Clinical Question: Does an initial course of proton pump inhibitors (PPIs) for patients with uninvestigated dyspepsia reduce the need for endoscopy?

Setting: Outpatient (any)

Study Design: Randomized controlled trial (double-blinded)

Synopsis: The test-and-treat strategy has been advocated by many physicians for patients with uninvestigated, uncomplicated dyspepsia. The strategy involves determining the status of Helicobacter pylori, eradicating H. pylori if positive, and trying antisecretory agents if negative. The researchers in this study argue, somewhat unconvincingly, that this strategy is potentially dangerous, that many physicians are reluctant to adopt the test-and-treat strategy, and that an initial course of PPIs for six weeks is preferred.

Adults with at least one week of significant dyspepsia were randomized to receive six weeks of omeprazole in a dosage of 20 mg orally twice a day (n = 71) or placebo (n = 69). Those with a history of ulcer, alarm symptoms, or primarily reflux symptoms were excluded. Because this was a Department of Veterans Affairs study, 95 percent of patients were men; the mean age was 51 years. Patients taking nonsteroidal anti-inflammatory drugs were instructed to stop, and were followed up at one, two, and six weeks, and at three, six, nine, and 12 months. Allocation was concealed, patients and investigators were appropriately masked, and analysis was by intention to treat.

The primary outcome was a Severity of Dyspepsia Assessment Pain Intensity score of 29 or more at any point (the possible score ranges from 2 to 47, and the instrument has been validated). Patients with treatment failure underwent endoscopy and were then treated on the basis of the endoscopy results. Initially, fewer treatment failures occurred in the omeprazole group, probably because patients with reflux were not completely excluded (36 percent undergoing endoscopy had erosive esophagitis). After one year, there was no significant difference in the number of treatment failures, so there was no long-term avoidance of endoscopy as a result of six weeks of treatment with PPIs.

Bottom Line: While an initial course of PPIs will help patients with reflux disease and will cure ulcers, it will not reduce the risk of recurrent ulcer and will do little or nothing for patients with functional dyspepsia. Now we know that it also does not reduce the likelihood of undergoing endoscopy down the road. Test and treat remains the preferred strategy for patients with uninvestigated dyspepsia. (Level of Evidence: 1b)