ISSN: 2008-2258
Vol 15, No 2 (2022): Spring
Comparison of the efficacy of 14-days concomitant quadruple therapy and 14-days high-dose dual therapy on H pylori eradication
Gastroenterology and Hepatology from Bed to Bench,
,
https://doi.org/10.22037/ghfbb.vi.2412
Abstract
Background: Helicobacter pylori (H. pylori) is a gram-negative bacillus that has strong association with chronic gastritis and peptic ulcer disease. H. pylori infection is difficult to treat, and successful treatment requires two or more antimicrobial agents. Different regimens with varying degrees of effectiveness have been used for H. pylori eradication. We compared the efficacy of two different regimens for H. pylori eradication in area with high antibiotic resistance.
Material and Methods: We performed a randomized clinical trial in which 217 patients who had indication for H. pylori eradication were assigned to two groups. One group were taken 14 days concomitant quadruple therapy (pantoprazole 40 mg, amoxicillin 1gr, clarithromycin 500 mg and metronidazole 500 mg every 12 hours for 14 days) and the other group received 14 days high-dose dual therapy, consisted of esomeprazole 40 mg, BID and amoxicillin 1g TDS. H. pylori eradication was assessed eight weeks after end of treatment.
Results: H. pylori eradication rates by per-protocol analysis for 14 days concomitant quadruple therapy and high-dose dual therapy were 88.6% (95% CI, 80.3−92.8) and 82.2% (95% CI, 74.8–89.5), respectively (P = 0.19). Also, according to intention to treat analysis, the eradication rates were 81.6% % (95% CI, 74.5−88.6) and 80.6% (95% CI, 73–88.1), respectively (P = 0.58). The overall drug Side effects was 20.8% in high-dose dual therapy vs. 49.6% in concomitant quadruple therapy. (P < 0.001).
Conclusion: Fourteen days concomitant quadruple therapy can be considered as a relatively acceptable regimen for H. pylori eradication in areas of high clarithromycin and metronidazole resistance. It seems that the high-dose dual therapy could be a promising alternative regimen as the first line H. pylori eradication in these areas.
Keywords:
- H. pylori, High-dose dual therapy, Concomitant quadruple therapy, Eradication
References
References:
1. Go M. Natural history and epidemiology of Helicobacter pylori infection. Alimentary pharmacology & therapeutics. 2002;16:3-15.
2. Ford AC, Delaney B, Forman D, Moayyedi P. Eradication therapy for peptic ulcer disease in Helicobacter pylori positive patients. Cochrane Database of Systematic Reviews. 2006(2).
3. Gisbert J, Calvet X. non‐bismuth quadruple (concomitant) therapy for eradication of Helicobater pylori. Alimentary pharmacology & therapeutics. 2011;34(6):604-17.
4. Gisbert JP, Calvet X, O'Connor A, Mégraud F, O'Morain CA. Sequential therapy for Helicobacter pylori eradication: a critical review. Journal of clinical gastroenterology. 2010;44(5):313-25.
5. Vakil N. H. pylori treatment: new wine in old bottles? American Journal of Gastroenterology. 2009;104(1):26-30.
6. Howden CW, Hunt RH. Guidelines for the management of Helicobacter pylori infection. The American journal of gastroenterology. 1998;93(12):2330-8.
7. Malfertheiner P, Megraud F, O’Morain C, Bazzoli F, El-Omar E, Graham D, et al. Current concepts in the management of Helicobacter pylori infection: the Maastricht III Consensus Report. Gut. 2007;56(6):772-81.
8. Selgrad M, Bornschein J, Malfertheiner P. Guidelines for treatment of Helicobacter pylori in the East and West. Expert review of anti-infective therapy. 2011;9(8):581-8.
9. Malfertheiner P, Megraud F, O'morain C, Gisbert J, Kuipers E, Axon A, et al. Management of Helicobacter pylori infection—the Maastricht V/Florence consensus report. Gut. 2017;66(1):6-30.
10. Fakheri H, Firoozi MS, Bari Z. Eradication of Helicobacter pylori in Iran: a review. Middle East journal of digestive diseases. 2018;10(1):5.
