[Is the clinical classification of dyspepsia patients worth the effort?].
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Dyspepsia↗
Biomedical subjects
P Bytzer
Publications and source records attributed to P Bytzer.
Empirical H2-blocker therapy or prompt endoscopy in management of dyspepsia.
The recommended strategy for management of dyspepsia is empirical treatment with an H2-blocking drug, followed by endoscopy if the symptoms do not respond or recur. We compared two strategies for the management of dyspepsia--treatment based on the results of prompt endoscopy (group 1) and empirical H2-blocker treatment with diagnostic endoscopy only in cases of therapeutic failure or symptomatic relapse within 1 year (group 2). Eligible patients had symptoms severe enough to justify empirical H2-blocker therapy. Symptoms, drug consumption, and sick-leave days were assessed through monthly diaries. Patients with non-organic dyspepsia diagnosed by endoscopy did not receive ulcer drugs. Of 414 patients randomised, 373 completed 1-year follow-up. Organic disease was found at endoscopy in 68 (33%) of 208 group-1 patients (ulcer in 45). Endoscopy was done in 136 (66%) of 206 group-2 patients. Case selection for endoscopy was not improved by the empirical treatment strategy, since the diagnostic profile was the same as in group 1 and 40% of the expected ulcer cases remained undiagnosed. After 1 year there were no differences in symptoms or quality of life measures. The empirical treatment strategy in dyspepsia was associated with higher costs, due mainly to a higher number of sick-leave days and cost of ulcer drug use. Prompt endoscopy is a cost-effective strategy in dyspeptic patients with symptoms severe enough to justify the current practice of empirical H2-blocker treatment.
Adult↗
Endoscopic follow-up for all gastric ulcers to detect malignancy?
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Follow-Up Studies↗
[Open access upper endoscopy. Selection of upper endoscopy].
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Endoscopy, Gastrointestinal↗
Interobserver variation in the endoscopic diagnosis of reflux esophagitis.
The interobserver variation among three experienced endoscopists in the endoscopic diagnosis and grading of reflux esophagitis was investigated in 150 dyspeptic patients. The interobserver variation was analyzed with kappa statistics to correct for the extent of agreement expected by chance alone. The observers diagnosed esophagitis in 22.7%, 32.7%, and 35.3% of the patients, respectively (p < 0.0002). Kappa values for grade-1 esophagitis varied from 0.34 to 0.47, a level generally considered to signify poor agreement, and despite partial agreement on the diagnosis in the individual patient there was almost complete disagreement on the features used to characterize grade 1. Kappa values for diagnosing erosive esophagitis (grades 2-4) were 0.68-0.79. Considering all three observers and all grades of esophagitis (grades 0-4) the overall chance-corrected agreement was 0.55. In patients with low-grade esophagitis without reflux-like dyspepsia and when the observers expressed uncertainty in the diagnosis, the agreement rates were particularly poor. Due to a large chance-corrected interobserver variation, the endoscopic diagnosis grade 1 esophagitis is not reliable and thus may be problematic as a selection criterion for clinical trials. Interobserver variation on the presence of erosive/ulcerative esophagitis is acceptable and comparable to the level for peptic ulcer.
Adult↗
[Health-economic aspects of newer anti-ulcer drugs].
Peptic ulceration is a common condition and is associated with considerable expense. Introduction of H2-blockers in the latter part of the nineteen seventies offered a new and effective therapeutic alternative for the patient with chronic peptic ulceration. On the basis of a review of the literature, the present authors have attempted to assess the consequences of the introduction of H2-blockers for the expenses of peptic ulceration. Introduction of medication is found to have reduced the expenses involved in peptic ulceration on account of elective operations but on account of the increased costs of medication, the total direct costs involved in the treatment of peptic ulceration have possibly increased after the introduction of the medication. Attempts are made to compare this with the reduction in the indirect costs achieved by reduction in loss of production involved by fewer early retirals and sick leaves on account of peptic ulceration, fewer deaths connected with peptic ulceration among young persons and, in general, improved quality of life for patients with peptic ulceration although it is difficult to provide a valid estimation of the savings involved.
