Abstract
Background
Helicobacter pylori (H. pylori) is one of the most common bacterial infections in humans. There is a risk factor for gastric or duodenal ulcers, gastric cancer and MALT (Mucosa Associated Lymphoid Tissue)-Lymphomas. There are several invasive and non-invasive methods available for the diagnosis of H. pylori. The 13C-urea breath test is a non-invasive method recommended for monitoring H. pylori eradication therapy. However, this test is not yet used for primary assessment of H. pylori in Germany.
Objectives
What are the clinical and health economic benefits of the 13C-urea breath test in the primary assessment of H. pylori compared to other invasive and non-invasive methods?
Methods
A systematic literature search including a hand search was performed for studies investigating test criteria and cost-effectiveness of the 13C-urea breath test in comparison to other methods used in the primary assessment of H. pylori. Only studies that directly compared the 13C-urea breath test to other H. pylori-tests were included. For the medical part, biopsy-based tests were used as the gold standard.
Results
30 medical studies are included. Compared to the immunoglobulin G (IgG) test, the sensitivity of the 13C-urea breath test is higher in twelve studies, lower in six studies and one study reports no differences. The specificity is higher in 13 studies, lower in three studies and two studies report no differences. Compared to the stool antigen test, the sensitivity of the 13C-urea breath test is higher in nine studies, lower in three studies and one study reports no difference. The specificity is higher in nine studies, lower in two studies and two studies report no differences. Compared to the urease test, the sensitivity of the 13C-urea breath test is higher in four studies, lower in three studies and four studies report no differences. The specificity is higher in five studies, lower in five studies and one study reports no difference. Compared to histology, the sensitivity of the 13C-urea breath test is higher in one study and lower in two studies. The specificity is higher in two studies and lower in one study. One study each compares the 13C-urea breath test to the 14C-urea breath test and the polymerase chain reaction (PCR) test, respectively, and reports no difference in sensitivity and specificity with the 14C-urea breath test, and lower sensitivity and higher specificity compared to PCR. The statistical significance of these differences is described for six of the 30 studies.
Nine health economic evaluations are included in the Health Technology Assessment (HTA) report. Among these studies, the test-and-treat strategy using the 13C-urea breath test is compared to test-and-treat using serology in six analyses and to test and treat using the stool antigen test in three analyses. Thereby, test-and-treat using the breath test is shown to be cost-effective over the serology based strategy in three models and is dominated by a test-and-treat strategy using the stool antigen test in one model. A cost-effectiveness comparison between the urea breath test approach and the empirical antisecretory therapy is carried out in four studies. Of these, two studies report that the strategy using the urea breath test is cost-effective over the empirical antisecretory therapy. In two studies, test-and-treat using the 13C-urea breath test is compared to the empirical eradication therapy and in five studies to endoscopy-based strategies. The breath test approach dominates endoscopy in two studies and is dominated by this strategy in one study.
Discussion
All included medical and economic studies are limited to a greater or lesser extent. Additionally, the results of the studies are heterogeneous regarding medical and economic outcomes respectively. Thus, the majority of the medical studies do not report the statistical significance of the differences in sensitivity and specificity. In direct comparisons the 13C- urea breath test shows higher sensitivity and specificity than the IgG and stool antigen tests. In comparison to the urease test, results for sensitivity are inconsistent, and the specificity is slightly higher for the 13C-urea breath test. There are not enough results for comparisons between the 13C-urea breath test and the 14C-urea breath test, histology and PCR to describe tendencies.
The included economic studies suggest that the test-and-treat strategy using the 13C-urea breath test is cost-effective compared to test-and-treat using serology as well as empirical antisecretory therapies. Due to a lack of valid studies, it is not possible to assess the breath test approach in comparison to test-and-treat using the stool antigen test and the empirical eradication therapy respectively, regarding the cost-effectiveness. The results of economic analyses comparing test-and-treat using the breath test to endoscopy strategies are too heterogeneous to draw any conclusions. Overall, none of the included economic models is able to completely capture the complexity of managing patients with dyspeptic complaints.
Conclusions/Recommendations
Based on available medical and economic studies, there is no sufficient evidence to recommend test and-treat using 13C-urea breath testing for the detection of H. pylori infection as the standard procedure for the management of uninvestigated dyspepsia in the German health care system. In addition, it must be considered that the DVGS guidelines of the Deutsche Gesellschaft für Verdauungs- und Stoffwechselkrankheiten (DVGS) recommend endoscopy based methods for the management of patients with dyspeptic complaints.
