An expert consensus definition of failure of a treatment to provide adequate relief (F-PAR) for chronic constipation - an international Delphi survey.

BACKGROUND: As treatments for constipation become increasingly available, it is important to know when to progress along the treatment algorithm if the patient is not better. AIM: To establish the definition of failure of a treatment to provide adequate relief (F-PAR) to support this management and referral process in patients with chronic constipation. METHODS: We conducted an international Delphi Survey among gastroenterologists and general practitioners with a special interest in chronic constipation. An initial questionnaire based on recognised rating scales was developed following a focus group. Data were collected from two subsequent rounds of questionnaires completed by all authors. Likert scales were used to establish a consensus on a shorter list of more severe symptoms. RESULTS: The initial focus group yielded a first round questionnaire with 84 statements. There was good consensus on symptom severity and a clear severity response curve, allowing 67 of the symptom-severity pairings to be eliminated. Subsequently, a clear consensus was established on further reduction to eight symptom statements in the final definition, condensed by the steering committee into five diagnostic statements (after replicate statements had been removed). CONCLUSIONS: We present an international consensus on chronic constipation, of five symptoms and their severities, any of which would be sufficient to provide clinical evidence of treatment failure. We also provide data representing an expert calibration of commonly used rating scales, thus allowing results of clinical trials expressed in terms of those scales to be converted into estimates of rates of provision of adequate relief.

Management of reflux esophagitis: does the choice of proton pump inhibitor matter?

BACKGROUND: Proton pump inhibitors (PPIs) are the treatment of choice for reflux esophagitis (RE). The effectiveness of PPIs throughout RE management, from healing to maintenance, has not been fully studied. AIM: To compare esomeprazole with lansoprazole or pantoprazole for RE management using a management model. METHODS: Data from six studies comparing esomeprazole with lansoprazole or pantoprazole for healing (4-8 weeks) or maintenance of healing (6 months) of RE were incorporated into hypothetical management models to determine the proportion of patients in endoscopic remission after sequential healing and maintenance therapy, assuming that patients received the same PPI throughout. The number needed to treat (NNT) to achieve one more patient in remission with esomeprazole vs. other PPIs was estimated. The hypothetical model was validated using results from the EXPO study, which compared esomeprazole with pantoprazole for RE healing and maintenance. RESULTS: Overall, esomeprazole 40 mg produced higher rates of healing (life-table estimates) than lansoprazole 30 mg (82.4-92.6% vs. 77.5-88.8%; p < 0.01) or pantoprazole 40 mg (95.5% vs. 92.0%; p < 0.001) and higher rates of endoscopic and symptomatic remission at 6 months than lansoprazole (83.0-84.8% vs. 74.0-75.9%; p < 0.001; life-table estimates) or pantoprazole (70.9% vs. 59.6%; p < 0.0001; observed rates). In the hypothetical management model, the NNT for esomeprazole was 9 vs. lansoprazole and 8 vs. pantoprazole. The actual NNT for esomeprazole vs. pantoprazole in the EXPO study was 9 (95% confidence interval: 6; 16). CONCLUSIONS: In this management model, esomeprazole was more effective than either lansoprazole or pantoprazole for maintaining remission after sequential healing and 6 months' maintenance therapy for RE.

Evolution of gastro-oesophageal reflux disease over 5 years under routine medical care--the ProGERD study.

BACKGROUND: The evolution of gastro-oesophageal reflux disease (GERD) under current management options remains uncertain. AIM: To examine whether, depending on the initial presentation, non-erosive (NERD) and erosive reflux disease (ERD) without Barrett's oesophagus will progress to more severe disease under current routine care following the resolution of the initial condition. METHODS: Patients with the primary symptom of heartburn were included at baseline, and stratified into non-erosive (NERD) and erosive reflux disease (ERD), LA grades A-D (Los Angeles classification). After a 2- to 8-week course with esomeprazole therapy to achieve endoscopic healing in ERD and symptom relief in NERD, patients were treated routinely at the discretion of their physician. We report oesophagitis status and the presence of endoscopic and confirmed Barrett's oesophagus after 5 years. RESULTS: A total of 6215 patients were enrolled in the study of whom 2721 patients completed the 5-year follow-up. Progression, regression and stability of GERD severity were followed from baseline to 5 years. Only a few patients with NERD and mild/moderate ERD progressed to severe forms of ERD and even Barrett's oesophagus. Most patients remained stable or showed improvement in their oesophagitis; 5.9% of the NERD patients, 12.1% of LA grade A/B patients and 19.7% of LA grade C/D patients in whom no Barrett's oesophagus was recorded at baseline progressed to endoscopic or confirmed Barrett's oesophagus at 5 years. CONCLUSION: Most GERD patients remain stable or improve over a 5-year observation period under current routine clinical care.

