Introduction

These are the initial results based on currently ongoing follow-up of the participants in the GISTAR study in Latvia (Multicentric randomized study of H. pylori eradication and pepsinogen testing for prevention of gastric cancer mortality) within the EUROHELICAN project.

Aims & Methods

The aim was to investigate the potential adverse health effects of the Helicobacter pylori (H. pylori) test-and-treat strategy in the long term. Baseline data on sociodemographic and lifestyle factors, medical history, body mass index (BMI), waist to hip ratio (WHR), and blood pressure were collected 5 to 11 years ago. Blood samples were also drawn. Participants in the intervention group were tested for H. pylori (initially with serology, then urea breath test (UBT)). Those who tested positive were offered eradication therapy. Participants in the control group were not tested for H. pylori and received regular healthcare. During follow-up, data on the same characteristics were collected. UBT was performed for those who were H. pylori positive at baseline. The symptom-based GERDQ score was assessed at the follow-up. The change in parameters from baseline to follow-up was examined between groups using chi-square and Mann-Whitney tests in SPSS 29.0.

Results

A total of 1305 GISTAR participants were recruited at follow up within EUROHELICAN. Their median age was 60 years (IQR 11). Among them, 57 % were female, of whom 691 (53%) were in the intervention group. Baseline data on H. pylori status and eradication were available for 687 participants, of whom 423 (61.6%) were positive at baseline.
When comparing differences in the change of characteristics between baseline and follow-up in the treated (n = 356, 51.8%) and non-treated groups (331, 48.2%), there were no significant differences in BMI, WHR, systolic and diastolic blood pressures (Table 1).
When examining changes in characteristics of participants in the eradicated (n = 281, 84%) and non-eradicated (53, 15.9%) groups, there were no significant differences in BMI and blood pressure. There was a significant difference in the WHR change.

Table 1. Comparison of the change in values from baseline to follow-up between groups.

Conclusion

The project will provide data missing on the potential negative effects of eradication. So far, no negative effects were confirmed. The study is ongoing, and a larger number of participants will be included. More data will be available to better assess whether there is a significant change in parameters covered in this abstract as well as additional variables pertaining to GERD, and potential metabolic and cardiovascular effects.

The EUROHELICAN project “Accelerating gastric cancer reduction in Europe through Helicobacter pylori eradication” received funding from EU4Health program, grant no. 101079944.

Introduction

It is still controversial whether the supplementation of Saccharomyces boulardii to bismuth quadruple therapy is beneficial for Helicobacter pylori eradication. The aim of the study was to determine the effects of S. boulardii supplementation on H. pylori eradication.

Aims & Methods

We performed a systematic literature search across PubMed, Embase, Web of Science, and China National Knowledge Infrastructure for articles published up to October 2023. We calculated the pooled relative risk (RR) with the 95% confidence interval (CI). Subgroup analyses were also performed. Statistical analyses were conducted using Stata/SE 15.1 software.

Results

Ten randomized controlled trials were included. Notably, S. boulardii supplementation to bismuth quadruple therapy significantly improved H. pylori eradication rates (RR = 1.08, 95% CI: 1.04–1.12, P < 0.0001) and reduced the incidence of total adverse effects (RR = 0.53, 95% CI: 0.45–0.62, P < 0.0001). Furthermore, it reduced the incidence of some gastrointestinal adverse effects and nonspecific adverse effects, including diarrhea (RR = 0.28, 95% CI: 0.22–0.36, P < 0.0001), constipation (RR = 0.32, 95% CI: 0.18–0.55, P < 0.0001), abdominal distention (RR = 0.39, 95% CI: 0.26–0.59, P < 0.0001), nausea (RR = 0.59, 95% CI: 0.36–0.97, P = 0.039), and rash (RR = 0.49, 95% CI: 0.28–0.86, P = 0.013). In the subgroup analysis, long-term eradication duration (>10 days; RR = 1.08, 95% CI: 1.04–1.13, P < 0.0001) and S. boulardii supplementation to be started and stopped at the same time as bismuth quadruple therapy (RR = 1.09, 95% CI: 1.04–1.14, P < 0.0001) were found to significantly improve the eradication rate regardless of the S. boulardii dose (500 mg/day, RR = 1.10, 95% CI: 1.03–1.17, P = 0.003; 1000 mg/day, RR =1.08, 95% CI: 1.03–1.12, P < 0.0001).

Conclusion

The addition of S. boulardii to bismuth quadruple therapy significantly increased H. pylori eradication rates and decreased the adverse effects. We recommend adding 500 mg/day S. boulardii concurrently with bismuth quadruple therapy and continuing this therapy for >10 days for optimal H. pylori eradication efficacy.

Introduction

Bismuth quadruple therapy (BQT) including bismuth, a proton pump inhibitor (PPI) and two antibiotics has been shown to be a very effective treatment for Helicobacter pylori infection even in areas of high bacterial antibiotic resistance. Bismuth prescriptions seem to be increasing in recent years.

Aims & Methods

To describe the use, effectiveness, and safety of BQT in Europe and the evolution of prescriptions as part of the European Registry on Helicobacter pylori management (Hp-EuReg).

All patients who had received BQT in a 9-year period were included. The thirty-one countries participating in the Hp-EuReg been clustered in previous studies in five main regions based both on their geographical situation and the gross domestic product per capita (North, Centre, Est, South-Est, South-West). Data on the prescribed schedules, previous eradication attempts, effectiveness and the incidence of adverse events was analysed. A time trend analysis of the different BQT treatment prescriptions was likewise performed. Effectiveness was defined by a modified intention-to-treat (mITT) analysis. A multivariate analysis was performed to determine the variables predicting treatment effectiveness.

