METHODS: Prospective, multicenter, international registry on the management of H. pylori (European Registry on H. pylori Management). All infected and culture-diagnosed adult patients registered in the Spanish Association of Gastroenterology-Research Electronic Data Capture from 2013 to 2021 were included.
RESULTS: A total of 2,852 naive patients with culture results were analyzed. Resistance to clarithromycin, metronidazole, and quinolones was 22%, 27%, and 18%, respectively. The most effective treatment, regardless of resistance, were the 3-in-1 single capsule with bismuth, metronidazole, and tetracycline (91%) and the quadruple with bismuth, offering optimal cure rates even in the presence of bacterial resistance to clarithromycin or metronidazole. The concomitant regimen with tinidazole achieved an eradication rate of 99% (90/91) vs 84% (90/107) with metronidazole. Triple schedules, sequential, or concomitant regimen with metronidazole did not achieve optimal results. A total of 1,118 non-naive patients were analyzed. Resistance to clarithromycin, metronidazole, and quinolones was 49%, 41%, and 24%, respectively. The 3-in-1 single capsule (87%) and the triple therapy with levofloxacin (85%) were the only ones that provided encouraging results.
DISCUSSION: In regions where the antibiotic resistance rate of H. pylori is high, eradication treatment with the 3-in-1 single capsule, the quadruple with bismuth, and concomitant with tinidazole are the best options in naive patients. In non-naive patients, the 3-in-1 single capsule and the triple therapy with levofloxacin provided encouraging results.
OBJECTIVE: To determine which factors influence compliance with treatment.
METHODS: A systematic prospective non-interventional registry (Hp-EuReg) of the clinical practice of European gastroenterologists. Compliance was considered adequate if ≥90% drug intake. Data were collected until September 2021 using the AEG-REDCap e-CRF and were subjected to quality control. Modified intention-to-treat analyses were performed. Multivariate analysis carried out the factors associated with the effectiveness of treatment and compliance.
RESULTS: Compliance was inadequate in 646 (1.7%) of 38,698 patients. The non-compliance rate was higher in patients prescribed longer regimens (10-, 14-days) and rescue treatments, patients with uninvestigated dyspepsia/functional dyspepsia, and patients reporting adverse effects. Prevalence of non-adherence was lower for first-line treatment than for rescue treatment (1.5% vs. 2.2%; p
METHODS: International, prospective, noninterventional registry of the clinical practice of the European gastroenterologists. Data were collected and quality reviewed until March 2021 at AEG-REDCap. The effectiveness was evaluated by modified intention-to-treat analysis, differentiating by geographic areas. Adverse events (AEs) were categorized as mild, moderate, and severe.
RESULTS: Overall, 36,699 treatments were recorded, where 8,233 (22%) were prescribed with probiotics. Probiotics use was associated with higher effectiveness in the overall analysis (odds ratio [OR] 1.631, 95% confidence interval [CI] 1.456-1.828), as well as in triple (OR 1.702, 95% CI 1.403-2.065), quadruple (OR 1.383, 95% CI 0.996-1.920), bismuth quadruple (OR 1.248, 95% CI 1.003-1.554), and sequential therapies (OR 3.690, 95% CI 2.686-5.069). Lactobacillus genus was associated with a higher therapy effectiveness in Eastern Europe when triple (OR 2.625, 95% CI 1.911-3.606) and bismuth quadruple (OR 1.587, 95% CI 1.117-2.254) first-line therapies were prescribed. In Central Europe, the use of probiotics was associated with a decrease in both the overall incidence of AEs (OR 0.656, 95% CI 0.516-0.888) and severe AEs (OR 0.312, 95% CI 0.217-0.449). Bifidobacterium genus was associated with lower overall (OR 0.725, 95% CI 0.592-0.888) and severe (OR 0.254, 95% CI 0.185-0.347) AEs, and Saccharomyces was associated with reduced overall (OR 0.54, 95% CI 0.32-0.91) and severe (OR 0.257, 95% CI 0.123-0.536) AEs under quadruple-bismuth regimen.
DISCUSSION: In Europe, the use of probiotics was associated with higher effectiveness and safety of H. pylori eradication therapy. Lactobacillus improved treatment effectiveness, whereas Bifidobacterium and Saccharomyces were associated with a better safety profile.