Abstract
Hintergrund
Helicobacter pylori (H. pylori) zählt trotz abnehmender Inzidenz zu den häufigsten bakteriellen Infektionskrankheiten des Menschen. Die Infektion mit H. pylori ist ein Risikofaktor für Krankheiten wie gastroduodenale Geschwüre, Magenkarzinomen und MALT (Mucosa Associated Lymphoid Tissue)-Lymphomen. Zur Diagnostik von H. pylori stehen verschiedene invasive und nichtinvasive Verfahren zur Verfügung. Der 13C-Harnstoff-Atemtest wird zur Kontrolle einer Eradikationstherapie empfohlen, kommt in der Primärdiagnostik von H. pylori derzeit jedoch nicht standardmäßig in Deutschland zum Einsatz.
Fragestellung
Welchen medizinischen und gesundheitsökonomischen Nutzen hat die Untersuchung auf H. pylori-Besiedlung mittels 13C-Harnstoff-Atemtest in der Primärdiagnostik im Vergleich zu invasiven und nichtinvasiven diagnostischen Verfahren?
Methodik
Basierend auf einer systematischen Literaturrecherche in Verbindung mit einer Handsuche werden Studien zur Testgüte und Kosten-Effektivität des 13C-Harnstoff-Atemtests im Vergleich zu anderen diagnostischen Verfahren zum primären Nachweis von H. pylori identifiziert. Es werden nur medizinische Studien eingeschlossen, die den 13C-Harnstoff-Atemtest direkt mit anderen H. pylori-Testverfahren vergleichen. Goldstandard ist eines oder eine Kombination der biopsiebasierten Testverfahren. Für die gesundheitsökonomische Beurteilung werden nur vollständige gesundheitsökonomische Evaluationsstudien einbezogen, bei denen die Kosten-Effektivität des 13C Harnstoff-Atemtests direkt mit anderen H. pylori-Testverfahren verglichen wird.
Ergebnisse
Es werden 30 medizinische Studien für den vorliegenden Bericht eingeschlossen. Im Vergleich zum Immunglobulin G (IgG)-Test ist die Sensitivität des 13C-Harnstoff-Atemtests zwölfmal höher, sechsmal niedriger und einmal gleich, und die Spezifität 13-mal höher, dreimal niedriger und zweimal gleich. Im Vergleich zum Stuhl-Antigen-Test ist die Sensitivität des 13C-Harnstoff-Atemtests neunmal höher, dreimal niedriger und einmal gleich, und die Spezifität neunmal höher, zweimal niedriger und zweimal gleich. Im Vergleich zum Urease-Schnelltest sind die Sensitivität des 13C-Harnstoff-Atemtests viermal höher, dreimal niedriger und viermal gleich und die Spezifität fünfmal höher, fünfmal niedriger und einmal gleich. Im Vergleich mit der Histologie ist die Sensitivität des 13C-Harnstoff-Atemtests einmal höher und zweimal niedriger und die Spezifität zweimal höher und einmal niedriger. In je einem Vergleich zeigt sich kein Unterschied zwischen 13C-Harnstoff-Atemtest und 14C-Harnstoff-Atemtest, sowie eine niedrigere Sensitivität und höhere Spezifität im Vergleich zur Polymerase-Kettenreaktion (PCR). Inwieweit die beschriebenen Unterschiede statistisch signifikant sind, wird in sechs der 30 Studien angegeben.
Es werden neun gesundheitsökonomische Evaluationen in dem vorliegenden Bericht berücksichtigt. Die Test-and-Treat-Strategie mittels 13C-Harnstoff-Atemtest wird in sechs Studien mit einem Test-and-Treat-Verfahren auf Basis der Serologie sowie in drei Studien mit einem Test-and-Treat-Verfahren auf Basis des Stuhl-Antigen-Tests verglichen. Dabei ist das Atemtestverfahren dreimal kosteneffektiv gegenüber der serologischen Methode und wird von der Stuhl-Antigen-Test-Strategie einmal dominiert. Vier Studien beinhalten einen Vergleich der Test-and -Treat-Strategie auf Basis des 13C-Harnstoff-Atemtests mit einer empirischen antisekretorischen Therapie, wobei sich das Atemtesverfahren zweimal als kosteneffektive Prozedur erweist und zwei Studien einen Vergleich mit einer empirischen Eradikationstherapie. In fünf Studien wird das Test-and-Treat-Verfahren mittels 13C-Harnstoff-Atemtest einer endoskopiebasierten Strategie gegenübergestellt. Zweimal dominiert die Atemteststrategie die endoskopische Prozedur und einmal wird sie von dieser Strategie dominiert.
