Abstract

BackgroundNone of current diagnostic methods has been proven to be a reliable tool for gastro-esophageal reflux disease (GERD). Pepsin in saliva has been proposed as a promising diagnostic biomarker for gastro-esophageal reflux. We aimed to determine the diagnostic value of salivary pepsin detection for GERD.MethodsTwo hundred and fifty patients with symptoms suggestive of GERD and 35 asymptomatic healthy volunteers provided saliva on morning waking, after lunch and dinner for pepsin determination using the Peptest lateral flow device. All patients underwent 24-h multichannel intraluminal impedance pH (24-h MII-pH) monitoring and upper gastrointestinal endoscopy. Based on 24-h MII-pH and endoscopy study, patients were defined as GERD (abnormal MII-pH results and/or reflux esophagitis) and non-GERD otherwise.ResultsPatients with GERD had a higher prevalence of pepsin in saliva and higher pepsin concentration than patients with non-GERD and healthy controls (P < 0.001 for all). The pepsin test had a sensitivity of 73% and a specificity of 88.3% for diagnosing GERD using the optimal cut-off value of 76 ng/mL. Postprandial saliva samples collected when the symptoms occurred had a more powerful ability to identify GERD.ConclusionsSalivary pepsin test had moderate diagnostic value for GERD. It may be a promising tool to replace the use of currently invasive tools with advantages of non-invasive, easy to perform and cost effective.Trial registrationChiCTR-DDD-16009506 (date of registration: October 20, 2016).

Highlights

  • None of current diagnostic methods has been proven to be a reliable tool for gastro-esophageal reflux disease (GERD)

  • A potential factor contributing to the mucosal tissues when gastro-esophageal reflux (GER) occurs, is a protease originating from pepsinogen synthesized by the

  • There were significant differences between non-GERD and GERD patients regarding to the parameters of reflux monitoring and HMR and the presence of Hiatus hernia (HH), except for resting Upper esophageal sphincter (UES) pressure (Table 2)

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Summary

Introduction

None of current diagnostic methods has been proven to be a reliable tool for gastro-esophageal reflux disease (GERD). Pepsin in saliva has been proposed as a promising diagnostic biomarker for gastro-esophageal reflux. We aimed to determine the diagnostic value of salivary pepsin detection for GERD. Gastro-esophageal reflux disease (GERD) refers to “a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications” in the Montreal Classification [1]. Current methods employed in the diagnosis of GERD include GERD questionnaires, “PPI test”, endoscopy and ambulatory esophageal reflux monitoring. Some studies have shown that pepsin detection in the sputum and/or saliva can be regarded as a sensitive, non-invasive method for the diagnosis of the proximal reflux of gastric contents or laryngopharyngeal reflux (LPR) [14,15,16,17]. In the present study, we aimed to determine whether the use of pepsin determination in saliva could be useful for diagnosing GERD in the adult cohort from China with Peptest (RD Biomed Ltd., Hull, UK)

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