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Biomedical subjects

P Bytzer

Publications and source records attributed to P Bytzer.

At least 19 recordsLinked to original sources

[Menetrier's disease. Another Helicobacter pylori associated disease?].

Ménétrier's disease is a rare and poorly outlined disease, diagnosed in patients with giant gastric folds, dyspeptic symptoms and hypoalbuminaemia due to gastrointestinal protein loss. The etiology is unknown, but Ménétrier's disease is often associated with Helicobacter pylori (Hp) infection. Case reports and studies concerning the effect of eradication therapy in patients with Ménétrier's disease were reviewed. It was found that complete normalisation of the gastric mucosa and gastrointestinal protein loss following eradication therapy has been reported in several cases. In conclusion, we recommend patients with Ménétrier's disease to be tested for Hp, and treated with eradication therapy in case of infection.

Adult↗

Helicobacter pylori test-and-eradicate versus prompt endoscopy for management of dyspeptic patients: a randomised trial.

BACKGROUND: Strategies based on screening for Helicobacter pylori to manage dyspeptic patients in primary care have been proposed, but the clinical consequences are unclear. We did a randomised trial to assess the efficacy and safety of a test-and-eradicate strategy compared with prompt endoscopy in the management of patients with dyspepsia. METHODS: 500 patients presenting in primary care with dyspepsia (> or = 2 weeks of epigastric pain, no alarm symptoms) were assigned H. pylori testing plus eradication therapy or endoscopy. Symptoms, quality of life, patients' satisfaction, and use of resources were recorded during 1 year of follow-up. FINDINGS: 250 patients were assigned test-and-eradicate, and 250 prompt endoscopy. The median age was 45 years and 28% were H. pylori infected. 1 year follow-up was completed by 447 patients. We found no differences in symptoms between the two groups (median registered days without dyspeptic symptoms=0.63 [IQR 0.27-0.81] in the test-and-eradicate group vs 0.67 [0.36-0.86] in the prompt endoscopy group; mean difference 0.04 [95% CI -0.01-0.10], p=0.12). Nor did we find any difference in quality of life or numbers of sick-leave days, visits to general practitioners, or hospital admissions. In the test-and-eradicate group, 27 (12%) of the patients were dissatisfied with management, compared with eight (4%) in the endoscopy group (p=0.013). After 1 year, the use of endoscopies in the test-and-eradicate group was 0.40 times (95% CI 0.31-0.51) the use in the endoscopy group, the use of H. pylori tests increased by a factor of 8.1 (5.7-13.1), the use of eradication treatments increased by a factor of 1.5 (0.9-2.7), and the use of proton-pump inhibitors was 0.89 (0.59-1.33) times the use in the endoscopy group. 43 (91% [80-98%]) of 47 peptic-ulcer patients would have been identified by endoscopy or treated by eradication therapy. INTERPRETATION: A H. pylori test-and-eradicate strategy is as efficient and safe as prompt endoscopy for management of dyspeptic patients in primary care, although fewer patients are satisfied with their treatment.

Adult↗

Management of uninvestigated and functional dyspepsia: a Working Party report for the World Congresses of Gastroenterology 1998.

