Upper Esophageal Sphincter Compression Device as an Adjunct to Proton Pump Inhibition for Laryngopharyngeal Reflux
| Autor: | Paul Menard-Katcher, John E. Pandolfino, Matthew Clary, Philip A. Weissbrod, Samir Gupta, Rena Yadlapati, Madeline Greytak, Alexander M. Kaizer, Jonathon Cahoon, Sachin Wani, Mary Clarke, Daniel Fink, Andrew M. Vahabzadeh-Hagh |
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| Rok vydání: | 2022 |
| Předmět: |
Male
Physiology Upper Gastroesophageal reflux disease Gastroenterology Oral and gastrointestinal Laryngopharyngeal reflux Pepsin Sore throat Clinical endpoint Esophagitis Prospective Studies Peptest Ambulatory reflux monitoring biology Proton Pumps Middle Aged Treatment Outcome 6.1 Pharmaceuticals Original Article Female medicine.symptom Adult medicine.medical_specialty medicine.drug_class Clinical Trials and Supportive Activities Clinical Sciences Extra-esophageal reflux Proton-pump inhibitor Clinical Research Internal medicine medicine Laryngopharyngeal Reflux Humans Esophagitis Peptic Esophageal Sphincter Peptic Gastroenterology & Hepatology business.industry Reflux Proton Pump Inhibitors Esophageal Sphincter Upper medicine.disease Pepsin A Clinical trial biology.protein business Digestive Diseases Body mass index |
| Zdroj: | Digestive diseases and sciences, vol 67, iss 7 Digestive Diseases and Sciences |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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