11. Zullo A, Scaccianoce G, De Francesco V, Ruggiero V, D’Ambrosio P, Castorani L, et al. Concomitant, sequential, and hybrid therapy for H. pylori eradication: a pilot study. Clinics and research in hepatology and gastroenterology. 2013;37(6):647-50.
12. Molina–Infante J, Romano M, Fernandez–Bermejo M, Federico A, Gravina AG, Pozzati L, et al. Optimized nonbismuth quadruple therapies cure most patients with Helicobacter pylori infection in populations with high rates of antibiotic resistance. Gastroenterology. 2013;145(1):121-8. e1.
13. Park SM, Kim JS, Kim BW, Ji JS, Choi H. Randomized clinical trial comparing 10‐or 14‐day sequential therapy and 10‐or 14‐day concomitant therapy for the first line empirical treatment of Helicobacter pylori infection. Journal of gastroenterology and hepatology. 2017;32(3):589-94.
14. De Francesco V, Hassan C, Ridola L, Giorgio F, Ierardi E, Zullo A. Sequential, concomitant and hybrid first-line therapies for Helicobacter pylori eradication: a prospective randomized study. Journal of medical microbiology. 2014;63(5):748-52.
15. Choe JW, Jung SW, Kim SY, Hyun JJ, Jung YK, Koo JS, et al. Comparative study of Helicobacter pylori eradication rates of concomitant therapy vs modified quadruple therapy comprising proton‐pump inhibitor, bismuth, amoxicillin, and metronidazole in Korea. Helicobacter. 2018;23(2):e12466.
16. Alhooei S, Fakheri HT, Hosseini V, Maleki I, Taghvaei T, Valizadeh SM, et al. A Comparison between Hybrid and Concomitant Regimens for Helicobacter Pylori Eradication: A Randomized Clinical Trial. Middle East journal of digestive diseases. 2016;8(3):219.
17. Bari Z, Fakheri H, Taghvaei T, Yaghoobi M. A Comparison between 10-day and 12-day Concomitant Regimens for Helicobacter Pylori Eradication: A Randomized Clinical Trial. Middle East Journal of Digestive Diseases. 2020;12(2):106.
18. Yao C-C, Kuo C-M, Hsu C-N, Yang S-C, Wu C-K, Tai W-C, et al. First-line Helicobacter pylori eradication rates are significantly lower in patients with than those without type 2 diabetes mellitus. Infection and drug resistance. 2019;12:1425.
19. Zullo A, Ridola L, De Francesco V, Gatta L, Hassan C, Alvaro D, et al. High-dose esomeprazole and amoxicillin dual therapy for first-line Helicobacter pylori eradication: a proof of concept study. Annals of gastroenterology: quarterly publication of the Hellenic Society of Gastroenterology. 2015;28(4):448.
20. Yang X, Wang J-X, Han S-X, Gao C-P. High dose dual therapy versus bismuth quadruple therapy for Helicobacter pylori eradication treatment: a systematic review and meta-analysis. Medicine. 2019;98(7).
21. Yang J, Zhang Y, Fan L, Zhu Y-J, Wang T-Y, Wang X-W, et al. Eradication efficacy of modified dual therapy compared with bismuth-containing quadruple therapy as a first-line treatment of Helicobacter pylori. American Journal of Gastroenterology. 2019;114(3):437-45.
22. Kwack W, Lim Y, Lim C, Graham DY. High dose ilaprazole/amoxicillin as first-line regimen for Helicobacter pylori infection in Korea. Gastroenterology research and practice. 2016;2016.
23. Yang J-C, Lin C-J, Wang H-L, Chen J-D, Kao JY, Shun C-T, et al. High-dose dual therapy is superior to standard first-line or rescue therapy for Helicobacter pylori infection. Clinical Gastroenterology and Hepatology. 2015;13(5):895-905. e5.
24. Yu L, Luo L, Long X, Liang X, Ji Y, Graham DY, et al. High‐dose PPI‐amoxicillin dual therapy with or without bismuth for first‐line Helicobacter pylori therapy: A randomized trial. Helicobacter. 2019;24(4):e12596.