BACKGROUND: The management of dyspepsia is controversial. METHODS: An international Working Party was convened in 1998 to review management strategies for dyspepsia and functional dyspepsia, based on a review of the literature and best clinical practice. RESULTS: Dyspepsia, defined as pain or discomfort centred in the upper abdomen, can be managed with reassurance and over-the-counter therapy if its duration is less than 4 weeks on initial presentation. For patients with chronic symptoms, clinical evaluation depends on alarm features including patient age. The age cut off selected should depend on the age specific incidence when gastric cancer begins to increase, but in Western nations 50 years is generally an acceptable age threshold. In younger patients without alarm features, Helicobacter pylori test and treatment is the approach recommended because of its value in eliminating the peptic ulcer disease diathesis. If, after eradication of H. pylori, symptoms either are not relieved or rapidly recur, then an empirical trial of therapy is recommended. Similarly, in H. pylori-negative patients without alarm features, an empirical trial (with antisecretory or prokinetic therapy depending on the predominant symptom) for up to 8 weeks is recommended. If drugs fail, endoscopy should be considered because of its reassurance value although the yield will be low. In older patients or those with alarm features, prompt endoscopy is recommended. If endoscopy is non-diagnostic, gastric biopsies are recommended to document H. pylori status unless already known. While treatment of H. pylori is unlikely to relieve the symptoms of functional dyspepsia, the long-term benefits probably outweigh the risks and treatment can be considered on a case-by-case basis. In H. pylori-negative patients with documented functional dyspepsia, antisecretory or prokinetic therapy, depending on the predominant symptom, is reasonable, assuming reassurance and explanation are insufficient, unless patients have already failed this approach. Other treatment options include antidepressants, antispasmodics, visceral analgesics such as serotonin type 3 receptor antagonists, and behavioural or psychotherapy although these are all of uncertain efficacy. Long-term drug treatment in functional dyspepsia should be avoided; intermittent short courses of treatment as needed is preferred. CONCLUSION: The management of dyspepsia recommended is based on current best evidence but must be tailored to local factors such as practice setting, the background prevalence of H. pylori and structural disease, and costs.

Decision Trees↗

Adenocarcinoma of the esophagus and Barrett's esophagus: a population-based study.

OBJECTIVE: We described incidence rates of esophageal adenocarcinoma in Denmark in a 20-yr period and determined the proportion of patients diagnosed with esophageal adenocarcinoma who had a previous diagnosis of Barrett's esophagus, making them potential candidates for endoscopic surveillance. METHODS: Rates of esophageal and gastric cancers were collected from the Danish Cancer registry for the period 1970-1991. The registry was used to identify all cases of esophageal adenocarcinoma in the period 1987-1992. Medical records were retrieved and details concerning previous diagnosis of reflux disease and Barrett's esophagus were recorded. RESULTS: The age- and gender-adjusted incidence of esophageal adenocarcinoma increased eightfold, from 0.3/10(5)/yr in 1970 to 2.3/10(5)/yr in 1990. This increase could not be explained by changes in classification or diagnostic routines. Medical data were retrieved for 524 of the 578 cases of esophageal adenocarcinoma reported during the period 1987-1992. A history of reflux symptoms or a diagnosis compatible with reflux was reported in 113 of 524 patients. A total of 119 patients (23%) had previously been investigated for dyspepsia or reflux symptoms, most often by endoscopy. A previous diagnosis of Barrett's esophagus was found in only 1.3% of the cancer patients. CONCLUSIONS: The rate of esophageal adenocarcinoma in Denmark has increased eightfold over a 20-yr period, and this increase is not explained by changes in classification or diagnostic routines. More than 98% of esophageal adenocarcinomas were found in patients who could not have entered endoscopic surveillance, as Barrett's esophagus had not been diagnosed before the cancer diagnosis. Endoscopic surveillance to detect dysplasia may be an option for the individual patient with Barrett's esophagus, but these screening programs are not likely to reduce the death rate from esophageal adenocarcinomas in the general population.

Adenocarcinoma↗

Design of treatment trials for functional gastrointestinal disorders.

Until recently many clinical trials of functional gastrointestinal disorders (FGIDs) suffered from important weaknesses in trial design, study execution, and data analysis. This makes it difficult to determine whether truly efficacious therapies exist for these disorders. One of the important methodologic problems is the absence of validated outcome measures and lack of consensus among stakeholders on how to measure outcome. Currently much of the effort is being put into the development of validated outcome measures for several of the FGIDs. The randomized, controlled trial with parallel groups is the design of choice. In this report, guidelines are given for the basic architecture of intervention studies of FGIDs. Further studies on design issues are required to ensure the recommendations will become evidence based in the future.

