Role of compliance in Helicobacter pylori eradication treatment: Results of the European Registry on H. pylori management.

BACKGROUND: Adherence to Helicobacter pylori (H. pylori) eradication treatment is a cornerstone for achieving adequate treatment efficacy. 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 < 0.001). Differences in non-adherence in the three most frequent first-line treatments were shown: 1.1% with proton pump inhibitor + clarithromycin + amoxicillin; 2.3% with proton pump inhibitor clarithromycin amoxicillin metronidazole; and 1.8% with bismuth quadruple therapy. These treatments were significantly more effective in compliant than in non-compliant patients: 86% versus 44%, 90% versus 71%, and 93% versus 64%, respectively (p < 0.001). In the multivariate analysis, the variable most significantly associated with higher effectiveness was adequate compliance (odds ratio, 6.3 [95%CI, 5.2-7.7]; p < 0.001). CONCLUSIONS: Compliance with Helicobacter pylori eradication treatment is very good. Factors associated with poor compliance include uninvestigated/functional dyspepsia, rescue-treatment, prolonged treatment regimens, the presence of adverse events, and the use of non-bismuth sequential and concomitant treatment. Adequate treatment compliance was the variable most closely associated with successful eradication.

Effectiveness of Helicobacter pylori Treatments According to Antibiotic Resistance.

INTRODUCTION: Antibiotic resistance is one of the main factors that determine the efficacy of treatments to eradicate Helicobacter pylori infection. Our aim was to evaluate the effectiveness of first-line and rescue treatments against H. pylori in Europe according to antibiotics resistance. 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.

Dynamics of Active Fluorescent Units (AFU) and Water Activity (aw) Changes in Probiotic Products-Pilot Study.

The flow cytometry method (FCM) is a widely renowned practice increasingly used to assess the microbial viability of probiotic products. Additionally, the measurement of water activity (aw) can be used to confirm the presence of viable cells in probiotic products throughout their shelf lives. The aim of this study was to investigate the correlation between changes in aw and variations in active fluorescent units (AFU), a unit commonly used in flow cytometry method, during the aging of probiotic products containing freeze-dried bacteria. We controlled the stability of probiotic products for bacterial counts (using ISO 19344 method) and aw levels in commercially available capsules containing freeze-dried bacteria such as Lactobacillus sp. or combinations of Lactobacillus sp. and Bifidobacterium sp. in standard conditions (25 ± 2 °C and 60% relative humidity) over a period of 24 months. During this time, the bacterial contents decreased by 0.12 Log10 in the single-strain product, by 0.16 Log10 in the two-strain product and by 0.26 Log10 in the multi-strain product. With the increase in aw, the number of bacteria decreased but the aw at the end point of the stability study did not exceed 0.15 in each of the three tested products. FCM combined with aw is a prospective analysis that can be used to assess the stability of probiotic products, both for its ability to detect bacterial viability and for practical (analysis time) and economic reasons.

Burnout in healthcare - the Emperor's New Clothes.

Burnout is common among physicians; it severely alters their health and has a negative impact on functioning of healthcare systems. Hypertension, increased cortisol levels, maladaptive behaviors with negative social consequences, and suboptimal quality of care have been associated with healthcare providers' burnout. As the number of patients with cancers, psychiatric and neurodegenerative disorders will rise, we need new solutions to maintain physicians' health and, therefore, quality of care. Coping strategies before the COVID-19 pandemic seem ineffective in scaling all the deficits of the global healthcare systems. Examples of new initiatives include new collaborative projects, such as COH-FIT (The Collaborative Outcomes study on Health and Functioning during Infection Times - https://www.coh-fit.com), which aims to collect global data and understand the impact of the COVID-19 pandemic on physical and mental health in order to identify various coping strategies for patients and healthcare workers during infection times, or MEMO (Minimizing Error, Maximizing Outcome), funded by the Agency of Healthcare Research and Quality (AHRQ). Others: i) Rome Foundation GastroPsych undertake efforts dedicated to the science and practice of psychogastroenterology, a burgeoning field with roots in behavioral intervention, cognitive science and experimental psychology focused on fostering the professional growth and collaboration of those engaged in medical practices, or ii) World Gastroenterology Organisation (WGO), Train The Trainers (TTT) program including a new topic of the impact of burnout on career longevity in order to foster strategies for staying healthy and increasing career satisfaction. There is a need for continuous development of digital technologies (e.g. training simulators, telemedicine, robots and artificial intelligence). Their implementation into medical practice is inevitable. Now more than ever, there is a need for a new spirit in healthcare. Together with others in the field, we believe this article is a desperate call for maximizing the use of novel technologies supported by collaborative interactions among healthcare providers and medical professionals of diverse medical fields.