25. Khademi F, Poursina F, Hosseini E, Akbari M, Safaei HG. Helicobacter pylori in Iran: A systematic review on the antibiotic resistance. Iranian journal of basic medical sciences. 2015;18(1):2.
26. Farzi N, Yadegar A, Sadeghi A, Asadzadeh Aghdaei H, Marian Smith S, Raymond J, et al. High prevalence of antibiotic resistance in Iranian Helicobacter pylori isolates: importance of functional and mutational analysis of resistance genes and virulence genotyping. Journal of clinical medicine. 2019;8(11):2004.
27. Hu J-L, Yang J, Zhou Y-B, Li P, Han R, Fang D-C. Optimized high-dose amoxicillin–proton-pump inhibitor dual therapies fail to achieve high cure rates in China. Saudi journal of gastroenterology: official journal of the Saudi Gastroenterology Association. 2017;23(5):275.
28. Zhang Y, Zhu Y-J, Zhao Z, Zhao J-T, Wang T-Y, Yang J, et al. Efficacy of modified esomeprazole-amoxicillin dual therapies for Helicobacter pylori infection: an open-label, randomized trial. European journal of gastroenterology & hepatology. 2020;32(5):563-8.
29. Anagnostopoulos GK, Tsiakos S, Margantinis G, Kostopoulos P, Arvanitidis D. Esomeprazole versus omeprazole for the eradication of Helicobacter pylori infection: results of a randomized controlled study. Journal of clinical gastroenterology. 2004;38(6):503-6.
30. Yuan Y, Ford AC, Khan KJ, Gisbert JP, Forman D, Leontiadis GI, et al. Optimum duration of regimens for Helicobacter pylori eradication. Cochrane Database of Systematic Reviews. 2013(12).
31. Ierardi E, Losurdo G, La Fortezza RF, Principi M, Barone M, Di Leo A. Optimizing proton pump inhibitors in Helicobacter pylori treatment: Old and new tricks to improve effectiveness. World journal of gastroenterology. 2019;25(34):5097.
32. Graham DY, Javed SU, Keihanian S, Abudayyeh S, Opekun AR. Dual proton pump inhibitor plus amoxicillin as an empiric anti-H. pylori therapy: studies from the United States. Journal of gastroenterology. 2010;45(8):816-20.
33. Ren L, Lu H, Li HY, Zhu LY, Xu XQ, Gu LY, et al. New dual therapy for primary treatment of H elicobacter pylori infection: A prospective randomized study in S hanghai, C hina. Journal of digestive diseases. 2014;15(11):622-7.
34. Kim SY, Jung SW, Kim JH, Koo JS, Yim HJ, Park JJ, et al. Effectiveness of three times daily lansoprazole/amoxicillin dual therapy for Helicobacter pylori infection in Korea. British journal of clinical pharmacology. 2012;73(1):140-3.
35. Sugimoto M, Shirai N, Nishino M, Kodaira C, Uotani T, Yamade M, et al. Rabeprazole 10 mg qds decreases 24‐h intragastric acidity significantly more than rabeprazole 20 mg bd or 40 mg om, overcoming CYP 2 C 19 genotype. Alimentary pharmacology & therapeutics. 2012;36(7):627-34.
1. Go M. Natural history and epidemiology of Helicobacter pylori infection. Alimentary pharmacology & therapeutics. 2002;16:3-15.
2. Ford AC, Delaney B, Forman D, Moayyedi P. Eradication therapy for peptic ulcer disease in Helicobacter pylori positive patients. Cochrane Database of Systematic Reviews. 2006(2).
3. Gisbert J, Calvet X. non‐bismuth quadruple (concomitant) therapy for eradication of Helicobater pylori. Alimentary pharmacology & therapeutics. 2011;34(6):604-17.
4. Gisbert JP, Calvet X, O'Connor A, Mégraud F, O'Morain CA. Sequential therapy for Helicobacter pylori eradication: a critical review. Journal of clinical gastroenterology. 2010;44(5):313-25.
5. Vakil N. H. pylori treatment: new wine in old bottles? American Journal of Gastroenterology. 2009;104(1):26-30.
6. Howden CW, Hunt RH. Guidelines for the management of Helicobacter pylori infection. The American journal of gastroenterology. 1998;93(12):2330-8.
