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Copyright 2011 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited. Evidence-based Guidelines From ESPGHAN and NASPGHAN for Helicobacter pylori Infection in Children à Sibylle Koletzko, y Nicola L. Jones, z Karen J. Goodman, § Benjamin Gold, jj Marion Rowland, ô Samy Cadranel, # Sonny Chong, Ãà Richard B. Colletti, yy Thomas Casswall, §§ Jeannette Guarner, jjjj Nicolas Kalach, ôô Armando Madrazo, ## Francis Megraud, and ÃÃà Giuseppina Oderda, on Behalf of the H pylori Working Groups of ESPGHAN and NASPGHAN ABSTRACT Objective: As the clinical implications of Helicobacter pylori infection in children and adolescents continue to evolve, ESPGHAN and NASPGHAN jointly renewed clinical guidelines using a standardized evidence-based approach to develop updated recommendations for children and adolescents in North America and Europe. Methods: An international panel of 11 pediatric gastroenterologists, 2 epidemiologists, 1 microbiologist, and 1 pathologist was selected by societies that developed evidence-based guidelines based on the Delphi process with anonymous voting in a final face-to-face meeting. A systematic literature search was performed on 8 databases of relevance including publications from January 2000 to December 2009. After excluding nonrelevant publications, tables of evidence were constructed for different focus areas according to the Oxford classification. Statements and recommendations were formulated in the following areas: whom to test, how to test, whom to treat, and how to treat. Grades of evidence were assigned to each recommendation based on the GRADE system. Results: A total of 2290 publications were identified, from which 738 were finally reviewed. A total of 21 recommendations were generated, and an algorithm was proposed by the joint committee providing evidence-based guidelines on the diagnostic workup and treatment of children with H pylori infection. Conclusions: These clinical practice guidelines represent updated, best- available evidence and are meant for children and adolescents living in Europe and North America, but they may not apply to those living on other continents, particularly in developing countries with a high H pylori infection rate and limited health care resources. Key Words: antibiotic resistance, children and adolescents, diagnostic tests, Helicobacter pylori, treatment (JPGN 2011;53: 230–243) SYNOPSIS
T he current recommendations for managing Helicobacter pylori infection in children are as follows: 1. The primary goal of clinical investigation of gastrointestinal symptoms is to determine the underlying cause of the symptoms and not solely the presence of H pylori infection. 2. Diagnostic testing for H pylori infection is not recommended in children with functional abdominal pain. 3. In children with first-degree relatives with gastric cancer, testing for H pylori may be considered. 4. In children with refractory iron-deficiency anemia, in which other causes have been ruled out, testing for H pylori infection may be considered. 5. There is insufficient evidence that H pylori infection is causally related to otitis media, upper respiratory tract infections, periodontal disease, food allergy, sudden infant death syndrome (SIDS), idiopathic thrombocytopenic purpura, and short stature. 6. For the diagnosis of H pylori infection during esophagogas- troduodenoscopy (EGD), it is recommended that gastric biopsies (antrum and corpus) for histopathology be obtained. 7. It is recommended that the initial diagnosis of H pylori infection be based on either a positive histopathology plus a positive rapid urease test or a positive culture. 8. The
13 C-urea breath test (UBT) is a reliable noninvasive test to determine whether H pylori has been eradicated. 9. A validated enzyme-linked immunosorbent assay (ELISA) test for detection of H pylori antigen in stool is a reliable Received March 28, 2011; accepted March 29, 2011. From the à Dr von Haunersches Kinderspital, Ludwig-Maximilians- University of Munich, Munich, Germany, the yDivision of Gastroenter- ology, Hepatology, and Nutrition, SickKids Hospital, University of Toronto, Toronto, the zDepartment of Medicine, University of Alberta, Edmonton, Canada, the §Children’s Center for Digestive Healthcare, Atlanta, GA, the jjChildren’s Research Centre, Our Lady’s Hospital for Sick Children, Crumlin, Ireland, the ôQueen Fabiola Children’s Hospi- tal, Brussels, Belgium, the #Queen Mary’s Hospital for Children, Carshalton, Surrey, UK, the Ãà Department of Pediatrics, University of Vermont, Burlington, VT, the yyDivision of Paediatrics, Karolinska University Hospital, Stockholm, Sweden, the zzDepartment of Pediatrics, Marshall University, Huntington, WV, the §§Department of Pathology and Laboratory Medicine, Emory University, Atlanta, GA, the jjjjSt Antoine Pediatric Clinic, Faculte´ Libre de Me´decine, Lille, France, the ôôHospital