Empirical Proton Pump Inhibitor Therapy Research Articles

Empiric proton pump inhibitor therapy after esophageal food impaction may mask eosinophilic esophagitis diagnosis at follow-up.

Esophageal food impaction (EFI) is often the first presentation for patients with eosinophilic esophagitis (EoE); however, there is significant heterogeneity in the management of EFI. We aimed to study the impact of EFI management, particularly post-EFI medication prescriptions on EoE diagnosis, follow-up, and recurrence in patients with endoscopic features of EoE. In our retrospective study, adults presenting between 2007 and 2017 with EFI requiring endoscopic dis-impaction with endoscopic features of EoE (furrows, rings, and/or exudates) were included. We examined the impact of demographics and EFI management on EoE diagnosis, follow-up (esophagogastroduodenoscopy [EGD] or clinic visit within 6months), and recurrence. We identified 164 cases of EFI due to suspected EoE. Biopsy was performed in 68 patients (41.5%), and 144 patients (87.8%) were placed on proton pump inhibitor (PPI) and/or swallow corticosteroids after EFI, including 88.5% of those not biopsied. PPI use at time of biopsy was negatively associated with EoE diagnosis (odds ratio: 0.39, confidence interval: 0.17-0.85). Sixty-one (37.4%) patients were lost to follow-up at 6months. Recurrent EFI at 1year occurred in 3.7% of patients. Medications, most commonly PPI, are frequently prescribed after EFI when the endoscopic features of EoE are present, which may mask the diagnosis of EoE on follow-up EGD. We estimated that for every five patients biopsied on PPI, one case of EoE is masked. As recurrent EFI within 1year is uncommon, empiric therapy should be avoided until diagnostic biopsies are obtained. Further efforts to reduce loss to follow-up after EFI are also needed.

BRAVO esophageal pH monitoring: more cost-effective than empiric medical therapy for suspected gastroesophageal reflux.

Early referral for catheter-based esophageal pH monitoring is more cost-effective than empiric proton-pump inhibitor (PPI) therapy to diagnose gastroesophageal reflux disease (GERD). We hypothesize that BRAVO wireless pH monitoring will also demonstrate substantial cost-savings compared to empiric PPI therapy, given its superior sensitivity and comfort. We reviewed 100 consecutive patients who underwent wireless pH monitoring for suspected GERD at our institution. A cost model and a cost equivalence calculation were generated. Cost-saving analyses were performed for both esophageal and extraesophageal symptoms. Eighty-seven patients were available for analysis. Median PPI use prior to referral was 215weeks (range 0-520). Forty-three patients (49%) had BRAVO results diagnosing GERD; 98% of these had esophageal symptoms. Patients with negative BRAVO studies had a median of 113 (0-520) weeks of unnecessary PPI therapy. Cost-savings ranged from $1048 to $15,853 per patient, depending on sensitivity (75-95%), PPI dosage, and brand. Maximum cost-savings occurred in patients with extraesophageal symptoms ($2948-$31,389 per patient). The PPI cost equivalence of BRAVO placement was 36 and 6weeks for low- and high-dose therapy, respectively. BRAVO wireless pH testing is more cost-effective than prolonged empiric medical management for GERD and should be incorporated early in the treatment algorithm.

Value of the "Test & Treat" Strategy for Uninvestigated Dyspepsia at Low Prevalence Rates of Helicobacter pylori in the Population.

In populations with a low prevalence rate of Helicobacter pylori (H.pylori) infection from Western countries, guidelines for the management of uninvestigated dyspepsia generally recommend that the "test and treat" strategy should be avoided in favor of empiric proton-pump inhibitor therapy in younger patients (on average < 50years of age) without alarm symptoms and signs. The prevalence of H.pylori infection has fallen from about 30% to about 10% in Sweden and other countries. We aimed to explore whether the rationale for test and treat is relevant in contemporary clinical practice. In settings with an infection rate in the adult population of 30% and 10%, we modeled the positive and negative predictive values for indirect (nonendoscopy) tests on current H.pylori infection with a presumed sensitivity and specificity of 95%. We then calculated the difference in false-negative and false-positive test outcome, and eradication prescription rates in the two scenarios. While the positive predictive value for the test decreased from 0.89 to 0.68 when the prevalence of H.pylori fell from 30% to 10%, there were only 1% more false-negative tests and 1% less false-positive tests. The eradication prescription rate would decrease by 18% with a 10% prevalence rate. The recommendation to stop applying "test and treat" at lower prevalence rates of H.pylori should be reconsidered. The test and treat strategy is the preferred approach for most patients who present with dyspepsia.

