Endoscopy‐negative reflux disease: what is the value of a proton‐pump inhibitor test in everyday clinical practice?

Abstract

Background: Our aim in this study was to evaluate a simple test with proton‐pump inhibitor (PPI) for use in everyday clinical practice in diagnosing endoscopy‐negative reflux disease. Methods: 68 patients with heartburn and/or acid regurgitation as their main complaint, symptoms of at least 3 months' duration prior to inclusion, all with a negative gastroscopy were included. The patients were given 60 mg of lansoprazole before breakfast for 7 days. After the test week, patients had to answer one single question on a formula. ‘Did you essentially, without any doubt, have less heartburn and/or acid regurgitation during the treatment?’ The only alternative answers were ‘Yes’ or ‘No’. Patients in doubt were told to answer ‘No’. 24‐h pH monitoring was performed at the earliest 14 days after the test. Results: 65 completed the PPI test and 52 fulfilled the pH monitoring. Defined by <4% time oesophageal pH <4, 34 (65%) had pathological reflux. The PPI test was positive in all patients with pathological reflux but also in 17 of 18 with normal pH‐metry, giving the test a sensitivity of 97% and specificity of 6%. Conclusion: Application of a diagnostic PPI test in clinical practice gave a high sensitivity and unusually low specificity compared to placebo‐controlled studies, indicating that a test of this nature should be used with caution in everyday practice. Most patients with endoscopy‐negative GORD will be diagnosed clinically. A positive test with PPI strengthens the diagnosis but has insufficient specificity to be an objective criterion alone. pH‐metry should be unnecessary for the diagnosis of ENGORD in patients with typical reflux symptoms.