Clinical trial NCT00247715: Comparison of a "Step-Up" Versus a "Step-Down" Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study)
Official title: Comparison of an Antacid/H2-Receptor Antagonist/Proton Pump Inhibitor Versus a Proton Pump Inhibitor/H2-Receptor Antagonist/Antacid Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspepsia
Gastrointestinal Diseases
Keywords: uninvestigated dyspepsia
cost effectiveness
acid suppressive medicine
primary care
gastrointestinal complaints
Gastrointestinal drugs
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2005-11-02
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cost-efficacy
timeFrame: 6 months
Secondary outcomes:
measure: Severity of gastrointestinal symptoms
timeFrame: 2 weeks, after each treatment steps, and 6 months
measure: Quality of life
timeFrame: 2 weeks, after each treatment step, and 6 months
measure: Genetic and psychosocial determinants
timeFrame: baseline and 6 months
measure: Patient compliance after treatment
timeFrame: 0 to 6 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: Radboud University Nijmegen Medical Center
name: Jan BMJ Jansen, MD, PhD
role: STUDY_CHAIR
affiliation: Radboud University Nijmegen Medical Center
name: Robert JF Laheij, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: Niek De Wit, MD, PhD
role: STUDY_CHAIR
affiliation: UMC Utrecht
name: Mattijs E Numans, MD, PhD
role: STUDY_CHAIR
affiliation: UMC Utrecht
name: Melvin Samsom, MD, PhD
role: STUDY_CHAIR
affiliation: Maastricht University
name: Jean WM Muris, MD, PhD
role: STUDY_CHAIR
affiliation: Maastricht University
name: Andre Knottnerus, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.