Economic evaluations of gastroesophageal reflux disease medical management.

Gastroesophageal reflux disease (GERD) contributes to substantial medication use and costs worldwide. Economic evaluations provide insight into the value of healthcare, taking into account cost, quality, and benefits of particular treatments. Our objectives were to systematically review the existing literature to identify economic evaluations of GERD management strategies, to assess the scientific quality of these reports, and to summarize the economic outcomes of these evaluations. We identified economic evaluations and cost studies of GERD management strategies by searching PubMed and the UK NHS Economic Evaluation Database via the Cochrane Library. Searching was restricted to articles in English-language journals from July 2003 to July 2013. Cost-identification articles were excluded from the final analysis. Eighteen articles were included in the final analysis; 61 % of these met all criteria for quality reporting. Overall, proton pump inhibitor (PPI) therapy was preferred (most effective and least costly) as empiric therapy for patients with reflux symptoms, except in patient populations with high Helicobacter pylori prevalence (>40 %). Initial empiric PPI therapy (vs. initial endoscopy stratification or H. pylori testing) is likely the most cost-effective initial strategy for patients with typical GERD symptoms. Surgery may be cost effective in patients with chronic GERD symptoms at time horizons of 3-10 years. Endoscopic anti-reflux procedures were not cost effective based on available data. Further economic evaluations should adhere to standard reporting measures of cost estimates and outcomes, and should attempt to account for and compare the large heterogeneity of patient phenotypes and treatment effects seen with anti-reflux therapies.

Response to Empiric Proton Pump Inhibitor Therapy in Patients With Esophageal Eosinophilia

Response to Empiric Proton Pump Inhibitor Therapy in Patients With Esophageal Eosinophilia

Diagnosis and management of gastroesophageal reflux disease (GERD): An indian perspective

NEED AND PURPOSE: The scarcity of literature and lack of published guidelines on gastroesophageal reflux disease (GERD) from India, have necessitated this review. A literature search in PubMed was conducted with regard to epidemiology, clinical features, investigation and management of GERD in children. English language studies published full over the last 20 years were considered and relevant information was extracted. Nearly half of all healthy babies regurgitate at least once a day by 4 months of age and this subsides in 90% of them by 1 year. In contrast, GERD prevalence increases with age and by adolescence it is similar to adults (20%). While regurgitation in infancy does not need investigation or therapy, empirical proton pump inhibitor (PPI) for 4 weeks is justified in older children with classical GERD symptoms. There is no gold-standard investigation for GERD. A pH study with or without impedance is useful in extraesophageal manifestations and endoscopy in esophagitis. Proton pump inhibitors (PPI) play a pivotal role in the management of GERD and its long-term use has been shown to be safe in children. Antireflux surgery plays a minor role due to, its associated morbidity and high failure rate, especially in the high risk group who needs it most. Regurgitation in infancy need not be investigated unless there are warning features. Empirical PPI therapy is justified in older children and adolescents with typical reflux symptoms. pH study in extraesophageal manifestations and endoscopy for esophagitis are the investigations of choice. PPI is the mainstay of therapy in GERD.