de Pediatria, Centro Medico Nacional Siglo XXI, Mexico City, Mexico, the ##Laboratoire de Bacte´riologie, Hoˆpital Pellegrin, Bordeaux, France, and the ÃÃà Scienze Mediche, Clinica Pediatrica, Universita degli Studi di Novara, Novarra, Italy. Address correspondence and reprint requests to Prof Dr Sibylle Koletzko, MD, Dr von Haunersches Kinderspital, Ludwig-Maximilians-Univer- sity of Munich, Lindwurmstraße 4, D-80337 Munich, Germany (e-mail: sibylle.koletzko@med.uni-muenchen.de). The authors report no conflicts of interest other than those reported on the ESPGHAN and NASPGHAN Web sites. Sibylle Koletzko and Nicola Jones contributed equally to this article. Copyright # 2011 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition DOI: 10.1097/MPG.0b013e3182227e90 C LINICAL G UIDELINES 230 JPGN
Volume 53, Number 2, August 2011 Copyright 2011 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited. noninvasive test to determine whether H pylori has been eradicated. 10. Tests based on the detection of antibodies (IgG, IgA) against H pylori in serum, whole blood, urine, and saliva are not reliable for use in the clinical setting. 11. It is recommended that clinicians wait at least 2 weeks after stopping proton pump inhibitor (PPI) therapy and 4 weeks after stopping antibiotics to perform biopsy-based and noninvasive tests (UBT, stool test) for H pylori. 12. In the presence of H pylori–positive peptic ulcer disease (PUD), eradication of the organism is recommended. 13. When H pylori infection is detected by biopsy-based methods in the absence of PUD, H pylori treatment may be considered. 14. A ‘‘test and treat’’ strategy is not recommended in children. 15. In children who are infected with H pylori and whose first- degree relative has gastric cancer, treatment may be offered. 16. Surveillance of antibiotic resistance rates of H pylori strains in children and adolescents is recommended in the different countries and geographic areas. 17. First-line eradication regimens are the following: triple therapy with a PPI þ amoxicillin þ clarithromyin or an imidazole or bismuth salts þ amoxicillin þ an imidazole or sequential therapy.
18. Antibiotic susceptibility testing for clarithromycin is recom- mended before initial clarithromycin-based triple therapy in areas/populations with a known high resistance rate (>20%) of H pylori to clarithromycin (Fig. 1). 19. It is recommended that the duration of triple therapy be 7 to 14 days. Costs, compliance, and adverse effects should be taken into account. 20. A reliable noninvasive test for eradication is recom- mended at least 4 to 8 weeks following completion of therapy.
21. If treatment has failed, 3 options are recommended: EGD, with culture and susceptibility testing including alternative antibiotics, if not performed before guide therapy; fluor- escence in situ hybridization (FISH) on previous paraffin- embedded biopsies if clarithromycin susceptibility testing has not been performed before guide therapy; modification of therapy by adding an antibiotic, using different antibiotics, adding bismuth, and/or increasing the dose and/or duration of therapy. H. pylori with PUD and/or gastritis CLA resistance?* Symptoms EGD with biopsies (with culture*) PPI-AMO-MET Noninvasive test for eradication HP eradicated? Observe CLA resistance or prior CLA therapy? Treat without CLA: PPI-AMO-MET 2 weeks or bismuth-based therapy FISH for CLA on paraffin slides of first biopsies EGD with
culture and CLA-testing Assess + encourage adherence Treat according to result of CLA testing Noninvasive test for eradication HP eradicated? Observe Consider: •other antibiotic •bismuth
•quadruple therapy •higher dosage Yes Yes
No Yes
No Yes
No 1 2 3 6 8 9 11 10 12 12 13 Unknown 14 15 16 17
18 19 20 PPI-AMO-CLA PPI-AMO-MET # or
# or bismuth-AMO-MET or sequential therapy 4 7 5 6 Unknown CLA resistance or prior CLA therapy? FIGURE 1. Proposed algorithm of how to treat Helicobacter pylori infection in pediatric patients. AMO ¼ amoxicillin; CLA ¼ clarithromycin; EGD ¼ esophagogastroduodenoscopy; FISH ¼ fluorescence in situ hybridization; HP ¼ H pylori; MET ¼ metronidazole; PPI ¼ proton pump inhibitor; PUD ¼ peptic ulcer disease. Ã In areas or populations with a primary clarithromycin- resistance rate of >20% or unknown background antibiotic resistance rates, culture and susceptibility testing should be performed and the treatment should be chosen accordingly. # If susceptibility testing has not been performed or has failed, antibiotics should be chosen according to the background of the child (1). JPGN
Volume 53, Number 2, August 2011 Recommendations for H pylori Infection in Children www.jpgn.org 231
