Original Title: Helicobacter pylori – démarche diagnostique, conduite thérapeutique optimale et suivi

Authors' objectives: Helicobacter pylori (H. pylori) is a Gram-negative bacterium that colonizes the inner lining of the stomach. The infection causes gastric inflammation and plays a role in the onset of dyspepsia, and when left untreated, can lead to the development of gastric or duodenal ulcers, and ultimately gastric cancer. Thus, early diagnosis of H. pylori infection and timely treatment remains the cornerstone of clinical management. Due to issues of accessibility to tests for H. pylori infection and their occasional misuse, and at the request of the Ministère de la Santé et des Services sociaux (MSSS), in May 2024 the Institut national d'excellence en santé et en services sociaux (INESSS) published recommendations on the judicious use of medical biology tests in the diagnosis and treatment of Helicobacter pylori infection to provide scientific and clinical insight into the clinical usefulness, diagnostic value and issues associated with these tests. To consolidate knowledge of this infection, support clinicians involved in diagnosing and managing it, and harmonize practice across the province, the MSSS has also asked the INESSS to produce a guide for the optimal use of medical biology tests and treatments for this infection.

Authors' results and conclusions: RESULTS (#1 CONSOLIDATING A CLINICAL PICTURE OF H. PYLORI INFECTION): The diagnostic approach is based primarily on the combination of symptoms and clinical signs suggestive of H. pylori infection, on health history, on the exclusion of other causes that may explain similar symptoms and/or signs, and on medical biology tests. (#2 LOOK FOR ACTIVE INFECTION FOR OPTIMAL THERAPEUTIC MANAGEMENT): Unless you have dyspepsia with at least one warning sign - a situation in which upper gastrointestinal endoscopy with biopsy is generally the gold standard for testing for H. pylori infection - the following clinical situations may justify testing for such infection using a non-invasive test: • Dyspepsia without warning signs; • History of peptic ulcer disease, unless eradication of the infection has been documented; • History of early gastric cancer resection without documented H. pylori investigation; • History of gastric cancer in a first-degree relative; • Investigations usually conducted in specialized medicine: – immune thrombocytopenia; – unexplained iron-deficiency anemia and vitamin B12 deficiency with no known cause. These conditions usually require upper gastrointestinal endoscopy. (#3 CURB THE MISUSE OF SEROLOGICAL TESTS): The detection of antibodies to H. pylori antigens cannot distinguish between active infection and past exposure. This is why the serological test is of little use in confirming H. pylori infection or verifying its eradication. Moreover, the probability of obtaining falsepositive results from the serological test in Quebec is significant, due to the low prevalence of infection. (#4 OPTIMIZE THERAPY BASED ON MEDICATION HISTORY): Responsible antibiotic prescribing aims to prevent the emergence and spread of antimicrobial resistance, and to limit adverse reactions and damage to the microbiome. Successful eradication of H. pylori in an individual depends on the choice of treatment, based on the person's medication history, compliance with therapy and the sensitivity of the bacterial strain to the prescribed treatment. Thus, to maximize the chances of treatment success and reduce the risk of H. pylori strains developing resistance to the antibiotics included in the treatment options (e.g., clarithromycin, metronidazole, levofloxacin), it is important to consider the person's allergic status to antibiotics such as amoxicillin, as well as the history of antibiotic use for previous infections. (#5 PROVIDE INFORMATION TO PROMOTE COMPLIANCE AND SUCCESS WITH COMPLEX THERAPY): The complexity of H. pylori therapy (e.g. duration of treatment, number and frequency of medications taken, tolerance to medication) can hinder compliance with the prescribed treatment and, consequently, eradication of the infection. An individual's adherence to treatment is more likely if he or she is aware of the advantages and disadvantages of treatment, as well as the importance of following the plan as prescribed to achieve the desired effects. Knowing what actions to take to offset or mitigate the adverse effects of therapy (e.g., taking antibiotics with meals, taking an antiemetic in case of nausea) generally leads to better compliance with treatment. (#6 PREVENT RECURRENCE AND COMPLICATIONS BY VERIFYING ERADICATION): Test results confirming eradication of H. pylori are essential to prevent recurrences and complications such as peptic ulcer disease and gastric cancer. A four-week period after the end of medication is required before verifying the efficacy of eradication therapy. Eradication of H. pylori infection can only be confirmed by testing for the presence of active H. pylori infection - i.e., not by serological tests. Unless a gastric ulcer is present, a non-invasive test (excluding serological testing, which cannot distinguish active infection from past exposure) is sufficient to confirm eradication of the infection. However, upper digestive endoscopy with biopsy sampling can be used to assess healing of a gastric ulcer and confirm eradication of the infection. CONCLUSION: dentifying and treating H. pylori infection can prevent complications such as peptic ulcer disease and even gastric cancer. Without replacing clinical judgment, the optimal use guideline should help optimize practices relating to the diagnosis, treatment and follow-up of people suspected of having H. pylori infection and promote harmonization of practice across the province. The enhancement and harmonization of practice will, however, depend on the dissemination and promotion of the optimal use guide within the network, as well as on the adherence and appropriation of the recommendations by the healthcare professionals involved.