Evaluation of 24-Hour Esophageal pH and Impedance Studies in Patients with Suspected Gastroesophageal Reflux

Purpose: Patients with suspected gastroesophageal reflux disease (GERD) are often treated empirically with proton pump inhibitor (PPI) therapy based on their clinical symptoms. Patients who are unresponsive to therapy may then undergo testing with 24-hour esophageal pH testing to confirm or exclude the diagnosis of GERD. The purpose of this study is to determine whether patients referred for the evaluation of typical and atypical reflux symptoms had GERD by 24-hour esophageal pH and impedance testing performed off of acid suppressive therapy. Methods: A clinical database was searched for 24-hour pH/impedance studies performed off of acid suppressive therapy between 2006 and 2011. Patients referred for evaluation had typical GERD symptoms (heartburn or acid regurgitation) or atypical symptoms (chest pain, chronic cough, hoarseness, dysphagia or dyspepsia). Many patients referred for evaluation were not responding clinically to a prescribed PPI. Patients were instructed to discontinue PPI at least one week prior to testing. A Johnson-DeMeester score of ≥22 was considered diagnostic for GERD by pH testing. An abnormal impedance study was defined as > 73. Categorical data was expressed as percentages and continuous data as means and standard deviation. Fisher exact tests and Student's t-test were used to analyze data. A p-value ≤ 0.05 was considered statistically significant. Results: 348 patients were identified (mean age of 47 ± 13 years; 55% were male, and 62% were Caucasians). The majority of patients (96%) were empirically treated with PPI prior to testing, of which 68% were on daily dosage and 32% on twice daily dosage. On 24-hour esophageal pH testing, the majority (72%) had a normal Johnson-DeMeester score. Among patients who had an abnormal pH score, 58% had typical GERD symptoms and 42% had atypical symptoms (P=0.023). Significantly more males had an abnormal pH score compared to females (34% versus 20%, P=0.004). There were no significant differences in race or age of patients with normal and abnormal pH testing. On impedance testing, 21.6% patients had an abnormal test. Of patients who had a normal 24-hour pH test, 87% had a normal impedance test. Of patients who had an abnormal 24-hour pH test, 44% had an abnormal impedance test (Kappa = 0.331, P<0.001). Conclusion: Most patients referred for GERD testing after failing empiric PPI therapy had a normal 24 hour pH/impedance study off of acid suppressive therapy. In these patients, an alternative diagnosis should be considered.

Multimodality evaluation of patients with gastroesophageal reflux disease symptoms who have failed empiric proton pump inhibitor therapy

Patients with symptoms suggestive of gastroesophageal reflux disease (GERD), such as chest pain, heartburn, regurgitation, and dysphagia, are typically treated initially with a course of proton pump inhibitors (PPIs). The evaluation of patients who have either not responded at all or partially and inadequately responded to such therapy requires a more detailed history and may involve an endoscopy and esophageal biopsies, followed by esophageal manometry, ambulatory esophageal pH monitoring, and gastric emptying scanning. To assess the merits of a multimodality 'structural' and 'functional' assessment of the esophagus in patients who have inadequately controlled GERD symptoms despite using empiric PPI, a retrospective cohort study of patients without any response or with poor symptomatic control to empiric PPI (>2 months duration) who were referred to an Esophageal Studies Unit was conducted. Patients were studied using symptom questionnaires, endoscopy (+ or - for erosive disease, or Barrett's metaplasia) and multilevel esophageal biopsies (eosinophilia, metaplasia), esophageal motility (aperistalsis, dysmotility), 24-hour ambulatory esophageal pH monitoring (+ if % total time pH < 4 > 5%), and gastric emptying scanning (+ if >10% retention at 4 hours and >70% at 2 hours). Over 3 years, 275 patients (147 men and 128 women) aged 16-89 years underwent complete multimodality testing. Forty percent (n= 109) had nonerosive reflux disease (esophagogastroduodenoscopy [EGD]-, biopsy-, pH+); 19.3% (n= 53) had erosive esophagitis (EGD+); 5.5% (n= 15) Barrett's esophagus (EGD+, metaplasia+); 5.5% (n= 15) eosinophilic esophagitis (biopsy+); 2.5% (n= 7) had achalasia and 5.8% (n= 16) other dysmotility (motility+, pH-); 16% (n= 44) had functional heartburn (EGD-, pH-), and 5.8% (n= 16) had gastroparesis (gastric scan+). Cumulative symptom scores for chest pain, heartburn, regurgitation, and dysphagia were similar among the groups (mean range 1.1-1.35 on a 0-3 scale). Multimodality evaluation changed the diagnosis of GERD in 34.5% of cases and led to or guided alternative therapies in 42%. Overlap diagnoses were frequent: 10/15 (67%) of patients with eosinophilic esophagitis, 12/16 (75%) of patients with gastroparesis, and 11/23 (48%) of patients with achalasia or dysmotility had concomitant pathologic acid reflux by pH studies. Patients with persistent GERD symptoms despite empiric PPI therapy benefit from multimodality evaluation that may change the diagnosis and guide therapy in more than one third of such cases. Because symptoms are not specific and overlap diagnoses are frequent and multifaceted, objective evidence-driven therapies should be considered in such patients.

