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<p>This study evaluates salivary pepsin as a non-invasive biomarker for diagnosing laryngopharyngeal reflux (LPR) in the Indian population, analyzing its diagnostic accuracy, correlation with videolaryngoscopic findings, and potential as a treatment response predictor. A cross-sectional study was conducted at a tertiary ENT center in Puducherry, involving 94 adults with LPR (Reflux Symptom Index &gt; 13 and Reflux Finding Score &gt; 7). Clinical data, videolaryngoscopic findings, and salivary samples were collected. Pepsin levels were measured using the Origin Diagnostics Human PP (Pepsin) ELISA Kit. Statistical analysis included chi-square tests, multivariate regression, and ROC curves to assess diagnostic performance and correlations. Among 94 patients (mean age 41.7 ± 9.9 years; 54.3% male), 85.1% tested positive for salivary pepsin (cutoff: 50 ng/ml). Diagnostic accuracy was high (sensitivity: 85.1%, specificity: 78.6%, AUC: 0.82). A strong correlation was found between RFS and pepsin levels (<i>r</i> = 0.732, <i>p</i> &lt; 0.001). Significant associations were observed with vocal fold edema (<i>r</i> = 0.377), posterior commissure hypertrophy (<i>r</i> = 0.311), subglottic edema (<i>r</i> = 0.300), and diffuse laryngeal edema (<i>r</i> = 0.250). Patients with vocal fold edema ≥ grade 2 had significantly higher pepsin levels (352.5 ± 90.4 ng/ml) than those with mild or no edema (272.8 ± 65.4 ng/ml; <i>p</i> &lt; 0.001). Pepsin positivity was also associated with age, gender, smoking, alcohol use, and BMI. Salivary pepsin testing is a sensitive, specific, and cost-effective diagnostic tool for LPR in resource-limited settings. Its strong correlation with objective laryngeal findings supports its use as both a diagnostic and prognostic biomarker. Multicenter studies are recommended for broader validation and guideline integration.</p>

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Salivary Pepsin as a Biomarker for Laryngopharyngeal Reflux: A Clinical and Endoscopic Correlation

  • 期刊论文

  • 发表日期：

    2025年12月17日

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  • Preethi Ravindranath,
  • V. Nirmal Coumare,
  • Padmanabhan Karthikeyan,
  • Sharad Ashish,
  • Agiesh Kumar,
  • S. Rajesh

摘要

This study evaluates salivary pepsin as a non-invasive biomarker for diagnosing laryngopharyngeal reflux (LPR) in the Indian population, analyzing its diagnostic accuracy, correlation with videolaryngoscopic findings, and potential as a treatment response predictor. A cross-sectional study was conducted at a tertiary ENT center in Puducherry, involving 94 adults with LPR (Reflux Symptom Index > 13 and Reflux Finding Score > 7). Clinical data, videolaryngoscopic findings, and salivary samples were collected. Pepsin levels were measured using the Origin Diagnostics Human PP (Pepsin) ELISA Kit. Statistical analysis included chi-square tests, multivariate regression, and ROC curves to assess diagnostic performance and correlations. Among 94 patients (mean age 41.7 ± 9.9 years; 54.3% male), 85.1% tested positive for salivary pepsin (cutoff: 50 ng/ml). Diagnostic accuracy was high (sensitivity: 85.1%, specificity: 78.6%, AUC: 0.82). A strong correlation was found between RFS and pepsin levels (r = 0.732, p < 0.001). Significant associations were observed with vocal fold edema (r = 0.377), posterior commissure hypertrophy (r = 0.311), subglottic edema (r = 0.300), and diffuse laryngeal edema (r = 0.250). Patients with vocal fold edema ≥ grade 2 had significantly higher pepsin levels (352.5 ± 90.4 ng/ml) than those with mild or no edema (272.8 ± 65.4 ng/ml; p < 0.001). Pepsin positivity was also associated with age, gender, smoking, alcohol use, and BMI. Salivary pepsin testing is a sensitive, specific, and cost-effective diagnostic tool for LPR in resource-limited settings. Its strong correlation with objective laryngeal findings supports its use as both a diagnostic and prognostic biomarker. Multicenter studies are recommended for broader validation and guideline integration.