Pilot study: Comparing efficacy of 14-day triple therapy Clarithromycin versus levofloxacin on eradication of Helicobacter Pylori infection in Syrian population single-center experience

Abstract

Context: Goals: To compare the efficacy of standard triple therapy with clarithromycin versus triple therapy with levofloxacin for treatment of Helicobacter pylori-positive infection in a referral hospital in Damascus, Syria. Design: pilot prospective open-label randomized controlled trial. Subjects and Methods: Eighty treatment-naive patients who tested positive for H. pylori gastric infection were randomly assigned to one of two treatment groups with randomization ratio of 50/50. Group (A) was treated with clarithromycin (500 mg), amoxicillin (1000 mg), and esomeprazole (20 mg), each twice/day for 14 days, while Group (B) was treated with levofloxacin (500 mg), amoxicillin (1000 mg), and esomeprazole (20 mg), each twice/day for 14 days.[1] After 6 weeks of treatment, all patients underwent endoscopy and biopsy to evaluate H. pylori infection eradication. Results: Forty patients were allocated in each group; 37 patients completed the follow-up in each group. Thirteen patients in Group (A) were cured, with an eradication rate of 35.1% according to per-protocol analysis (PPA) and 32.5% according to intention-to-treat analysis (ITT), while in Group (B), 11 patients were cured, with an eradication rate of 29.7% according to PPA and 27.5% according to ITT with P = 0.80. No serious adverse events reported in both the groups. Conclusions: Clarithromycin is slightly better than levofloxacin in treatment of H. pylori gastric infection, but both regimens show low effectiveness with suboptimal eradication rates in our selected population.

Keywords

Clarithromycin resistance - Clarithromycin - Helicobacter pylori - levofloxacin resistance - levofloxacin - Syria - triple therapy

Publication History

Article published online:
12 August 2021

• References

• 1 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; 12: CD008337
• 2 Eshraghian A. Epidemiology of Helicobacter pylori infection among the healthy population in Iran and countries of the Eastern Mediterranean Region: A systematic review of prevalence and risk factors. World J Gastroenterol 2014; 20: 17618-25
• 3 Kusters JG, van Vliet AH, Kuipers EJ. Pathogenesis of Helicobacter pylori infection. Clin Microbiol Rev 2006; 19: 449-90
• 4 Sgouras DN, Trang TT, Yamaoka Y. Pathogenesis of Helicobacter pylori infection. Helicobacter 2015; 20: 8-16
• 5 Suerbaum S, Michetti P. Helicobacter pylori infection. N Engl J Med 2002; 347: 1175-86
• 6 Ford AC, Forman D, Hunt R, Yuan Y, Moayyedi P. Helicobacter pylori eradication for the prevention of gastric neoplasia. Cochrane Database Syst Rev 2015; 7: CD005583
• 7 Venerito M, Vasapolli R, Rokkas T, Malfertheiner P. Helicobacter pylori and gastrointestinal malignancies. Helicobacter 2015; 20 Suppl 1: 36-9
• 8 Ford AC, Gurusamy KS, Delaney B, Forman D, Moayyedi P. Eradication therapy for peptic ulcer disease in Helicobacter pylori-positive people. Cochrane Database Syst Rev 2016; 4: CD003840
• 9 Agudo S, Pérez-Pérez G, Alarcón T, López-Brea M. High prevalence of clarithromycin-resistant Helicobacter pylori strains and risk factors associated with resistance in Madrid, Spain. J Clin Microbiol 2010; 48: 3703-7
• 10 Alba C, Blanco A, Alarcón T. Antibiotic resistance in Helicobacter pylori. Curr Opin Infect Dis 2017; 30: 489-97
• 11 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: 2-7
• 12 Kuo YT, Liou JM, El-Omar EM, Wu JY, Leow AH, Goh KL. et al. Primary antibiotic resistance in Helicobacter pylori in the Asia-Pacific region: A systematic review and meta-analysis. Lancet Gastroenterol Hepatol 2017; 2: 707-15
• 13 Saracino IM, Zullo A, Holton J, Castelli V, Fiorini G, Zaccaro C. et al. High prevalence of primary antibiotic resistance in Helicobacter pylori isolates in Italy. J Gastrointestin Liver Dis 2012; 21: 363-5
• 14 Vianna JS, Ramis IB, Ramos DF, Vong A, Silva PE. Drug resistance in Helicobacter pylori. Arq Gastroenterol 2016; 53: 215-23
• 15 Lim SG, Park RW, Shin SJ, Yoon D, Kang JK, Hwang JC. et al. The relationship between the failure to eradicate Helicobacter pylori and previous antibiotics use. Dig Liver Dis 2016; 48: 385-90
• 16 Tongtawee T, Kaewpitoon S, Kaewpitoon N, Dechsukhum C, Leeanansaksiri W, Loyd RA. et al. Diagnosis of Helicobacter pylori infection. Asian Pac J Cancer Prev 2016; 17: 1631-5
• 17 Chey WD, Wong BC. Practice Parameters Committee of the American College of Gastroenterology. American college of gastroenterology guideline on the management of Helicobacter pylori infection. Am J Gastroenterol 2007; 102: 1808-25
• 18 Satoh K, Kimura K, Taniguchi Y, Kihira K, Takimoto T, Saifuku K. et al. Biopsy sites suitable for the diagnosis of Helicobacter pylori infection and the assessment of the extent of atrophic gastritis. Am J Gastroenterol 1998; 93: 569-73
• 19 Lee JY, Kim N. Diagnosis of Helicobacter pylori by invasive test: Histology. Ann Transl Med 2015; 3: 10
• 20 R Development Core Team. R: A Language and Environment for Statistical Computing. Vienna, Austria: R Foundation for Statistical Computing; 2017.
• 21 Kirkwood B, Sterne J. Comparing two proportions. Essential Medical Statistics. 2nd ed. Massachusetts. USA: Wiley 2003; 2: 148-64
• 22 Schmidt CO, Kohlmann T. When to use the odds ratio or the relative risk. Int J Public Health 2008; 53: 165-7
• 23 Ghotaslou R, Leylabadlo HE, Asl YM. Prevalence of antibiotic resistance in Helicobacter pylori: A recent literature review. World J Methodol 2015; 5: 164-74
• 24 Geneva World Health Organization. http://www.who.int/mediacentre/ news/releases/2017/bacteria‑antibiotics‑needed/en/. [Last updated on 2017 Feb 27].
• 25 De Francesco V, Giorgio F, Hassan C, Manes G, Vannella L, Panella C. et al. Worldwide H. Pylori antibiotic resistance: A systematic review. J Gastrointestin Liver Dis 2010; 19: 409-14
• 26 Blaser MJ, Berg DE. Helicobacter pylori genetic diversity and risk of human disease. J Clin Invest 2001; 107: 767-73
• 27 Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res 2016; 25: 1057-73
• 28 Fallone CA, Chiba N, van Zanten SV, Fischbach L, Gisbert JP, Hunt RH, et al. The toronto consensus for the treatment of Helicobacter pylori infection in adults. Gastroenterology 2016;151:51‑6.e14.