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STUDY DESIGN
Design:
randomised controlled trial (Dutch study on Initial Management Of Newly diagnosed Dyspepsia [DIAMOND]). ClinicalTrials.gov NCT00247715.
Allocation:
concealed.*
Blinding:
blinded (patients, {investigators, and study personnel}†).*
STUDY QUESTION
Setting:
312 primary care physician practices in the Netherlands.
Patients:
664 patients ⩾18 years of age (54% women) who visited their general practitioner for new onset dyspepsia (pain or discomfort in upper abdomen and originating in upper gastrointestinal tract). Exclusion criteria included gastroscopy in the past year, use of prescribed acid suppressive medication in the past 3 months, alarm symptoms (dysphagia, weight loss, anaemia, or haematemesis), pregnancy, or insufficient knowledge of Dutch.
Intervention:
step-up treatment (n = 341) given in 3 four-week steps: (1) antacid (aluminium oxide, 200 mg/magnesium hydroxide, 400 mg) 4 times/day, …
Footnotes
Source of funding: Netherlands Organisation for Health Research and Development.