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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 664
- 试验地点
- 3
- 主要终点
- Cost-efficacy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Step-up
Stepwise treatment:
- step1: antacid (+placebo proton pump inhibitor)
- step2: H2-receptor antagonist
- step3: proton pump inhibitor (+ placebo antacid)
干预措施: algeldrate/magnesium oxide (Drug)
Step-up
Stepwise treatment:
- step1: antacid (+placebo proton pump inhibitor)
- step2: H2-receptor antagonist
- step3: proton pump inhibitor (+ placebo antacid)
干预措施: ranitidine (Drug)
Step-up
Stepwise treatment:
- step1: antacid (+placebo proton pump inhibitor)
- step2: H2-receptor antagonist
- step3: proton pump inhibitor (+ placebo antacid)
干预措施: pantoprazole (Drug)
step-down
Stepwise treatment:
- step1: proton pump inhibitor (+placebo antacid)
- step2: H2-receptor antagonist
- step3: antacid (+proton pump inhibitor)
干预措施: algeldrate/magnesium oxide (Drug)
step-down
Stepwise treatment:
- step1: proton pump inhibitor (+placebo antacid)
- step2: H2-receptor antagonist
- step3: antacid (+proton pump inhibitor)
干预措施: ranitidine (Drug)
step-down
Stepwise treatment:
- step1: proton pump inhibitor (+placebo antacid)
- step2: H2-receptor antagonist
- step3: antacid (+proton pump inhibitor)
干预措施: pantoprazole (Drug)
结局指标
主要结局
Cost-efficacy
时间窗: 6 months
次要结局
- 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)
