Early tumor shrinkage and response assessment according to mRECIST predict overall survival in hepatocellular carcinoma patients under sorafenib.

BACKGROUND: The aim of this study was to explore the relationship between follow-up imaging characteristics and overall survival (OS) in advanced hepatocellular carcinoma (HCC) patients under sorafenib treatment. METHODS: Associations between OS and objective response (OR) by mRECIST or early tumor shrinkage (ETS; ≥20% reduction in enhancing tumor diameter at the first follow-up imaging) were analyzed in HCC patients treated with sorafenib within a multicenter phase II trial (SORAMIC). 115 patients were included in this substudy. The relationship between survival and OR or ETS were explored. Landmark analyses were performed according to OR at fixed time points. Cox proportional hazards models with OR and ETS as a time-dependent covariate were used to compare survival with factors known to influence OS. RESULTS: The OR rate was 29.5%. Responders had significantly better OS than non-responders (median 30.3 vs. 11.4 months; HR, 0.38 [95% CI, 0.22-0.63], p < 0.001), and longer progression-free survival (PFS; median 10.1 vs. 4.3 months, p = 0.015). Patients with ETS ≥ 20% had longer OS (median 22.1 vs. 11.4 months, p = 0.002) and PFS (median 8.0 vs. 4.3 months, p = 0.034) than patients with ETS < 20%. Besides OR and ETS, male gender, lower bilirubin and ALBI grade were associated with improved OS in univariate analysis. Separate models of multivariable analysis confirmed OR and ETS as independent predictors of OS. CONCLUSION: OR according to mRECIST and ETS in patients receiving sorafenib treatment are independent prognostic factors for OS. These parameters can be used for assessment of treatment benefit and optimal treatment sequencing in patients with advanced HCC.

Cost-effectiveness modelling of use of urea breath test for the management of Helicobacter pylori-related dyspepsia and peptic ulcer in the UK.

OBJECTIVE: Clinical data comparing diagnostic strategies in the management of Helicobacter pylori-associated diseases are limited. Invasive and noninvasive diagnostic tests for detecting H. pylori infection are used in the clinical care of patients with dyspeptic symptoms. Modelling studies might help to identify the most cost-effective strategies. The objective of the study is to assess the cost-effectiveness of a 'test-and-treat' strategy with the urea breath test (UBT) compared with other strategies, in managing patients with H. pylori-associated dyspepsia and preventing peptic ulcer in the UK. DESIGN: Cost-effectiveness models compared four strategies: 'test-and-treat' with either UBT or faecal antigen test (FAT), 'endoscopy-based strategy' and 'symptomatic treatment'. A probabilistic cost-effectiveness analysis was performed using a simulation model in order to identify probabilities and costs associated with relief of dyspepsia symptoms (over a 4-week time horizon) and with prevention of peptic ulcers (over a 10-year time horizon). Clinical and cost inputs to the model were derived from routine medical practice in the UK. RESULTS: For relief of dyspepsia symptoms, 'test-and-treat' strategies with either UBT (€526/success) and FAT (€518/success) were the most cost-effective strategies compared with 'endoscopy-based strategy' (€1317/success) and 'symptomatic treatment' (€1 029/success). For the prevention of peptic ulcers, 'test-and-treat' strategies with either UBT (€208/ulcer avoided/year) or FAT (€191/ulcer avoided/year) were the most cost-effective strategies compared with 'endoscopy-based strategy' (€717/ulcer avoided/year) and 'symptomatic treatment' (€651/ulcer avoided/year) (1 EUR=0,871487 GBP at the time of the study). CONCLUSION: 'Test-and-treat' strategies with either UBT or FAT are the most cost-effective medical approaches for the management of H. pylori-associated dyspepsia and the prevention of peptic ulcer in the UK. A 'test-and-treat' strategy with UBT has comparable cost-effectiveness outcomes to the current standard of care using FAT in the UK.

Screening and eradication of Helicobacter pylori for gastric cancer prevention: the Taipei global consensus.