Clinical trial: factors associated with freedom from relapse of heartburn in patients with healed reflux oesophagitis--results from the maintenance phase of the EXPO study.

BACKGROUND: Ability to predict freedom from heartburn relapse during maintenance therapy for healed reflux oesophagitis may facilitate optimal treatment choices for individual patients. AIM: To determine factors predicting freedom from heartburn relapse during maintenance proton pump inhibitor therapy in patients with healed reflux oesophagitis. METHODS: This post-hoc analysis used data from the maintenance phase of the EXPO study (AstraZeneca study code: SH-NEG-0008); 2766 patients with healed reflux oesophagitis and resolved heartburn received once-daily esomeprazole 20 mg or pantoprazole 20 mg for 6 months. Multiple logistic regression analysis determined factors associated with freedom from heartburn relapse. RESULTS: Heartburn relapse rates were lower with esomeprazole than pantoprazole in all subgroups analysed. Esomeprazole treatment was the factor most strongly associated with freedom from heartburn relapse (odds ratio 2.08; P < 0.0001). Other factors significantly associated with freedom from heartburn relapse were Helicobacter pylori infection, greater age, non-obesity, absence of epigastric pain at baseline, pre-treatment nonsevere heartburn and GERD symptom duration < or =5 years. CONCLUSIONS: Several factors predict freedom from heartburn relapse during maintenance proton pump inhibitor therapy for healed reflux oesophagitis, the strongest being choice of proton pump inhibitor. These findings outline the importance of optimizing acid control and identifying predictors of relapse for effective long-term symptom management in reflux oesophagitis patients.

Clinical course of laryngo-respiratory symptoms in gastro-oesophageal reflux disease during routine care--a 5-year follow-up.

BACKGROUND: Gastro-oesophageal reflux disease (GERD) can be associated with laryngo-respiratory symptoms (LRS) such as chronic cough, asthma or laryngeal symptoms. AIM: To analyse the long-term clinical course of LRS in a large population with GERD and LRS. METHODS: ProGERD is a prospective multicentre cohort study of 6215 adult out-patients with GERD. At baseline, the prevalence of LRS was assessed. Initial standardized treatment was esomeprazole for up to 8 weeks. After 5 years of follow-up, patients were interviewed for LRS and a multivariate analysis was performed with resolved vs. persistent symptoms for chronic cough, asthma and laryngeal symptoms. RESULTS: In all, 2886 patients (46.4%) were available for analysis at baseline and at 5 years. The prevalence of chronic cough and laryngeal disorders had decreased while the prevalence of asthma had increased. Resolution of LRS was independent of clinical reflux characteristics or PPI medication. CONCLUSIONS: In a large population with GERD, only few patients reported persistent LRS over 5 years. Resolution of LRS was independent of the stage of GERD and PPI treatment. Accordingly, data on the direction of causality between GERD and LRS are lacking and the strength of the association between the two must remain controversial.

Clinical trial: factors associated with resolution of heartburn in patients with reflux oesophagitis--results from the EXPO study.

BACKGROUND: The ability to predict symptom response to reflux oesophagitis-healing therapy may optimize treatment decisions. AIM: To identify factors associated with heartburn resolution in patients receiving acid-suppressive therapy for reflux oesophagitis. METHODS: In this multicentre, randomized, double-blind trial (EXPO; AstraZeneca study code: SH-NEG-0008), patients with endoscopically confirmed reflux oesophagitis and reflux symptoms received once-daily proton pump inhibitor therapy [esomeprazole 40 mg (n = 1562) or pantoprazole 40 mg (n = 1589)] for >or=4 weeks. Factors associated with heartburn resolution after 4 weeks were identified by multiple logistic regression analysis. RESULTS: Esomeprazole therapy, positive Helicobacter pylori status and greater age were associated with an increased likelihood of heartburn resolution [odds ratio (95% confidence interval): 1.31 (1.12, 1.54), 1.44 (1.19, 1.74) and 1.013 (1.007, 1.019) per year, respectively; all P < 0.001]. Men and patients with no acid regurgitation or epigastric pain pre-treatment were also more likely to achieve heartburn resolution (all P < 0.05). CONCLUSIONS: The use of esomeprazole rather than pantoprazole increases the probability of achieving resolution of heartburn during reflux oesophagitis-healing therapy. Other factors, including H. pylori status, age, gender and symptom profile may be helpful in determining the likelihood of heartburn resolution in such patients.

