1. Upper Esophageal Sphincter Compression Device as an Adjunct to Proton Pump Inhibition for Laryngopharyngeal Reflux
- Author
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Yadlapati, Rena, Pandolfino, John E, Greytak, Madeline, Cahoon, Jonathon, Clarke, Mary, Clary, Matthew, Fink, Daniel, Menard-Katcher, Paul, Vahabzadeh-Hagh, Andrew M, Weissbrod, Philip, Gupta, Samir, Kaizer, Alexander, and Wani, Sachin
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Digestive Diseases ,Clinical Research ,Clinical Trials and Supportive Activities ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Oral and gastrointestinal ,Adult ,Esophageal Sphincter ,Upper ,Esophagitis ,Peptic ,Female ,Humans ,Laryngopharyngeal Reflux ,Male ,Middle Aged ,Pepsin A ,Prospective Studies ,Proton Pump Inhibitors ,Proton Pumps ,Treatment Outcome ,Gastroesophageal reflux disease ,Extra-esophageal reflux ,Peptest ,Ambulatory reflux monitoring ,Gastroenterology & Hepatology ,Clinical sciences - Abstract
BackgroundThe 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).MethodsThis 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.ResultsThirty-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
- Published
- 2022