The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults

doi:10.1053/j.gastro.2016.04.006

Gastroenterology

Volume 151, Issue 1, July 2016, Pages 51-69.e14

https://doi.org/10.1053/j.gastro.2016.04.006 Get rights and content

Background & Aims

Helicobacter pylori infection is increasingly difficult to treat. The purpose of these consensus statements is to provide a review of the literature and specific, updated recommendations for eradication therapy in adults.

Methods

A systematic literature search identified studies on H pylori treatment. The quality of evidence and strength of recommendations were rated according to the Grading of Recommendation Assessment, Development and Evaluation (GRADE) approach. Statements were developed through an online platform, finalized, and voted on by an international working group of specialists chosen by the Canadian Association of Gastroenterology.

Results

Because of increasing failure of therapy, the consensus group strongly recommends that all H pylori eradication regimens now be given for 14 days. Recommended first-line strategies include concomitant nonbismuth quadruple therapy (proton pump inhibitor [PPI] + amoxicillin + metronidazole + clarithromycin [PAMC]) and traditional bismuth quadruple therapy (PPI + bismuth + metronidazole + tetracycline [PBMT]). PPI triple therapy (PPI + clarithromycin + either amoxicillin or metronidazole) is restricted to areas with known low clarithromycin resistance or high eradication success with these regimens. Recommended rescue therapies include PBMT and levofloxacin-containing therapy (PPI + amoxicillin + levofloxacin). Rifabutin regimens should be restricted to patients who have failed to respond to at least 3 prior options.

Conclusions

Optimal treatment of H pylori infection requires careful attention to local antibiotic resistance and eradication patterns. The quadruple therapies PAMC or PBMT should play a more prominent role in eradication of H pylori infection, and all treatments should be given for 14 days.

Section snippets

Scope and Purpose

The consensus development process was initiated in the summer of 2013 with the first meeting of the steering committee and lasted approximately 2 years, with the meeting of the full consensus group taking place in June 2015.

Sources and Searches

The Editorial Office of the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group at McMaster University performed a systematic literature search of the Cochrane Register, MEDLINE, EMBASE, and CENTRAL for trials published from January 2008 to December 2013. The main

Recommendation Statements

The individual recommendation statements are provided and include the quality of supporting evidence as assessed by the GRADE method and the voting results; a discussion of the evidence considered for the specific statement is also presented. The quality of evidence was determined to be low for some statements, largely because of high risk of bias (most often due to lack of adequate blinding). Acknowledging the importance of quality of evidence, the consensus group also considered other factors

Future Directions

The lack of availability of data on local susceptibility patterns and eradication success rates was identified as a knowledge gap that has a major impact on the choice of therapy and hence best management. Periodic susceptibility testing should be considered by health authorities, and clinicians should be encouraged to record their successes. These data should be published or presented at conferences to help monitor susceptibility on an ongoing basis.

There is a need for well-conducted,

Limitations of the Consensus

There are some limitations of this consensus that should be mentioned. It would have been ideal if the consensus panel also included primary care physicians, patients, or other stakeholders, although their potential viewpoints were discussed at the face-to-face meeting before every vote. In addition, it was decided not to search for data before 2008 to avoid confounding of data from earlier studies that had higher eradication success rates likely as a result of lower antibiotic resistance.

Summary

Based on evidence of higher eradication rates with regimens of longer duration and increasing failure of shorter treatment durations, the consensus group strongly recommended that all H pylori eradication regimens be given for 14 days. Recommended first-line strategies include traditional quadruple bismuth therapy (PBMT), concomitant nonbismuth quadruple therapy (PAMC), and the restricted use of PPI triple therapy (PAC or PMC) to regions with known low clarithromycin resistance or high

Acknowledgments

The consensus group thanks Paul Sinclair (Canadian Association of Gastroenterology [CAG] representative, administrative and technical support) and Louise Hope and Lesley Marshall (CAG, logistics assistance) as well as Pauline Lavigne and Steven Portelance (unaffiliated), who provided medical writing services supported entirely by funds from CAG and the Canadian Helicobacter Study Group.

