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

Radboud University Medical Center

Status: Completed

Conditions: Gastrointestinal Diseases; Dyspepsia

Treatments: Drug: ranitidine; Drug: algeldrate/magnesium oxide; Drug: pantoprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00247715

945-03-052

CMO 2002/141

Details and patient eligibility

About

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.

Full 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.

Enrollment: 664 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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664 participants in 2 patient groups

Step-up

Other group

Description:

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

Treatment:

Drug: ranitidine

Drug: pantoprazole

Drug: algeldrate/magnesium oxide

step-down

Other group

Description:

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

Treatment:

Drug: ranitidine

Drug: pantoprazole

Drug: algeldrate/magnesium oxide