Cross-Over Studies↗

Cost-effectiveness of gastroscopy.

In a health economics perspective, no other decision area in gastroenterology has been more debated than the role of gastroscopy in dyspepsia. Cost-effectiveness analyses correlate costs with health outcomes. The cost-effectiveness of a diagnostic strategy must be compared to that of a competing strategy to produce useful information. This review examines the cost-effectiveness of gastroscopy in the management of dyspeptic patients, in particular in relation to the competing strategies of deferred referral guided by the outcome of either empirical antisecretory medication or of a non-invasive Helicobacter pylori test. Estimates of costs of gastroscopy differ widely. Cost estimates are usually much lower in European countries compared to the US. This is probably mainly due to differences in the calculations and in the payer perspective used. Cost-effectiveness analyses in dyspepsia management and the role of gastroscopy are difficult to interpret and impossible to compare due to a lack of uniformity in designing, measuring and reporting costs and health-care related outcome. Compared to empirical acid inhibition and to a test-and-scope strategy initial endoscopy is probably cost-effective--at least in Europe. Based on preliminary findings from clinical trials and from decision analyses a test-and-eradicate management strategy in young dyspeptic patients without warning symptoms seems to be cost-effective compared to early endoscopy. Implementing a test-and-eradicate strategy in primary care will probably save endoscopies without harmful effects. In view of the rapidly changing epidemiology of Helicobacter pylori infection in the Western world the long-term effects of such a policy should be monitored closely.

Cost-Benefit Analysis↗

How should new-onset dyspepsia be managed in general and specialist practice?

Managing patients with new-onset dyspeptic symptoms represents a real challenge in clinical decision-making. The major controversy has been over the optimal management strategy of patients with new-onset dyspeptic symptoms who do not present with alarm symptoms. Since unaided clinical diagnosis is unreliable, proposed management strategies have included empirical treatment algorithms, computer-assisted predictive score models and Helicobacter pylori-based strategies such as test-and-scope or test-and-treat algorithms. Endoscopy remains the diagnostic 'gold standard', and the management should ideally be based on endoscopic diagnosis. Because of economic constraints and increasing waiting lists, this is not possible. When precise and comprehensive guidelines have been formulated, future patients will probably be managed in primary care by a Helicobacter test-and-treat policy, leaving only empirical treatment failures for specialist evaluation.

Dyspepsia↗

Management of dyspeptic patients in primary care. Value of the unaided clinical diagnosis and of dyspepsia subgrouping.

BACKGROUND: Most dyspeptic patients in primary care are managed without confirmatory investigations. In this study the reliability of the unaided clinical diagnosis and the diagnostic value of dyspepsia subgrouping are evaluated in unselected dyspeptic patients in primary care. METHODS: Six hundred and twelve unselected dyspeptic patients were referred for interview and endoscopy. General practitioners stated a provisional diagnosis and a proposed management strategy. Before endoscopy, patients were classified on the basis of predominant symptoms as reflux-, ulcer-, or dysmotility-like or as unclassifiable RESULTS: The sensitivity and the positive predictive value of the diagnosis of ulcer were 0.58 and 0.29, respectively, and those for esophagitis 0.30 and 0.43. The predictive value of a clinical diagnosis of functional dyspepsia was high, but, considering the high prevalence of the condition, the chance-corrected validity was at the same level as for the other diagnoses (0.18-0.22). Classification of patients by predominant symptoms increased the a priori probability of ulcer and esophagitis in the respective subgroups. However, more than one-third of the patients with ulcer or esophagitis were classified in inappropriate subgroups. CONCLUSIONS: It is difficult to select an appropriate management strategy for dyspeptic patients on the basis of symptoms and history alone. Dyspepsia subgroups are of limited help in the decision process because of the low predictive value of the endoscopic diagnosis.

