December 17, 2012
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PPI test showed limitations in identifying patients with GERD

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Patients with and without GERD are likely to have positive proton-pump inhibitor test results, limiting its usefulness in identifying the condition, according to recent study results.

Researchers evaluated data collected from a multinational study comparing the effectiveness of the reflux disease questionnaire to symptom-based diagnoses in identifying GERD in patients complaining of recurrent upper gastrointestinal symptoms. In the study, 308 patients received placebo for a median of 8 days while they were assessed via endoscopy, symptom association monitoring (SAM) and wireless esophageal pH-metry. All participants then received a proton pump inhibitor (PPI) test consisting of 40 mg esomeprazole once a day for 2 weeks, during which treatment impact on their symptoms was observed.

GERD was diagnosed in 197 patients according to esophageal pH levels measuring less than 4 for more than 5.5% of a 24-hour period, positive results from symptom association monitoring or the PPI test, or the presence of reflux esophagitis.

Among 299 evaluable cases, PPI tests were positive (defined as an absence of heartburn, central chest pain and regurgitation in the last 2 days of treatment) in 69% of patients with and 51% of those without GERD. Excluding positive test results did not significantly affect diagnostic precision.

The researchers calculated likelihood ratios (LRs) for positive and negative predictive PPI tests and concluded that the test had limited diagnostic value. LRs for positive predictive tests were 1.52 among all participants, 1.81 among nonresponders to placebo and 1.26 among patients with typical GERD symptoms. LRs for negative predictive PPI tests were 0.71, 0.69, and 0.67, respectively, for the same groups.

“The PPI test is likely to be positive in the majority of patients with typical reflux symptoms, but is not a definitive test for GERD because a significant proportion of non-GERD patients also have a positive PPI test,” the researchers wrote. “Even when combined with clinical diagnosis or a diagnostic questionnaire, the outcome of a PPI test does not add reliable information to distinguish between patients with and without GERD. Thus, in a well-characterized population of primary care patients with frequent upper-GI symptoms of any type, the PPI test has limited ability to predict GERD correctly.”

Disclosure: See the study for a full list of relevant disclosures.