Randomized Controlled Trial of Upper Esophageal Sphincter Assist Device in Laryngopharyngeal Reflux Disease

Effective therapies for laryngopharyngeal reflux disease (LPRD) are limited. The noninvasive upper esophageal sphincter assist device (UESAD) applies external cricoid pressure to prevent esophago-pharyngeal reflux events and has been associated with symptom improvement in uncontrolled single-arm studies. We aimed to conduct the first randomized controlled trial of the UESAD in patients with LPRD refractory to anti-secretory therapy.

Enrolled adults with objective LPRD and ≥8 weeks of laryngopharyngeal symptoms despite anti-secretory therapy were randomly assigned 1:1 to 8 weeks of intervention (UESAD applying therapeutic pressure [20-30 mm Hg]) or comparator (UESAD applying low pressure [4-11 mm Hg]), followed by an optional 4-week open-label extension. The primary outcome was change in reflux symptom index (RSI); secondary outcomes included salivary pepsin concentration and adverse events.

Of 72 participants enrolled, 68 were randomized: mean age, 56.0 years (standard deviation [SD], 16.4 years); 60.3% female; body mass index, 26 kg/m² (SD, 4.7 kg/m²). In intention-to-treat analyses, the primary endpoint was met in 45.2% of the intervention and 53.6% of the comparator group with significant reduction in RSI scores (-6.13 and -5.90) and significant reduction in salivary pepsin among both groups (-52.95 and -49.12 ng/mL). There were no serious adverse events.

In this randomized double-blinded controlled trial of patients with LPRD, significant differences in laryngopharyngeal symptoms were not seen between application of the UESAD at therapeutic vs lower pressures. Laryngopharyngeal symptoms as well as pepsin concentrations significantly improved among both groups, suggesting that application of external cricoid pressure, even at lower levels, is a safe, noninvasive, well-tolerated, and effective therapy for LPRD.

gov, Number: NCT04827355.