Cost Savings↗
Prediction of major pathologic conditions in dyspeptic patients referred for endoscopy. A prospective validation study of a scoring system.
This study aimed to validate the use of a decision support system previously developed on answers to a structured interview of dyspeptic outpatients and designed to identify patients at low risk of organic dyspepsia. We evaluated the performance of the scoring system in two cohorts of dyspeptic outpatients: 878 consecutive Danish patients (study group) referred for upper endoscopy and 1279 British patients whose results had previously been reported (validation group). Performance of the scoring system was analysed by receiver-operating characteristic (ROC) curves and comparison of loss in detection rate of organic dyspepsia, defined as cancer, ulcer, and complicated oesophagitis. The performance of the scoring system in the study group was less favourable over the entire span of cut-off points evaluated. This was reflected by a significant decrease in area under the ROC curve (65.1% versus 75.0%). The only cut-off point with an acceptable loss in detection rate (3.1%) led to a reduction in endoscopic activity of only 7.5%. Despite optimal working conditions the scoring system could not be used as a safe method of extracting dyspeptic patients with a low probability of organic dyspepsia. Before adopting a predictive scoring system, clinicians must evaluate its applicability in their own setting.
Aged↗
[Drug therapy of non-ulcer dyspepsia].
The results of placebo-controlled clinical trials of the treatment of non-ulcer dyspepsia with antacids, H2-receptor blockers, pirenzepine, sucralfate and colloidal bismuth subcitrate are reviewed. The methodological difficulties involved in connection with clinical trials of treatment of a vaguely defined condition such as non-ulcer dyspepsia are discussed with particular attention to the criteria for inclusion, assessment of effect and selection bias. None of the pharmacological agents have proved convincingly better than a placebo but sub-groups of the condition probably exist where symptomatic effects may be anticipated.
Antacids↗
[Ulcer complications in the county of Funen during 1980-1990. Are there any changes in the frequency of hospitalization following the release of potent ulcer drugs for over-the-counter sale?].
With the object of investigating whether the release of H2-blockers and sucralfate for over-the-counter sale in 1989 in Denmark and the simultaneous discontinuation of the general subsidy for potent ulcer medicine have had any influence on the frequency of hospitalisation for ulcer complications, the number of these were investigated in the County of Funen during a nine-year period prior to these alterations. The number of hospitalisations on account of ulcer complications during the first year after the alterations and thereafter were assessed on the basis of the prior tendency. In addition, the characteristics of the patients were assessed by a retrospective review of the case reports for the one-year periods before and after the alterations in the dispensing rules. The number of hospitalisations on account of ulcer complications in the County of Funen rose by 45% during the period 1.4.1980-31.3.1989. No increases in the number of hospitalisations after the alterations could be demonstrated. The number of patients admitted to Odense Hospital with ulcer complications and their characteristics are, similarly, unchanged after the alterations. Three case histories are, however, registered in which the alterations may have influenced the development of the ulcer complications. There appear to be good ground to continue registration of ulcer complications with the object of investigating the long-term consequences of these alterations particularly if potent ulcer medicine is used to a greater extent as over-the-counter medicine.
Adult↗
[Over-the-counter availability of potent ulcer drugs. Study of changes in the drug use pattern and the pressure on diagnostic measures].
In spring 1989, H2-receptor blockers and sucralfate were released for sale over-the-counter in Denmark and, simultaneously, the automatic National Health Insurance subsidy for all ulcer medicine was discontinued. The consequences of these alterations for the pressure on the diagnostic measures for upper dyspepsia are assessed by analysis of the number of referrals for gastroscopy, outpatient history-taking or radiographic examination of the stomach and oesophagus. The consequences for the consumer pattern were assessed in questionnaire investigations both to the practitioners who prescribed ulcer medicine before the alterations were introduced and also to patients who bought ulcer medicine after these alterations. Only approximately 3% of ulcer medicine is sold directly over-the-counter without medical assessment or control. No problems in safety were observed as regards incorrect treatment or delayed diagnosis. The relative proportion of patients with demonstrated indications for necessary ulcer medicine has increased after the alterations primarily on account of decrease in employment of medicine in therapeutic trials. This does not appear, however, to have resulted in any marked increased in the diagnostic possibilities. Potent ulcer medicine has not become generally accepted as over-the-counter medicine. The health and health-economic consequences should, therefore, be followed up for a more prolonged period.
