Abstract
As high clarithromycin resistance (>20%) in the Split-Dalmatia region of Croatia hinders the treatment of H. pylori infection, the primary objective of this study was to compare concomitant quadruple with the tailored, personalized therapy as first-line eradication treatment of H. pylori. In an open-label, randomized clinical trial, 80 patients with H. pylori infection were randomly assigned to either concomitant (esomeprazole 40 mg, amoxicillin 1 gr, metronidazole 500 mg, clarithromycin 500 mg, twice daily for 14 days) or tailored therapy in accordance with the results of the antimicrobial susceptibility testing. Eradication status was assessed 4 weeks after treatment. Eradication rates were significantly higher in tailored group than in concomitant group both in intention-to-treat (70 vs. 92.5%, p = 0.010) and per-protocol (87.5 vs. 100%, p = 0.030) analysis in the setting of increasing antibiotic resistance (clarithromycin 37.5%, metronidazole 17.5%, dual resistance 10%). Adverse effects were more frequent in the concomitant group (32.5 vs. 7.5%, p = 0.006). Tailored therapy achieves higher eradication with a lower adverse events rate. With the increasing resistance of H. pylori strains to antibiotic treatment, eradication regimes with such characteristics should be strongly considered as a reasonable choice for first-line treatment.
Highlights
More than half of the world’s population are H. pylori carriers [1]
The aim of our study was to compare concomitant nonbismuth quadruple therapy with a tailored therapy based on antibiotic strain susceptibility testing, assuming that the eradication rate with tailored therapy will be above 90%
Patients with any one of the following criteria were excluded from the study: age less than 18 years; previously unsuccessful application of empirical H. pylori eradication therapy; malignant disease of the stomach or any other site; taking proton pump inhibitors (PPI), H2 antagonists, bismuths or antibiotics during the last month; associated comorbidity; drug allergies: proton pumps inhibitors or antibiotics; pregnancy and lactation; refusal to participate in the survey
Summary
More than half of the world’s population are H. pylori carriers [1]. The infection is mostly acquired in childhood and persists lifelong. A notable risk factor is a lower social and economic status during childhood, reflecting mostly poor hygienic standards or small and dense living areas [2]. Acquired infections in adulthood are a rarity. The reservoir of H. pylori is the human stomach. H. pylori is considered to be the main pathogen involved in causing benign peptic ulcers and functional dyspepsia, as well as gastric cancer [3,4]. It was shown that H. pylori contains cytosolic alcohol dehydrogenase (ADH) and is capable of producing acetaldehyde from excess ethanol in vitro
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