INTRODUCTION: The safety of Helicobacter pylori eradication treatments and to what extent adverse events (AEs) influence therapeutic compliance in clinical practice are hardly known. Our aim was to assess the frequency, type, intensity, and duration of AEs, and their impact on compliance, for the most frequently used treatments in the “European Registry on Helicobacter pylori management.” METHODS: Systematic prospective noninterventional registry of the clinical practice of European gastroenterologists (27 countries, 300 investigators) on the management of H. pylori infection in routine clinical practice. All prescribed eradication treatments and their corresponding safety profile were recorded. AEs were classified depending on the intensity of symptoms as mild/moderate/severe and as serious AEs. All data were subject to quality control. RESULTS: The different treatments prescribed to 22,492 patients caused at least 1 AE in 23% of the cases; the classic bismuth-based quadruple therapy was the worst tolerated (37% of AEs). Taste disturbance (7%), diarrhea (7%), nausea (6%), and abdominal pain (3%) were the most frequent AEs. The majority of AEs were mild (57%), 6% were severe, and only 0.08% were serious, with an average duration of 7 days. The treatment compliance rate was 97%. Only 1.3% of the patients discontinued treatment due to AEs. Longer treatment durations were significantly associated with a higher incidence of AEs in standard triple, concomitant, bismuth quadruple, and levofloxacin triple or quadruple therapies. DISCUSSION: Helicobacter pylori eradication treatment frequently induces AEs, although they are usually mild and of limited duration. Their appearance does not interfere significantly with treatment compliance.

On behalf of the scientific Committee and researchers Hp-EuReg European Registry on the management of Helicobacter pylori infection («Hp-EuReg») - a multicenter prospective observational study initiated by the European Helicobacter and Microbiota Study Group, conducted in 27 European countries in order to evaluate the real clinical practice of diagnosis and treatment of H. pylori and its comparison with international recommendations. Materials and methods. The analysis of 2360 patients entered in the register by the Russian centres of «Hp-EuReg» in 2013-2017, who were underwent 1st line eradication therapy. Results. The most common methods of primary diagnosis of H. pylori are histological (37.7%), rapid urease test (29.2%) and serology (29.7%). The duration of eradication therapy in 9.4% of cases was 7 days, in 65.3% - 10 days, and in 25.3% - 14 days. To control the effectiveness of treatment, H. pylori antigen in feces (31.3%), urea breath test (23.4%) and histological method (23.3%) were used. In 3.6% cases was used serology by mistake. In 17.3% of patients control was not carried out. The effectiveness of triple therapy with a PPI, amoxicillin, clarithromycin (per protocol) was 67.6%, with 7-day course, 81.1% at 10-day and 86.7% at 14-day course. Еradication rate of triple therapy with addition of bismuth (per protocol) reached 90,6% in the group receiving 10-day scheme and 93.6% in the group receiving the 14-day treatment. Conclusion. Significant deviations of clinical practice from expert recommendations, most pronounced at the stage of monitoring the effectiveness of therapy, were noted. The suboptimal efficacy of triple therapy is shown.

No abstract

Background Efficacy of Helicobacter pylori eradication therapy depends on the chance of having a resistant H. pylori strain, which is ultimately related to the local antimicrobial resistance epidemiology. Aim To assess H. pylori resistance to clarithromycin, amoxicillin, metronidazole, levofloxacin, and tetracycline in adult patients in the Smolensk region of Russian Federation over a 9‐year period. Materials and methods Biopsy samples were taken from the gastric antrum and body of 573 and 210 patients with dyspepsia symptoms and positive rapid urease test during esophagogastroduodenoscopy in 2015‐2017 and 2009‐2010, respectively. Antimicrobial susceptibility testing was performed for clarithromycin, amoxicillin, metronidazole, levofloxacin, and tetracycline by the agar dilution method. Results A total of 143 strains of H. pylori isolated during 2015‐2017 and 133 strains isolated during 2009‐2010 were tested. Culture success rates were 30% vs 64% for the two periods. Over the 2015‐2017, the prevalence of resistance to clarithromycin was 6.3%, to amoxicillin 1.4%, to metronidazole 23.8%, to levofloxacin 24.5%, and to tetracycline 0.7%. Over the 2009‐2010, the corresponding resistance rates were 5.3%, 4.5%, 3.8%, 8.3%, and 0%, respectively. There were no significant increases in resistance to clarithromycin, amoxicillin, and tetracycline (P > 0.05) over the 9 years period. Significant increase in resistance to levofloxacin (8.3% in 2009‐2010% vs 24.5% in 2015‐2017, P < 0.01) and metronidazole (3.8% in 2009‐2010% vs 23.8% in 2015‐2017, P < 0.01) was observed. Conclusions H. pylori resistance to clarithromycin remained low in the Smolensk region of Russian Federation between 2009 and 2017. Resistance to levofloxacin and metronidazole increased between 2009 and 2017.

Justification The participants of the round table on diagnosis and treatment of acid - and Helicobacter-dependent diseases, held on November 20, 2020 at the XXIII congress of the Scientific Society of Gastroenterologists of Russia within the framework of the XV National Congress of Therapists (Authors) having discussed the status of the issue, decided on the need to harmonize measures and pool efforts to reduce the incidence of H. pylori infection by approaching the medical community with this Memorandum.