ISSN: 2008-2258
Vol 14, No 4 (2021): Autumn
Efficacy of levofloxacin, omeprazole, nitazoxanide, and doxycycline (LOAD) regimen compared with standard triple therapy to eradicate Helicobacter pylori infection: a prospective randomized study from a tertiary hospital in India comparison of LOAD and Standard triple therapy in eradication of h.pylori infection.
Gastroenterology and Hepatology from Bed to Bench,
,
https://doi.org/10.22037/ghfbb.v14i4.2256
Abstract
Introduction/Aim :
Helicobacter pylorus is a widespread infection in India. Resistance to commonly used antibiotics against Helicobacter pylori increases rapidly, leading to traditional triple therapy's lower success. So, a search for a new regimen is needed.
In this study, we compared the efficacy of 14-day triple therapy with a novel ten-day LOAD regimen to eradicate Helicobacter pylori infection in India .
Methods:
In this randomized trial, patients with Helicobacter pylori infection were randomized to LOAD therapy (levofloxacin 250 mg OD, omeprazole 40 mg BD, nitazoxanide 500mg BD, and doxycycline 100 mg OD) for ten days and standard triple therapy ( pantoprazole 80 mg, amoxicillin 2000 mg, and clarithromycin 1000 mg daily in divided doses for 14 days ). Gastric biopsy/RUT was done 10–12 weeks after completing therapy to confirm Helicobacter pylori eradication.
Result :
The eradication rates with LOAD regimen were significantly greater than with standard triple therapy on both intention-to-treat analysis (82.75 % vs. 60.26 %, p = 0.001; difference, 22.49 % [95 % CI, 8.5-18 %] and per-protocol analysis (83.3 % vs. 62.75 %, p = 0.002; difference, 20.55 % [95 % CI, 7.1-22.5 %]). Both the treatment regimens were well tolerated.
Conclusion :
Although the rate of eradication of H. pylori infection with the LOAD regimen was significantly higher than that with triple therapy, the efficacy was still suboptimal. It may be due to fluoroquinolone resistance or a short course of treatment.
Keywords:
- Helicobacter pylori. LOAD regimen, Standard triple therapy.Eradication
How to Cite
RAINA, H., Sainani, R., Parray , A., Wani , A. H., Ashraf , U., & Manzoor Ahmad Raina. (2021). Efficacy of levofloxacin, omeprazole, nitazoxanide, and doxycycline (LOAD) regimen compared with standard triple therapy to eradicate Helicobacter pylori infection: a prospective randomized study from a tertiary hospital in India : comparison of LOAD and Standard triple therapy in eradication of h.pylori infection. Gastroenterology and Hepatology from Bed to Bench, 14(4). https://doi.org/10.22037/ghfbb.v14i4.2256
References
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2. Crowe SE. Helicobacter pylori Infection. N Engl J Med 2019;380:1158–1165.
3.Hooi J, Lai WY, Ng WK, Suen M, Underwood FE, Tanyingoh D, et al. Global prevalence of Helicobacter pylori infection: systematic review and meta-analysis. Gastroenterology 2017;153:420–429.
4. M Zamani , F Ebrahimtabar , V Zamani , W H Miller , R Alizadeh-Navaei , J Shokri-Shirvani , M H Derakhshan .Systematic review with meta-analysis: the worldwide prevalence of Helicobacter pylori infection. Aliment Pharmacol Ther 2018;47:868–876.
5 Sanjeev Kumar Jha, Manish K. Mishra, Kuldeep Saharawat, Praveen Jha, Shubham Purkayastha & Ravish Ranjan .Comparison of concomitant therapy versus standard triple-drug therapy for eradication of Helicobacter pylori infection: A prospective open-label randomized controlled trial. Indian J Gastroenterol 2019; 38, 325–331.
6.Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut 2010;59:1143–1153.
7.P. Patrick Basu,, Krishna Rayapudi ,Tommy Pacana, , Niraj James Shah,, Nithya Krishnaswamy, and Molly Flynn . A Randomized Study Comparing Levofloxacin, Omeprazole, Nitazoxanide, and Doxycycline versus Triple Therapy for the Eradication of Helicobacter pylori .Am J Gastroenterol 2011; 106:1970–1975.
8.Malfertheiner P, Megraud F, O’Morain CA, Atherton J, Axon AT,Bazzoli F, et al. Management of Helicobacter pylori infection–theMaastricht IV/Florence Consensus Report. Gut 2012;61:646–664.
9.Roy AD, Deuri S, Dutta UC. The diagnostic accuracy of rapid urease biopsy test compared to histopathology in implementing “test and treat” policy for Helicobacter pylori. Int J Appl Basic Med Res.2016;6:18–22.
