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| ID | Type | Description | Link |
|---|---|---|---|
| CMO 2002/141 |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Step-up | Other | Stepwise treatment:
|
|
| step-down | Other | Stepwise treatment:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| algeldrate/magnesium oxide | Drug |
| ||
| ranitidine |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-efficacy | 6 months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan BMJ Jansen, MD, PhD | Radboud University Nijmegen Medical Center | Study Chair |
| Robert JF Laheij, PhD | Radboud University Nijmegen Medical Center | Principal Investigator |
| Niek De Wit, MD, PhD | UMC Utrecht | Study Chair |
| Mattijs E Numans, MD, PhD | UMC Utrecht | Study Chair |
| Melvin Samsom, MD, PhD | UMC Utrecht | Study Chair |
| Jean WM Muris, MD, PhD | Maastricht University | Study Chair |
| Andre Knottnerus, MD, PhD | Maastricht University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Nijmegen Medical Center | Nijmegen | Gelderland | 6500 HB | Netherlands | ||
| Maastricht University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17451599 | Background | Fransen GA, van Marrewijk CJ, Mujakovic S, Muris JW, Laheij RJ, Numans ME, de Wit NJ, Samsom M, Jansen JB, Knottnerus JA. Pragmatic trials in primary care. Methodological challenges and solutions demonstrated by the DIAMOND-study. BMC Med Res Methodol. 2007 Apr 23;7:16. doi: 10.1186/1471-2288-7-16. | |
| 19150702 | Derived |
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| Drug |
|
| pantoprazole | Drug |
|
| baseline and 6 months |
| Patient compliance after treatment | 0 to 6 months |
| Maastricht |
| Limburg |
| 6200 MB |
| Netherlands |
| UMC Utrecht | Utrecht | Utrecht | Netherlands |
| van Marrewijk CJ, Mujakovic S, Fransen GA, Numans ME, de Wit NJ, Muris JW, van Oijen MG, Jansen JB, Grobbee DE, Knottnerus JA, Laheij RJ. Effect and cost-effectiveness of step-up versus step-down treatment with antacids, H2-receptor antagonists, and proton pump inhibitors in patients with new onset dyspepsia (DIAMOND study): a primary-care-based randomised controlled trial. Lancet. 2009 Jan 17;373(9659):215-25. doi: 10.1016/S0140-6736(09)60070-2. |
| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000536 | Aluminum Hydroxide |
| D008277 | Magnesium Oxide |
| D011899 | Ranitidine |
| D000077402 | Pantoprazole |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D017607 | Aluminum Compounds |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D017616 | Magnesium Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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