Comparison of the management of Helicobacter pylori infection between the older and younger European populations.

The prevalence of Helicobacter pylori remains high in the older population. Specific age-related peculiarities may impact the outcomes of H. pylori treatment. The aim of the study was to evaluate the diagnostics and effectiveness of H. pylori eradication between the younger and older European populations. "European Registry on H. pylori Management (Hp-EuReg)" data from 2013 to 2022 were analyzed. Patients were divided into older (≥ 60 years) and younger (18-59 years) groups. Modified intention-to-treat (mITT) and per-protocol (PP) analysis was performed. 49,461 patients included of which 14,467 (29%) were older-aged. Concomitant medications and penicillin allergy were more frequent among the older patients. Differences between younger and older populations were observed in treatment duration in first-line treatment and in proton pump inhibitors (PPIs) doses in second-line treatment. The overall incidence of adverse events was lower in the older adults group. The overall first-line treatment mITT effectiveness was 88% in younger and 90% in the older patients (p < 0.05). The overall second-line mITT treatment effectiveness was 84% in both groups. The effectiveness of the most frequent first- and second-line triple therapies was suboptimal (< 90%) in both groups. Optimal efficacy (≥ 90%) was achieved by using bismuth and non-bismuth-based quadruple therapies. In conclusion, the approach to the diagnostics and treatment of H. pylori infection did not generally differ between younger and older patients. Main differences were reported in the concurrent medications, allergy to penicillin and adverse events both in first- and second-line treatment. Optimal effectiveness rates were mostly achieved by using bismuth and non-bismuth-based quadruple therapies. No clinically relevant differences in the effectiveness between the age groups were observed.

Analysis of Clinical Phenotypes through Machine Learning of First-Line H. pylori Treatment in Europe during the Period 2013-2022: Data from the European Registry on H. pylori Management (Hp-EuReg).

The segmentation of patients into homogeneous groups could help to improve eradication therapy effectiveness. Our aim was to determine the most important treatment strategies used in Europe, to evaluate first-line treatment effectiveness according to year and country. Data collection: All first-line empirical treatments registered at AEGREDCap in the European Registry on Helicobacter pylori management (Hp-EuReg) from June 2013 to November 2022. A Boruta method determined the "most important" variables related to treatment effectiveness. Data clustering was performed through multi-correspondence analysis of the resulting six most important variables for every year in the 2013-2022 period. Based on 35,852 patients, the average overall treatment effectiveness increased from 87% in 2013 to 93% in 2022. The lowest effectiveness (80%) was obtained in 2016 in cluster #3 encompassing Slovenia, Lithuania, Latvia, and Russia, treated with 7-day triple therapy with amoxicillin-clarithromycin (92% of cases). The highest effectiveness (95%) was achieved in 2022, mostly in Spain (81%), with the bismuth-quadruple therapy, including the single-capsule (64%) and the concomitant treatment with clarithromycin-amoxicillin-metronidazole/tinidazole (34%) with 10 (69%) and 14 (32%) days. Cluster analysis allowed for the identification of patients in homogeneous treatment groups assessing the effectiveness of different first-line treatments depending on therapy scheme, adherence, country, and prescription year.

Robotic-Assisted Solutions for Invasive Cardiology, Cardiac Surgery and Routine On-Ward Tasks: A Narrative Review.