10. Uotani T, Graham DY. Diagnosis of Helicobacter pylori using therapid urease test. Ann Transl Med. 2015;3:9
11.Sharma S, Mittal G, Agarwal RK, Ahuja V, Gupta R, Ahmad S. Comparison of different diagnostic methods of Helicobacter pylori in dyspeptic patients of a tertiary care hospital of Uttarakhand, India. Natl J Lab Med. 2016;5:MO06–10
12.Sp Thyagarajan, Pallab ray, Bimal kumar Das,Archana Ayyagari, Aleem Ahmed khan ,Ddharmalingam, Usha anand Rao, et al .Geographical difference in antimicrobial resistance pattern of Helicobacter pylori clinical isolates from Indian patients:Multicentric study .Journal of Gastroenterology and Hepatology (2003) 18, 1373–1378.
13.Graham DY , Shiotani A . New concepts of resistance in the treatment of Helicobacter pylori infections . Nat Clin Pract Gastroenterol Hepatol 2008 ; 5 : 321 – 31.
14. Gisbert JP , Pajares JM . Treatment of Helicobacter pylori infection: the past and the future . Eur J Intern Med 2010 ; 21 : 357 – 9 .
15 . Javier P Gisbert , Xavier Calvet, Anthony O'Connor, Francis Mégraud, Colm A O'MorainA .Sequential therapy for Helicobacter pylori eradication: a critical review . J Clin Gastroenterol 2010 ; 44 : 313 – 25 .
16 . Sotirios Georgopoulos,Vasilios Papastergiou,w Elias Xirouchakis,
Foteini Laoudi, Philipos Lisgos,w Charikleia Spiliadi,Nikitas Papantoniou and Stylianos Karatapani. Sequential and concomitant therapy with 4drugs are equally effective for eradication of H. pylori infection . Clin Gastroenterol Hepatol 2010 ; 8 : 36 – 41 .
17. William M. Duck, Jeremy Sobel, Janet M. Pruckler, Qunsheng Song, David L. Swerdlow, Cindy R. Friedman, Alana Sulka, Balasubra Swaminathan et al . Antimicrobial resistance incidence and risk factors among H. pylori-infected persons, United States . Emerg Infect Dis 2004 ; 10 : 1088 – 94
18. Brian J McMahon , Thomas W Hennessy, J Michael Bensler, Dana L Bruden, Alan J Parkinson, Julie M Morris, et al. Te relationship among previous antimicrobial use, antimicrobial resistance, and treatment outcomes for Helicobacter pylori infections . Ann Intern Med 2003 ; 139 : 463 – 9
19.P. Patrick Basu, Krishna Rayapudi, Tommy Pacana, Niraj James Shah, Nithya Krishnaswamy, and Molly Flynn, Pharm. A Randomized Study Comparing Levofloxacin,Omeprazole, Nitazoxanide, and Doxycycline versus Triple Therapy for the Eradication of Helicobacter pylori
20.Basu P , Rayapudi K , Esteves J . LEND (levofloxacin, esomeprazole, nitazoxanide and doxycycline) for the treatment of previously non-re Helicobacter pylori. Am J Gastroenterol 2008 ; 103 (suppl 1) : S52
21.Walker RC . Symposium on antimicrobial agents – part XIII: the fluoroquinolones . Mayo Clin Proc 1999 ; 74 : 1030 – 7.
22.Gisbert JP , de la Morena F . Systematic review and meta-analysis: levofloxacin-based rescue regimens afer Helicobacter pylori treatment failure .Aliment Pharmacol Ter 2006 ; 23 : 35 – 44.
23 . Di Caro S , Franceschi F , Mariani A et al. Second-line levofloxacin-based triplechemes for Helicobacter pylori eradication . Dig Liver Dis 2009 ; 41 : 480 – 5
24.Chey WD , Wong BC . American College of Gastroenterology guideline on the management of Helicobacter pylori infection . Am J Gastroenterol 2007 ; 102 : 1808 – 25 .
25.Graham DY , Shiotani A . New concepts of resistance in the treatment of Helicobacter pylori infections . Nat Clin Pract Gastroenterol Hepatol 2008 ; 5 : 321 – 31 .
26.Smilack JD . Symposium on antimicrobial agents – part X: the tetracyclines . Mayo Clin Proc 1999 ; 74 : 727 – 9
27. Duck WM, Sobel J, Pruckler JM, Song Q, Swerdlow DL, Friedman CR et al. Antimicrobial resistance incidence and risk factors among H. pylori-infected persons, United States . Emerg Infect Dis 2004 ; 10 : 1088 – 94
28. McMahon BJ(1), Hennessy TW, Bensler JM, Bruden DL, Parkinson AJ, Morris JM, Reasonover AL, Hurlburt DA et al. The relationship among previous antimicrobial use, antimicrobial resistance, and treatment outcomes for Helicobacter pylori infections . Ann Intern Med 2003 ; 139 : 463 – 9
29.Taghavi SA , Jafari A , Eshraghian A . Efcacy of a new therapeutic regimen versus two routinely prescribed treatments for eradication of Helicobacter pylori: a randomized, double-blind study of doxycycline, co-amoxiclav, and omeprazole in Iranian patients . Dig Dis Sci 2009 ; 54 : 599 – 603.
