Upper Esophageal Sphincter Compression Device as an Adjunct to Proton Pump Inhibition for Laryngopharyngeal Reflux

Rena Yadlapati, John E Pandolfino, Madeline Greytak, Jonathon Cahoon, Mary Clarke, Matthew Clary, Daniel Fink, Paul Menard-Katcher, Andrew M Vahabzadeh-Hagh, Philip Weissbrod, Samir Gupta, Alexander Kaizer, Sachin Wani, Rena Yadlapati, John E Pandolfino, Madeline Greytak, Jonathon Cahoon, Mary Clarke, Matthew Clary, Daniel Fink, Paul Menard-Katcher, Andrew M Vahabzadeh-Hagh, Philip Weissbrod, Samir Gupta, Alexander Kaizer, Sachin Wani

Abstract

Background: The Reflux Band, an external upper esophageal sphincter (UES) compression device, reduces esophago-pharyngeal reflux events. This study aimed to assess device efficacy as an adjunct to proton pump inhibitor (PPI) therapy in patients with laryngopharyngeal reflux (LPR).

Methods: This two-phase prospective clinical trial enrolled adults with at least 8 weeks of laryngeal symptoms (sore throat, throat clearing, dysphonia) not using PPI therapy at two tertiary care centers over 26 months. Participants used double dose PPI for 4 weeks in Phase 1 and the external UES compression device nightly along with PPI for 4 weeks in Phase 2. Questionnaire scores and salivary pepsin concentration were measured throughout the study. The primary endpoint of symptom response was defined as reflux symptom index (RSI) score ≤ 13 and/or > 50% reduction in RSI.

Results: Thirty-one participants completed the study: 52% male, mean age 47.9 years (SD 14.0), and mean body mass index (BMI) 26.2 kg/m2 (5.1). Primary endpoint was met in 11 (35%) participants after Phase 1 (PPI alone) and 17 (55%) after Phase 2 (Device + PPI). Compared to baseline, mean RSI score (24.1 (10.9)) decreased at end of Phase 1 (PPI alone) (21.9 (9.7); p = 0.06) and significantly decreased at end of Phase 2 (Device + PPI) (15.5 (10.3); p < 0.01). Compared to non-responders, responders to Device + PPI had a significantly lower BMI (p = 0.02) and higher salivary pepsin concentration (p = 0.01).

Conclusion: This clinical trial highlights the potential efficacy of the external UES compression device (Reflux Band) as an adjunct to PPI for patients with LPR (ClinicalTrials.Gov NCT03619811).

Keywords: Ambulatory reflux monitoring; Extra-esophageal reflux; Gastroesophageal reflux disease; Peptest.

Conflict of interest statement

RY: Consultant for Medtronic (Institutional), Ironwood Pharmaceuticals (Institutional), Phathom Pharmaceuticals. Medical Advisory board with Stock Options: RJS Mediagnostix. Research funding: Ironwood Pharmaceuticals. SW: Consultant for Boston Scientific, Medtronic, Cernostics, Exact Sciences and Interpace. Supported by the NIH/NIDDK (U34 DK124174) and University of Colorado Department of Medicine Outstanding Early Scholars Program. None: JC, MC, MC, DF, MG, SG, AK, PMK, AMVH, JEP, and PW.

© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Figures

Fig. 1
Fig. 1
Study protocol. This two-phase 8-week study protocol included baseline data collection at enrollment, 4 weeks of PPI use alone in Phase 1, a mid-study visit at week 4 for data collection and external UES compression device fitting, 4 weeks of external UES compression device use with PPI in Phase 2, and an end of study visit at week 8 for data collection and follow-up
Fig. 2
Fig. 2
Participant study flow. Of 43 participants enrolled, 36 completed Phase 1 and 31 completed both Phase 1 and Phase 2
Fig. 3
Fig. 3
Box plot of reflux symptom index (RSI) scores throughout the study. Compared to baseline, mean RSI scores did not significantly change during Phase 1 (with PPI alone). Compared to baseline and end of Phase 1, mean RSI scores significantly reduced during Phase 2 (with Device and PPI use)
Fig. 4
Fig. 4
Personalized clinical approach for suspected LPR. This approach synthesizes results from this study with current practice guidelines to provide a personalized clinical approach for patients with chronic laryngeal symptoms based on symptom presentation and results of esophageal physiologic testing

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