The value of esomeprazole test in diagnosing gastroesophageal reflux disease:A randomized multi-center controlled trial / 中华消化杂志

ABSTRACT

Objective To evaluate the diagnostic value of esomeprazole test in patients with gastroesophageal reflux disease.Methods Consecutive patients with heartburn and/or acid regurgitation in three medical centers were enrolled in a prospective,randomized,double-blind study with a placebo-control design.After upper endoscopy examination,patients were divided into non-erosive reflux diseases and erosive esophagitis.All patients underwent 24-hour ambulatory esophageal pH monitoring.Those who were diagnosed as gastroesophageal reflux diseases had either esophagitis under endoscopy or abnormal esophageal acid exposure in 24-hour ambulatory esophageal pH monitoring.The patients were randomly divided into treatment group and control group.The patients in treatment group were received 40 mg of esomeprazole daily while the patients in control group were given placebo once daily for 14 days.The severity and frequency of heartburn were recorded both by doctors and patients before and during treatment.Results Two hundred and seventeen patients were completed the study(105 patients in treatment group and 112 patients in control group).If the symptom of heartburn which disappeared in the sixth and seventh day of the first week,it was defined as positive for esomeprazole test,the sensitivity and specificity in treatment group were 87.7% and 42.5%,respectively If the symptom of heartburn disap peared in the second week,it was defined as positive for esomeprazole test.The corresponding sensitivity and specificity in treatment group were 84.6% and 45%,respectively.The Youden index was 0.362 and 0.296 for criteria of one and two weeks,respectively.If the heartburn score improved by more than 50%,75% or 100% from the baseline score after treatment,it was defined as positive for esomeprazole test,the sensitivity and specificity were 95.4% and 32.5%,87.7% and 32.5%,84.6% and 45%,respectively.Conclusions The esomeprazole test has high value in diagnosis of GERD with sensitivity of 87.7% and specificity of 42.5%.Positive definition of heartburn disappeared in the sixth and seventh day is superior in cost-effective.