Copyright 2011 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited. 1. SCOPE AND PURPOSE 1.1. Introduction and Aims Children differ from adults with respect to H pylori infection in terms of the prevalence of the infection, the complication rate, the near-absence of gastric malignancies, age-specific problems with diagnostic tests and drugs, and a higher rate of antibiotic resistance. Compared with adults, PUD is found less often in infected children undergoing upper endoscopy. In a large European multicenter study including 1233 symptomatic children with H pylori infection, PUD was diagnosed in <5% of children younger than 12 years of age and
$10% of teenagers (1). Gastric malignancies associated with H pylori
infection typically occur in adulthood, with only a few case reports of lymphomas in the pediatric age group (2,3). The differential diagnosis for abdominal pain and dyspeptic symptoms is different. Children are often unable to provide precise des- criptions of the location and the character of the pain (4,5). Some disorders such as idiopathic thrombocytopenic purpura, which have been associated with H pylori infection in adults, do not show a relation in children, probably because of a different pathogenesis in the pediatric population. The level of evidence for most disease outcomes is lower. Few randomized placebo-controlled treatment trials are available for the different outcomes, often with only small numbers of cases included (6,7). These and other differences explain why some of the recommendations for adults (8) may not apply in children. H pylori infection is usually acquired during the first years of life in both developing and industrialized countries (9,10). In Europe and North America, the epidemiology of H pylori infection in children has changed in recent decades. Low incidence rates are found in the northern and western European countries, resulting in prevalence far below 10% in children and adolescents. In contrast, the infection is still common in certain geographic areas such as southern or eastern Europe, Mexico, and certain immigrant populations from South America, Africa, and most Asian countries, and aboriginal people in North America (11–13). The different prevalence of infection and the corresponding effect on health care resources in industrialized compared with developing countries require different recommendations with respect to testing and treating children. These guidelines apply only to children living in Europe and North America, but not to those living in other continents, particularly in developing countries with a high H pylori infection rate in children and adolescents and with limited resources for health care. The guidelines may need to be adapted to national health care systems because certain tests or treatment regimens may not be available and/or reimbursed by health insurance programs. 2. DEVELOPMENT OF GUIDELINES 2.1. Selection of Topics and Patients In 2000, the Pediatric Task Force of the H pylori Study Group of the European Society for Pediatric Gastroenterology, Hepato- logy, and Nutrition (ESPGHAN) published consensus statements on H pylori infection in children (14). Shortly thereafter, a working group of the North American Society for Pediatric Gastroentero- logy, Hepatology, and Nutrition (NASPGHAN) published a Medical Position Paper on the same topic, including recommendations for treatment (15). In 2004, the Canadian Helicobacter Study Group initiated a consensus conference including patients from Canada, the United States, and Europe. Recommendations covered how to approach H pylori infection in children (6). In 2005, ESPGHAN and NASPGHAN decided independently to renew their guidelines, this time with a joint evidence-based methodology. The councils of both societies decided in 2006 that the process should be combined to have the same recommendations for North America and Europe. The following 4 areas were identified and covered by 4 sub- groups, which formulated the critical questions for each area: 1. Who should be tested? (differentiating among screening, surveillance, and clinically based testing) 2. What tests should be used? 3. Who should be treated? 4. What treatment regimens are most appropriate? Each society assigned 1 chair (Benjamin Gold for NASP- GHAN and Sibylle Koletzko for ESPGHAN). At least 2 members from each society were assigned to the subgroups for the 4 areas of interest. Members were mostly pediatric gastroenterologists, but experts in epidemiology, microbiology, and pathology were also selected based on their peer-reviewed publications, research acti- vities in the field, and participation in national or international activities. The European patients were recruited from the Pediatric Task Force on H pylori Infection (ESPGHAN Working Group on H pylori