OBJECTIVE: A global consensus meeting was held to review current evidence and knowledge gaps and propose collaborative studies on population-wide screening and eradication of Helicobacter pylori for prevention of gastric cancer (GC). METHODS: 28 experts from 11 countries reviewed the evidence and modified the statements using the Delphi method, with consensus level predefined as ≥80% of agreement on each statement. The Grading of Recommendation Assessment, Development and Evaluation (GRADE) approach was followed. RESULTS: Consensus was reached in 26 statements. At an individual level, eradication of H. pylori reduces the risk of GC in asymptomatic subjects and is recommended unless there are competing considerations. In cohorts of vulnerable subjects (eg, first-degree relatives of patients with GC), a screen-and-treat strategy is also beneficial. H. pylori eradication in patients with early GC after curative endoscopic resection reduces the risk of metachronous cancer and calls for a re-examination on the hypothesis of 'the point of no return'. At the general population level, the strategy of screen-and-treat for H. pylori infection is most cost-effective in young adults in regions with a high incidence of GC and is recommended preferably before the development of atrophic gastritis and intestinal metaplasia. However, such a strategy may still be effective in people aged over 50, and may be integrated or included into national healthcare priorities, such as colorectal cancer screening programmes, to optimise the resources. Reliable locally effective regimens based on the principles of antibiotic stewardship are recommended. Subjects at higher risk of GC, such as those with advanced gastric atrophy or intestinal metaplasia, should receive surveillance endoscopy after eradication of H. pylori. CONCLUSION: Evidence supports the proposal that eradication therapy should be offered to all individuals infected with H. pylori. Vulnerable subjects should be tested, and treated if the test is positive. Mass screening and eradication of H. pylori should be considered in populations at higher risk of GC.

Helicobacter pylori "Test-and-Treat" strategy with urea breath test: A cost-effective strategy for the management of dyspepsia and the prevention of ulcer and gastric cancer in Spain-Results of the Hp-Breath initiative.

BACKGROUND: Data from clinical trials comparing Helicobacter pylori (H. pylori) management strategies in patients with dyspepsia are limited. Cost-effectiveness simulation models might help to identify the optimal strategy. OBJECTIVE: To assess the cost-effectiveness of the H. pylori "Test and Treat" (T&T) strategy including the use of urea breath test (UBT) vs symptomatic treatment (ST) and vs upper gastrointestinal endoscopy (UGE) as a first procedure in patients with dyspepsia. METHODS: Three main strategies: "T&T" strategy including the use of UBT, "UGE" and "ST" have been compared using cost-effectiveness models developed in accordance with the Spanish medical practice. For the model simulations, a time horizon of 4 weeks was considered for the endpoint "Dyspepsia symptoms relief" and 10 years when using "Peptic ulcer avoided" and "Gastric cancer avoided" endpoints. RESULTS: For the endpoint "Dyspepsia symptoms relief", T&T strategy appears to be the most cost-effective (883€/success) compared to UGE strategy and to ST strategy (respectively 1628€ and 990€/success). For the endpoint "Probability of peptic ulcer", the T&T strategy appears to be the most cost-effective (421€/peptic ulcer avoided/y) compared to UGE strategy and ST strategy (respectively 728€ and 632€/peptic ulcer avoided/y). For the endpoint "Gastric cancer avoided", the T&T strategy appears to be the most cost-effective (524€/gastric cancer avoided/y) compared to UGE strategy and "ST" strategy (respectively 716€ and 696€/gastric cancer avoided/y). CONCLUSIONS: T&T strategy including the use of UBT is the most cost-effective medical approach for management of dyspepsia and for the prevention of ulcer and gastric cancer.

Use of Evidence-Based Herbal Medicines for Patients with Functional Gastrointestinal Disorders: A Conceptional Framework for Risk-Benefit Assessment and Regulatory Approaches.

