Dyspepsia, Gastrointestinal Diseases
Conditions
Keywords
uninvestigated dyspepsia, cost effectiveness, acid suppressive medicine, primary care, gastrointestinal complaints, Gastrointestinal drugs
Brief summary
The purpose of this study was to determine which treatment strategy, the step-up or the step-down treatment strategy, is the most cost-effective treatment for patients with new onset dyspepsia in primary care.
Detailed description
Dyspepsia is very common in the population. On an annual basis, 20%-40% of the general population suffers from upper gastrointestinal symptoms. The prevalence of dyspepsia presenting in primary care is about 3%, on average 24% of these patients are referred for secondary care in the same year. In spite of consensus statements and guidelines, the most effective treatment strategy for managing dyspepsia in primary care remains to be determined. In 2000 the Health Council of the Netherlands published some advice for the Minister of Health, Welfare and Sport with special consideration to the most cost-effective strategies for the management of dyspepsia. The Health Counsel Committee agrees in general with the existing guidelines of the Dutch College of General Practitioners to start with empirical treatment. However, the committee concluded that more research is necessary for management of dyspepsia in primary care, especially in uninvestigated patients as most research has been conducted in patients with persistent dyspeptic symptoms referred for secondary care. Comparison: In this study empirical treatment according to the existing guidelines of the Dutch College of General Practitioners (the step-up treatment strategy) is compared to a step-down treatment strategy. According to this step-down treatment strategy the patient begins treatment with a proton pomp inhibitor, which is an expensive acid-suppressor and is often prescribed by general practitioners. Step-up strategy: Algeldrate-magnesium oxide, in case of persisting/relapsing symptoms continued with ranitidine, if necessary continued with pantoprazole. Step-down strategy: Pantoprazole, in case of persisting or relapsing symptoms continued with ranitidine, if necessary continued with algeldrate-magnesium oxide.
Interventions
DRUGalgeldrate/magnesium oxide
DRUGranitidine
DRUGpantoprazole
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of a new episode of dyspepsia, defined as episodic or persistent symptoms including abdominal pain or discomfort and which are, in the opinion of the general practitioner, referable to the upper gastrointestinal tract. * Over 18 years of age * Informed consent (written) given.
Exclusion criteria
* Use of prescribed acid suppressive medication during 3 months before consult * Investigated by upper gastrointestinal endoscopy one year before inclusion * Malignancy * Contraindication to the study medication * Pregnancy * Alarming symptoms like weight loss, bleeding, and disturbed food passage * Patients with insufficient comprehension of the Dutch language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cost-efficacy | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Severity of gastrointestinal symptoms | 2 weeks, after each treatment steps, and 6 months |
| Quality of life | 2 weeks, after each treatment step, and 6 months |
| Genetic and psychosocial determinants | baseline and 6 months |
| Patient compliance after treatment | 0 to 6 months |
Countries
Netherlands
Outcome results
None listed