Robots are defined as programmable machines that can perform specified tasks. Medical robots are emerging solutions in the field of cardiology leveraging recent technological innovations of control systems, sensors, actuators, and imaging modalities. Robotic platforms are successfully applied for percutaneous coronary intervention, invasive cardiac electrophysiology procedures as well as surgical operations including minimally invasive aortic and mitral valve repair, coronary artery bypass procedures, and structural heart diseases. Furthermore, machines are used as staff-assisting tools to support nurses with repetitive clinical duties i.e., food delivery. High precision and resolution allow for excellent maneuverability, enabling the performance of medical procedures in challenging anatomies that are difficult or impossible using conventional approaches. Moreover, robot-assisted techniques protect operators from occupational hazards, reducing exposure to ionizing radiation, and limiting risk of orthopedic injuries. Novel automatic systems provide advantages for patients, ensuring device stability with optimized utilization of fluoroscopy. The acceptance of robotic technology among healthcare providers as well as patients paves the way for widespread clinical application in the field of cardiovascular medicine. However, incorporation of robotic systems is associated with some disadvantages including high costs of installation and expensive disposable instrumentations, the need for large operating room space, and the necessity of dedicated training for operators due to the challenging learning curve of robotic-assisted interventional systems.

Long-lasting dyspeptic symptoms - another consequence of the COVID-19 pandemic?

Introduction: It is known that the virus SARS-CoV-2 can attack the gastrointestinal (GI) tract and induce gastroenteritis. This can trigger a wide variety of disorders of gut-brain interaction (DGBIs) or functional gastrointestinal disorders (FGIDs), including post-infectious dyspepsia, which remains underestimated. Aim: To estimate the prevalence of dyspeptic symptoms following COVID-19, immediately after discharge and 3, 6, and 9 months after hospitalization. Material and methods: A prospective, single-centre evaluation of questions regarding functional dyspepsia (FD) as assessed by the Gastroduodenal Module of ROME IV Diagnostic Questionnaire for Adult FGIDs among 320 patients who had had COVID-19. Results: The FD ROME IV criteria were met at the respective time-points by 0.0% (0), 4.8% (12), 3.2% (8), and 3.2% (8) of cases. However, the presence of GI symptoms that suggested FD but did not meet the timeframe ROME IV criteria for FD were found in 9.6% (24), 23.5% (59), 20.7% (52), and 20.7% (52) of cases, respectively. Conclusions: The presence and persistence of gastrointestinal dyspeptic symptoms following COVID-19 is a significant problem. The timeframe of the Rome IV criteria may underestimate the number of patients with persistent dyspeptic symptoms following COVID-19 disease.

Clinical Relevance of Gut Microbiota Alterations under the Influence of Selected Drugs-Updated Review.

As pharmacology and science progress, we discover new generations of medicines. This relationship is a response to the increasing demand for medicaments and is powered by progress in medicine and research about the respective entities. However, we have questions about the efficiency of pharmacotherapy in individual groups of patients. The effectiveness of therapy is controlled by many variables, such as genetic predisposition, age, sex and diet. Therefore, we must also pay attention to the microbiota, which fulfill a lot of functions in the human body. Drugs used in psychiatry, gastroenterology, diabetology and other fields of medicine have been demonstrated to possess much potential to change the composition and probably the function of the intestinal microbiota, which consequently creates long-term risks of developing chronic diseases. The article describes the amazing interactions between gut microbes and drugs currently used in healthcare.

Concomitant diverticulosis among patients undergoing liver transplantation. Does it influence the length of hospitalization after the procedure?

Aim of the study: We tried to assess the influence of concomitant diverticulosis and other factors, e.g., Child-Pugh (C-P) and MELD scores, viral etiology, and presence of alcoholic disease, on short-term results of liver transplantation (LT) with an emphasis on duration of patient's hospitalization. Material and methods: This prospective study was performed on 206 cirrhotic patients who were selected for LT. In order to assess the presence of diverticculosis we performed colonoscopy. Results: The duration of hospitalization after LT did not differ significantly between patients with and without diverticulosis (27.5 [21.0-33.5] vs. 24.0 [18.0-32.0] days, p = 0.28). Patients with C-P class C were hospitalized longer in comparison to the class B patients. It is reflected in the positive correlation between C-P score and days of hospitalization (r = 0.22, p = 0.002). Patients with diverticulosis were significantly older (59.6 [51.1-63.3] vs. 52.9 [43.8-59.2] years, p = 0.03). Alcoholic liver disease (ALD) was associated with a greater risk of diverticulosis (OR = 3.89, 95% CI [1.13-15.87], p = 0.04). Conclusions: Presence of diverticulosis among subjects undergoing LT did not influence the duration of hospitalization after the procedure. Significantly longer hospitalization was observed in patients with the most advanced liver disease according to C-P score. To determine the exact impact of diverticulosis on short-term results of LT additional studies are required.

