Background: Although the 'test-and-treat' strategy is suggested as first-line therapy for uninvestigated dyspepsia, no large-scale studies in a real-life setting are available.
Methods: 1552 dyspeptic patients aged between 25 and 60 with no alarm symptoms were recruited to the study. After screening with a 13C-urea breath test, they were randomized into three treatment arms: Helicobacter pylori-positive either to eradication therapy with OAM (omeprazole, amoxycillin and metronidazole) (Hp+/erad) or omeprazole 20 mg daily (Hp+/ome) for 10 days, whereas H. pylori-negative patients (Hp-/ome) were treated with 20 mg omeprazole for 10 days. Gastrointestinal symptoms were registered at baseline at 1 and 2 years on the Gastrointestinal Symptom Rating Scale (GSRS) and quality of life with the Psychological General Well-Being index (PGWB). Additional visits, referrals for and number of endoscopies and their findings were registered during the 2 years' follow-up.
Results: Of the 1552 patients, 583 were H. pylori-positive (37.6%), and 288 of these were randomized for omeprazole and 295 to OAM. The Hp-/ome group had fewer general practitioner (GP) contacts (P<0.0001) than the H. pylori-positive groups. Eradication therapy significantly improved general well-being and reduced upper gastrointestinal symptoms: abdominal pain (P=0.0001), heartburn (P=0.0061), acid regurgitation (P=0.003), hunger pain (P=0.009), especially in Hp+/erad. Peptic ulcer was found in 6.2%, 1.0%, 0.2% in Hp+/ome, Hp-+/erad and Hp-/ome, respectively (P=0.0007). Only 3 patients (1.0%) developed peptic ulcers in Hp-+/erad, all eradication failures.
Conclusions: In uninvestigated dyspepsia, a negative test result for H. pylori reduces the number of GP contacts and endoscopy referrals compared to H. pylori-positive regardless of eradication therapy. Applied in real life, the test-and-treat strategy failed to reduce the number of endoscopies, but significantly reduced peptic ulcer disease and improved dyspeptic symptoms and quality of life.