Michael Zhang1, Clemente Chia1, Claire Stanley1, Debra J Phyland1,2,3, Paul M Paddle1,2,3. 1. Department of Otolaryngology-Head and Neck Surgery, Monash Health, Melbourne, Australia. 2. Department of Surgery, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia. 3. Melbourne Swallow Analysis Centre, Melbourne, Australia.
Abstract
OBJECTIVE: Laryngopharyngeal reflux (LPR) is defined as the retropulsion of gastric contents into the larynx, oropharynx, and/or nasopharynx. The 24-hour combined hypopharyngeal-esophageal multichannel intraluminal impedance with dual pH probe (24h-HEMII-pH) is currently the gold standard in LPR diagnosis; however, it is invasive, user dependent, and not always tolerated. This study assesses the diagnostic utility of salivary pepsin (Peptest) at different thresholds and during symptomatic periods as compared with the 24h-HEMII-pH probe in diagnosing LPR. STUDY DESIGN: Prospective cohort study. SETTING: Private laryngology clinic in Melbourne, Australia. SUBJECTS AND METHODS: Thirty-five patients with a clinical history and endoscopic findings of LPR were recruited and simultaneously evaluated for LPR via 24h-HEMII-pH probe and salivary pepsin analysis at 5 key time points over the same 24-hour period. RESULTS: Salivary pepsin was 76.9% sensitive and had a positive predictive value (PPV) of 87.0% at a threshold of 16 ng/mL when compared with the 24h-HEMII-pH probe. If the pathologic pepsin threshold was raised to 75 ng/mL, salivary pepsin had a sensitivity of 57.7%, a specificity of 75.0%, and a PPV of 93.8%. Symptomatic testing conferred a superior specificity at 16 ng/mL (66.7%) and 75 ng/mL (100.0%) and a superior PPV at 16 ng/mL (92.3%) and 75 ng/mL (100.0%). CONCLUSION: Salivary pepsin detection is a simpler, more cost-effective, and less traumatic universal first-line alternative to 24h-HEMII-pH probe in diagnosing LPR. Superior specificities conferring greater diagnostic value may be achieved with higher thresholds and symptomatic testing. If clinical suspicion remains high following negative salivary pepsin analysis, a 24h-HEMII-pH study could provide further diagnostic information.
OBJECTIVE: Laryngopharyngeal reflux (LPR) is defined as the retropulsion of gastric contents into the larynx, oropharynx, and/or nasopharynx. The 24-hour combined hypopharyngeal-esophageal multichannel intraluminal impedance with dual pH probe (24h-HEMII-pH) is currently the gold standard in LPR diagnosis; however, it is invasive, user dependent, and not always tolerated. This study assesses the diagnostic utility of salivary pepsin (Peptest) at different thresholds and during symptomatic periods as compared with the 24h-HEMII-pH probe in diagnosing LPR. STUDY DESIGN: Prospective cohort study. SETTING: Private laryngology clinic in Melbourne, Australia. SUBJECTS AND METHODS: Thirty-five patients with a clinical history and endoscopic findings of LPR were recruited and simultaneously evaluated for LPR via 24h-HEMII-pH probe and salivary pepsin analysis at 5 key time points over the same 24-hour period. RESULTS: Salivary pepsin was 76.9% sensitive and had a positive predictive value (PPV) of 87.0% at a threshold of 16 ng/mL when compared with the 24h-HEMII-pH probe. If the pathologic pepsin threshold was raised to 75 ng/mL, salivary pepsin had a sensitivity of 57.7%, a specificity of 75.0%, and a PPV of 93.8%. Symptomatic testing conferred a superior specificity at 16 ng/mL (66.7%) and 75 ng/mL (100.0%) and a superior PPV at 16 ng/mL (92.3%) and 75 ng/mL (100.0%). CONCLUSION: Salivary pepsin detection is a simpler, more cost-effective, and less traumatic universal first-line alternative to 24h-HEMII-pH probe in diagnosing LPR. Superior specificities conferring greater diagnostic value may be achieved with higher thresholds and symptomatic testing. If clinical suspicion remains high following negative salivary pepsin analysis, a 24h-HEMII-pH study could provide further diagnostic information.