7. Malfertheiner P, Megraud F, O’Morain C, Bazzoli F, El-Omar E, Graham D, et al. Current concepts in the management of Helicobacter pylori infection: the Maastricht III Consensus Report. Gut. 2007;56(6):772-81.
8. Selgrad M, Bornschein J, Malfertheiner P. Guidelines for treatment of Helicobacter pylori in the East and West. Expert review of anti-infective therapy. 2011;9(8):581-8.
9. Malfertheiner P, Megraud F, O'morain C, Gisbert J, Kuipers E, Axon A, et al. Management of Helicobacter pylori infection—the Maastricht V/Florence consensus report. Gut. 2017;66(1):6-30.
10. Fakheri H, Firoozi MS, Bari Z. Eradication of Helicobacter pylori in Iran: a review. Middle East journal of digestive diseases. 2018;10(1):5.
11. Zullo A, Scaccianoce G, De Francesco V, Ruggiero V, D’Ambrosio P, Castorani L, et al. Concomitant, sequential, and hybrid therapy for H. pylori eradication: a pilot study. Clinics and research in hepatology and gastroenterology. 2013;37(6):647-50.
12. Molina–Infante J, Romano M, Fernandez–Bermejo M, Federico A, Gravina AG, Pozzati L, et al. Optimized nonbismuth quadruple therapies cure most patients with Helicobacter pylori infection in populations with high rates of antibiotic resistance. Gastroenterology. 2013;145(1):121-8. e1.
13. Park SM, Kim JS, Kim BW, Ji JS, Choi H. Randomized clinical trial comparing 10‐or 14‐day sequential therapy and 10‐or 14‐day concomitant therapy for the first line empirical treatment of Helicobacter pylori infection. Journal of gastroenterology and hepatology. 2017;32(3):589-94.
14. De Francesco V, Hassan C, Ridola L, Giorgio F, Ierardi E, Zullo A. Sequential, concomitant and hybrid first-line therapies for Helicobacter pylori eradication: a prospective randomized study. Journal of medical microbiology. 2014;63(5):748-52.
15. Choe JW, Jung SW, Kim SY, Hyun JJ, Jung YK, Koo JS, et al. Comparative study of Helicobacter pylori eradication rates of concomitant therapy vs modified quadruple therapy comprising proton‐pump inhibitor, bismuth, amoxicillin, and metronidazole in Korea. Helicobacter. 2018;23(2):e12466.
16. Alhooei S, Fakheri HT, Hosseini V, Maleki I, Taghvaei T, Valizadeh SM, et al. A Comparison between Hybrid and Concomitant Regimens for Helicobacter Pylori Eradication: A Randomized Clinical Trial. Middle East journal of digestive diseases. 2016;8(3):219.
17. Bari Z, Fakheri H, Taghvaei T, Yaghoobi M. A Comparison between 10-day and 12-day Concomitant Regimens for Helicobacter Pylori Eradication: A Randomized Clinical Trial. Middle East Journal of Digestive Diseases. 2020;12(2):106.
18. Yao C-C, Kuo C-M, Hsu C-N, Yang S-C, Wu C-K, Tai W-C, et al. First-line Helicobacter pylori eradication rates are significantly lower in patients with than those without type 2 diabetes mellitus. Infection and drug resistance. 2019;12:1425.
19. Zullo A, Ridola L, De Francesco V, Gatta L, Hassan C, Alvaro D, et al. High-dose esomeprazole and amoxicillin dual therapy for first-line Helicobacter pylori eradication: a proof of concept study. Annals of gastroenterology: quarterly publication of the Hellenic Society of Gastroenterology. 2015;28(4):448.
20. Yang X, Wang J-X, Han S-X, Gao C-P. High dose dual therapy versus bismuth quadruple therapy for Helicobacter pylori eradication treatment: a systematic review and meta-analysis. Medicine. 2019;98(7).
21. Yang J, Zhang Y, Fan L, Zhu Y-J, Wang T-Y, Wang X-W, et al. Eradication efficacy of modified dual therapy compared with bismuth-containing quadruple therapy as a first-line treatment of Helicobacter pylori. American Journal of Gastroenterology. 2019;114(3):437-45.
