Be. Schenk et al., OMEPRAZOLE AS A DIAGNOSTIC-TOOL IN GASTROESOPHAGEAL REFLUX DISEASE, The American journal of gastroenterology, 92(11), 1997, pp. 1997-2000
Objective: To determine the diagnostic value of empirical treatment wi
th omeprazole in the diagnosis of gastroesophageal reflux disease (GER
D), Methods: Patients with symptoms suggestive of GERD underwent upper
gastrointestinal endoscopy and 24-h esophageal pH monitoring, Patient
s with reflux esophagitis grade 0 or 1 were included in the study and
were randomized to double-blind treatment with either 40 mg omeprazole
or placebo o.m. The effect of treatment was evaluated after 1 and 2 w
k with a symptom questionnaire with a four-grade Likert scale, and sym
ptomatic response outcome was compared with the results of 24-h pH-met
ry, Results: Ninety-eight patients were included; however, 13 were exc
luded from the final analysis because of protocol violation, Of the re
maining 85 patients, 54 had no signs of esophagitis at endoscopy, and
31 had esophagitis grade 1, The pH registration showed pathological ga
stroesophageal reflux in 47 patients (55%), Forty-one patients were ra
ndomized to treatment with omeprazole and 44 to placebo, There was a s
ignificant correlation between the pH registration result and response
to omeprazole (p = 0.04, chi(2)), but not to placebo (p = 0.16), With
ps-metry as the gold standard, the omeprazole test had positive and n
egative predictive values of 68% and 63%, respectively, for the diagno
sis of GERD, When the omeprazole test was used as the gold standard, t
he positive and negative predictive values of pH monitoring were 68% a
nd 63%, respectively, Similar sensitivity was found when the pH-metry
was compared with presence of esophagitis, Conclusion: Determination o
f the symptomatic response to 40 mg of omeprazole for 14 days is a sim
ple and inexpensive tool for the diagnosis of GERD, with a sensitivity
and specificity comparable to 24-h pH monitoring.