Background & Aims It has been a challenge to confirm the association between laryngeal symptoms and physiologic reflux disease. We examined the ability of oropharyngeal pH tests (with the Restech Dx-pH system) and salivary pepsin tests (with Peptest) to discriminate between asymptomatic volunteers (controls) and subjects with a combination of laryngeal and reflux symptoms (laryngeal±reflux). Methods We performed a physician-blinded prospective cohort study of 59 subjects at a single academic institution. Adult volunteers were recruited and separated into 3 groups based on GerdQ and reflux symptom index scores: controls (n=20), laryngeal symptoms (n=20), or laryngeal+reflux symptoms (n=19). Subjects underwent laryngoscopy and oropharyngeal pH tests and submitted saliva samples for analysis of pepsin concentration. Primary outcomes included abnormal acid exposure and composite (RYAN) score for oropharyngeal pH tests and abnormal mean salivary pepsin concentration based on normative data. Results Complete oropharyngeal pH data were available from 53 subjects and complete salivary pepsin data from 35 subjects. We did not observe any significant differences between groups in percent time spent below pH 4.0, 5.0, 5.5, 6.0 or RYAN scores; or percent of subjects with positive results from tests for salivary pepsin (53% vs 40% vs 75%; P=.50, respectively). The laryngeal+reflux group had a significantly higher estimated mean concentration of salivary pepsin (117.9±147.4ng/mL) than the control group (32.4±41.9ng/mL) or laryngeal symptom group (7.5±11.2ng/mL) (P=.01 and P=.04, respectively). Conclusions Using current normative thresholds, oropharyngeal pH testing and salivary pepsin analysis are not able to distinguish between healthy volunteers and subjects with a combination of laryngeal and reflux symptoms.
Introduction Predicting response to proton-pump inhibitor (PPI) therapy in patients with laryngeal symptoms is challenging. The Restech Dx-pH probe is a transnasal catheter that measures oropharyngeal pH. In this study, we aimed to investigate the prognostic potential of oropharyngeal pH monitoring to predict responsiveness to PPI therapy in patients with laryngeal symptoms. Methods We conducted a physician blinded prospective cohort study at a single academic institution between 1/2013–10/2014. Adult patients with Reflux Symptom Index scores (RSI) ≥13 off PPI therapy were recruited. Patients underwent video laryngoscopy and 24-hour oropharyngeal pH monitoring, followed by an 8–12 week trial of omeprazole 40 mg daily. Prior to, and following PPI therapy, patients completed various symptom questionnaires. The primary outcome was the association between PPI response and oropharyngeal pH metrics. PPI response was separated into three subgroups based on post-treatment RSI score and % RSI response: Non-response = RSI ≥ 13; Partial response = post-treatment RSI < 13 and change in RSI < 50%; and Complete response = post-treatment RSI < 13 and change in RSI ≥ 50%. The primary analysis utilized a multinomial logistic regression controlling for pre-treatment RSI score. A secondary analysis assessed the relationship between change in RSI (post-pre) and oropharyngeal pH metrics via ordinary least square regression. Results Thirty-four patients completed the study and were included in final analysis. Symptom response to PPI therapy was as follows: 50% no response, 15% partial-response and 35% complete-response. Non-responders had a higher pre-treatment RSI (P < 0.01). There were no significant differences in oropharyngeal acid exposure (below pH of 4.0, 5.0, 5.5, 6.0 and RYAN scores) between responder types. The secondary analysis noted a trend between lower PPI response and greater total percent time below pH of 5.0 (P = 0.03), upright percent time below pH of 5.0 (p = .07) and RYAN supine (corrected) (P = 0.03), as well as an association between PPI response and greater decreases in the Anxiety Sensitivity Inventory (P < 0.01), Brief Symptom Inventory-18 (P < 0.01), and Negative Affect Scale (P < 0.01). Discussion Oropharyngeal pH testing did not predict laryngeal symptom response to PPI therapy. Contrary to hypothesis, our study signaled that the degree of oropharyngeal acid exposure is inversely related to PPI response. In addition, reduction in negative affect and psychological distress parallels PPI response.
Laryngopharyngeal reflux (LPR) is a clinical entity diagnosed by history laryngoscopic findings that has a variable response to empiric proton-pump inhibitor (PPI) therapy. While the reflux finding score (RFS), an endoscopic scoring scheme, has been advanced as a measure of LPR, it has not been externally validated against symptom severity in practice. Extralaryngeal pharyngeal endoscopic findings may have diagnostic utility but remain underexplored. This study assesses the correlation between extralaryngeal findings and (1) 24-hour oropharyngeal pH & (2) PPI response in patients with suspected LPR. Subjects presented to a tertiary care center with laryngeal symptoms ≥1 month and reflux symptom index (RSI) ≥13. Following baseline questionnaires, laryngoscopy, and a 24-hour oropharyngeal pH probe study, subjects were prescribed 8-12 week omeprazole trials. Baseline endoscopic findings were scored in a blinded fashion using the RFS and extralaryngeal score criteria, summatively the 'ELS.' PPI response was defined as ≥50% improvement in RSI. Thirty-three subjects with flexible endoscopic recordings completed baseline and follow-up questionnaires. The cohort's baseline mean RSI was 23.0 ± 7.2 with a ΔRSI = 9.8 after PPI therapy. The baseline RFS score averaged 5.3 ± 2.7. 45% of our subjects was found to be PPI responsive. The Cohen's kappa for the ELS but not the RFS was significant. There were no significant differences between the RFS (P = 0.10) or ELS (P = 0.07) for PPI responders & nonresponders. Oropharyngeal pH measures did not correlate with the RFS or ELS. In conclusion, endoscopic scores of laryngeal and extralaryngeal findings did not predict PPI response or oropharyngeal acid exposure in suspected LPR.
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