Probiotics in the Management of Mental and Gastrointestinal Post-COVID Symptomes.

Patients with "post-COVID" syndrome manifest with a variety of signs and symptoms that continue/develop after acute COVID-19. Among the most common are gastrointestinal (GI) and mental symptoms. The reason for symptom occurrence lies in the SARS-CoV-2 capability of binding to exact receptors, among other angiotensin converting enzyme 2 (ACE2) receptors in gastrointestinal lining and neuropilin-1 (NRP-1) in the nervous system, which leads to loss of gastrointestinal and blood-brain barriers integrity and function. The data are mounting that SARS-CoV-2 can trigger systemic inflammation and lead to disruption of gut-brain axis (GBA) and the development of disorders of gut brain interaction (DGBIs). Functional dyspepsia (FD) and irritable bowel syndrome (IBS) are the most common DGBIs syndromes. On the other hand, emotional disorders have also been demonstrated as DGBIs. Currently, there are no official recommendations or recommended procedures for the use of probiotics in patients with COVID-19. However, it can be assumed that many doctors, pharmacists, and patients will want to use a probiotic in the treatment of this disease. In such cases, strains with documented activity should be used. There is a constant need to plan and conduct new trials on the role of probiotics and verify their clinical efficacy for counteracting the negative consequences of COVID-19 pandemic. Quality control is another important but often neglected aspect in trials utilizing probiotics in various clinical entities. It determines the safety and efficacy of probiotics, which is of utmost importance in patients with post-acute COVID-19 syndrome.

Irritable bowel syndrome following COVID-19: an underestimated consequence of SARS-CoV-2 infection.

INTRODUCTION: Gastrointestinal (GI) symptoms are a common manifestation of COVID­19. OBJECTIVES: We aimed to investigate whether GI symptoms persist in patients previously infected with SARS­CoV­2 in the form of post­infection irritable bowel syndrome (PI­IBS). PATIENTS AND METHODS: A prospective, single­center evaluation of questions regarding IBS was conducted using the Rome IV Adult Diagnostic Questionnaire among 257 patients previously hospitalized for COVID­19. RESULTS: GI symptoms (abdominal pain with diarrhea or constipation) were reported at the following time points: at discharge from the hospital, and after 3 and 6 months of follow­up. GI symptoms not meeting the full Rome IV diagnostic criteria for IBS due to too short symptom duration were reported by 28 individuals (10.6%) at hospital discharge, 58 (22.3%) after 3 months, and 70 (26.9%) after 6 months. The full Rome IV criteria for IBS were not met at discharge by any of the participants, but they were met after 3 and 6 months of follow­up in 14 (5.4%) and 15 individuals (5.8%), respectively. CONCLUSION: Persistent GI symptoms following COVID­19 are frequent and deserve significant and growing attention of gastroenterologists and other health care practitioners. The Rome IV criteria may be too strict to address the full spectrum of GI symptoms following COVID­19.

Indications, Detection, Completion and Retention Rates of Capsule Endoscopy in Two Decades of Use: A Systematic Review and Meta-Analysis.

BACKGROUND: Capsule endoscopy (CE) has become a widespread modality for non-invasive evaluation of the gastrointestinal (GI) tract, with several CE models having been developed throughout the years. The aim of this systematic review and meta-analysis is to evaluate performance measures such as completion, detection and retention rates of CE. METHODS: Literature through to August 2021 was screened for articles regarding all capsule types: small bowel, double-headed capsule for the colon or PillCam®Crohn's capsule, magnetically-controlled capsule endoscopy, esophageal capsule and patency capsule. Primary outcomes included detection rate (DR), completion rate (CR) and capsule retention rate (RR). DR, CR and RR were also analyzed in relation to indications such as obscure GI bleeding (OGIB), known/suspected Crohn's disease (CD), celiac disease (CeD), neoplastic lesions (NL) and clinical symptoms (CS). RESULTS: 328 original articles involving 86,930 patients who underwent CE were included. OGIB was the most common indication (n = 44,750), followed by CS (n = 17,897), CD (n = 11,299), NL (n = 4989) and CeD (n = 947). The most used capsule type was small bowel CE in 236 studies. DR, CR and RR for all indications were 59%, 89.6% and 2%, respectively. According to specific indications: DR were 55%, 66%, 63%, 52% and 62%; CR were 90.6%, 86.5%, 78.2%, 94% and 92.8%; and RR were 2%, 4%, 1%, 6% and 2%. CONCLUSIONS: Pooled DR, CR and RR are acceptable for all capsule types. OGIB is the most common indication for CE. Technological advancements have expanded the scope of CE devices in detecting GI pathology with acceptable rates for a complete examination.