30.Smilack JD . Symposium on antimicrobial agents – part X: the tetracyclines . Mayo Clin Proc 1999 ; 74 : 727 – 9
31.Kumar D, Ahuja V, Dhar A, Sharma MP. Randomized trial of a quadruple-drug regimen and a triple-drug regimen for eradication of Helicobacter pylori: long-term follow-up study. Indian J Gastroenterol. 2001;20:191–4.
32. Pai CG, Thomas CP, Biswas A, Rao S, Ramnarayan K. Quadruple therapy for initial eradication of Helicobacter pylori in peptic ulcer: comparison with triple therapy. Indian J Gastroenterol. 2003;22:85–7.
33. Das R, Sureshkumar S, Sreenath GS, Kate V. Sequential versus concomitant therapy for eradication of Helicobacter Pylori in patients with perforated duodenal ulcer: A randomized trial. Saudi J Gastroenterol 2016 ;22:309-15.
1.Graham DY. Helicobacter pylori update: gastric cancer, reliable therapy, and possible benefits. Gastroenterology 2015;148:719–731.
2. Crowe SE. Helicobacter pylori Infection. N Engl J Med 2019;380:1158–1165.
3.Hooi J, Lai WY, Ng WK, Suen M, Underwood FE, Tanyingoh D, et al. Global prevalence of Helicobacter pylori infection: systematic review and meta-analysis. Gastroenterology 2017;153:420–429.
4. M Zamani , F Ebrahimtabar , V Zamani , W H Miller , R Alizadeh-Navaei , J Shokri-Shirvani , M H Derakhshan .Systematic review with meta-analysis: the worldwide prevalence of Helicobacter pylori infection. Aliment Pharmacol Ther 2018;47:868–876.
5 Sanjeev Kumar Jha, Manish K. Mishra, Kuldeep Saharawat, Praveen Jha, Shubham Purkayastha & Ravish Ranjan .Comparison of concomitant therapy versus standard triple-drug therapy for eradication of Helicobacter pylori infection: A prospective open-label randomized controlled trial. Indian J Gastroenterol 2019; 38, 325–331.
6.Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut 2010;59:1143–1153.
7.P. Patrick Basu,, Krishna Rayapudi ,Tommy Pacana, , Niraj James Shah,, Nithya Krishnaswamy, and Molly Flynn . A Randomized Study Comparing Levofloxacin, Omeprazole, Nitazoxanide, and Doxycycline versus Triple Therapy for the Eradication of Helicobacter pylori .Am J Gastroenterol 2011; 106:1970–1975.
8.Malfertheiner P, Megraud F, O’Morain CA, Atherton J, Axon AT,Bazzoli F, et al. Management of Helicobacter pylori infection–theMaastricht IV/Florence Consensus Report. Gut 2012;61:646–664.
9.Roy AD, Deuri S, Dutta UC. The diagnostic accuracy of rapid urease biopsy test compared to histopathology in implementing “test and treat” policy for Helicobacter pylori. Int J Appl Basic Med Res.2016;6:18–22.
10. Uotani T, Graham DY. Diagnosis of Helicobacter pylori using therapid urease test. Ann Transl Med. 2015;3:9
11.Sharma S, Mittal G, Agarwal RK, Ahuja V, Gupta R, Ahmad S. Comparison of different diagnostic methods of Helicobacter pylori in dyspeptic patients of a tertiary care hospital of Uttarakhand, India. Natl J Lab Med. 2016;5:MO06–10
12.Sp Thyagarajan, Pallab ray, Bimal kumar Das,Archana Ayyagari, Aleem Ahmed khan ,Ddharmalingam, Usha anand Rao, et al .Geographical difference in antimicrobial resistance pattern of Helicobacter pylori clinical isolates from Indian patients:Multicentric study .Journal of Gastroenterology and Hepatology (2003) 18, 1373–1378.
13.Graham DY , Shiotani A . New concepts of resistance in the treatment of Helicobacter pylori infections . Nat Clin Pract Gastroenterol Hepatol 2008 ; 5 : 321 – 31.
14. Gisbert JP , Pajares JM . Treatment of Helicobacter pylori infection: the past and the future . Eur J Intern Med 2010 ; 21 : 357 – 9 .
15 . Javier P Gisbert , Xavier Calvet, Anthony O'Connor, Francis Mégraud, Colm A O'MorainA .Sequential therapy for Helicobacter pylori eradication: a critical review . J Clin Gastroenterol 2010 ; 44 : 313 – 25 .