22. Kwack W, Lim Y, Lim C, Graham DY. High dose ilaprazole/amoxicillin as first-line regimen for Helicobacter pylori infection in Korea. Gastroenterology research and practice. 2016;2016.
23. Yang J-C, Lin C-J, Wang H-L, Chen J-D, Kao JY, Shun C-T, et al. High-dose dual therapy is superior to standard first-line or rescue therapy for Helicobacter pylori infection. Clinical Gastroenterology and Hepatology. 2015;13(5):895-905. e5.
24. Yu L, Luo L, Long X, Liang X, Ji Y, Graham DY, et al. High‐dose PPI‐amoxicillin dual therapy with or without bismuth for first‐line Helicobacter pylori therapy: A randomized trial. Helicobacter. 2019;24(4):e12596.
25. Khademi F, Poursina F, Hosseini E, Akbari M, Safaei HG. Helicobacter pylori in Iran: A systematic review on the antibiotic resistance. Iranian journal of basic medical sciences. 2015;18(1):2.
26. Farzi N, Yadegar A, Sadeghi A, Asadzadeh Aghdaei H, Marian Smith S, Raymond J, et al. High prevalence of antibiotic resistance in Iranian Helicobacter pylori isolates: importance of functional and mutational analysis of resistance genes and virulence genotyping. Journal of clinical medicine. 2019;8(11):2004.
27. Hu J-L, Yang J, Zhou Y-B, Li P, Han R, Fang D-C. Optimized high-dose amoxicillin–proton-pump inhibitor dual therapies fail to achieve high cure rates in China. Saudi journal of gastroenterology: official journal of the Saudi Gastroenterology Association. 2017;23(5):275.
28. Zhang Y, Zhu Y-J, Zhao Z, Zhao J-T, Wang T-Y, Yang J, et al. Efficacy of modified esomeprazole-amoxicillin dual therapies for Helicobacter pylori infection: an open-label, randomized trial. European journal of gastroenterology & hepatology. 2020;32(5):563-8.
29. Anagnostopoulos GK, Tsiakos S, Margantinis G, Kostopoulos P, Arvanitidis D. Esomeprazole versus omeprazole for the eradication of Helicobacter pylori infection: results of a randomized controlled study. Journal of clinical gastroenterology. 2004;38(6):503-6.
30. Yuan Y, Ford AC, Khan KJ, Gisbert JP, Forman D, Leontiadis GI, et al. Optimum duration of regimens for Helicobacter pylori eradication. Cochrane Database of Systematic Reviews. 2013(12).
31. Ierardi E, Losurdo G, La Fortezza RF, Principi M, Barone M, Di Leo A. Optimizing proton pump inhibitors in Helicobacter pylori treatment: Old and new tricks to improve effectiveness. World journal of gastroenterology. 2019;25(34):5097.
32. Graham DY, Javed SU, Keihanian S, Abudayyeh S, Opekun AR. Dual proton pump inhibitor plus amoxicillin as an empiric anti-H. pylori therapy: studies from the United States. Journal of gastroenterology. 2010;45(8):816-20.
33. Ren L, Lu H, Li HY, Zhu LY, Xu XQ, Gu LY, et al. New dual therapy for primary treatment of H elicobacter pylori infection: A prospective randomized study in S hanghai, C hina. Journal of digestive diseases. 2014;15(11):622-7.
34. Kim SY, Jung SW, Kim JH, Koo JS, Yim HJ, Park JJ, et al. Effectiveness of three times daily lansoprazole/amoxicillin dual therapy for Helicobacter pylori infection in Korea. British journal of clinical pharmacology. 2012;73(1):140-3.
35. Sugimoto M, Shirai N, Nishino M, Kodaira C, Uotani T, Yamade M, et al. Rabeprazole 10 mg qds decreases 24‐h intragastric acidity significantly more than rabeprazole 20 mg bd or 40 mg om, overcoming CYP 2 C 19 genotype. Alimentary pharmacology & therapeutics. 2012;36(7):627-34.
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