Health-related quality of life in patients with gastro-oesophageal reflux disease under routine care: 5-year follow-up results of the ProGERD study.

BACKGROUND: Gastro-oesophageal reflux disease (GERD) is a common disorder associated with substantial reductions in health-related quality of life (HRQL). AIM: To describe patterns of change in HRQL during 5 years of follow-up in a large population of GERD patients. METHODS: In 2000, a total of 6215 GERD patients were enrolled in the Progression of GERD (ProGERD) study. During follow-up, patients received any medication considered necessary. HRQL was assessed yearly with the Short-Form 36 and the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaires. Associations between patient characteristics and changes in HRQL were analysed using multiple logistic regression models. RESULTS: After 5 years, data on HRQL were available for 4597 (74%) patients. Both generic and disease-specific HRQL improved after baseline and remained well above baseline levels in the following years. A clinically relevant decrease in QOLRAD scores was reported by 3-5% of patients. According to our multivariate analysis, a decrease in HRQL was associated with a higher reflux symptom load and the presence of night-time heartburn. CONCLUSIONS: Only a small minority of the ProGERD population reported a clinically relevant decrease in HRQL, which was associated most strongly with nocturnal heartburn.

[Medication therapeutic strategies for gastro-esophageal reflux disease]. / Medikamentöse Therapieoptimierung bei gastroösophagealer Refluxkrankheit und ihren Komplikationen.

Gastroesophageal reflux disease (GERD) is a common condition in industrialised countries. According to a recently published, globally accepted definition and classification of GERD, clinical presentations include oesophageal and extraoesophageal syndromes, with extraoesophageal syndromes divided into established and proposed associations. Proton pump inhibitors (PPI) are the drug class of choice for all patients with GERD, irrespective of the severity. The individual strategy of treatment (e. g., dose and duration of PPI) depends on the clinical presentation. As a rule, the magnitude of acid control gained by PPIs is related to clinically meaningful outcome parameters: speed and extent of symptom control, healing of reflux oesophagitis, maintenance of symptomatic and endoscopic remission of the disease. In individual cases, the efficacy of PPI therapy can be improved by switching from one compound to another and by increasing the frequency of dosing. Current evidence suggests that PPI therapy is remarkably safe without any relevant differences between the PPIs on the market.

Histological effects of esomeprazole therapy on the squamous epithelium of the distal oesophagus.

BACKGROUND: Proton pump inhibitor therapy has been reported to reduce proliferative changes of the oesophagus significantly in gastro-oesophageal reflux disease (GERD). AIM: To assess the histological effects of esomeprazole treatment on the oesophagus. METHODS: Data were derived from a subgroup of patients participating in the proGERD study, who had either erosive reflux disease (n = 720) or non-erosive reflux disease (n = 35) and who had biopsy data from two sites [(i) 2 cm above the z-line and (ii) at the z-line], obtained at baseline and following treatment with esomeprazole. Proliferative changes of the squamous epithelium were assessed histologically by measuring thickness of the basal cell layer and elongation of the papillae as a percentage of the whole epithelial thickness. RESULTS: In erosive reflux disease patients, the thickness of the basal cell layer and length of the papillae pretreatment were associated with the severity of oesophagitis (P < 0.05), at both biopsy sites. After esomeprazole treatment, baseline thickness and length of papillae were significantly reduced (P < 0.05) at both biopsy sites in non-erosive reflux disease and erosive reflux disease patients (particularly those with Los Angeles grades C and D). CONCLUSION: This demonstrates a strong correlation between severity of GERD and histological parameters. Esomeprazole therapy resulted in clear reversal of proliferative changes observed prior to treatment in the squamous epithelium at both biopsy locations.

Long-term clinical course of extra-oesophageal manifestations in patients with gastro-oesophageal reflux disease. A prospective follow-up analysis based on the ProGERD study.