The steering committee (CAF, NC, SVvZ), GIL, and PM reviewed the literature and drafted the statements. GIL

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Bismuth quadruple therapy is currently consensus recommendation for first-line Helicobacter pylori (H. pylori) treatment; however, the optimal duration is unknown. We compared the efficacy of 10-day bismuth quadruple therapy with that of 14-day bismuth quadruple therapy for first-line eradication.
For our multicentre, parallel randomised, open-label, and non-inferiority study, we recruited H. pylori treatment-naïve patients from one medical centre and one teaching hospital in Taiwan. Patients were randomly assigned (1:1) to receive 10-day (PBMT-10) or 14-day (PBMT-14) bismuth quadruple therapy. The primary outcome was the eradication rate as determined by intention-to-treat (ITT) and per-protocol (PP) analyses. The eradication rates between the two groups were compared using a one-sided α value of 0.025 and a non-inferiority margin of 7%. The secondary outcomes were the rate of adverse effects. The trial is registered with ClincialTrials.gov (NCT04527055).
From August 3, 2020 to April 28, 2023, 313 H. pylori treatment-naïve patients (PBMT-10 = 157; PBMT-14 = 156) were enrolled. 35 patients were excluded from PP analyses. The eradication rates (95% CI) for PBMT-10 and PBMT-14 were respectively 92.4% (88.2%–96.5%) and 92.9% (88.9%–97.0%) by ITT analyses, and 97.9% (95.5%–100.0%) and 99.3% (97.8%–100.0%) by PP analyses. The eradication rates for PBMT-10 were non-inferior to those for PBMT-14 (absolute difference [lower boundary of the one-sided 97.5% CI] −0.6% [−6.7%], P_NI = 0.020 in ITT analyses, −1.4% [−5.8%], P_NI = 0.007 in PP analyses). The rates of overall adverse effects (54.1% versus 57.1%, P = 0.604) were similar between the two groups; nevertheless, the rates of dizziness (18.5% versus 34.0%, P = 0.003) and vomiting (4.5% versus 12.8%, P = 0.008) were lower in PBMT-10 than in PBMT-14.
The 10-day bismuth quadruple therapy was non-inferior to the 14-day therapy as a first-line treatment for eradicating H. pylori infection and had no different rates of overall adverse effects, but less serious adverse events in terms of dizziness and vomiting.
The National Science and Technology Council and Ministry of Health and Welfare, Taiwan.
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Helicobacter pylori is the most common chronic bacterial infection worldwide and the most significant risk factor for gastric cancer, which remains a leading cause of cancer-related death globally. H pylori and gastric cancer continue to disproportionately impact racial and ethnic minority and immigrant groups in the United States. The approach to H pylori case-finding thus far has relied on opportunistic testing based on symptoms or high-risk indicators, such as racial or ethnic background and family history. However, this approach misses a substantial proportion of individuals infected with H pylori who remain at risk for gastric cancer because most infections remain clinically silent. Moreover, individuals with chronic H pylori infection are at risk for gastric preneoplastic lesions, which are also asymptomatic and only reliably diagnosed using endoscopy and biopsy. Thus, to make a significant impact in gastric cancer prevention, a systematic approach is needed to better identify individuals at highest risk of both H pylori infection and its complications, including gastric preneoplasia and cancer. The approach to H pylori eradication must also be optimized given sharply decreasing rates of successful eradication with commonly used therapies and increasing antimicrobial resistance. With growing acceptance that H pylori should be managed as an infectious disease and the increasing availability of susceptibility testing, we now have the momentum to abandon empirical therapies demonstrated to have inadequate eradication rates. Molecular-based susceptibility profiling facilitates selection of a personalized eradication regimen without necessitating an invasive procedure. An improved approach to H pylori eradication coupled with population-level programs for screening and treatment could be an effective and efficient strategy to prevent gastric cancer, especially in minority and potentially marginalized populations that bear the heaviest burden of H pylori infection and its complications.
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We conducted this study to systematically review and assess the current clinical practice guidelines (CPGs) related to the diagnosis and treatment of Helicobacter pylori (H. pylori) infection. The aim was to evaluate the quality of these included CPGs and provide clinicians with a convenient and comprehensive reference for updating their own CPGs. We searched four databases to identify eligible CPGs focusing on H. pylori diagnosis and treatment recommendations. The results were presented using evidence mappings. Quality and clinical applicability were assessed comprehensively using AGREE-II and AGREE-REX. Statistical tests, specifically Bonferroni tests, were employed to compare the quality between evidence-based guidelines and consensus. A total of 30 eligible CPGs were included, comprising 17 consensuses and 13 guidelines. The quality showed no statistical significance between consensuses and guidelines, mainly within the moderate to low range. Notably, recommendations across CPGs exhibited inconsistency. Nevertheless, concerning diagnosis, the urea breath test emerged as the most frequently recommended method for testing H. pylori. Regarding treatment, bismuth quadruple therapy stood out as the predominantly recommended eradication strategy, with high-dose dual therapy being a newly recommended option. Our findings suggest the need for specific organizations to update their CPGs on H. pylori or refer to recently published CPGs. Specifically, CPGs for pediatric cases require improvement and updating, while a notable absence of CPGs for the elderly was observed. Furthermore, there is a pressing need to improve the overall quality of CPGs related to H. pylori. Regarding recommendations, additional evidence is essential to elucidate the relationship between H. pylori infection and other diseases and refine test indications. Clinicians are encouraged to consider bismuth quadruple or high-dose dual therapy, incorporating locally sensitive antibiotics, as empirical radical therapy.
.
Hemos realizado este estudio para revisar y evaluar sistemáticamente las guías de práctica clínica (GPC) actuales sobre las recomendaciones de diagnóstico y tratamiento de la infección por Helicobacter pylori (H. pylori), así como valorar la calidad de las GPC incluidas. Esperamos que esto facilite a los clínicos el diagnóstico al igual que el tratamiento y proporcione una referencia para la actualización de las GPC. Se realizaron búsquedas en cuatro bases de datos para encontrar GPC elegibles sobre recomendaciones de diagnóstico y tratamiento de H. pylori y los resultados se presentaron en mapeos de evidencia. Se emplearon la Appraisal of Guidelines, Research and Evaluation Colaboration (AGREE) II y la AGREE-Recommendation EXcellence (REX) para evaluar rotundamente la índole y la aplicabilidad clínica. La calidad entre las guías basadas en la evidencia y los consensos se comparó mediante pruebas estadísticas de Bonferroni. Se incluyeron 30 GPC elegibles, de las cuales 17 eran consensos y 13 guías. La calidad no tuvo significación estadística entre consensos y guías, siendo en su mayoría moderada o incluso baja. Las recomendaciones de las GPC presentaban incoherencias. Sin embargo, en cuanto al diagnóstico, la prueba del aliento con urea fue el método más recomendado para detectar H. pylori. Y en cuanto al tratamiento, la terapia cuádruple con bismuto fue la estrategia de erradicación más utilizada, mientras el método dual a dosis altas es la recomendada recientemente. Nuestros hallazgos sugieren la necesidad de que organizaciones específicas actualicen sus GPC sobre H. pylori o se remitan las publicadas recientemente. Las GPC para niños deberían mejorarse y actualizarse, y faltan también las de ancianos. Además, es necesario mejorar la calidad de las GPC sobre H. pylori. En cuanto a las recomendaciones, se necesitan más pruebas que ilustren la relación entre la infección por H. pylori y otras enfermedades para perfeccionar las indicaciones de las pruebas, y los clínicos podrían elegir la terapia cuádruple con bismuto o la dual a dosis altas con antibióticos localmente sensibles como tratamiento radical empírico.
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: This article has an accompanying continuing medical education activity, also eligible for MOC credit, on page e25. Learning Objective: Upon completion of this examination, successful learners will be able to establish a treatment plan for patients with H pylori infection.

