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

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).

• Authors: 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
• Journal: Digestive diseases and sciences (Dig Dis Sci) Vol. 67 Issue 7 Pg. 3045-3054 (07 2022) ISSN: 1573-2568 [Electronic] United States
• PMID: 34275061 (Publication Type: Clinical Trial, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: © 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Chemical References

• Proton Pump Inhibitors
• Proton Pumps
• Pepsin A

Topics

• Adult
• Esophageal Sphincter, Upper
• Esophagitis, Peptic (drug therapy)
• Female
• Humans
• Laryngopharyngeal Reflux (diagnosis, therapy)
• Male
• Middle Aged
• Pepsin A (therapeutic use)
• Prospective Studies
• Proton Pump Inhibitors (therapeutic use)
• Proton Pumps (therapeutic use)
• Treatment Outcome