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

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.