Improvement of bowel movements among people with a sedentary lifestyle after prebiotic snack supply - preliminary study.

Introduction: Dietary fiber is one of the most important components of food. Fulfilling regulatory and nutritional functions for the intestinal microbiota, it appears to be an essential ingredient for people with a sedentary lifestyle. Aim: We hypothesized that regular intake of a snack containing high amounts of soluble fibre in parallel to a regular diet may rapidly improve bowel habits with simultaneous elevation of synthesis of short-chain fatty acids (SCFA). Material and methods: A total of 20 healthy volunteers, with a stool frequency of less than 3 spontaneous bowel movements per week, completed a 14-day double-blind, parallel-arm, randomized clinical trial with the intervention comprising daily intake of 2 doses (9.99% per 100 g or 13.91% per 100 g) of fibre. Food consumption was evaluated via 72-hour recall diaries at baseline and after 14 days of intervention. Gastrointestinal symptoms (abdominal comfort, distension, bloating, flatulence, stomach rumbling, number of bowel movements) were monitored via the IBS/VAS scale every day. Results: We found that the elevated fibre intake improved bowel habits significantly (defecation frequency increased from 0.28 to 0.87 times/day; p = 0.0002) in both study arms. After 14 days of the trial, an increase in SCFA concentration (for whole study group: acetic p < 0.036, propionic p < 0.019, and butyric acid p < 0.0012 compared to baseline parameters) with no adverse gastrointestinal symptoms was reported. Conclusions: Short-term, regular intake of a snack containing soluble fibre improves the SCFA synthesis and bowel habits in healthy people living a sedentary lifestyle. The exact mechanism behind this observation requires further investigation.

Empirical rescue treatment of Helicobacter pylori infection in third and subsequent lines: 8-year experience in 2144 patients from the European Registry on H. pylori management (Hp-EuReg).

OBJECTIVE: To evaluate the use, effectiveness and safety of Helicobacter pylori empirical rescue therapy in third and subsequent treatment lines in Europe. DESIGN: International, prospective, non-interventional registry of the clinical practice of European gastroenterologists. Data were collected and quality reviewed until October 2021 at Asociación Española de Gastroenterología-Research Electronic Data Capture. All cases with three or more empirical eradication attempts were assessed for effectiveness by modified intention-to-treat and per-protocol analysis. RESULTS: Overall, 2144 treatments were included: 1519, 439, 145 and 41 cases from third, fourth, fifth and sixth treatment lines, respectively. Sixty different therapies were used; the 15 most frequently prescribed encompassed >90% of cases. Overall effectiveness remained <90% in all therapies. Optimised treatments achieved a higher eradication rate than non-optimised (78% vs 67%, p<0.0001). From 2017 to 2021, only 44% of treatments other than 10-day single-capsule therapy used high proton-pump inhibitor doses and lasted ≥14 days. Quadruple therapy containing metronidazole, tetracycline and bismuth achieved optimal eradication rates only when prescribed as third-line treatment, either as 10-day single-capsule therapy (87%) or as 14-day traditional therapy with tetracycline hydrochloride (95%). Triple amoxicillin-levofloxacin therapy achieved 90% effectiveness in Eastern Europe only or when optimised. The overall incidence of adverse events was 31%. CONCLUSION: Empirical rescue treatment in third and subsequent lines achieved suboptimal effectiveness in most European regions. Only quadruple bismuth-metronidazole-tetracycline (10-day single-capsule or 14-day traditional scheme) and triple amoxicillin-levofloxacin therapies reached acceptable outcomes in some settings. Compliance with empirical therapy optimisation principles is still poor 5 years after clinical practice guidelines update. TRIAL REGISTRATION NUMBER: NCT02328131.