BACKGROUND: Herbal or complementary medicines are frequently used for the treatment of patients with functional gastrointestinal disorders (FGID). Regulatory requirements for herbal therapies are inconsistent and, in many jurisdictions, herbal therapies are either self-, minimally- or unregulated. AIM: To provide guidance for the appropriate and safe use of herbal medicines in patients with FGID patients with special consideration of the regulatory frameworks. METHODS: A PubMed search of the literature was performed; relevant articles were included. RESULTS: Similar to chemically defined therapies herbal medicines can cause adverse events. Thus, a risk-benefit appraisal should be undertaken for these therapies. While there is no disease specific mortality in FGID patients, patients with FGID who fail to respond to "empiric" chemically defined therapies undergo diagnostic and therapeutic measures that can be associated with appreciable morbidity and mortality. Thus, effective herbal treatments that subsequently reduce health-care utilization, reduce risks related to diagnostic or therapeutic measures that are initiated if no improvement of symptoms occurs. This "protective" effect of effective treatments for FGID needs to be taken in consideration when the risks and benefits of treatments are determined. In addition, standards that mirror regulations for chemically defined treatments should apply and the components of the respective preparations should undergo ongoing toxicological testing and rigorous quality assurance measures (including pharmacovigilance) applied. CONCLUSIONS: Some herbal therapies offer significant benefits for patients with FGID. To ensure the safety of these treatments, the regulatory requirements should mirror requirements for chemically defined treatments.

Validation of Hepa-index as a non-invasive biomarkers panel for assessment of hepatic fibrosis in Egyptians with chronic hepatitis C.

OBJECTIVES: To validate the diagnostic performance of Hepa-Index in predicting different stages of hepatic fibrosis in Egyptian patients with chronic hepatitis C (CHC). Methods: Hundred treatment naïve chronic hepatitis C Egyptian patients were prospectively enrolled between June 2014 and January 2015. They were subjected to: platelet count, alpha-2-macroglobulin (α2-MG), total bilirubin, gamma glutamyl transpeptidase (GGT), total cholesterol, liver biopsy and histopathological staging of hepatic fibrosis according to METAVIR scoring system. Hepa-Index was calculated according to the formula: Hepa-Index=exp (-0.021 x platelet +1.65 x α2-MG+0.2 x total bilirubin + 0.026 x GGT -1.215 x total cholesterol) / (1+exp (-0.021 x platelet + 1.65 x α2-MG + 0.2 x total bilirubin +0.026 x GGT -1.215 x total cholesterol).  Results: Hepa-Index correlates positively with the stage of hepatic fibrosis. Cut off values of Hepa-Index were: 0.2 for predicting significant hepatic fibrosis (≥F2 METAVIR), 0.3 for severe hepatic fibrosis (≥F3 METAVIR) and 0.4 for cirrhosis (F4 METAVIR). Hepa-Index was able to detect significant fibrosis with sensitivity of 69.4%, specificity of 76.3% and AUROC of 0.803. Hepa-Index was also able to detect severe hepatic fibrosis with sensitivity of 79.2%, specificity of 64.5% and AUROC of 0.783 and cirrhosis with sensitivity of 81.8%, specificity of 68.5% and AUROC of 0.744. Conclusion: Hepa-Index is a good non-invasive biomarkers panel that can be used for non-invasive assessment of hepatic fibrosis in chronic hepatitis C patients.

Influence of laboratory-related and endoscopy-related factors on the assessment of serum pepsinogens and gastrin-17.

BACKGROUND AND AIM: Serum pepsinogen I (PGI) and pepsinogen II (PGII) are noninvasive parameters in the detection of atrophic gastritis. The diagnostic add-on value of serum gastrin-17 (G-17) remains uncertain. The aim of this study was to assess the stability of these serum parameters over time and to evaluate the influence of clinical factors, such as upper gastrointestinal (GI) endoscopy and bowel cleansing, on serum PGI, PGII, and G-17 assessment. PATIENTS AND METHODS: A prospective study was carried out in healthy individuals and patients. For the stability analyses, the plasma and serum samples from 23 individuals were processed at different time points with and without the addition of a stabilizer. Ten patients were included to evaluate the influence of upper GI endoscopy and 18 patients to evaluate the effect of bowel cleansing before colonoscopy. RESULTS: PGI, PGII, and G-17 levels were not statistically different in the serum and plasma. PGI and PGII serum levels were stable over time. G-17 is associated with time-dependent degradation (P=0.0001). The addition of the G-17 stabilizer showed no improvement in stability. Upper GI endoscopy and bowel preparation before colonoscopy were associated with minimal variations in PGI and PGII, whereas G-17 showed patient-specific alterations. CONCLUSION: PGI and PGII serum levels are stable over time. However, G-17 stability is strongly dependent on the time of processing and storage; therefore, samples for G-17 analysis need to be processed no later than 6 h after blood collection. Upper GI endoscopy and colonoscopy preparation lead to minimal nonsignificant changes in basal PGI, PGII, and G-17 levels.