BACKGROUND: Gastro-oesophageal reflux disease can be associated with extra-oesophageal reflux disease such as chronic cough or laryngeal symptoms. The aim of this study was to analyse the clinical course of extra-oesophageal reflux disease in a large population with gastro-oesophageal reflux disease and extra-oesophageal reflux disease under routine clinical care. METHODS: ProGERD is a prospective multicentre cohort study of 6215 outpatients with gastro-oesophageal reflux disease. At baseline all patients underwent endoscopies and were interviewed for extra-oesophageal reflux disease. Initial standardised treatment was esomeprazole for up to 8 weeks. After 2 years of follow-up, reflux symptoms and the prevalence of extra-oesophageal reflux disease were assessed. A multivariate analysis was performed with resolved versus persistent symptoms for chronic cough and laryngeal symptoms as dependent predictors. Independent variables were gender, age, body mass index (BMI), alcohol consumption, cigarette smoking, gastro-oesophageal reflux disease classification, history of gastro-oesophageal reflux disease in the family, duration of gastro-oesophageal reflux disease and proton pump inhibitors medication. RESULTS: Four thousand four hundred and four patients (71%) were available for analysis at 2 years, including 570 and 454 patients who had chronic cough and laryngeal disorders at baseline, respectively. In 63% and 74% of the patients, chronic cough and laryngeal disorders had resolved. Patients with persistent respiratory symptoms in year 2 had significantly more reflux symptoms. Further clinically relevant associations were smoking and non-steroidal anti-inflammatory drugs use. According to the multivariate analysis, classification of gastro-oesophageal reflux disease, proton pump inhibitors medication or duration of gastro-oesophageal reflux disease were not associated with the resolution of cough or laryngeal symptoms. CONCLUSION: In most patients with gastro-oesophageal reflux disease and extra-oesophageal reflux disease, respiratory symptoms resolve during long-term routine care. A high reflux symptom load was associated with the persistence of respiratory disorders.

[Reflux-associated sleep disorders]. / Refluxassoziierte Schlafstörungen.

Difficulties of initiating or maintaining sleep are very common in the general population. Individuals with clinical sleep disorders have a greatly impaired quality of life. The causes for sleeping disorders are complex, but evidence has recently come from different trials supporting a causal relationship between gastro-esophageal reflux disease (GERD) and sleep disorders in some patients. The majority of patients with GERD report reflux symptoms during the night. It is well known that especially at night reflux is characterized by prolonged esophageal acid exposure. Recent data have indicated that sleep disorders significantly improve while on efficacious antisecretory treatment. In particular in patients with sleep disorders but no previously known GERD, the search for it is recommended and should be followed by adequate antisecretory treatment. In other severe diseases associated with sleep, like the obstructive sleep apnoea syndrome (OSAS), an association with esophageal acid exposure has been proven. The sleep apnea-associated reflux has probably a multifactorial etiology: in cases with other predisposing conditions for gastro-esophageal reflux, OSAS promotes the development of reflux. Antisecretory treatment has been able to improve the severity of OSAS. The purpose of this review has been to survey of recent publications in GERD-associated sleep disorders, as well as the possible pathophysiological basis of the observed phenomena.

Validation of the Reflux Disease Questionnaire for a German population.

OBJECTIVE: We describe the validation of a German-language version of the Reflux Disease Questionnaire in what is the first validation study of this patient questionnaire for a non-English speaking population. Gastro-oesophageal reflux disease is one of the most common diseases in primary care and has a significant negative impact on patients' quality of life. There is no gold standard for diagnosing gastro-oesophageal reflux disease, however, so the valid assessment of symptoms is especially important. DESIGN AND METHODS: A total of 5689 patients (92%) completed the questionnaire both before treatment and after 2 weeks. The results were tested for validity and reliability. Predictive validity was tested in a pilot study of 100 patients. Convergent validity was examined using the Quality of Life in Reflux and Dyspepsia Questionnaire for the assessment of disease-specific quality of life and the McMaster Overall Treatment Evaluation for the assessment of therapeutic success. RESULTS: Principal component analysis suggested a three-factor solution with the subscores heartburn, regurgitation, and dyspepsia. The internal consistencies of the subscores were between 0.84 and 0.86. Item difficulty ranged from 0.33 to 0.53, and corrected item-total correlation from 0.66 to 0.72. Effect sizes were between 0.8 and 1.0. CONCLUSION: The German version of the questionnaire has good psychometric properties and is responsive to changes in health. Thus, we conclude that the German Reflux Disease Questionnaire is suitable for the assessment of heartburn, regurgitation, and treatment response, both in primary care settings and clinical studies.

