Introduction
Helicobacter pylori (Hp) infection remains a major public health problem, associated with significant morbidity and mortality, whose eradication therapy has proven to be effective in preventing these complications.1,2 Given the high resistance to antibiotics and the scarcity of available antibiotic therapy worldwide, there is not enough data on the best eradication strategy.3,4
Aims & Methods
Aim: The aim of this study was to perform a comparative evaluation of the efficacy and safety of the different quadruple therapy regimens currently recommended for the Hp eradication, including Esomeprazole 40 mg bid.
Methods: A blind randomized controlled clinical trial of consecutive patients with gastric infection by Hp, diagnosed by 13C-urea breath test (UBT) or histological analysis were randomized in 5 therapy arms (A: Quadruple with metronidazole 500 mg tid, 14 days; B: Quadruple with metronidazole 500 mg bid, 14 days; C: Quadruple with bismuth, 10 days; D: Sequential, 7 days; E: Hybrid, 7 days). Hp eradication with evaluation of the efficacy and safety rates at 1-2 months after the eradication therapy was made.
Results
From a total of 200 patients currently included, 193 concluded the protocol study (164-histological analysis; 29-UBT), 102 males (52.8%), mean age of 57.2±16.3 (A: 38; B: 39; C: 38; D: 41; E: 37). Overall efficacy rate of quadruple therapy regimens was 95.9% (n=185), being 100.0% for arm A, 92.3% for arm B, 97.3% for arm C, 97.6% for arm D and 91.9% for arm E (p=0.431). Overall adverse events rate of quadruple therapy regimens was 53.9% (n=104), being diarrhea (27.5%) and nausea (26.9%) the most common. Major symptoms (need for therapy or impairment of daily living activities) occurred in 8.3%. Adverse events/Major adverse events rates for the different regimens were 50.0%/5.3% for arm A, 69.2%/15.4% for arm B, 48.6%/7.9% for arm C, 48.8%/4.9% for arm D and 54.0%/8.1% for arm E (p=0.287/p=0.451).
Conclusion
In Portugal, all the quadruple therapy regimens currently recommended for the eradication of Hp, with or without bismuth, have been effective in eradicating Hp gastric infection. However, concomitant therapy with metronidazole bid seems to have a higher rate of adverse effects, including major adverse effects.
References
1. Zamani, M., Ebrahimtabar, F., Zamani, V., et al. Systematic review with meta-analysis: the worldwide prevalence of Helicobacter pylori infection. Aliment Pharmacol Ther 2018; 47(7): 868-876.
2. Malfertheiner, P., Megraud, F., O’Morain, C.A., et al. Management of Helicobacter pylori infection – the Maastricht V/Florence Consensus Report. Gut 2017; 66(1): 6-30.
3. Savoldi, A., Carrara, E., Graham, D.Y., et al. Prevalence of antibiotic resistance in Helicobacter pylori: a systematic review and meta-analysis in World Health Organization Regions. Gastroenterology 2018; 155(5): 1372-1382.
4. Lopo, I., Libânio, D., Pita, I., et al. Helicobacter pylori antibiotic resistance in Portugal: Systematic review and meta[1]analysis. Helicobacter 2018; 23(4): e12493.
Disclosure
Nothing to declare.