Algorithmic Approach to Patients Presenting with Heartburn and Epigastric Pain Refractory to Empiric Proton Pump Inhibitor Therapy

Reflux-like dyspepsia (RLD), where predominant epigastric pain is associated with heartburn and/or regurgitation, is a common clinical syndrome in both primary and specialty care. Because symptom frequency and severity vary, overlap among gastroesophageal reflux disease (GERD), non-erosive reflux disease (NERD), and RLD, is quite common. The chronic and recurrent nature of RLD and its variable response to proton pump inhibitor (PPI) therapy remain problematic. To examine the prevalence of GERD, NERD, and RLD in a community setting using an algorithmic approach and to assess the potential, reproducibility, and validity of a multi-factorial scoring system in discriminating patients with RLD from those with GERD or NERD. Using a novel algorithmic approach, we evaluated an outpatient, community-based cohort referred to a gastroenterologist because of epigastric pain and heartburn that were only partially relieved by PPI. After an initial symptom evaluation (for epigastric pain, heartburn, regurgitation, dysphagia), an endoscopy and distal esophageal biopsies were performed, followed by esophageal motility and 24-h ambulatory pH monitoring to assess esophageal function and pathological acid exposure. A scoring system based on presence of symptoms and severity of findings was devised. Data was collected in two stages: subjects in the first stage were designated as the derivation cohort; subjects in the second stage were labeled the validation cohort. The total cohort comprised 159 patients (59 males, 100 females; mean age 52). On endoscopy, 30 patients (19%) had complicated esophagitis (CE) and 11 (7%) had Barrett's esophagus (BE) and were classified collectively as patients with GERD. One-hundred and eighteen (74%) patients had normal esophagus. Of these, 94 (59%) had one or more of the following: hiatal hernia, positive biopsy, abnormal pH, and/or abnormal motility studies and were classified as patients with NERD. The remaining 24 patients (15%) had normal functional studies and were classified as patients with RLD. Utilizing the scoring system a total score was calculated for each patient and effectively distinguished patients with GERD (mean score 9), NERD (mean score 6), and RLD (mean score 3). Receiver operating characteristic (ROC) curves confirmed the optimization of the model, particularly in RLD (P=0.0001, 95% CI: 0.91-0.98). In a community cohort of patients presenting with heartburn and epigastric pain partly refractory to empiric PPI therapy, the prevalence of CE was 19%, BE 7%, NERD 59%, and RLD 15%. An algorithmic approach coupled with a novel scoring system, effectively distinguishes GERD from NERD and RLD and facilitates further management decisions. This novel and simple scoring system is both reproducible and validated as a diagnostic aid in evaluating patients presenting with both epigastric pain and heartburn.