Impact of gastroesophageal reflux disease symptoms on the quality of life in pregnant women: a prospective study.

OBJECTIVE: Pregnant women often suffer from gastroesophageal reflux disease (GERD). GERD symptoms are known to influence the quality of life; however, there is a lack of data in pregnant women. The aim of this study was to establish the impact of GERD symptoms on health-related quality of life (HRQOL) during pregnancy. PARTICIPANTS AND METHODS: A prospective longitudinal cohort study to investigate the impact of GERD symptoms on the HRQOL was carried out in 510 pregnant women and 330 nonpregnant women as controls. Two validated questionnaires, the Reflux Disease Questionnaire and the Quality of Life in Reflux and Dyspepsia Questionnaire, were used. RESULTS: The study showed a significant negative impact on HRQOL in pregnant women with GERD symptoms. All five areas, emotional distress, sleep disturbance, vitality, food/drink problems, and physical/social functioning, were significantly reduced, but the most significant impact was on sleep (Quality of Life in Reflux and Dyspepsia Questionnaire score -35%). Overall, quality of life in women with GERD worsened throughout pregnancy. CONCLUSION: GERD is frequently seen in pregnant women and has a negative impact on HRQOL, especially in late pregnancy. Therefore, there is a need for adequate therapy of GERD in pregnant women and HRQOL could be an adequate monitoring tool in this population.

Validation of Two Calprotectin Rapid Tests in Daily Routine.

BACKGROUND: The differentiation of organic and functional intestinal diseases and monitoring of disease activity in inflammatory bowel diseases are frequent challenges in daily clinical routine. Fecal calprotectin is a noninvasive screening marker for intestinal inflammation. Its quantification by ELISA is considered to be the gold standard, but an increasing number of semiquantitative and quantitative point-of-care-tests (POCT) have been launched to optimize the duration between sample input and result. METHODS: The objective of this study was to evaluate sensitivity and specificity of two fecal calprotectin rapid test assays compared to an enzyme-linked immunosorbent assay (ELISA) as gold-standard considering the costs, time to result, and effort. For this purpose, fecal samples were collected from 68 patients with either confirmed Crohn´s disease (CD) (n = 37), confirmed ulcerative colitis (UC) (n = 21) or with confirmed IBS (n = 10) and analyzed with all three tests. RESULTS: Both rapid tests analyzed in this study revealed a high sensitivity in comparison to ELISA defined as gold standard (93.0 % PreventID®, 99.9 % Quantum Blue). The negative predictive value of Quantum Blue was better than of PreventID® (99.8% vs. 84.2%). When analyzing the capacity of all applied tests to differentiate IBD from IBS, the sensitivity of all three tests was similar, but the ELISA was more specific than the POCTs. The expense of the POCT per sample is significantly above the costs per sample for the ELISA. CONCLUSIONS: Both POCTs, Quantum Blue and PreventID®, provide high diagnostic accuracy and were less time consuming in clinical routine than quantification of fecal calprotectin by ELISA. This makes these tests excellent candidates for the use in clinical routine. The routine application of ELISA techniques for the quantification of fecal calprotectin levels is a valid option in laboratories or clinical departments with high quantities of samples to allow prompt follow up for patient management.

GERD assessment including pH metry predicts a high response rate to PPI standard therapy.