Diskussion
Sowohl die medizinischen als auch die ökonomischen Studien weisen mehr oder minder gravierende Mängel auf und liefern heterogene Ergebnisse. So werden in der Mehrzahl der medizinischen Studien keine Angaben zur statistischen Signifikanz der berichteten Unterschiede zwischen den jeweiligen Testverfahren gemacht. Im direkten Vergleich weist der 13C-Harnstoff-Atemtest überwiegend eine höhere Testgüte als der IgG und der Stuhl-Antigen-Test auf. Aus den Vergleichen mit dem Urease-Schnelltest lassen sich keine Tendenzen bezüglich der Sensitivität ableiten, wohingegen die Spezifität des 13C-Harnstoff-Atemtests höher einzuschätzen ist. Für die Vergleiche des 13C-Harnstoff-Atemtest mit der Histologie, dem 14C-Harnstoff-Atemtest und der PCR liegen zu wenige Ergebnisse vor.
In der eingeschlossenen ökonomischen Literatur deuten einige Studienergebnisse auf eine Kosten-Effektivität der Test-and-Treat-Strategie mittels 13C-Harnstoff-Atemtest gegenüber dem Test-and-Treat-Verfahren auf Basis der Serologie und der empirischen antiskretorischen Therapie hin. Um Tendenzen bezüglich der Kosten-Effektivität der Atemteststrategie gegenüber der Test-and-Treat-Strategie mittels Stuhl-Antigen-Test sowie der empirischen Eradikationstherapie abzuleiten, mangelt es an validen Ergebnissen bzw. ökonomischer Evidenz. Die Untersuchungsresultate hinsichtlich eines Vergleichs mit endoskopiebasierten Verfahren fallen diesbezüglich zu heterogen aus. Insgesamt kann keines der ökonomischen Modelle der Komplexität des Managements von Patienten mit dyspeptischen Beschwerden gänzlich gerecht werden.
Schlussfolgerungen/Empfehlungen
Zusammenfassend ist festzuhalten, dass die Studienlage zur medizinischen und ökonomischen Beurteilung des 13C-Harnstoff-Atemtests im Vergleich zu anderen diagnostischen Methoden nicht ausreichend ist, um den Atemtest als primärdiagnostisches Standardverfahren im Rahmen einer Test-and-Treat-Strategie beim Management von Patienten mit dyspeptischen Beschwerden für die deutsche Versorgungslandschaft insbesondere vor dem Hintergrund der Leitlinien der Deutschen Gesellschaft für Verdauungs- und Stoffwechselkrankheiten (DGVS) anstelle einer endoskopiebasierten Methode zu empfehlen.
Executive Summary
1. Health political background
Diseases of the gastro-intestinal system are very common in Germany. About 28 million patients are treated for gastro-intestinal illnesses per year. In 2007, gastro-intestinal diseases accounted for 34.6 million prescriptions and a turnover of 1.363 billion Euro. A large number of gastroenterological diseases are caused by Helicobacter pylori (H. pylori). H. pylori infections in humans are one of the most common infections in developed countries, even though the incidence rates are decreasing. According to the Institute for Microbiology and Hygiene at the University of Freiburg, about 20 to 30 million people (30% of the German population) in Germany are infected. The infection of the mucus layer of the stomach with H. pylori causes usually a chronic inflammatory reaction, resulting in morbidity and mortality in four to six million people in Germany (about 20% of the infected population).
In this context, this Health Technology Assessment (HTA) report assesses the medical and health economic benefit of the 13C-urea breath test compared to other invasive and non-invasive tests used in the primary assessment of H. pylori.
2. Scientific background
The infection with H. pylori occurs via the oral-oral or the faecal-oral route and is associated with low socioeconomic status, residential density and poor hygiene. An acute H. pylori infection usually causes no symptoms. A persisting infection causes a chronic inflammation of the mucus layer in the stomach. This chronic inflammation is a risk factor for gastro duodenal ulcers, gastric cancer and MALT-lymphomas (Mucosa Associated Lymphoid Tissue).
