillin 1 g, tinidazole 500 mg for 7 days, followed by levofloxacin 500 mg for the second 7 days (PBATL group). Main outcomes were eradication rate, tolerance of treatment, and dyspepsia severity. Results: The eradication rates for PBAC regimen was 81.1% (95% confidence interval [CI]: 71.9–90.2) and for PBATL regimen was 70.8% (95% CI: 60.1–81.6), which was not significantly different (P = 0.147). Tolerance of treatment was similar between groups. The median of severity of dyspeptic after treatment in PBAC group was 10 [9–14.75], which was similar to PBATL group 10 [9–13.5] (P = 0.690). Conclusion: There is no significant difference between PBAC and PBATL regimen, and efficacy was similar in both groups. The overall rate of treatment failure suggests that up to 18%–30% of patients will fail bismuth-based quadruple therapy and require retreatment for the infection.

Keywords

References

1.	McColl KE. Clinical practice. Helicobacter pylori infection. N Engl J Med 2010;362:1597-604. [PUBMED]
2.	de Martel C, Ferlay J, Franceschi S, Vignat J, Bray F, Forman D, et al. Global burden of cancers attributable to infections in 2008: A review and synthetic analysis. Lancet Oncol 2012;13:607-15.
3.	Hunt RH, Xiao SD, Megraud F, Leon-Barua R, Bazzoli F, van der Merwe S, et al. Helicobacter pylori in developing countries. World Gastroenterology Organisation Global Guideline. J Gastrointestin Liver Dis 2011;20:299-304.
4.	Ford AC, Axon AT. Epidemiology of Helicobacter pylori infection and public health implications. Helicobacter 2010;15 Suppl 1:1-6.
5.	Hooi JK, Lai WY, Ng WK, Suen MM, Underwood FE, Tanyingoh D, et al. Global prevalence of Helicobacter pylori infection: Systematic review and meta-analysis. Gastroenterology 2017;153:420-9.
6.	Zullo A, De Francesco V, Manes G, Scaccianoce G, Cristofari F, Hassan C, et al. Second-line and rescue therapies for Helicobacter pylori eradication in clinical practice. J Gastrointestin Liver Dis 2010;19:131-4.
7.	Fock KM, Katelaris P, Sugano K, Ang TL, Hunt R, Talley NJ, et al. Second Asia-Pacific consensus guidelines for Helicobacter pylori infection. J Gastroenterol Hepatol 2009;24:1587-600.
8.	Dib J Jr., Alvarez B, Mendez L, Cruz ME. Efficacy of PPI, levofloxacin and amoxicillin in the eradication of Helicobacter pylori compared to conventional triple therapy at a Venezuelan hospital. Arab J Gastroenterol 2013;14:123-5.
9.	Megraud F, Coenen S, Versporten A, Kist M, Lopez-Brea M, Hirschl AM, et al. Helicobacter pylori resistance to antibiotics in Europe and its relationship to antibiotic consumption. Gut 2013;62:34-42.
10.	Federico A, Nardone G, Gravina AG, Iovene MR, Miranda A, Compare D, et al. Efficacy of 5-day levofloxacin-containing concomitant therapy in eradication of Helicobacter pylori infection. Gastroenterology 2012;143:55-610.
11.	Shah A, Javid G, Zargar SA, Teli F, Khan BA, Yattoo GN, et al. Safety and efficacy of 1-week levofloxacin-based triple therapy in first-line treatment for Helicobacter pylori-related peptic ulcer disease in Kashmir, India. Indian J Gastroenterol 2013;32:32-6.
12.	Fakheri H, Taghvaei T, Hosseini V, Bari Z. A comparison between sequential therapy and a modified bismuth-based quadruple therapy for Helicobacter pylori eradication in Iran: A randomized clinical trial. Helicobacter 2012;17:43-8.
