Randomized controlled trial of omeprazole or endoscopy in patients with persistent dyspepsia: a cost‐effectiveness analysis

Abstract

INTRODUCTIONOpen access to endoscopy facilities for general practitioners has resulted in increased endoscopic workload and an increase in hospital costs.1 Consequently, it is now under discussion whether the service should only be targeted at a selected group of patients who genuinely need endoscopy.2 Several studies have investigated whether empirical treatment instead of prompt endoscopy could increase appropriate use of endoscopy facilities and decrease costs. 3±7 Regrettably, most of the data are based on decision analysis 3±5 and, to our knowledge, only one randomized clinical trial 6 and one cohort study 7 have prospectively compared an empirical treatment strategy to prompt endoscopy in patients with dyspeptic symptoms. The randomized clinical trial demonstrated that empirical treatment was associated with higher costs and lower patient satisfaction, whereas in the cohort study, an empirical treatment strategy was cheaper and achieved comparable clinical results to the conventional strategy. A pitfall in both studies was that empirical treatment was given with either an H 2 -receptor antagonist (ranitidine) or prokinetics and not with proton pump inhibitors, the latter being the most effective acidsuppressing drugs available. 8,9 Thus in acid-related SUMMARY Background: Cost-effectiveness analysis, Helicobacter pylori research and the development of proton pump inhibitors are having an increasing impact on the management of dyspepsia. However, clinical trials have not always included both H. pylori diagnosis and proton pump inhibitors in their protocols. Methods: Patients who were referred for upper gastrointestinal endoscopy by their general practitioner were randomized to either prompt endoscopy followed by directed medical treatment (conventional group, n 38), or to empirical treatment with omeprazole and, in the case of symptom relapse, serological screening for H. pylori infection followed by eradication therapy in seropositive patients (empirical group, n 42). The study lasted for up to 1 year.

Reassurance After Diagnostic Testing With a Low Pretest Probability of Serious Disease

“…25,26,29 One each involved blood tests and electrocardiography for chest pain, 32 imaging for headache, 31 and continuous event recorders for palpitations. 24 With the exception of 2 trials, 19,27 studies involved recent rather than persistent symptoms. Several studies specified a minimum duration to exclude trivial conditions for which diagnostic testing may not be clinically necessary.…”

“…Several studies specified a minimum duration to exclude trivial conditions for which diagnostic testing may not be clinically necessary. Trials comparing testing with nontesting reported outcome data on illness concern, 25,31,32 nonspecific or general anxiety, 24,26 symptoms, 19,[21][22][23][25][26][27][28][29][30]32 and subsequent primary care visits. [19][20][21][22][23][25][26][27][28]31,32 Ten trials reported short-term data 20,23-27,29-32 and 13, long-term data.…”

“…Nine trials took place in a general practice/ family medicine setting, [19][20][21][22][23][24][25][26][27] and 5, in a general or specialist internal medicine practice setting. [28][29][30][31][32] Eight of the trials involved diagnostic testing for dyspepsia (endoscopy or radiography) [19][20][21][22][23]27,28,30 ; 3 involved radiography for back pain. 25,26,29 One each involved blood tests and electrocardiography for chest pain, 32 imaging for headache, 31 and continuous event recorders for palpitations.…”

Role of symptoms in diagnosis and outcome of gastric cancer

“…Endoscopy is, however, expensive, troublesome to the patient, and, in more than 50% of endoscopic examinations, no organic cause can be found [7] . Therefore, non-invasive treatment strategies such as H pylori test-and-treat or empirical treatment with acid inhibitory drugs, i.e., proton pump inhibitors and H 2 -antagonists, have been proposed and it has become evident that these strategies are at least as effective as upper gastro-intestinal endoscopy followed by targeted treatment [7][8][9][10] . However, the main concern, in the application of empirical treatments of dyspepsia are the possibility of missing gastric cancer or of delaying the time to diagnosis.…”

A rational approach to uninvestigated dyspepsia in primary care: review of the literature

“…Laheij et al compared prompt endoscopy with an approach in which patients initially received empirical treatment with omeprazole, followed by a "test-and-treat" strategy if symptoms persisted. 189 After one year of follow up, 31% of the patients in the group receiving empirical treatment had been referred for endoscopy. Clinical outcome was the same in both groups, but medical costs were lower in the group at first subjected to empirical treatment.…”