The tests available for assessing an infection with H. pylori can be categorized into invasive and non-invasive methods. The invasive methods are based on the direct detection of H. pylori in biopsy samples taken during endoscopy. The invasive methods are: histology, urease tests, microbiological tests and the polymerase chain reaction (PCR). The non-invasive methods are based on the indirect detection of H. pylori in the blood, breath, urine or stool. The non-invasive methods are: the immunoglobin G (IgG) test, the stool antigen test and the 13C-urea breath test and 14C-urea breath test. The 13C-urea breath test is recommended for monitoring H. pylori eradication. The test is currently not used in the primary assessment of H. pylori in Germany.
3. Health economic background
The resources of health care systems are limited. Therefore it is crucial to allocate resources rationally within the health care system, i. e. by optimising the resource allocation. This implies that the medical benefit cannot be the only criterion for assessing medical procedures. Both, the effectiveness (˜ medical results) and the costs of the medical procedures have to be regarded. This is the purpose of health economic evaluation studies. The price of the 13C-urea breath tests are relatively high compared to other relevant tests. Thus, the objective of the health economic part of this report is to investigate whether the medical effectiveness as well as the other cost components of the test-and-treat strategy can compensate for the costliness of this test.
Health economic studies of high quality should be capable of capturing the complexity of treatment-oriented diagnostics of gastroenterological diseases. Therefore the following matters should be taken into account. The study should be based on comparative analysis. In order to include all relevant direct, indirect and intangible costs, a social perspective should be used. Furthermore multidimensional measures of effectiveness would be more appropriate for capturing all relevant outcomes. As the treatment of stomach and intestinal disorders are associated with several factors of uncertainty, complex multivariate and probabilistic sensitivity analysis should be carried out. Moreover, the time horizon of the model should be rather long-term.
4. Research questions
Medical questions:
ME1 What is the sensitivity and specificity of the 13C-urea breath test in the primary assessment of H. pylori compared to other methods?
Health economic questions:
HE1 What is the cost-effectiveness of the 13C-urea breath test for the diagnosis of H. pylori infection compared to that of other diagnostic methods?
HE2 What factors should be considered in health economic evaluations to assess the cost-effectiveness of the 13C-urea breath test compared to other invasive and non-invasive methods?
HE3 What can be concluded from current health economic studies, especially concerning the reimbursement regulations for the 13C-urea breath test?
HE4 What further health economic research is needed?
Ethical questions:
ETH1 What ethical aspects concerning the reimbursement regulations for the 13C-urea breath test have to be considered?
ETH2 What ethical aspects concerning the test-and-treat strategy using the 13C-urea breath test in the management of dyspepsia have to be considered?
ETH3 What ethical aspects concerning invasive diagnostic methods for H. pylori infections have to be considered?
5. Methods
A structured and sensitive search of the literature was performed on 03/09/2008 by the Deutsches Institut für Medizinische Dokumentation und Information (DIMDI) to assess the medical and health economic effectiveness of the 13C-urea breath test for H. pylori for the primary assessment of H. pylori compared to other invasive and non-invasive methods. The following databases were used:
Deutsches Ärzteblatt (AR96); CCMed (CC00); NHS-CRD-DARE (CDAR94); DAHTA (DAHTA); gms Meetings (GM03); Hogrefe-Verlagsdatenbank und Volltexte (HG05); NHS-CRD-HTA (INAHTA); Kluwer-Verlagsdatenbank (KL97); Krause & Pachernegg-Verlagsdatenbank (KP05); Karger-Verlagsdatenbank (KR03); MEDIKAT (MK77); SOMED (SM78); Springer-Verlagsdatenbank (SP97); Thieme-Verlagsdatenbank (TV01); Cochrane Library – Central (CCTR93); MEDLINE (ME60); CAB Abstracts (CV72); NHS Economic Evaluation Database (NHSEED); GLOBAL Health (AZ72); AMED (CB85); IPA (IA70); Derwent Drug Backfile (DH64); EMBASE (EM74); EMBASE Alert (EA08); Derwent Drug File (DD83); ISTPB + ISTP/ISSHP (II78); SciSearch (IS74); BIOSIS Previews (BA26).