Adult↗

Screening for drug related dyspepsia: an analysis of prescription symmetry.

OBJECTIVE: Most patients with severe upper dyspepsia are treated empirically with ulcer drugs. Drug-induced dyspepsia might therefore be reflected in the sequencing of ulcer drugs relative to other medications. Our aim was to screen a large population-base prescription database for evidence of drug-induced dyspepsia. METHODS: Prescription data on 31,232 incident users of ulcer drugs were drawn from a research database, covering the county of Funen, Denmark. We identified all individuals who had started their first recorded therapies with an ulcer drug and another non-ulcer drug within a 100 day span. In this selected group, there would normally be an equal number starting either drug first, while a dyspepsia-provoking effect of the non-ulcer drug would manifest as an excess of individuals with the ulcer drug prescribed last. This screening method is robust to confounders that are stable over time. RESULTS: Only non-steroidal antiinflammatory drugs (adjusted rate ratio (RR) 1.8, 95% confidence interval (CI), 1.6-2.0), calcium blockers (RR 1.4, CI 1.2-1.7), corticosteroids (RR 1.1, CI 1.0-1.3), angiotensin converting enzyme inhibitors (RR 1.4, CI 1.1-1.7) and methylxanthines (RR 1.5, CI 1.1-2.2) showed a significant asymmetry suggesting a dyspepsia-provoking effect. An analysis of effect modifiers suggested that the signals for corticosteroids and for angiotensin converting enzyme inhibitors were explained by concurrent use of non-steroidal anti-inflammatory drugs and by underlying congestive heart failure. The signal for non-steroidal anti-inflammatory drugs may be explained by the known reputation of non-steroidal antiinflammatory drugs for causing ulcers. CONCLUSION: There are hardly any important unknown drug effects that mimic acid related dyspepsia. Drug-induced dyspepsia contributes little to the overall use of ulcer drugs.

Aged↗

Placebo-controlled trial of cisapride and nizatidine in unselected patients with functional dyspepsia.

OBJECTIVE: Patients in most trials of pharmacotherapy for nonorganic dyspepsia have been groups referred selectively for endoscopy, which could have led to a selection bias of nonresponders, explaining the negative outcome of most controlled treatment trials in nonorganic dyspepsia. The aim of this study was to evaluate the effects of cisapride and nizatidine in patients with nonorganic dyspepsia who were recruited directly from primary care settings, and to evaluate the therapeutic implications of dyspepsia subgrouping. METHODS: A consecutive series of patients who consulted their general practitioner with dyspepsia were invited to an interview and endoscopy. Before endoscopy, symptoms were classified as reflux-like, dysmotility-like, ulcer-like, or unclassifiable. A total of 330 patients with either minor or no abnormalities at endoscopy were randomized to double blind treatment with cisapride 10 mg t.i.d., nizatidine 300 mg at night, or placebo for 2 wk. RESULTS: A symptomatic response was found in 62% of patients on cisapride (therapeutic gain cisapride vs placebo: 0.1% [95% confidence interval -14% to 14%]) and in 54% of patients on nizatidine (therapeutic gain nizatidine vs placebo: -8% [95% confidence interval -22% to 7%]). Response to treatment was independent of symptom classification. CONCLUSIONS: The effects of a 2-wk course of cisapride or nizatidine in unselected patients with dyspepsia recruited from primary care were not superior to those of placebo. Symptom subgrouping was not predictive of response to therapy.

Adult↗

[NSAID and ulcer complications. An analysis of risk factors].

