ONE-WEEK OMEPRAZOLE TREATMENT IN THE DIAGNOSIS OF GASTROESOPHAGEAL REFLUX DISEASE

Background: Symptoms of gastro-oesophageal reflux are common, and curr ently available methods for diagnosing reflux disease are expensive an d uncomfortable for the patient. The diagnostic value of a treatment t est with omeprazole is unclear. Methods: Patients with dyspepsia inclu ding heartburn admitted for upper gastrointestinal endoscopy were stud ied in a prospective, randomized, double-blind Scandinavian multicentr e study. Before entry 188 patients were enrolled, and 160 were randomi zed to 1-week treatment with 20 mg omeprazole twice daily or placebo. Gastro-oesophageal reflux disease (GERD) was defined as reflux oesopha gitis Savary-Miller grades II-III at endoscopy or pH <4 exceeding 4% o f the total time at 24-h oesophageal pH-monitoring and was found in 13 5 patients. The treatment test was considered positive when the patien t's symptoms improved during the treatment week compared with the pret reatment day. Results: The sensitivity in diagnosing reflux disease wa s 71-81% with omeprazole as a diagnostic test, compared with 36-47% fo r placebo during treatment days 3-7. The specificity was similar for t he two treatment arms during the first days of the study. During the e nd of the week a larger proportion of the patients with normal endosco py and pH test responded to omeprazole treatment, giving omeprazole lo wer specificity than placebo. The investigators' overall evaluation of whether the patient was a responder to the test had a sensitivity of 75% and a specificity of 55% in the omeprazole-treated patients. The c orresponding figures in the placebo group were 17% and 92%, respective ly. Conclusion: One week of omeprazole treatment is a simple diagnosti c test with a fairly high sensitivity. The specificity is poor owing t o the placebo effect and to the lack of a gold standard in diagnosing reflux disease.