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

NCT ID: NCT00247715

Last Updated: 2007-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

664 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2007-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dyspepsia Gastrointestinal Diseases

Keywords

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uninvestigated dyspepsia cost effectiveness acid suppressive medicine primary care gastrointestinal complaints Gastrointestinal drugs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Step-up

Stepwise treatment:

* step1: antacid (+placebo proton pump inhibitor)
* step2: H2-receptor antagonist
* step3: proton pump inhibitor (+ placebo antacid)

Group Type OTHER

algeldrate/magnesium oxide

Intervention Type DRUG

ranitidine

Intervention Type DRUG

pantoprazole

Intervention Type DRUG

step-down

Stepwise treatment:

* step1: proton pump inhibitor (+placebo antacid)
* step2: H2-receptor antagonist
* step3: antacid (+proton pump inhibitor)

Group Type OTHER

algeldrate/magnesium oxide

Intervention Type DRUG

ranitidine

Intervention Type DRUG

pantoprazole

Intervention Type DRUG

Interventions

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algeldrate/magnesium oxide

Intervention Type DRUG

ranitidine

Intervention Type DRUG

pantoprazole

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Jan BMJ Jansen, MD, PhD

Role: STUDY_CHAIR

Radboud University Nijmegen Medical Center

Robert JF Laheij, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Nijmegen Medical Center

Niek De Wit, MD, PhD

Role: STUDY_CHAIR

UMC Utrecht

Mattijs E Numans, MD, PhD

Role: STUDY_CHAIR

UMC Utrecht

Melvin Samsom, MD, PhD

Role: STUDY_CHAIR

UMC Utrecht

Jean WM Muris, MD, PhD

Role: STUDY_CHAIR

Maastricht University

Andre Knottnerus, MD, PhD

Role: STUDY_CHAIR

Maastricht University

Locations

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Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, Netherlands

Site Status

Maastricht University

Maastricht, Limburg, Netherlands

Site Status

UMC Utrecht

Utrecht, Utrecht, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 17451599 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19150702 (View on PubMed)

Other Identifiers

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CMO 2002/141

Identifier Type: -

Identifier Source: secondary_id

945-03-052

Identifier Type: -

Identifier Source: org_study_id