Use of NSAIDs is recognized as an important cause of peptic ulcer complications. The aim of this nested case-control study was to identify risk factors for NSAID-related ulcer complications. Cases were consecutive NSAID users admitted with an ulcer complication (n = 94), and controls were a random sample of all NSAID users without ulcer complication identified by a pharmaco-epidemiological database (n = 324). Risk factors for patients at start of NSAID-therapy were: high age: 60-75 yr; Odds Ratio (OR) 3.5 (95% CI: 1.8-7.0); > 75 yr: OR 8.8 (4.3-18.1); male sex: OR 1.7 (1.0-3.0); ulcer history: OR 2.5 (1.2-5.1); steroid treatment: OR 2.0 (0.8-4.6); smoking: OR 1.6 (0.9-2.7); alcohol use: OR 1.8 (0.9-3.6). Risk factors for patients on NSAID-therapy were: high age, male sex, ulcer history, and smoking, and furthermore dyspepsia: OR 2.1 (1.0-4.2), especially NSAID-related dyspepsia: OR 8.9 (4.1-19.2). Risk was lower for patients treated more than three months. In conclusion, risk measured from this design can be shown to correlate strongly with the rate difference, a measure that is more clinically relevant than conventional relative risk estimates. Strong risk factors for NSAID-related ulcer complication are high age, male sex, ulcer history, and dyspepsia related to the NSAID therapy.

Adult↗

Predicting endoscopic diagnosis in the dyspeptic patient. The value of predictive score models.

BACKGROUND: Score models to predict endoscopic diagnosis in dyspepsia may compensate for the unreliable clinical diagnosis. This study aimed to construct and test score models designed to predict diagnosis in dyspepstic patients managed in primary care. METHODS: Three models to predict organic dyspepsia, major dyspepsia, or peptic ulcer were constructed by regression analysis of clinical data from 1026 consecutive dyspeptic patients referred for endoscopy. The models were tested in 207 patients in primary care, who were potential candidates for endoscopy. Validation experiments were analysed using receiver operating characteristic (ROC) curves. RESULTS: Significant losses of predictive power were found for all models when applied to primary care patients, and no model could be used as a reliable decision support instrument in primary care. CONCLUSIONS: Predictive score models developed in patients referred for endoscopy are not reliable when applied to patients in primary care who are potential candidates for endoscopy. Future models should be constructed and validated in unselected primary care populations.

Decision Support Techniques↗

Predicting endoscopic diagnosis in the dyspeptic patient: the value of clinical judgement.

OBJECTIVE: To compare the quality of chance-corrected clinical diagnosis in two groups of dyspeptic patients, using endoscopy as the diagnostic standard. DESIGN: Structured interview before endoscopy and clinical predictions of endoscopic diagnosis as either malignancy, peptic ulcer, oesophagitis or non-ulcer dyspepsia. The quality of the predictions was corrected for chance using iota-correction. Patients gave a provisional prediction of their own endoscopic diagnosis. SETTING: Two endoscopy units in Odense and Svendborg, Denmark. PATIENTS: Two groups of dyspeptic outpatients: (1) 1026 patients referred for open-access endoscopy and (2) 207 empirically managed patients randomly assigned to prompt endoscopy as part of a clinical trial. RESULTS: The overall diagnostic validity for all diagnoses was equal in the two groups of patients (57 and 59%) and was mainly accounted for by positive predictive values for non-ulcer dyspepsia of 75%. Elimination of random accuracy for non-ulcer dyspepsia showed a validity of only 23 and 21%. Patients with a major pathologic lesion (cancer, ulcer, complicated oesophagitis) were misclassified clinically as non-ulcer dyspepsia in 36 and 38% of cases. The sensitivity of a clinical prediction of ulcer was only 52 and 36%, despite positive predictive values of 34%, and most valid when corrected for chance in the group of patients referred for open-access endoscopy. The patients' provisional diagnoses had no predictive value. CONCLUSION: Clinical diagnosis in dyspepsia was unreliable as it misclassified one-third of patients with a major pathological lesion. Fifty percent of patients with ulcer were misclassified and that clinical diagnosis could only be confirmed in one-third of the cases. The chance-corrected validity of non-ulcer dyspepsia was only slightly better than chance. There was no predictive value of the patients' predictions of their own diagnosis.

Adult↗