This article is more than 5 years old. Information may no longer be current.
Novel device helps treat reflux-associated laryngeal symptoms
Click Here to Manage Email Alerts
A novel upper esophageal sphincter assist device successfully treated reflux-associated laryngeal symptoms in a pragmatic exploratory clinical trial, according to research published in Clinical Gastroenterology and Hepatology.
Rena Yadlapati, MD, MSHS, of the division of gastroenterology and hepatology at the University of Colorado Anschutz Medical Campus, and colleagues conducted the trial to assess the therapeutic efficacy of the upper esophageal sphincter assist device (UESAD), marketed as the Reza Band (Somna Therapeutics),which uses light pressure to keep the upper esophageal sphincter (UES) closed while a patient is sleeping.
“For those that have true reflux-associated laryngeal symptoms [RALS], the UESAD may effectively improve symptoms and reduce esophagopharyngeal reflux,” Yadlapati told Healio Gastroenterology and Liver Disease. “This is probably most effective for patients with impaired UES reflexes, however this has yet to be formally studied.”
Yadlapati and colleagues enrolled patients who had reported at least 1 month of laryngeal complaints — like throat clearing, sore throat or cough — with a reflux symptom index (RSI) score of at least 13. Proton pump inhibitor use was permitted if the patient did not begin or modify therapy within 4 weeks of the study.
The study included a baseline assessment, an intervention period during which the patients wore a UESAD for 14 consecutive nights, and an assessment after the intervention.
Out of 20 enrolled patients, researchers included in their analysis the 15 who completed the study.
Compared with baseline, mean RSI scores decreased significantly following UESAD intervention (26 ± 7.8 vs 19.4 ± 8.5; P < 0.01). Overall, 29% of the entire cohort reported greater than 50% reduction from baseline RSI and a post-intervention RSI less than 13.
“Safe and effective treatment options are needed for RALS,” Yadlapati said. “The UESAD may be a non-pharmacologic, non-invasive, and non-surgical therapeutic option for RALS, and clinicians may want to consider using the UESAD when patients they believe to have RALS are not responding to PPI therapy prior to considering more aggressive anti-reflux options.”
Yadlapati emphasized that the study was exploratory, and more research is needed to understand the UESAD’s role with PPI therapy, its placebo effect and its role in relation to UES reflex mechanisms. – by Alex Young
Disclosures: The authors report no relevant financial disclosures.
Click Here to Manage Email Alerts