: Conflicts of interest The authors disclose the following: Advisory Board: AbbVie (JPG), Allergan (JPG), Almirall (JPG), AstraZeneca (JPG), Casen Fleet (JPG), Casen Recordati (JPG), Chiesi (JPG), Dr Falk Pharma (JPG), Faes Farma (JPG), Ferring Pharmaceuticals (JPG), Gebro Pharma (JPG), Hospira (JPG), Janssen (JPG), Kern Pharma (JPG), MSD (JPG), Nycomed (JPG), Otsuka Pharmaceuticals (JPG), Pfizer (JPG), Shire Pharmaceuticals (JPG), Takeda (JPG), Vifor Pharma (JPG).

: Consultation Fees: AbbVie (JKM, SVvZ), Actavis (CAF), AstraZeneca (JKM), Celltrion (JKM), Cubist (JKM), Ferring Pharmaceuticals (JKM), Forest (JKM), Hospira (JKM), Janssen (CAF, JKM, SVvZ), Procter & Gamble (JKM), Pendopharm (CAF), Shire (JKM, SVvZ), Takeda (CAF, JKM).

: Educational Support: AstraZeneca (PM).

: Research Grants/Clinical Trial Funding: AbbVie (JPG), Allergan (JPG), Almirall (JPG), AstraZeneca (JPG), Casen Fleet (JPG), Casen Recordati (JPG), Chiesi (JPG), Dr Falk Pharma (JPG), Faes Farma (JPG), Ferring Pharmaceuticals (JPG), Gebro Pharma (JPG), Hospira (JPG), Janssen (JPG), Kern Pharma (JPG), MSD (JPG), Nycomed (JPG), Otsuka Pharmaceutical (JPG), Pfizer (JPG), Shire Pharmaceuticals (JPG), Takeda (JPG), Vifor Pharma (JPG).