Authors' recommendations: that health care institutions, family medicine groups and medical/nursing clinics: – include a link to the optimal use guide in their protocols and tools, or host the most up-to-date version of the INESSS guide in their healthcare and pharmaceutical software; – if necessary, update the protocols and clinical tools created for this infection in their environment; • that educational institutions: – update the basic training provided to future clinicians involved in identifying and diagnosing this infection; • that professional orders, federations and associations: – offer training to update knowledge of this infection, whose prevalence could increase in Quebec over the next few years as a result of demographic change.

Authors' methods: The evaluation questions for this work were formulated to cover the population and clinical dimensions of the INESSS' Statement of Principles and Ethical Foundations. In collaboration with a scientific information consultant, a systematic search of the scientific literature published up to August 2023 was conducted in the MEDLINE, Embase and EBM Reviews databases (Cochrane Database of Systematic Reviews, Health Technology Assessment, NHS Economic Evaluation Database). A manual search of the grey literature in spring 2024 was also conducted by consulting, among others, the websites of learned societies specializing in the field related to the theme of the work, as well as regulatory, public health or health technology assessment agencies, government bodies, professional associations and healthcare establishments. A targeted information watch of this literature was conducted until September 2024. Selection, information extraction and assessment of the methodological quality of the selected documents were conducted independently by two scientific professionals. Official monographs for drugs approved by Health Canada, as well as tertiary references in pharmacotherapy, were also consulted. The analysis and synthesis of the data and contextual elements gathered were conducted by one professional, then validated by a second. This analysis was conducted to determine practice in Quebec, based in particular on elements of the legislative, regulatory and organizational framework specific to Quebec, and on the perspective of the various stakeholders consulted. The stakeholders' perspective was gathered by an advisory committee made up of healthcare professionals from various specialties and areas of expertise. The identification of key clinical benchmarks and the formulation of recommendations were conducted in collaboration with members of the advisory committee, based in particular on an assessment of all the documented evidence. Finally, the overall quality of the work, its acceptability and applicability were assessed by external readers specializing in the field of interest, as well as future users who had not participated in the work.

Authors' identified further research: The relevance of updating the recommendations will be assessed four years from the date of publication, based on the advancement of scientific data, changes in clinical practices, significant changes in complementary background documents published by the Ministère de la Santé et des Services sociaux or the Institut national de santé publique du Québec, and the needs of the health and social services network.

Project Status: Completed

Year Published: 2024

URL for published report: https://www.inesss.qc.ca/fileadmin/doc/INESSS/Rapports/Biologie_medicale/GN_Helicobacter_pylori_GUO_INESSS.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: L'Institut national d'excellence en sante et en services sociaux (INESSS)