16 . Sotirios Georgopoulos,Vasilios Papastergiou,w Elias Xirouchakis,
Foteini Laoudi, Philipos Lisgos,w Charikleia Spiliadi,Nikitas Papantoniou and Stylianos Karatapani. Sequential and concomitant therapy with 4drugs are equally effective for eradication of H. pylori infection . Clin Gastroenterol Hepatol 2010 ; 8 : 36 – 41 .
17. William M. Duck, Jeremy Sobel, Janet M. Pruckler, Qunsheng Song, David L. Swerdlow, Cindy R. Friedman, Alana Sulka, Balasubra Swaminathan et al . Antimicrobial resistance incidence and risk factors among H. pylori-infected persons, United States . Emerg Infect Dis 2004 ; 10 : 1088 – 94
18. Brian J McMahon , Thomas W Hennessy, J Michael Bensler, Dana L Bruden, Alan J Parkinson, Julie M Morris, et al. Te relationship among previous antimicrobial use, antimicrobial resistance, and treatment outcomes for Helicobacter pylori infections . Ann Intern Med 2003 ; 139 : 463 – 9
19.P. Patrick Basu, Krishna Rayapudi, Tommy Pacana, Niraj James Shah, Nithya Krishnaswamy, and Molly Flynn, Pharm. A Randomized Study Comparing Levofloxacin,Omeprazole, Nitazoxanide, and Doxycycline versus Triple Therapy for the Eradication of Helicobacter pylori
20.Basu P , Rayapudi K , Esteves J . LEND (levofloxacin, esomeprazole, nitazoxanide and doxycycline) for the treatment of previously non-re Helicobacter pylori. Am J Gastroenterol 2008 ; 103 (suppl 1) : S52
21.Walker RC . Symposium on antimicrobial agents – part XIII: the fluoroquinolones . Mayo Clin Proc 1999 ; 74 : 1030 – 7.
22.Gisbert JP , de la Morena F . Systematic review and meta-analysis: levofloxacin-based rescue regimens afer Helicobacter pylori treatment failure .Aliment Pharmacol Ter 2006 ; 23 : 35 – 44.
23 . Di Caro S , Franceschi F , Mariani A et al. Second-line levofloxacin-based triplechemes for Helicobacter pylori eradication . Dig Liver Dis 2009 ; 41 : 480 – 5
24.Chey WD , Wong BC . American College of Gastroenterology guideline on the management of Helicobacter pylori infection . Am J Gastroenterol 2007 ; 102 : 1808 – 25 .
25.Graham DY , Shiotani A . New concepts of resistance in the treatment of Helicobacter pylori infections . Nat Clin Pract Gastroenterol Hepatol 2008 ; 5 : 321 – 31 .
26.Smilack JD . Symposium on antimicrobial agents – part X: the tetracyclines . Mayo Clin Proc 1999 ; 74 : 727 – 9
27. Duck WM, Sobel J, Pruckler JM, Song Q, Swerdlow DL, Friedman CR et al. Antimicrobial resistance incidence and risk factors among H. pylori-infected persons, United States . Emerg Infect Dis 2004 ; 10 : 1088 – 94
28. McMahon BJ(1), Hennessy TW, Bensler JM, Bruden DL, Parkinson AJ, Morris JM, Reasonover AL, Hurlburt DA et al. The relationship among previous antimicrobial use, antimicrobial resistance, and treatment outcomes for Helicobacter pylori infections . Ann Intern Med 2003 ; 139 : 463 – 9
29.Taghavi SA , Jafari A , Eshraghian A . Efcacy of a new therapeutic regimen versus two routinely prescribed treatments for eradication of Helicobacter pylori: a randomized, double-blind study of doxycycline, co-amoxiclav, and omeprazole in Iranian patients . Dig Dis Sci 2009 ; 54 : 599 – 603.
30.Smilack JD . Symposium on antimicrobial agents – part X: the tetracyclines . Mayo Clin Proc 1999 ; 74 : 727 – 9
31.Kumar D, Ahuja V, Dhar A, Sharma MP. Randomized trial of a quadruple-drug regimen and a triple-drug regimen for eradication of Helicobacter pylori: long-term follow-up study. Indian J Gastroenterol. 2001;20:191–4.
32. Pai CG, Thomas CP, Biswas A, Rao S, Ramnarayan K. Quadruple therapy for initial eradication of Helicobacter pylori in peptic ulcer: comparison with triple therapy. Indian J Gastroenterol. 2003;22:85–7.
33. Das R, Sureshkumar S, Sreenath GS, Kate V. Sequential versus concomitant therapy for eradication of Helicobacter Pylori in patients with perforated duodenal ulcer: A randomized trial. Saudi J Gastroenterol 2016 ;22:309-15.
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