Non-Bismuth Quadruple Therapy, Sequential Therapy or High-Dose Esomeprazole and Amoxicillin Dual Therapy for First-Line Helicobacter Pylori Eradication: A Prospective Randomized Study

Overview

Journal Cureus

Specialty Biomedical Engineering

Date 2021 Jan 7

PMID 33409077

Citations 2

Authors

Meriem Zeriouh

Amine Elmekkaoui

Mouna Bouqfar

Abdelkrim Zazour

Wafaa Khannoussi

Ghizlane Kharrasse

Naima Abda

Zahi Ismaili

Affiliations

Soon will be listed here.

Abstract

Aim: The study aims were to evaluate and compare the effectiveness and safety of non-bismuth quadruple therapy with sequential therapy and dual therapy with high dose esomeprazole and amoxicillin as an empirical first-line approach to eradicate infection.

Patients And Methods: Prospective randomized trial included 393 patients infected with naïve to eradication therapy, randomized to receive a 10-day non-bismuth quadruple or concomitant (CT) therapy, 10-day sequential therapy (SQ), or 14-day high-dose esomeprazole and amoxicillin (BT). Treatment outcome was assessed by C13-urea breath test at least six weeks after therapy. Adverse events and compliance were assessed with questionnaires and residual medication count.

Results: The baseline demographic clinical and endoscopic characteristics were similar among the three groups. The intention to treat (ITT) analysis was performed in 130, 132, and 131 patients in the BT, SQ, and CT groups, respectively. The eradication rates in ITT were 64.6%, 83.1%, and 92.3%, respectively, in the BT, SQ and CT groups (p = 0.0001). The eradication rates per protocol were 67.7%, 88.5%, and 95.3% (p = 0.0001), respectively, in the BT, SQ, and CT groups. The CT and SQ groups were higher than the BT group (p = 0,0001) but no significant results were seen in the eradication rate between CT and SQ, both in PP analysis and in ITT analysis (p = 0.09). The prevalence of the side effects following the non-bismuth quadruple therapy was 38.2%, significantly higher (p = 0.001) than the BT group (13.80%) and SQ group (22%). There were no significant differences in compliance among the three therapies (p = 0.16).

Conclusion: This study found that non-bismuth quadruple therapy yielded a higher eradication rate over sequential regimen as a first-line treatment in Morocco, with no statistical difference between the two protocols studied, while the eradication rate of dual high-dose of esomeprazole and amoxicillin did not exceed 60%. All three therapy schemes showed excellent compliance. However, the prevalence of side events was more important and significantly higher with non-bismuth quadruple therapy.

Citing Articles

Effectiveness of eradication therapy for Helicobacter pylori infection in Africa: a systematic review and meta-analysis.

Fekadu S, Engiso H, Seyfe S, Iizasa H, Godebo A, Deyno S BMC Gastroenterol. 2023; 23(1):55.

PMID: 36882697 PMC: 9990047. DOI: 10.1186/s12876-023-02707-5.

High-dose dual therapy versus bismuth-containing quadruple therapy for the treatment of infection - A review of the strengths, weaknesses, and proposed solutions.

Hu C Tzu Chi Med J. 2022; 34(3):303-309.

PMID: 35912055 PMC: 9333101. DOI: 10.4103/tcmj.tcmj_185_21.

References

Yang J, Lin C . CYP2C19 genotypes in the pharmacokinetics/pharmacodynamics of proton pump inhibitor-based therapy of Helicobacter pylori infection. Expert Opin Drug Metab Toxicol. 2009; 6(1):29-41. DOI: 10.1517/17425250903386251. View

Agrawal A, Tutuian R, Hila A, Freeman J, Castell D . Ingestion of acidic foods mimics gastroesophageal reflux during pH monitoring. Dig Dis Sci. 2005; 50(10):1916-20. DOI: 10.1007/s10620-005-2961-6. View

Siddique O, Ovalle A, Siddique A, Moss S . Helicobacter pylori Infection: An Update for the Internist in the Age of Increasing Global Antibiotic Resistance. Am J Med. 2018; 131(5):473-479. DOI: 10.1016/j.amjmed.2017.12.024. View

Megraud F, Coenen S, Versporten A, Kist M, Lopez-Brea M, Hirschl A . Helicobacter pylori resistance to antibiotics in Europe and its relationship to antibiotic consumption. Gut. 2012; 62(1):34-42. DOI: 10.1136/gutjnl-2012-302254. View