BACKGROUND: Inadequate response to proton pump inhibitor (PPI) therapy in patients with gastroesophageal reflux disease (GERD) is reported in up to 40%. Patients with non erosive reflux disease (NERD) have lower response rates compared to patients with erosive reflux disease (ERD); pH metry contributes to GERD diagnosis and is critical for proper diagnosis of NERD. Aim of the study was to assess the need for doubling esomeprazole standard dose (40 mg) for 4 weeks in PPI naive patients with typical reflux symptoms and diagnosis of GERD based on endoscopy and 48 hours, wireless pH metry. METHODS: All patients underwent upper GI endoscopy. Symptoms were recorded with a structured questionnaire (RDQ) and acid exposure was determined by 48 hours, wireless pH monitoring (BRAVO). In case of abnormal acid exposure, patients received a short term treatment with esomeprazole 40 mg q.d. for 4 weeks. If symptoms persisted, patients underwent a second pH metry on PPI and the dose was increased to 40 mg b.i.d. RESULTS: 31 consecutive patients with typical reflux symptoms underwent 48 hours pH monitoring. 22 patients (71%) had abnormal acid exposure, 9 patients had normal pH metry (29%). Of the 9 patients with normal pH metry, 2 were found with erosive esophagitis and 7 without endoscopic abnormalities. 24 patients with documented GERD received esomeprazole treatment. 21 patients achieved complete symptom resolution with 40 mg q.d. after 4 weeks (88%). Only 2 patients required doubling the dose of esomeprazole for complete symptom resolution, 1 patient remained with symptoms. CONCLUSIONS: Patients with typical reflux symptoms and abnormal acid exposure have a high response rate to standard dose esomeprazole regardless of whether they have ERD or NERD.

HIV/AIDS-related stigma felt by people living with HIV from Buea, Cameroon.

The universal access to treatment and care for people living with HIV (PLWHIV) is a major problem especially in Sub-Saharan Africa, where the majority of HIV infected people live. However, equally important is the fact that HIV/AIDS-related stigma is recognized to be a major obstacle to successfully control the spread of this disease. In this study we measured the HIV/AIDS-related stigma felt by PLWHIV in Cameroon using "The people living with HIV stigma index" questionnaire developed by UNAIDS, International Planned Parenthood Federation and Global Network of PLWHIV/AIDS among others. A total of 200 questionnaires were anonymously administered to PLWHIV in the HIV/AIDS treatment center of the Regional Hospital Annex Buea in the South West Region of Cameroon by trained academics who were themselves PLWHIV. In this setting the major problems faced by the PLWHIV with regard to stigmatization and discrimination were gossiping and verbal insults, which was felt by about half of the interviewees. Equally important was internal stigma, half of the PLWHIV felt ashamed and guilty to be HIV infected. This is the first report of this kind in Cameroon. These results will help to better understand HIV/AIDS-related stigma in this setting and in turn will improve the quality of life of PLWHIV by promoting their acceptance by the community.

Assessment of desmosomal components (desmoglein 1-3, plakoglobin) in cardia mucosa in relation to gastroesophageal reflux disease and Helicobacter pylori infection.

Gastroesophageal reflux disease is associated with impaired epithelial barrier function and abnormal expression of proteins forming cell-cell contacts by tight junctions and desmosomes in distal esophageal squamous mucosa. Although gastroesophageal reflux disease and Helicobacter pylori are both associated with chronic inflammation of the adjacent cardia mucosa, it is not known whether these lead to derangements of the desmosomal complexes. Here, we assessed the expression of 4 proteins (plakoglobin and desmoglein 1, 2, and 3) forming epithelial desmosomal complexes by quantitative reverse transcription polymerase chain reaction and immunohistochemistry in biopsies from 67 patients with gastroesophageal reflux disease and 23 gastroesophageal reflux disease-negative controls. Plakoglobin and desmoglein 2 were ubiquitously expressed in all samples, whereas desmoglein 1 and 3 were not expressed in cardia mucosa. Gastroesophageal reflux disease was specifically associated with elevated transcript levels of desmoglein 2 and plakoglobin. These were significantly increased from 2.0- to 2.7-fold in patients with gastroesophageal reflux disease compared with controls (P < .01), and significantly increased immunohistochemical scores for both proteins were observed (P < .05) as well. The combined presence of gastroesophageal reflux disease and Helicobacter pylori infection had no additional effect on desmosomal gene expression. Taken together, the up-regulation of plakoglobin and desmoglein 2 in cardia mucosa of patients with gastroesophageal reflux disease supports the concept that the "transition zone" between distal esophagus and proximal stomach is affected by gastroesophageal reflux disease as well, and architectural and molecular changes in the desmosomal compartment contribute to the pathogenesis of gastroesophageal reflux disease in the cardia mucosa.

Serological assessment of gastric mucosal atrophy in gastric cancer.

