Clinical and economic assessment of the omeprazole test in patients with symptoms suggestive of gastroesophageal reflux disease

Objective: To evaluate the diagnostic accuracy of a trial of a high-dose pr oton pump inhibitor (the omeprazole test) in detecting gastroesophageal ref lux disease (GERD) in patients with heartburn symptoms. Design: A randomized, double-blind, placebo-controlled, crossover trial. Patients and Setting: Forty-three consecutive patients with symptoms sugges tive of GERD were enrolled at a Veterans Affairs medical center. Main Outcome Measures: Symptom response to the omeprazole test vs placebo i n GERD-positive and GERD-negative patients; sensitivity, specificity, and p ositive and negative predictive values of the omeprazole test; and cost per correct diagnosis achieved with the omeprazole test compared with traditio nal diagnostic strategies. Results: Of 42 patients (98%) who completed the study, 35 (83%) were classi fied as GERD positive and 7 (17%) as GERD negative. Twenty-eight GERD-posit ive and 3 GERD-negative patients responded to the omeprazole test, providin g a sensitivity of 80.0% (99% confidence interval, 66.7%-93.3%) and a speci ficity of 57.1% (95% confidence interval, 20.5%-93.8%). Economic analysis r evealed that the omeprazole test saves $348 per average patient evaluated, and results in a 64% reduction in the number of upper endoscopies performed and a 53% reduction in the use of pH testing. Conclusions: The omeprazole test is sensitive and fairly specific for diagn osing GERD in patients with typical GERD symptoms. This strategy could resu lt in significant cost savings and decreased use of invasive diagnostic tes ts.