Titles and abstracts of the studies were assessed for relevance by two independent reviewers. The quality evaluation of the medical studies was done in accordance with the standards for reporting of diagnostic accuracy checklist. Only primary studies and systematic reviews describing sensitivity and specificity were included. For the health economic assessment only evaluation studies describing cost-effectiveness, incremental cost-effectiveness ratio, cost benefit ratio or cost value benefit ratio were included. Special attention was paid to the method of analysis and the quality of the health economic models.
6. Results
6.1 Quantitative results
Using the defined search terms 1,035 medical, 117 economic and one ethical/legal publication are identified. Thereof, 30 medical, five economic and no ethical/legal publications are included. The hand search resulted in four other relevant economic publications so that a total of nine economic publications are included.
6.2 Qualitative results
6.2.1 Included medical publications
Using the search terms 1,035 publications are identified. After titles/abstracts are reviewed, 99 publications are ordered as full texts. Of these 99 publications, 30 meet the inclusion criteria.
The studies include between 22 and 316 participants. In total 3,415 patients take part in 30 studies. 15 studies include adults, 14 studies comprehend children and youths and one study does not report the age of the patients involved.
The 13C-urea breath test is compared to the IgG test 18 times, 13 times with the stool antigen test, eleven times with the urease test, three times with histology, and one time each with PCR and the 14C-urea breath test. The sensitivity of the 13C-urea breath test is between 75% and 100%, the specificity between 55% and 100%. The sensitivity of the IgG test is between 50% and 100%, the specificity between 52% and 100%. The sensitivity of the stool antigen tests is between 50% and 98%, the specificity between 63% and 100%. The sensitivity of the urease tests is between 79 % and 100 %, the specificity between 59% and 100%. Sensitivity and specificity higher than 90% are found in 84% of the studies for the 13C-urea breath test. Sensitivity and specificity higher than 90% are found in 62% of the studies for the stool antigen test, for the IgG test in 56% (sensitivity) and 44% (specificity) of the studies, for the urease test in 73% (sensitivity) and 55% (specificity) of the studies. Compared to the IgG, the sensitivity of the IgG test is higher in twelve studies, lower in six studies and one study reports no differences. The specificity is higher in 13 studies, lower in three studies and two studies do not find any differences. Compared to the stool antigen test, the sensitivity of the 13C-urea breath test is higher in nine studies, lower in three studies and one study reports no difference. The specificity is higher in nine studies, lower in two studies and two studies do not inform about any differences. Compared to the urease tests, the sensitivity of the 13C-urea breath test is higher in four studies, lower in three studies and four studies report no variations. The specificity grows in five studies, decreases in five studies and one study reports no difference. Compared to histology, the sensitivity of the 13C-urea breath test is higher in one study and lower in two studies. The specificity is higher in two studies and lower in one study. The 13C-urea breath test has a lower sensitivity and a higher specificity compared to the PCR. There is no difference between the 13C-urea breath test and the 14C-urea breath test.
6.2.2 Included economic publications
On the basis of defined inclusion and exclusion criteria, nine economic studies are included in this HTA report. Four of these studies report a comparison of cost-effectiveness between test-and-treat using the 13C-urea breath test and test-and-treat using other non-invasive diagnostic tests for the detection of H. pylori. In three studies, a cost-effectiveness analysis is performed comparing a test-and-treat approach based on the 13C-urea breath test to other management strategies for dyspepsia. A discrete event simulation incorporating first and second order simulation to determine the benefits and costs of a test-and-treat strategy using the urea breath test as well as other strategies for the management of uninvestigated dyspepsia is carried out in another study. In one case, the model only compares the costs of test-and-treat on the basis of urea breath test to endoscopy assuming medical equivalence of both methods. Test-and-treat using the 13C-urea breath test is compared to test-and-treat procedures on the basis of serology in six studies and to test-and-treat based on the stool antigen test in three models (but only one study reports the outcomes of both strategies). Additionally, test-and-treat strategies using several diagnostic tests (as confirmation) are evaluated in two studies. Furthermore, test-and-treat based on the urea breath test is compared to different antisecretory therapies in four models, to empirical eradication therapy in two models and to endoscopy based procedures in five models. If necessary the endoscopy based strategies include invasive testing for H. pylori infection.