BACKGROUND: Non-invasive tools for gastric cancer screening and diagnosis are lacking. Serological testing with the detection of pepsinogen 1 (PG1), pepsinogen 2 (PG2) and gastrin 17 (G17) offers the possibility to detect preneoplastic gastric mucosal conditions. Aim of this study was to assess the performance of these serological tests in the presence of gastric neoplasia. METHODS: Histological and serological samples of 118 patients with gastric cancer have been assessed for tumor specific characteristics (Laurén type, localisation), degree of mucosal abnormalities (intestinal metaplasia, atrophy) and serological parameters (PG1, PG2, PG1/2-ratio, G17, H. pylori IgG, CagA status). Association of the general factors to the different serological values have been statistically analyzed. RESULTS: Patients with intestinal type gastric cancer had lower PG1 levels and a lower PG1/2-ratio compared to those with diffuse type cancer (p = 0.003). The serum levels of PG2 itself and G17 were not significantly altered. H. pylori infection in general had no influence on the levels of PG1, PG2 and G17 in the serum of gastric cancer patients. There was a trend towards lower PG1 levels in case of positive CagA-status (p = 0.058). The degree of both intestinal metaplasia and atrophy correlated inversely with serum levels for PG1 and the PG1/2-ratio (p < 0.01). Laurén-specific analysis revealed that this is only true for intestinal type tumors. Univariate ANOVA revealed atrophy and CagA-status as the only independent factors for low PG1 and a low PG1/2-ratio. CONCLUSIONS: Glandular atrophy and a positive CagA status are determinant factors for decreased pepsinogen 1 levels in the serum of patients with gastric cancer. The serological assessment of gastric atrophy by analysis of serum pepsinogen is only adequate for patients with intestinal type cancer.

Hepatocellular carcinoma and liver cirrhosis: assessment of the liver function after Yttrium-90 radioembolization with resin microspheres or after CT-guided high-dose-rate brachytherapy.

PURPOSE: To identify changes of liver function after single-fraction irradiation or yttrium-90 radioembolization ((90)Y-RE) of hepatocellular carcinoma associated with liver cirrhosis on the basis of laboratory data. METHODS AND MATERIALS: 24 patients with primary liver carcinoma and liver cirrhosis classified Child-Pugh A or B were treated either by image-guided high-dose-rate brachytherapy (HDR-BT) (12 patients) or by (90)Y-RE (12 patients). The following laboratory parameters were assessed 1 day before and 3 days, 6 weeks and 3 months after the intervention: total bilirubin and gamma-glutamyl transpeptidase (GGTP) as parameters of detoxification function, albumin and cholinesterase (ChE) as direct synthesis parameters, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (AP) as indicators of liver tissue damage. Preinterventional values were taken as baseline, following values were calculated as percentage changes from the baseline value. Statistical analysis was performed using the Wilcoxon-matched pairs test, comparing postinterventional with preinterventional values. Differences were considered statistically significant with a p value <0.05. RESULTS: In all patients the median bilirubin, ALT, AP and albumin values remained within normal limits at any time of follow-up. AST levels in the RE group and GGTP in both groups have been already elevated over a normal range before the intervention, and in both groups both parameters showed a slight increase after interventions. ChE activity was lowered already in the baseline values and showed a further decrease 3 days after BT as well as 3 days and 6 weeks after RE, with final reconstitution to baseline values. All liver function test parameters showed mild changes shortly after radiation therapy but floating laboratory values recovering within 12 weeks to baseline values. Radiation or RE-induced liver disease was recorded in no patient. CONCLUSIONS: Liver function parameters show only mild changes shortly after intervention with recovery within 6-12 weeks to baseline values.

Does the treatment of gastroesophageal reflux disease (GERD) meet patients' needs? A survey-based study.