Risk factors of gastroesophageal reflux disease: methodology and first epidemiological results of the ProGERD study.

OBJECTIVE: We describe the design and report the first results of the Progression of Gastroesophageal Reflux Disease (ProGERD) study, to our knowledge the largest prospective study of GERD patients. STUDY DESIGN AND SETTING: Patients were recruited at 1,253 centers in Germany, Austria, and Switzerland. Following an assessment of medical history, all patients were endoscoped and received esomeprazole for 2 to 8 weeks before entering the 5-year observational phase. RESULTS: A total of 6,215 patients (53% male, age 54+/-14) were included. Of these patients, 46% reported at least daily symptoms, 15% were unable to work at least once during the prior year, and 71% had visited a physician due to reflux symptoms. Barrett's esophagus (BE) was found in 11% of our GERD patients. In polychotomous regression analysis, the main factors related to the occurrence of the three GERD subgroups (nonerosive, erosive disease, and BE) were age, gender, duration of GERD, body mass index (BMI), smoking, and previous PPI use. Factors associated with longer disease duration were increasing age, male gender, BMI, increasing symptom severity, presence of erosive GERD or BE, positive family history, and smoking. CONCLUSION: The findings indicate that GERD is a great burden for patients, and has significant socioeconomic implications. The long-term follow-up period with further endoscopic and histologic evaluations, will help further our understanding of the natural course of the disease.

[Long-term course of reflux symptoms following Helicobacter pylori eradication]. / Langzeitverlauf von Refluxbeschwerden nach Helicobacter pylori-Eradikation.

BACKGROUND AND OBJECTIVE: Conflicting data regarding new onset or deterioration of gastroesophageal reflux disease (GORD) following eradication of Helicobacter pylori infection have been reported. Successful eradication therapy may influence gastric acid output. The study aimed to to investigate whether patients with pre-existing GORD or peptic ulcer disease may experience deterioration of GORD. PATIENTS AND METHODS: 75 consecutive patients of a prospective longitudinal study (median age 66 years, n = 45 males) had received successful H. pylori eradication therapy because of the following main diagnosis: peptic ulcer (n = 37), GORD (n = 16), functional dyspepsia (n = 22). Two to three years later, they had an interview regarding the course of their dyspeptic and reflux symptoms. Negative H. pylori status at present was confirmed by (13)C-urea breath test in all patients. Ten patients were excluded because of proton pump inhibitor treatment. RESULTS: Patients with deterioration of GORD (new onset or increasing reflux symptoms) were found significantly more frequently in the group with functional dyspepsia (36 %) compared to pre-existing GORD (16 %) or peptic ulcer disease (5 %). Improvement of pre-existing reflux complaints were reported mostly by patients with peptic ulcer disease. There was no significant impact of initial reflux manifestations like reflux symptoms or reflux oesophagitis on the course. CONCLUSIONS: During long-term follow-up after H. pylori eradication, patients experience improvement as frequently as deterioration of reflux symptoms. There is a tendency towards improvement of reflux symptoms if peptic ulcer disease had been the indication for eradication, but towards deterioration in patients with initial functional dyspepsia. A clinical relevant prediction, however, is not feasible.

Diagnostics of Helicobacter pylori infection in patients with peptic ulcer bleeding.

BACKGROUND: In peptic ulcer bleeding, the sensitivity of H. pylori tests, in particular of the rapid urease test (RUT), has been reported to be insufficient. AIM: To validate the RUT, serology and the urea breath test were carried out in patients with bleeding peptic ulcers, and to study the influence of H. pylori suppressive treatment (HpSuT), i. e., antibiotics and proton pump inhibitors. PATIENTS AND METHODS: 123 consecutive patients (mean age 65.5 years) with a relevant bleeding from gastric or duodenal ulcers were prospectively tested for H. pylori infection by directs tests (RUT, histology, culture, urea breath test) and by IgG serology as an indirect test. Positive H. pylori status was defined by positive histology or culture. RESULTS: In patients without HpSuT during the preceding four weeks (N = 83), the sensitivity and specificity of RUT was 94 and 84 %, that of serology 83 and 68 % respectively. The sensitivity of urea breath test decreased from 82 to 60 % after even one day of HpSuT. In the overall group, the duration of HpSuT and preceding hospitalization were independent factors linked with negative results of all direct tests. CONCLUSIONS: In peptic ulcer bleeding, RUT combined with histology is an adequate diagnostic approach. However, false negative results have to be considered following even short-term HpSuT or hospitalization. Non-invasive diagnosis based on serology alone is inaccurate and should be complemented by the urea breath test prior to starting HpSuT.