Results

Of the 49,690 patients included in the Hp-EuReg, 15,582 (31%) had received BQT. BQT use increased from 8.6% to 39% during the study period. Forty-six different schedules were used, of which 8 were administered to more than 100 patients. Single-capsule BQT (ScBQT) containing bismuth, metronidazole and tetracycline plus a PPI was the most used therapy (43%). In naïve patients, the following BQTs obtained over 90% effectiveness: those using tetracycline and metronidazole, either drugs prescribed separately for 14 days, or as 10-day ScBQT; and those using amoxicillin either with clarithromycin or metronidazole, both for 14 days. ScBQT was the only schedule achieving optimal cure rates in all the geographical areas. Standard- or high-dose PPIs, prescriptions of 10-14 days and the schedule type are significantly related to higher cure rates in the multivariate analysis.



Table.Predictive factors of treatment effectiveness in multivariate analysis

Conclusion

The use of BQT has increased progressively in the last decade.10-Day ScBQT or 14-day BQT schedules achieved an effectiveness over 90% in Europe.

Disclosure

Prof. J. Gisbert has served as speaker, consultant, and advisory member for or has received research funding from Mayoly, Allergan, Diasorin, Gebro Pharma, and Richen.

Introduction

Antibiotic resistance is the leading cause of failure in the eradication of Helicobacter pylori (H. pylori) infection. In addition to general overuse and misuse of antibiotics, the repetition of the same therapy regimen further promotes the prevalence of resistant H. pylori strains. Molecular PCR techniques have enabled clinicians to tailor the treatment according to the antibiotic sensitivity of specific H. pylori. For the first time, the Maastricht VI Consensus has made a statement regarding the implementation of PCR.

Aims & Methods

Our aim was to assess the effectiveness of tailored therapy implementation in eradicating H. pylori infection evaluating the data from a multicentric, prospective registry of the clinical practice of European gastroenterologists in the management of H. pylori infection (Hp-EuReg). All H. pylori-infected and PCR-diagnosed patients registered until December 2023 at e-CRF AEG-REDCap were included. Treatment effectiveness was analysed per protocol (accounting only those adherent cases and those with a result either as success or failure to treatment). Effectiveness >85% was considered as satisfactory and >90% as optimal.

Results

A total of 265 patients from XX European countries were tested using the molecular PCR method, 203 (77%) cases on gastric tissue and 62 (23%) on stools. . The effectiveness of tailored therapy in treatment-naïve patients was 95%, while the eradication rate in the rescue (from 2^nd to 6^th) line was 86%. In the first line, the most common prescribed regimens were quadruple-clarithromycin+amoxicillin+metronidazole (C+A+M) therapy, followed by single-capsule quadruple therapy with metronidazole+tetracycline+bismuth (M+T+B), with an eradication rate of 95% and 97%,respectively. In the rescue line, the most common prescribed regimen was single-capsule quadruple therapy with M+T+B (achieving 87% effectiveness by PP), followed by quadruple C+A+M therapy (94%), triple-amoxicilin+metronidazole (A+M) (93%), and triple levofloxacin+amoxicilin (L+A) therapy (91%) (Table). Clarithromycin and fluoroquinolone resistance rates in the first line were 31% and 33%, respectively; while in rescue line, they were reported higher, that is 63% and 52%; respectively.
Table. Most frequent PCR-guided treatments prescriptions and per protocol effectiveness in Europe.

Conclusion

PCR-guided tailored therapy showed a consistent optimal (>90%) effectiveness in all therapy lines and prescriptions. This indicates that clarithromycin-based therapy can still be a reasonable treatment choice even in regions with high clarithromycin resistance rate, provided that pretreatment H. pylori antibiotic sensitivity is assessed.

Disclosure

Olga P. Nyssen received research funding from Mayoly and Allergan. Javier P. Gisbert served as speaker, consultant, and advisory member for or received research funding from Mayoly, Allergan, Diasorin, Gebro Pharma, and Richen.

Introduction

Previous studies have suggested an association between Helicobacter pylori (HP) infection and osteoporosis. However, the influence of HP eradication on osteoporosis has not been established.

Aims & Methods

The objective of this study was to evaluate whether the risk of developing osteoporosis could be decreased by HP eradication. So, we conducted an observational study of prospectively enrolled cohort. All participants received esophagogastroduodenoscopy with HP tests at the Seoul National University Bundang Hospital from May 2003 to February 2023. HP infection was defined if any one of the following tests was positive: urea breath test, rapid urease test, or histology. Osteoporosis was diagnosed using dual-energy X-ray absorptiometry. The risk of osteoporosis was analyzed using Cox proportional hazard regression analyses.

Results

A total of 8,025 patients were included in the study, and patients under the age of 20, with unknown HP infection status, having a prior history of HP eradication, gastric cancer, or osteoporosis were excluded. Finally, there were 730 patients in the eradicated group and 116 patients in the non-eradicated group. In Cox proportional hazard analyses, the hazard ratio (HR) for osteoporosis in the eradicated group was 0.588 (95% confidence interval [CI] 0.41-0.84, p=0.003) referring the non-eradicated group as reference. In addition, multivariate analyses showed that advanced age (HR 1.05, 95% CI 1.03-1.06, p<0.001), menopause (HR 3.46, 95% CI 2.25-5.32, p<0.001), and history of medicine use (HR 2.86, 95% CI 2.13-3.84, p<0.001) were risk factors for osteoporosis (Table).
Table. Univariate and multivariate analysis of incidence of osteoporosis with Helicobacter pylori.

Conclusion

The beneficial effect of HP eradication on preventing osteoporosis was observed in this study, even after the adjustment of other confounding factors.