OBJECTIVE: Symptoms of gastroesophageal reflux disease (GERD) affect approximately 20% of people on a weekly basis. A number of different therapies are prescribed to control the disease. This survey-based study was carried out to assess patients' and physicians' perceptions of GERD and its treatment. METHODS: Randomly selected general practitioners (GPs) from five countries (USA, UK, Japan, Germany and France) took part in a faceto-face interview, using a standard questionnaire, concerning the last four GERD patients (those taking GERD medication) who had consulted them and who consented to be interviewed. Those patients were then interviewed via telephone, also using a standard questionnaire. RESULTS: Completed questionnaires were available for 927 of the 1044 patients who were identified. The mean length of time that patients suffered GERD symptoms prior to consultation was more than 1.5 years, with 52.3% of those consulting a GP stating the reason they sought medical attention was that 'symptoms were too uncomfortable to bear'. Only 36% of patients receiving prescription therapy reported that they were currently asymptomatic; 20.5% of patients were also taking at least one over-the-counter (OTC) medication. CONCLUSIONS: In the primary care setting, many patients receiving GERD therapy do not have fully controlled symptoms. It is recommended that GPs question patients routinely about persistent symptoms on therapy, and OTC use, in order that effective treatment choices are made in the management of GERD.

Gastro esophageal reflux disease is associated with absence from work: results from a prospective cohort study.

AIM: To study the association of gastro-esophageal reflux disease (GERD) with the absence from work and to estimate the extent of loss in gross domestic product due to inability to work. METHODS: Analysis was based on the prospectively gathered data of a large European cohort study involving 6 215 symptomatic GERD patients (ProGERD). Among these patients, 2 871 were initially employed. The calculation of the loss of gross domestic product was based on the assumption that the prevalence of GERD was about 15% in Germany. According to the German Federal Statistical Office, the mean gross wage of employees was 150 EUR/d in 2002. RESULTS: The data of 2 078 employed patients who were prospectively followed up for over 2 years were analyzed. At study entry, the patients reported a mean of 1.8 d per year of inability to work. During the prospective follow-up under routine clinical care, the proportion of patients reporting days with inability to work decreased from 14% to 6% and the mean number of days per year with inability to work decreased to 0.9 d. Assuming a prevalence of troublesome GERD of 15% in the employed German population, the loss of gross domestic product amounted to 668 million EUR/year in Germany. CONCLUSION: GERD causes a relevant impairment on the national economics by absence from work. The presented data demonstrate the importance of GERD, not only for patients and health insurance companies, but also for the community at large.

Evaluation of a near-patient fecal antigen test for the assessment of Helicobacter pylori status.

The assessment of Helicobacter pylori antigen in stool specimens is widely accepted. Recently a immunochromatographic near-patient test assay has been developed. In this first evaluation in 100 patients before and after H. pylori eradication therapy we observed a sensitivity (76%) and specificity (98%) of this near-patient test.

Comparison of two enzyme immunoassays for the assessment of Helicobacter pylori status in stool specimens after eradication therapy.

OBJECTIVES: Assessment of Helicobacter pylori antigen in stool specimens has recently been proposed as a valid method for the noninvasive detection of H. pylori infection, especially as posttreatment control. After the development of an enzyme immunoassay based on polyclonal antibodies (Premier Platinum HpSA) a monoclonally based test has recently been developed (FemtoLab H. pylori). The aim of the present study was to assess the diagnostic accuracy of both tests in adult patients undergoing H. pylori eradication therapy. METHODS: Stool samples were collected and the 13C-urea breath test performed in 148 patients (79 females and 69 males aged 21-75 yr) 4-6 wk after eradication therapy. The FemtoLab H. pylori and Premier Platinum HpSA tests were performed in accordance with the manufacturers' protocols. A receiver operator characteristics analysis was performed to define the optimal cutoff value on the basis of the results of the 13C-urea breath test. RESULTS: H. pylori eradication was successful in 113 of the 148 patients (76%). After adjusting the cutoff, the sensitivity of FemtoLab H. pylori was found to be higher than that of the Premier Platinum HpSA (94.3% vs 80.0%, ns). Specificity, positive predictive value, and negative predictive value of the two tests were comparable (93.8% vs 95.6%, 82.8% vs 85.2%, and 98.1% vs 93.8%, respectively). CONCLUSIONS: The new stool antigen test (FemtoLab H. pylori) is an excellent tool for diagnosing H. pylori infection after eradication therapy, and its accuracy is comparable with that of the Premier Platinum HpSA. Adjustment of the cutoff after H. pylori eradication therapy increases the overall accuracy.