Intestinal Spirochetosis: An Unclear Pathogen

Purpose: Case: Intestinal Spirochetosis (IS) is a rare disorder whose pathogenicity is unclear. A 64 year old Nicaraguan man reported a 3 month history of nausea, abdominal pain and intermittent loose stools. His medical history comprised alcoholism, recent emigration to U.S.A. and engagement in MSM (Men who have Sex with Men). He denied any other symptoms. Physical exam was remarkable only for mild epigastric tenderness. Despite empiric proton pump inhibitor therapy, his symptoms persisted, and he underwent an EGD and colonoscopy. Random biopsies of the colon revealed IS in the transverse and proximal descending colon. Additional laboratory tests showed an elevated serum IgE (1250, range 0-158 IU/mL) but normal IgG and IgM levels. Tests for HIV, syphilis, and Hepatitis A, B, and C were negative. Discussion: IS is most often due to colonization of the colon or appendix with Brachyspira aalborgi or pilosicoli1. Reports from the United States are uncommon but have been observed in MSM regardless of HIV infection. There are often few or no symptoms, but it can cause more severe symptoms of colitis including weight loss, hematochezia and rectal bleeding2. Colorectal biopsies in patients with IS show mild thickening of the colonic brush border (“false brush border”), staining deeply with hematoxylin 2. The organisms are found diffusely along the surface of the mucosa with superficial extension into the crypts. The goblet cells are rarely infected. In most cases, no inflammatory reaction to the spirochete is seen, leading to a debate as to the pathogenic nature of this infection1. In adults, treatment with metronidazole is often curative. Our patient's symptoms likely correlate with his spirochete infection. Colonic biopsy is vital to diagnosis, and IS should remain on the differential diagnosis of a patient presenting with protracted gastrointestinal symptoms suggestive of enterocolitis.Figure: Intestinal spirochetosis. Photograph courtesy of Carmela Monteiro, MD and Cindy Davis, MD, University of Florida College of Medicine Jacksonville, Department of Pathology.

Predictors of heartburn resolution and erosive esophagitis in patients with GERD

ABSTRACTObjectives: The primary objective was to assess gastroesophageal reflux disease (GERD) symptom resolution rates with esomeprazole by erosive esophagitis (EE) status, and the secondary objective was to evaluate potential predictors of the presence of EE and heartburn resolution.Background: Patients with GERD who have EE have higher reported symptom resolution rates than those with nonerosive reflux disease (NERD) when treated with proton pump inhibitors (PPIs).Study: This open-label multicenter study included adults with GERD symptoms. Patients were stratified by EE status after endoscopy and received once-daily esomeprazole 40 mg for 4 weeks. Questionnaires determined symptom response rates, and baseline predictors of EE or heartburn resolution were evaluated. Potential predictors, including years with GERD, history of EE, and time to relief with antacids, were examined.Results: Heartburn resolution rates at 4 weeks were higher for patients with EE than NERD (69% [124/179] vs. 48% [85/177]; p < 0.0001). Multivariate models had moderate predictive ability for EE (c-index, 0.76) and poor predictive ability (c-index, 0.57) for heartburn resolution. However, faster heartburn relief with antacid use, particularly within 15 min, was predictive of EE and heartburn resolution.Conclusions: Patients with EE have higher heartburn resolution rates than patients with NERD after treatment, although recall bias may be possible. Fast relief with antacid use is predictive of EE and heartburn resolution with a PPI and suggests that a history of antacid relief may provide corroborative evidence to empiric PPI therapy in determining whether patients with heartburn have acid reflux disease.Trial registration: ClinicalTrials.gov identifier: NCT00242736.

American Gastroenterological Association Institute Technical Review on the Management of Gastroesophageal Reflux Disease

American Gastroenterological Association Institute Technical Review on the Management of Gastroesophageal Reflux Disease

Step-up and step-down approaches to treatment of gastroesophageal reflux disease in children

The single biggest change in the approach to treating pediatric gastroesophageal reflux disease (GERD) in recent years has been the empiric use of proton pump inhibitors (PPIs) for symptoms suspected to be those of GERD. In other words, PPIs have been used increasingly as a first-line concurrent diagnostic test and treatment before any investigation. Although this approach is useful for some patients, there are a number of caveats about its application to children. In general, these caveats are related to age per se (eg, infancy) and to age-related symptoms and severity of GERD itself. The most important caveats relate to the prescription of empiric PPI therapy in infants--which generally is to be avoided--and to how PPIs are used in older children--specifically, the advisability of empiric trials being of limited duration. Even in children with proven reflux esophagitis, GERD is not chronic and relapsing in all; thus, trials of therapy withdrawal are warranted. In light of many factors, including the burgeoning literature on potential risks of infections in acid-suppressed children and adults, caution with dose and duration of acid-suppressive drugs in children is urged. The role of antireflux surgery is also mentioned.