: Speaker’s Bureau: AbbVie (JPG, JKM), Allergan (JPG), Almirall (JPG), Aptalis (JKM), AstraZeneca (JPG), Casen Fleet (JPG), Casen Recordati (JPG), Chiesi (JPG), Dr. Falk Pharma (JPG), Faes Pharma (JPG), Ferring Pharmaceuticals (JPG, JKM), Forest (JKM), Gebro Pharma (JPG), Hospira (JPG), Janssen (JPG, JKM), Kern Pharma (JPG), MSD (JPG), Nycomed (JPG), Otsuka Pharmaceutical (JPG), Pfizer (JPG), Procter & Gamble (JKM), Purdue Pharma (SVvZ), Shire (JPG, JKM), Takeda (JPG, JKM, SVvZ), Warner Chilcott (JKM), Vifor Pharma (JPG).

: Funding Supported by the Canadian Association of Gastroenterology and the Canadian Helicobacter Study Group, with no external funding sources.

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Consensus StatementThe Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults

Background & Aims

Methods

Results

Conclusions

Section snippets

Scope and Purpose

Sources and Searches

Recommendation Statements

Future Directions

Limitations of the Consensus

Summary

Acknowledgments

Gastrointest Endosc Clin North Am

J Clin Epidemiol

Clin Gastroenterol Hepatol

Gastroenterology

Clin Gastroenterol Hepatol

Gastroenterology

Gastroenterology

Futures

Clin Gastroenterol Hepatol

Clin Gastroenterol Hepatol

Gastroenterology

Am J Gastroenterol

Gastroenterology

Clin Gastroenterol Hepatol

Lancet

Clin Gastroenterol Hepatol

Gastroenterology

Eur J Intern Med

Int J Antimicrob Agents

Am J Emerg Med

Int J Antimicrob Agents

Am J Gastroenterol

Epidemiology of Helicobacter pylori infection

Helicobacter

Epidemiology of Helicobacter pylori infection and public health implications

Helicobacter

Epidemiology of Helicobacter pylori infection and public health implications

Helicobacter

Prevalence of Helicobacter pylori in a First Nations population in northwestern Ontario

Can Fam Physician

Disease manifestations of Helicobacter pylori infection in Arctic Canada: using epidemiology to address community concerns

BMJ Open

High prevalence of Helicobacter pylori in the Alaska native population and association with low serum ferritin levels in young adults

Clin Diagn Lab Immunol

Clinical practice. Helicobacter pylori infection

N Engl J Med

Kyoto global consensus report on Helicobacter pylori gastritis

Gut

Canadian Helicobacter Study Group Consensus Conference: update on the management of Helicobacter pylori—an evidence-based evaluation of six topics relevant to clinical outcomes in patients evaluated for H pylori infection

Can J Gastroenterol

Canadian Helicobacter pylori Consensus Conference update: infections in adults. Canadian Helicobacter Study Group

Can J Gastroenterol

Current concepts in the management of Helicobacter pylori infection: the Maastricht III Consensus Report

Gut

Review article: Helicobacter pylori-negative duodenal ulcer disease

Aliment Pharmacol Ther

Helicobacter pylori eradication therapy to prevent gastric cancer in healthy asymptomatic infected individuals: systematic review and meta-analysis of randomised controlled trials

BMJ

Treating Helicobacter pylori infection in primary care patients with uninvestigated dyspepsia: the Canadian adult dyspepsia empiric treatment-Helicobacter pylori positive (CADET-Hp) randomised controlled trial

BMJ

Eradication of Helicobacter pylori for non-ulcer dyspepsia

Cochrane Database Syst Rev

In-vitro susceptibility of Helicobacter pylori to ampicillin, clarithromycin, metronidazole and omeprazole

J Antimicrob Chemother

Helicobacter pylori antibiotic resistance: trends over time

Can J Gastroenterol

Helicobacter pylori antibiotic resistance in Canadian populations (abstr S1293)

Gastroenterology

Empiric quadruple vs. triple therapy for primary treatment of Helicobacter pylori infection: systematic review and meta-analysis of efficacy and tolerability

Am J Gastroenterol

Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection

Digestion

The relationship among previous antimicrobial use, antimicrobial resistance, and treatment outcomes for Helicobacter pylori infections

Ann Intern Med

Helicobacter pylori-related disease: guidelines for testing and treatment

Arch Intern Med

Effect of pretreatment antibiotic resistance to metronidazole and clarithromycin on outcome of Helicobacter pylori therapy: a meta-analytical approach

Consensus Statement
The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults