ABSTRACT
The studies were conducted at the Department of Medical Gastroenterology, Odense University Hospital, and the Research Unit of General Practice, University of Southern Denmark.
Dyspepsia is a frequent occurring disorder, associated with considerable costs due to sick-leave days, health care services and pharmacological treatment. Since dyspepsia is a frequent reason for consulting a general practitioner (GP), the choice of initial management has major influence on health care costs.
The aim of the study was to identify and compare competing alternatives in the initial management strategies for dyspepsia in general practice. Special emphasis was on consequences for patients, economic perspectives, and organisational perspectives.
The design was a prospective, cluster-randomised trial performed in 106 general practices in the County of Funen, Denmark, between June 2001 and October 2003. Each practice was randomised to one of three management strategies: 1) empirical antisecretory therapy, 2)
Helicobacter pylori
test-and-eradicate and 3) empirical antisecretory therapy, followed by
Helicobacter pylori
test-and-eradicate if symptoms improved. Patients were followed for a 12-month-period and decisions about any additional treatment or referrals for investigations were left at the discretion of the GP. On the basis of a prospective collection of clinical outcome measures and resource utilisation data, cost-effectiveness of the strategies was determined. Organisational perspectives were elucidated from a GP questionnaire.
A total of 722 patients presenting with dyspepsia in general practice were recruited. No differences were found in symptom outcomes, QoL or patient satisfaction between the three groups in the 1-year follow-up period. Sub-analysis showed that
H. pylori
-positive patients given eradication therapy had more days without dyspeptic symptoms, used less antisecretory therapy and were more satisfied than
H. pylori
-negative patients. The mean use of endoscopies per patient and the number of sick-leave days after one year were higher in the empirically treatment group. On the basis of this, we found the strategies based on eradication of
H. pylori
infection cost-effective compared with empirical treatment.
Strategies based on use of the
13
C-urea breath-test for
H. pylori
were realisable in general practice, and most of the general practitioners found the
13
C-urea breath-test for
H. pylori
useful in the management of their dyspeptic patients.
Given the dynamics associated with the variables included in the evaluation, the cost-effectiveness of the strategies requires periodic re-evaluations. Furthermore, a long-term follow-up of the study population is relevant, as
H. pylori
eradication may enjoy benefits that are not accounted for in the present study.