Lambert J . Pharmacology of the gastric mucosa: a rational approach to Helicobacter polytherapy. Gastroenterology. 1996; 111(2):521-3. DOI: 10.1053/gast.1996.v111.agast961110521. View

Wang Y, Zhao R, Wang B, Zhao Q, Li Z, Zhu-Ge L . Sequential versus concomitant therapy for treatment of Helicobacter pylori infection: an updated systematic review and meta-analysis. Eur J Clin Pharmacol. 2017; 74(1):1-13. DOI: 10.1007/s00228-017-2347-7. View

Papastergiou V, Georgopoulos S, Karatapanis S . Treatment of Helicobacter pylori infection: Past, present and future. World J Gastrointest Pathophysiol. 2014; 5(4):392-9. PMC: 4231503. DOI: 10.4291/wjgp.v5.i4.392. View

Yang J, Lin C, Wang H, Chen J, Kao J, Shun C . High-dose dual therapy is superior to standard first-line or rescue therapy for Helicobacter pylori infection. Clin Gastroenterol Hepatol. 2014; 13(5):895-905.e5. PMC: 4404168. DOI: 10.1016/j.cgh.2014.10.036. View

Miehlke S, Mannes G, Lehn N, Hele C, Stolte M, Bayerdorffer E . An increasing dose of omeprazole combined with amoxycillin cures Helicobacter pylori infection more effectively. Aliment Pharmacol Ther. 1997; 11(2):323-9. DOI: 10.1046/j.1365-2036.1997.140316000.x. View

10.

Malfertheiner P, Megraud F, OMorain C, Atherton J, Axon A, Bazzoli F . Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012; 61(5):646-64. DOI: 10.1136/gutjnl-2012-302084. View

11.

Wu D, Hsu P, Wu J, Opekun A, Kuo C, Wu I . Sequential and concomitant therapy with four drugs is equally effective for eradication of H pylori infection. Clin Gastroenterol Hepatol. 2009; 8(1):36-41.e1. PMC: 2838430. DOI: 10.1016/j.cgh.2009.09.030. View

12.

Lahbabi M, Alaoui S, El Rhazi K, Abkari M, Nejjari C, Amarti A . Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: result of the HPFEZ randomised study. Clin Res Hepatol Gastroenterol. 2012; 37(4):416-21. DOI: 10.1016/j.clinre.2012.10.002. View

13.

Seddik H, Ahid S, El Adioui T, El Hamdi F, Hassar M, Abouqal R . Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a prospective randomized study. Eur J Clin Pharmacol. 2013; 69(9):1709-15. DOI: 10.1007/s00228-013-1524-6. View

14.

Sapmaz F, Kalkan I, Atasoy P, Basyigit S, Guliter S . A Non-Inferiority Study: Modified Dual Therapy Consisting Higher Doses of Rabeprazole Is as Successful as Standard Quadruple Therapy in Eradication of Helicobacter pylori. Am J Ther. 2015; 24(4):e393-e398. DOI: 10.1097/MJT.0000000000000316. View

15.

Grayson M, Eliopoulos G, Ferraro M, Moellering Jr R . Effect of varying pH on the susceptibility of Campylobacter pylori to antimicrobial agents. Eur J Clin Microbiol Infect Dis. 1989; 8(10):888-9. DOI: 10.1007/BF01963775. View

16.

He L, Deng T, Luo H . Meta-analysis of sequential, concomitant and hybrid therapy for Helicobacter pylori eradication. Intern Med. 2015; 54(7):703-10. DOI: 10.2169/internalmedicine.54.3442. View

17.

Joutei H, Hilali A, Fechtali T, Rhallabi N, Benomar H . [Helicobacter pylori infection in 755 patients with digestive complaints: Pasteur Institute, Morocco, 1998-2007]. East Mediterr Health J. 2010; 16(7):778-82. View

18.

Malfertheiner P, Megraud F, OMorain C, Gisbert J, Kuipers E, Axon A . Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2016; 66(1):6-30. DOI: 10.1136/gutjnl-2016-312288. View

19.

Bayerdorffer E, Miehlke S, Mannes G, Sommer A, Hochter W, Weingart J . Double-blind trial of omeprazole and amoxicillin to cure Helicobacter pylori infection in patients with duodenal ulcers. Gastroenterology. 1995; 108(5):1412-7. DOI: 10.1016/0016-5085(95)90689-4. View

20.

Suerbaum S, Michetti P . Helicobacter pylori infection. N Engl J Med. 2002; 347(15):1175-86. DOI: 10.1056/NEJMra020542. View