13.	Yuan Y, Ford AC, Khan KJ, Gisbert JP, Forman D, Leontiadis GI, et al. Optimum duration of regimens for Helicobacter pylori eradication. Cochrane Database Syst Rev 2013; 11;(12): CD008337.
14.	Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, et al. Management of Helicobacter pylori infection – The maastricht IV/florence consensus report. Gut 2012;61:646-64.
15.	Fraser A, Delaney BC, Ford AC, Qume M, Moayyedi P. The short-form Leeds Dyspepsia Questionnaire validation study. Aliment Pharmacol Ther 2007;25:477-86.
16.	Graham DY, Lu H, Yamaoka Y. A report card to grade Helicobacter pylori therapy. Helicobacter 2007;12:275-8.
17.	Gatta L, Vakil N, Vaira D, Scarpignato C. Global eradication rates for Helicobacter pylori infection: Systematic review and meta-analysis of sequential therapy. BMJ 2013;347:f4587.
18.	Warrington E, López-Román O, Tirado Montijo R, Urbina R, Cruz-Correa M, Toro DH, et al. Neither 10- nor 14-day sequential treatment is better than standard triple therapy for Helicobacter pylori eradication.P R Health Sci J 2016;35:203-8.
19.	Liou JM, Chen CC, Chen MJ, Chen CC, Chang CY, Fang YJ, et al. Sequential versus triple therapy for the first-line treatment of Helicobacter pylori: A multicentre, open-label, randomised trial. Lancet 2013;381:205-13.
20.	Ergül B, Doǧan Z, Sarikaya M, Filik L. The efficacy of two-week quadruple first-line therapy with bismuth, lansoprazole, amoxicillin, clarithromycin on Helicobacter pylori eradication: A prospective study. Helicobacter 2013;18:454-8.
21.	Su J, Zhou X, Chen H, Hao B, Zhang W, Zhang G, et al. Efficacy of 1^st-line bismuth-containing quadruple therapies with levofloxacin or clarithromycin for the eradication of Helicobacter pylori infection: A 1-week, open-label, randomized trial. Medicine (Baltimore) 2017;96:e5859.
22.	Masoodi M, Panahian M, Rezadoost A, Heidari A. Eradication rate of Helicobacter pylori using a two-week quadruple therapy: A Report from Southern Iran. Middle East J Dig Dis 2013;5:81-5.
23.	Bahremand S, Nematollahi LR, Fourutan H, Tirgari F, Nouripour S, Mir E, et al. Evaluation of triple and quadruple Helicobacter pylori eradication therapies in Iranian children: A randomized clinical trial. Eur J Gastroenterol Hepatol 2006;18:511-4.
24.	Mousavi S, Toussy J, Yaghmaie S, Zahmatkesh M. Azithromycin in one week quadruple therapy for H pylori eradication in Iran. World J Gastroenterol 2006;12:4553-6.
25.	Aminian K, Farsad F, Ghanbari A, Fakhreih S, Hasheminasab SM. A randomized trial comparing four Helicobacter pylori eradication regimens: Standard triple therapy, ciprofloxacin based triple therapy, quadruple and sequential therapy. Trop Gastroenterol 2010;31:303-7.
26.	Metanat HA, Valizadeh SM, Fakheri H, Maleki I, Taghvaei T, Hosseini V, et al. Comparison between 10- and 14-day hybrid regimens for Helicobacter pylori eradication: A Randomized clinical trial. Helicobacter 2015;20:299-304.
27.	Cai W, Zhou L, Ren W, Deng L, Yu M. Variables influencing outcome of Helicobacter pylori eradication therapy in South China. Helicobacter 2009;14:91-6.
28.	Silva FM, Zaterka S, Eisig JN, Chehter EZ, Chinzon D, Laudanna AA, et al. Factors affecting Helicobacter pylori eradication using a seven-day triple therapy with a proton pump inhibitor, tinidazole and clarithromycin, in Brazilian patients with peptic ulcer. Rev Hosp Clin Fac Med Sao Paulo 2001;56:11-6.

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