Abstract
Objectives:
(1) Describe treatment of the heterogeneous disorder of laryngopharyngeal reflux (LPR) with a new upper esophageal sphincter (UES) assist medical device designed to eliminate the reflux of gastric contents into the laryngopharynx. (2) Analyze the reduction of symptoms pre-therapy compared to posttherapy.
Methods:
Patients presenting with a reflux symptoms index (RSI) >13 and diagnosed with chronic cough, postnasal drip, globus, or throat clearing were included in the study. The UES assist device was fitted individually to apply external pressure above 20 mm Hg at the cricoid and worn when sleeping. The primary effectiveness endpoint was reduction of the RSI at 4 weeks. SF-36 Health Survey, Functional Outcomes of Sleep Questionnaire (FOSQ), and patient and physician satisfaction scores were secondary end points. Intent to treat (ITT) analysis was performed. Safety was based on reported adverse reactions.
Results:
Forty-four patients consented, with 42 (ITT) completing the study (age, 47 ± 13.1 years; body mass index, 24.8 ± 3.5; 66% female; 75% Caucasian). Most troublesome symptoms were post nasal drip, throat clearing, and annoying cough. Adverse events were mild and short in duration with no study withdrawals due to an adverse event. There was a significant (P < .0001) reduction of the RSI at 2 weeks (13.2 ± 8.8) and 4 weeks (10.2 ± 7.6) posttherapy compared with pretherapy (24.5 ± 5.9). Ninety-one percent of patients improved at least 25% with 33% improving at least 75%.
Conclusions:
The UES assist device is a safe and effective noninvasive method for the treatment of LPR and provides clinical utility within 2 weeks. This could be a potential alternative for LPR before considering medications or surgery.
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