962 Empirical Proton Pump Inhibitor Therapy or Helicobacter pylori “Test and Treat” in the Initial Management of Dyspepsia? An Individual Patient Data Meta-Analysis

962 Empirical Proton Pump Inhibitor Therapy or Helicobacter pylori “Test and Treat” in the Initial Management of Dyspepsia? An Individual Patient Data Meta-Analysis

Cost-effectiveness of Helicobacter pylori “test and treat” for patients with typical reflux symptoms in a population with a high prevalence of H. pylori infection: A Markov model analysis

Objective. Patients with typical reflux symptoms may have underlying peptic ulcer disease (PUD) in a population with a high prevalence of Helicobacter pylori infection. In the present study we sought to compare the cost-effectiveness of the H. pylori “test and treat” strategy with that of empirical proton-pump inhibitor (PPI) therapy and endoscopy in patients with typical reflux and a high prevalence of H. pylori infection. Material and methods. A Markov model was designed to compare the outcomes of three treatment strategies over 12 months among a hypothetical cohort of patients presenting with typical reflux symptoms. There were four exclusive underlying H. pylori- and PUD-related comorbidities in the hypothetical cohort: (1) H. pylori-related PUD, (2) H. pylori infection without PUD, (3) PUD without H. pylori infection and (4) absence of both PUD and H. pylori infection. The transition probabilities and resource utilization were derived from the literature. Percentage of PUD patients treated, total number of symptom-free patient-years gained and total direct medical cost were estimated. Results. By comparing each strategy individually with the no therapy strategy, it was found that the incremental costs per ulcer treated for H. pylori “test and treat”, endoscopy and empirical PPI therapy were USD 1778, USD 1797 and USD 2158, respectively. The results of the model were sensitive to the prevalence of H. pylori infection. Conclusions. Both the H. pylori “test and treat” and initial endoscopic strategies were shown to be more cost-effective than empirical PPI therapy for treating undiagnosed PUD among patients presenting with typical reflux symptoms. The H. pylori “test and treat” strategy appeared to be only slightly more cost-effective than initial endoscopy in a population with a high prevalence of H. pylori infection.

American Gastroenterological Association Medical Position Statement: Evaluation of Dyspepsia

American Gastroenterological Association Medical Position Statement: Evaluation of Dyspepsia

Diagnostic Value of Potent Acid Inhibition in Gastro-Oesophageal Reflux Disease

Gastro-oesophageal reflux disease (GORD) is defined as 'Chronic symptoms or mucosal damage produced by abnormal reflux of gastric contents into the esophagus'. The Genval Workshop Report defines that GORD exists when the frequency of heartburn is equal to or greater than 2 days/week and that it is one of the most common gastrointestinal conditions in the general population. Endoscopy is the most recommendable exploratory procedure in a patient with symptoms of GORD, fundamentally heartburn and regurgitation. However, 50-75% of the patients with symptoms compatible with GORD have normal endoscopy. Thus, endoscopy does not appear to be indispensable in a large group of patients with GORD. Endoscopy is therefore the gold standard for the diagnosis of reflux oesophagitis (histopathological changes in the oesophageal mucosa), but there is no gold standard for the diagnosis of non-erosive GORD. Twenty-four-hour pH monitoring has come to be considered the most sensitive and specific test in the diagnosis of GORD, but a significant proportion of patients (about 25%) have symptoms compatible with GORD and have 24-h pH monitoring results that can be considered normal. Besides, demonstrating the presence of acid reflux alone does not prove that it is the cause of suspected GORD-related signs or symptoms. Therefore, despite 'positive' pH studies, there is a significant number of patients failing to respond to therapy, mainly ear, nose and throat complaints, supposed as manifestations of gastro-oesophageal reflux disease. Despite 24-h oesophageal pH testing being an excellent diagnostic tool, it has no utility in routine clinical settings and hence its availability should be limited to tertiary care settings. With the demonstration that antisecretory treatment with high doses of proton pump inhibitors (PPIs) for 1 week or 2 weeks achieves significant improvement or even remission of the symptoms of GORD, it not surprising that it has been proposed as a diagnostic test for the disease. For patients with symptoms compatible with GORD without alarm symptoms or other suspected complications of GORD, a short course of empiric PPI therapy gives valuable information about the presence of GORD. The PPI test is a simple, sensitive and cost-effective tool, but it has insufficient specificity for use as an objective criterion alone. The use of PPIs both as a diagnostic test (1-2 weeks) and as a diagnostic-therapeutic test (1-4 months) has a moderate usefulness and may be used especially in those environments in which there are difficulties in performing the objective test.