) and also included a representative from the European Helicobacter Study Group (Francis Me´graud). 2.2. Literature Search and Grading the Articles for Quality of Evidence A systematic literature search was designed by Karen Goodman, an epidemiologist, using accessible databases of relevance: PubMed, MEDLINE, EMBASE, Cochrane Library, Biosis Previews, EBM Reviews, ISI Web of Science, and Scopus. The search included publications from 2000 to August 2007. The search included publications of all types presenting or reviewing data on H pylori in patients younger than 20 years old, selecting on Medical Subjects Headings (MeSH) terms as listed below, with no language restrictions: Search Strategy 1 Helicobacter pylori 2 Helicobacter infection 3 pylori 4 or/1–3
5 Newborn
6 Infant
7 Child
8 Adolescent 9 Pediatrics 10 or/5–9
11 4 and 10
12 11 and py ¼ 2005:2006 13 Limit 12 to human The search identified 1979 unique publications and an additional 63 publications were generated from the citations of relevant reviews. Of these 2042 papers, the following were excluded: 800 that did not present evidence on relevant topics; 635 that did not present evidence for pediatric groups; 40 letters, commentaries, or case reports; 33 abstracts; 25 non–English- language publications that did not present relevant data in an English-language abstract; and 19 nonsystematic reviews. The total number of selected papers was 490, including 80 reviews. The papers were grouped according to the review focus areas. Sum- maries of review papers were prepared and tables were constructed Koletzko et al JPGN
232 www.jpgn.org Copyright 2011 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited. to organize key data regarding study, quality, and findings from the original research reports. In addition, within each subgroup, the members were asked to search the literature with respect to their topics to add evidence that may have been missed by the search criteria. In particular, this increased inclusion of publications from less widely circulated journals and from non–English-language sources. Grading of the quality of evidence was performed by epidemiologists and individual group members, according to the classification system of the Oxford Centre for Evidence-Based Medicine (http://www. cebm.net/index.asp ), because this is the only grading system in which studies of diagnostic tests can be scored accordingly. The lists of rated articles and synthesis tables were circulated to the subgroups, and the information was expanded or revised upon closer inspection as appropriate. 2.3. Voting on Consensus Statements and Grading the Statements for Quality of Evidence In preparation for a meeting in December 2007 in Munich, Germany, each subgroup had formulated the statements circulated to each member of the subgroups. In addition, the European members of the 4 subgroups presented the statements during the annual meeting of the ESPGHAN Pediatric Task Force in October 2007 in Istanbul, Turkey, where they were extensively discussed and adapted according to the comments of the attendees. At the meeting in Munich, the group voted on 2 iterations of each of the consensus statements. Statements were revised based on feedback provided from the patients and further critical review of the available literature. Some of the statements were deleted by voting and the content of these was condensed into comments pertaining to relevant statements that remained. Additional statements were added on matters that had not been addressed previously. All of the votes were anonymous. A 6-point scale was used: 1, agree strongly (A þ); 2, agree moderately (A); 3, just agree (A–); 4, just disagree (D–); 5, disagree moderately (D); and 6, disagree strongly (D þ). Agreement with the statement (the sum of voting for A þ, A, or A–) by three-quarters (ie, !75%) of the voting members was defined a priori as consensus. The level of agreement in the final vote is provided for each statement, expressed as a percentage. 2.4. Grades of Evidence Grades of evidence for each statement were based on the grading of the literature and were finally assigned using the GRADE system of 2004 (16) as follows: 1. High: further research is unlikely to change our confidence in the estimate of effect. 2. Moderate: further research is likely to have an important influence on our confidence in the estimate of effect and may change the estimate. 3. Low: further research is very likely to have an important influence on our confidence in the estimate of effect and may change the estimate. 4. Very low: any estimate of effect is uncertain. The designation ‘‘not applicable’’ was used for situations in which these grades of evidence were not relevant for a particular statement. 2.5. Consensus Meeting and Funding Sources The Munich meeting was organized by Sibylle Koletzko and supported financially by NASPGHAN and ESPGHAN. There was no financial support from industry. Seven North American members (4 from the United States, 2 from Canada, 1 from Mexico) and 8 European members attended the final meeting. One attendee, who was not eligible to vote, observed and documented the voting process, which was later compared with the recorded electronic Yüklə 330,04 Kb. Dostları ilə paylaş:
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