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

Study Overview
=================
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.

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)

Conditions
-----------------
Dyspepsia, Gastrointestinal Diseases

Intervention / Treatment
-----------------
* Drug: algeldrate/magnesium oxide
* Drug: ranitidine
* Drug: pantoprazole


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Step-up<br>Stepwise treatment: step1: antacid (+placebo proton pump inhibitor) step2: H2-receptor antagonist step3: proton pump inhibitor (+ placebo antacid) | Drug: algeldrate/magnesium oxide<br> <br> Drug: ranitidine<br> <br> Drug: pantoprazole<br> <br> |
| Other: step-down<br>Stepwise treatment: step1: proton pump inhibitor (+placebo antacid) step2: H2-receptor antagonist step3: antacid (+proton pump inhibitor) | Drug: algeldrate/magnesium oxide<br> <br> Drug: ranitidine<br> <br> Drug: pantoprazole<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-efficacy |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | baseline and 6 months | 
| Patient compliance after treatment |  | 0 to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uninvestigated dyspepsia, cost effectiveness, acid suppressive medicine, primary care, gastrointestinal complaints, Gastrointestinal drugs