Comparison of concomitant therapy versus standard triple-drug therapy for eradication of Helicobacter pylori infection: A prospective open-label randomized controlled trial
- 29 Downloads
Resistance to commonly used antibiotics against Helicobacter pylori (H. pylori) is increasing rapidly leading to lower success of traditional triple therapy to eradicate H. pylori infection. So, search for a new regimen as the first-line therapy of H. pylori infection is needed.
In this study, we compared the efficacy of 14-day concomitant therapy and 14-day triple therapy for the eradication of H. pylori infection.
In this open-labeled prospective trial, patients with H. pylori infection were randomized to concomitant therapy (pantoprazole 80 mg, amoxicillin 2000 mg, clarithromycin 1000 mg, and metronidazole 1000 mg daily in divided doses) and triple therapy (pantoprazole 80 mg, amoxicillin 2000 mg, and clarithromycin 1000 mg daily in divided doses). Duration of treatment was 14 days. Gastric biopsy was done 10–12 weeks after completion of therapy to confirm H. pylori eradication.
The eradication rate achieved with the concomitant therapy was significantly greater than that obtained with the triple therapy. Per-protocol eradication rates of concomitant and triple therapy were 77% and 58.3% (p = 0.028), respectively. Intention-to-treat eradication rates of concomitant and triple therapy were 70.1% and 49.3% (p = 0.013), respectively. Both the treatment regimens were well tolerated.
KeywordsAntibiotics Helicobacter pylori Human pathogen
Compliance with ethical standards
Conflict of interest
SKJ, MKM, KS, PJ, SP, and RR declare that they have no conflict of interest.
The study was performed conforming to the Helsinki declaration of 1975, as revised in 2000 and 2008 concerning human and animal rights, and the authors followed the policy concerning informed consent as shown on Springer.com.
The authors are solely responsible for the data and the contents of the paper. In no way, the Honorary Editor-in-Chief, Editorial Board Members, or the printer/publishers are responsible for the results/findings and content of this article.
- 3.Sodhi JS, Javid G, Zargar SA, et al. Prevalence of Helicobacter pylori infection and the effect of its eradication on symptoms of functional dyspepsia in Kashmir, India. J Gastroenterol Hepatol. 2013;28:808–13.Google Scholar
- 4.Thirumurthi S, Graham DY. Helicobacter pylori infection in India from a western perspective. Indian J Med Res. 2012;136:549–62.Google Scholar
- 8.Malfertheiner P, Mégraud F, O’Morain CA, et al. Management of Helicobacter pylori infection—the Maastricht IV Florence Consensus Report. Gut. 2012;61:646–64.Google Scholar
- 9.Fallone CA, Chiba N, van Zanten SV, et al. The Toronto consensus for the treatment of Helicobacter pylori infection in adults. Gastroenterology. 2016;151:51–69.Google Scholar
- 10.Fock KM, Katelaris P, Sugano K, et al. Second Asia-Pacific Consensus Guidelines for Helicobacter pylori infection. J Gastroenterol Hepatol. 2009;24:1587–600.Google Scholar
- 12.Gehlot V, Mahant S, Mukhopadhyay AK, et al. Antimicrobial susceptibility profiles of Helicobacter pylori isolated from patients in North India. J Glob Antimicrob Resist. 2016;5:51–6.Google Scholar
- 14.Thyagarajan SP, Ray P, Das BK, et al. Geographical difference in antimicrobial resistance pattern of Helicobacter pylori clinical isolates from Indian patients: Multicentric study. J Gastroenterol Hepatol. 2003;18:1373–8.Google Scholar
- 15.Yuan Y, Ford AC, Khan KJ, et al. Optimum duration of regimens for Helicobacter pylori eradication. Cochrane Database Syst Rev. 2013;12:CD008337.Google Scholar
- 16.Yeo YH, Shiu S-I, Ho HJ, et al. First-line Helicobacter pylori eradication therapies in countries with high and low clarithromycin resistance: a systematic review and network meta-analysis. Gut. 2017;67:20–7.Google Scholar
- 18.Uotani T, Graham DY. Diagnosis of Helicobacter pylori using the rapid urease test. Ann Transl Med. 2015;3:9.Google Scholar
- 19.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.Google Scholar
- 20.Choudhury G, Mohindra S. Epidemiology of Helicobacter pylori in India. Indian J Gastroenterol. 2000;19 Suppl 1:S3–6.Google Scholar
- 21.Lee HJ, Kim JI, Lee JS, et al. Concomitant therapy achieved the best eradication rate for Helicobacter pylori among various treatment strategies. World J Gastroenterol. 2015;21:351–9.Google Scholar
- 23.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.Google Scholar
- 24.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.Google Scholar
- 29.Javid G, Zargar SA, Bhat K, et al. Efficacy and safety of sequential therapy versus standard triple therapy in Helicobacter pylori eradication in Kashmir India: a randomized comparative trial. Indian J Gastroenterol. 2013;32:190–4.Google Scholar
- 30.Heo J, Jeon SW, Jung JT, et al. A randomised clinical trial of 10-day concomitant therapy and standard triple therapy for Helicobacter pylori eradication. Dig Liver Dis. 2014;46:980–4.Google Scholar
- 31.Georgopoulos S, Papastergiou V, Xirouchakis E, et al. Nonbismuth quadruple “concomitant” therapy versus standard triple therapy, both of the duration of 10 days, for first-line H. pylori eradication. A randomized trial. J Clin Gastroenterol. 2013;47:228–32.Google Scholar