According to the results of the economic studies, the test-and-treat strategy based on the 13C-urea breath test for the management of patients with unexamined dyspepsia is neither dominated by serological strategy nor by an empirical anti-secretory therapy or an empirical eradication therapy. Test-and-treat using the breath test turns out to be cost-effective over test-and-treat using serology in three studies and over the empirical antisecretory therapy in two studies but is dominated in another study by the test-and-treat strategy on the basis of the stool antigen test. The results of two models show a domination of the breath test approach over endoscopy based strategies whereas one study reports a domination of endoscopy over test-and-treat using the 13C-urea breath test.
6.2.3 Included ethical, social and judicial publications
No publications could be found that described ethical, social or judicial aspects of the primary assessment methods of H. pylori infection. Therefore it is not possible to evaluate the ethical, social and judicial implications of the assessment methods for H. pylori infection in this HTA report.
7. Discussion
7.1 Discussion of medical aspects
The results of the included studies are heterogeneous with regard to the sensitivity and specificity of the tests. Possible explanations are the differences in the study populations, the choice of the reference tests and the different ways of conducting the H. pylori tests. Also, the majority of the studies do not report the statistical significance of the differences in sensitivity and specificity, i. e. based on the results of the included studies, only tendencies can be described for the test quality of the 13C-urea breath test and alternative testing methods for H. pylori.
In direct comparisons the 13C-urea breath test shows higher sensitivity and specificity than the IgG and stool antigen tests. In comparison to the urease test, results for sensitivity are inconsistent, and the specificity is slightly higher for the 13C-urea breath test. There are not enough results for comparisons between the 13C-urea breath test and the 14C-urea breath test, histology and PCR to describe tendencies.
7.2 Discussion of economic aspects
The cost-effectiveness of testing for H. pylori infection using the 13C-urea breath test compared to other diagnostic methods must be assessed using management strategies, because H. pylori assessment should only be performed if there are clear strategies for dealing with the test results. To identify an optimal method, strategies that do not incorporate a H. pylori test are also to be taken into consideration.
All included studies had limitations to a greater or lesser extent. None of the included models is able to completely capture the complexity of managing patients with dyspeptic complaints. This is due to the use of one-dimensional outcome measures, insufficient consideration of therapeutic implications and follow-ups, time horizons which are too short or unverifiable determination of utility values and social costs. Furthermore, it must be considered that a cost-effectiveness comparison between alternative management strategies is limited in several economic analyses. In the majority of the included studies, disease specific outcome measures are used. Due to the lack of expert literature on threshold values for incremental outcome gains, the reported incremental cost-effectiveness ratios cannot be assessed. Therefore, conclusions on the cost-effectiveness of test-and-treat using the urea breath test in comparison to other strategies can only be drawn for dominant cost-effectiveness ratios.
According to the results of the included economic studies, the test-and-treat strategy using the 13C-urea breath test seems to be cost-effective compared to test-and-treat based on serology and compared to the empirical antisecretory therapy. Due to a lack of valid studies, it is not possible to assess the breath test approach in comparison to test-and-treat using the stool antigen test and the empirical eradication therapy respectively, regarding the cost-effectiveness. The results of economic analyses comparing test-and-treat using the breath test to endoscopy strategies are too heterogeneous to draw any conclusions.
7.3 Discussion of ethical, judicial and social aspects
From a social and ethical perspective, available resources should be effectively used to prevent rationing. Because there are no high-quality health economic studies that compare test-and-treat strategies using the 13C-urea breath test to alternative methods explicitly for the German population, the effectiveness of the current resource allocation remains uncertain.
A limitation of test-and-treat strategies is that they cannot be used to diagnose gastric cancer, ulcers etc. Endoscopy on the other hand, is associated with significant discomfort and a very low risk of serious complications. Currently, the only fully reimbursed alternative to endoscopy for the primary assessment of H. pylori is IgG testing. The IgG test is less effective than the 13C-urea breath test and other methods. This regulation will become more important, as the incidence of H. pylori infections continues to increase in persons with lower socioeconomic status.
8. Conclusions/Recommendations
The results of the included medical and health economic studies assessing the 13C-urea breath test in comparison to other diagnostic methods for H. pylori detection are not sufficient to recommend the 13C-urea breath test as a standard primary assessment method in the context of a test-and-treat strategy for managing patients with dyspeptic disorders in Germany.
Because of the public health relevance of the topic, high-quality economic and medical studies are needed in order to assess the effectiveness of the 13C-urea breath test for H. pylori infection. In addition the cost-effectiveness of serology test should be studied in more detail.