Adult↗
Endoscopic follow-up study of gastric ulcer to detect malignancy: is it worthwhile?
Endoscopic follow-up study of gastric ulcer to detect cancer is held to be mandatory. To evaluate the benefits of this routine strategy, 913 index endoscopies for gastric ulcer in 773 patients during the 3-year period 1985-87 were analyzed. Correctness of diagnosis was verified through surgery, autopsy, or clinical follow-up. Endoscopic follow-up was done in 83% of the cases, totaling 1269 endoscopies, showing gastric cancer in 10 patients. Clinical outcome, however, was poor for five of these (early death). Five additional cancer cases were missed by the endoscopic follow-up. In the same period 63 gastric cancers were found at the first endoscopy; 9 of these were diagnosed through biopsies only. Predictive values of the macroscopic judgements of benign lesion or probable/definite malignancy were 0.98 and 0.40, respectively. Evaluation of case records did not indicate characteristics that would have helped in the correct differentiation between benign and malignant lesions. Thus, each case of curable gastric cancer is found at the expense of approximately 250 follow-up endoscopies. We are in need of sensitive and specific markers for possible malignancy in the patient with apparently benign gastric ulcer.
Aged↗
Efficacy and outcome of an open access endoscopy service.
In a retrospective questionnaire-study, we have attempted to elucidate how open access endoscopy influences management of dyspeptic patients, with special focus on young patients (less than 40 year), since the proportion of examinations with findings not requiring medical treatment are consistently reported higher in this age group. During a one-year period, 436 patients referred for open access endoscopy and their general practitioners completed questionnaires giving details of medical treatment, consultation rate for dyspepsia and global assessment before and 6-18 months after the endoscopy. Relevant changes in medical treatment (stopped in patients with no or minor abnormalities or started in patients with major abnormalities) was found for 27% of the patients, irrespective of age group. The result of the endoscopy provided reassurance for 70% of the patients with no or minor abnormalities. Reassurance was coupled with a lower consultation rate and with fewer symptoms. Altogether, 83% of the young patients with no or minor abnormalities had a positive outcome of the endoscopy. As the endoscopy service introduced relevant and lasting prescription habits and reduced consultation rates at general practitioners, also for younger dyspeptic patients with no or minor abnormalities, the strategy generally proposed of a trial with H2-receptor antagonists before considering referral for endoscopy should be subjected to formal clinical trial evaluating all relevant levels of efficacy.
Adolescent↗
Aetiology, medical history, and faecal weight in adult patients referred for diarrhoea. A prospective survey.
All patients referred for diarrhoea over a 2-year period were studied to determine the relative frequency of organic diarrhoea and functional disorder. One hundred and nine patients had diarrhoea of established aetiology at admission. Two hundred and one patients with diarrhoea of unestablished aetiology at admission were interviewed about symptoms, and faecal output was measured. An organic or other explanation was eventually found in 78 patients (39%), whereas the bowel symptoms were categorized as functional or transient in 58%. Chronic diarrhoea of unknown origin was seen in 3%. Only 40% of the patients referred for diarrhoea had faecal output greater than 200 g/day. A reliable differentiation between organic and functional diarrhoea based solely on history and a physical examination at admission was not possible, as the initial diagnostic guess was only confirmed in 42% of the patients. More sensitive and specific indicators of functional diarrhoea are needed before the patients can be safely classified without the need for thorough diagnostic study.
Adult↗
Prevalence of surreptitious laxative abuse in patients with diarrhoea of uncertain origin: a cost benefit analysis of a screening procedure.