Dyspepsia

Dyspepsia

Reflux symptoms in general practice: diagnostic evaluation of the Carlsson-Dent gastro-oesophageal reflux disease questionnaire.

Amongst primary care patients with dyspeptic symptoms, those with reflux-like symptoms or gastro-oesophageal reflux disease are expected to benefit most from empirical proton pump inhibitor therapy. Recognition of this patient group, however, is difficult. The Carlsson-Dent gastro-oesophageal reflux disease questionnaire was developed to justify the selection of primary care patients for empirical proton pump inhibitor treatment. To evaluate the diagnostic test characteristics of the Carlsson-Dent questionnaire in a primary care population. A prospective, open-label, multi-centre diagnostic prevalence study was conducted amongst primary care adults with reflux symptoms. All patients completed the questionnaire and underwent gastroscopy. If no abnormalities were found, the patients were prescribed 2 weeks of treatment with omeprazole (20 mg daily). Receiver operating characteristic curve analysis was used to determine the overall discriminative value of the questionnaire. Diagnostic test characteristics of both the cut-off score (total diagnostic score) in the questionnaire and the physician's provisional classification were measured using oesophagitis and omeprazole treatment success as the reference tests. Of the 536 patients included, 515 underwent endoscopy. No abnormalities were found in 286 (55%). Omeprazole treatment success occurred more frequently in patients with a total diagnostic score of > 7 and oesophagitis II-IV in patients with a total diagnostic score of > 9. The diagnostic test characteristics of the questionnaire were comparable with those of the physician's provisional classification. The area under the receiver operating characteristic curve did not exceed 0.65. Kappa values for observer agreement with the gold standard were far below 0.4. The diagnostic performance of this version of the Carlsson-Dent questionnaire was poor. It equalled the physician's clinical judgement and therefore its value for clinical use is limited.

Reappraisal of non-invasive management strategies for uninvestigated dyspepsia: a cost-minimization analysis.

The benefits of the Helicobacter pylori test-and-treat strategy are attributable largely to the cure of peptic ulcer disease while limiting the use of endoscopy. To reappraise the test-and-treat strategy and empirical proton pump inhibitor therapy for the management of uninvestigated dyspepsia in the light of the decreasing prevalence of H. pylori infection, peptic ulcer disease and peptic ulcer disease attributable to H. pylori. Using a decision analytical model, we estimated the cost per patient with uninvestigated dyspepsia managed with the test-and-treat strategy ($25/test; H.pylori treatment, $200) or proton pump inhibitor ($90/month). Endoscopy ($550) guided therapy for persistent or recurrent symptoms. In the base case (25%H. pylori prevalence, 20% likelihood of peptic ulcer disease, 75% of ulcers due to H.pylori), the cost per patient is $545 with the test-and-treat strategy and $529 with proton pump inhibitor, and both strategies yield similar clinical outcomes at 1 year. H. pylori prevalence, the likelihood of peptic ulcer disease and the proportion of ulcers due to H.pylori are important determinants of the least costly strategy. At an H. pylori prevalence below 20%, proton pump inhibitor is consistently less costly than the test-and-treat strategy. As the H. pylori prevalence, the likelihood of peptic ulcer disease and the proportion of ulcers due to H. pylori decrease, empirical proton pump inhibitor becomes less costly than the test-and-treat strategy for the management of uninvestigated dyspepsia. Given the modest cost differential between the strategies, the test-and-treat strategy may be favoured if patients without peptic ulcer disease derive long-term benefit from H.pylori eradication.