Comparison of a "Step-Up" Versus a "Step-Down" Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study)

Condition(s) targeted: Dyspepsia; Gastrointestinal Diseases

Intervention: algeldrate/magnesium oxide (Drug); ranitidine (Drug); pantoprazole (Drug)

Phase: N/A

Status: Completed

Sponsored by: Radboud University

Official(s) and/or principal investigator(s):
Jan BMJ Jansen, MD, PhD, Study Chair, Affiliation: Radboud University Nijmegen Medical Center
Robert JF Laheij, PhD, Principal Investigator, Affiliation: Radboud University Nijmegen Medical Center
Niek De Wit, MD, PhD, Study Chair, Affiliation: UMC Utrecht
Mattijs E Numans, MD, PhD, Study Chair, Affiliation: UMC Utrecht
Melvin Samsom, MD, PhD, Study Chair, Affiliation: UMC Utrecht
Jean WM Muris, MD, PhD, Study Chair, Affiliation: Maastricht University
Andre Knottnerus, MD, PhD, Study Chair, Affiliation: Maastricht University

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.

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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Cost-efficacy

Secondary outcome:

Severity of gastrointestinal symptoms

Quality of life

Genetic and psychosocial determinants

Patient compliance after treatment

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

UMC Utrecht, Utrecht, Netherlands

Radboud University Nijmegen Medical Center, Nijmegen, Gelderland 6500 HB, Netherlands

Maastricht University, Maastricht, Limburg 6200 MB, Netherlands

Related publications:

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. Review.

Starting date: October 2003
Ending date: January 2007
Last updated: August 28, 2007