The costs and medical benefits of an early, routine laxative screening test in patients with diarrhoea of uncertain origin was evaluated. During a two year period 200 consecutive, unselected patients complaining of diarrhoea were considered for the study in whom a three day faecal collection was undertaken. Fifty four patients denying laxative consumption had diarrhoea (mean daily stool weight greater than 200 g) of uncertain origin at their initial visit of whom 47 were screened to detect ingestion of anthraquinones, bisacodyl, phenolphthalein, and magnesium salts. Seven patients had positive tests. No single clinical feature could have predicted the outcome of the test. The possible cost savings of the programme were estimated by not releasing the results of the test to the clinicians until the patient's investigations were complete. The seven patients with laxative abuse spent a total of 35 days in hospital and were seen on 29 occasions in the outpatient clinic after the laxative screening test was positive. The cost of the screening programme was cheaper than the costs of the diagnostic procedures in patients with laxative abuse. We recommend the use of a comprehensive, early laxative screening programme in all patients with diarrhoea of uncertain origin as a cost effective procedure.
Adult↗
Effect of omeprazole and cimetidine on prepyloric gastric ulcer: double blind comparative trial.
We conducted a six week double blind randomised study of 176 patients with prepyloric gastric ulcer to determine whether the proton pump inhibitor, omeprazole 30 mg daily would accelerate healing and pain relief, as compared with cimetidine 1 g daily. At two, four, and six weeks after entry ulcers healed in a larger percentage of patients treated with omeprazole (54, 81, and 86%) than of those treated with cimetidine (39, 73, and 78%) ('intention to treat' cohort; p less than 0.05 at two weeks). A higher proportion of patients on omeprazole became free of pain during the first week of treatment (p less than 0.05). No major clinical or biochemical side effects were noted. Omeprazole is an efficient treatment for patients with prepyloric gastric ulcers.
Adult↗
Enprostil and ranitidine in prevention of duodenal ulcer relapse: one year double blind comparative trial.
One hundred and forty two patients with duodenal ulcer who after a short term study had relief of pain and healed ulcers proved endoscopically were allocated at random to double blind maintenance treatment with enprostil (a synthetic dehydroprostaglandin E2) 35 micrograms or ranitidine 150 mg at bedtime for up to 12 months. Patients were monitored every third month and examined by endoscopy at three, six, and 12 months, or more often if warranted. The cumulative relapse rates in the enprostil group at three, six, and 12 months were 37% (25/67), 56% (37/66), and 62% (41/66), respectively. The corresponding rates in the ranitidine group were 8% (6/71), 19% (13/69), and 29% (20/69). These differences were highly significant and further enhanced by life table analysis adjusting for withdrawals and by an "intention to treat" analysis in which absence of proof of non-recurrence was counted as failure, more patients in the enprostil group having been withdrawn because of adverse events or recorded as non-compliant with the protocol. Enprostil 35 micrograms at bedtime cannot be recommended for preventing relapse of duodenal ulcer. Furthermore, the results challenge the clinical relevance of using so called "cytoprotection" for preventing recurrence.
Adult↗
5-Aminosalicylic acid in the treatment of Crohn's disease. A 16-week double-blind, placebo-controlled, multicentre study with Pentasa.
The response to 5-aminosalicylic acid (5-ASA) in mild and moderately active Crohn's disease localized in the small bowel was studied in a randomized, double-blind, placebo-controlled trial in four centres. Sixty-seven patients were included, of whom 30 were treated with 1500 mg slow-release 5-ASA/day (Pentasa) for a scheduled period of 16 weeks. In the 5-ASA group 40% of the patients improved, versus 30% of the placebo-treated group ('intent to treat' basis; p greater than 0.1). Four of the patients treated with 5-ASA left the study owing to disease deterioration, versus 10 of the placebo-treated patients (p greater than 0.2). Seventeen patients were secondarily excluded, and the remaining 50 patients (23 receiving 5-ASA) were reevaluated in greater detail. No statistically significant differences in outcome were shown. Three patients (one given 5-ASA) were withdrawn from the study because of presumed side effects, but no serious adverse reactions were recorded. The present results indicate that 5-ASA, at least in the dosage used, is not superior to placebo. Nevertheless, trends towards a beneficial effect in Crohn's disease in the small bowel justify further clinical trials with a larger dosage of 5-ASA.
Adolescent↗