Simultaneous detection and differentiation of anti-Helicobacter pylori antibodies by flow microparticle immunofluorescence assay.

Helicobacter pylori is the key pathogen for gastroduodenal diseases. The clinical outcome of H. pylori infection is influenced by the presence of strain-specific virulence factors that are usually detected by the presence of specific anti-H. pylori antibodies in serum. Apart from the detection of these antibodies by enzyme-linked immunosorbent assay (ELISA), it is desirable to obtain additional information concerning the presence of certain virulence factors of H. pylori that are currently detected by immunoblot analysis. At present, the immunodiagnosis of an H. pylori infection includes two separate methods: ELISA and immunoblot analysis. Here, we report the development and evaluation of a new rapid flow microparticle immunofluorescence assay (FMIA) for detection of anti-H. pylori antibodies in human serum. The assay allows rapid qualitative and quantitative detection of anti-H. pylori antibodies by using crude antigen preparations as well as single recombinant antigens (urease A, urease B, CagA, and alkylhydroxy peroxide reductase) in the same sample with one measurement, and thus it combines the advantages of enzyme immunoassay and Western blot analysis. Seventy-five patient samples were analyzed by FMIA, ELISA, and Western blotting with respect to their immunoreactivity against crude H. pylori extracts and individual H. pylori antigens. Statistical analyses revealed an overall similarity of more than 90% among the results for FMIA, ELISA, and Western blot. Therefore, we conclude that FMIA is a powerful and time- and cost-saving assay system for the detection of antimicrobial antibodies, with higher sensitivity and a larger measurement range than ELISA.

Prevention of gastric cancer by Helicobacter pylori eradication.

The evidence supporting the important role of Helicobacter pylori causing gastric cancer is getting stronger. The mechanisms by which H. pylori can influence the progression to severe changes in the gastric mucosa are under investigation. An increased gastric epithelial cell proliferation has been observed in individuals infected with H. pylori. This lifelong increased cell turnover is deemed to be a major risk factor for increased mutational changes and may lead to the development of gastric cancer. Successful eradication of H. pylori infection induces the healing of the gastritis and a significant decrease in gastric epithelial cell proliferation. Nevertheless, it is right now unknown at which time the point of no return, meaning at which time an eradication therapy leads to a benefit for the individual to prevent gastric cancer, has been reached. Therefore the major question that arises is to whom an eradication therapy should be offered to prevent gastric cancer. A general elimination of the infection might be worthwhile, but seems to be unrealistic now because of the high prevalence of the infection and the missing of a vaccine. This review reflects possible mechanisms of gastric cancer development induced by chronic H. pylori infection and recent investigational trials for prevention of gastric cancer by H. pylori eradication therapy will be discussed.

European multicentre validation trial of two new non-invasive tests for the detection of Helicobacter pylori antibodies: urine-based ELISA and rapid urine test.

AIM: Non-invasive tests for the assessment of Helicobacter pylori status are now an integral part of the management strategies for patients with dyspepsia. The aim of this study was to evaluate a urine based antibody ELISA and a near patient urine test for the diagnosis of H. pylori infection in a European population. METHODS: Urine samples were collected from 449 patients (240 females, 209 males, mean age 54 years), with dyspeptic symptoms but no previous H. pylori eradication therapy, at five centres in four European countries. All patients underwent GI endoscopy and biopsies were taken for H. pylori diagnosis. Urine samples were analysed using an IgG ELISA (URINELISA) and a near patient urine test (RAPIRUN). In addition, a serum IgG ELISA (Pyloriset-EIA-GIII), a whole blood test (Pyloriset-Screen) and a 13C-urea breath test were performed. RESULTS: The sensitivity of the urine based ELISA and the near patient urine test was 90% and 82%, and the specificity 68% and 83%, respectively. The accuracy of the serum ELISA and the whole blood test was comparable with the urine based test. CONCLUSION: The urine based ELISA and the near patient urine test are just as accurate as the serological tests. This comparable accuracy and complete non-invasiveness of the former gives it an advantage over blood based tests. This limits the application of these tests in general practice.