External compression device reduces reflux symptoms when used as PPI adjunct

When used as an adjunct to proton pump inhibitor (PPI) therapy, the Reflux Band, an upper oesophageal sphincter (UES) compression device, effectively improves reflux symptoms, according to a recent study.

“This first-of-its-kind trial highlights the potential clinical efficacy of the external UES compression device, a well-tolerated noninvasive device that augments UES pressure to reduce oesophago-pharyngeal reflux burden, in conjunction with acid suppression for patients with laryngopharyngeal reflux (LPR),” the researchers said.

The researchers conducted a two-phase prospective clinical trial including 31 LPR patients (mean age 47.9±14.0 years, 52 percent men) who had at least 8 weeks of laryngeal symptoms. Phase I involved treatment with double-dose PPI for 4 weeks, followed by phase II, which included an additional 4 weeks with the UES device as an adjunct. The primary endpoint was symptom response, defined as reflux symptom index (RSI) score ≤13 or a ≥50-percent drop in RSI.

Mean RSI at baseline was 24.1±10.9, which dropped marginally to 21.9±9.7 (p=0.06) after PPI-only treatment during phase I. After add-on intervention with the UES device, RSI decreased even further to 15.5±10.3, a significant reduction relative to baseline and post-phase I (p<0.01 for both). [Dig Dis Sci 2021;doi:10.1007/s10620-021-07172-2]

Similarly, the magnitude of change after phase II was significantly greater than that in phase I (–6.4±6.3 vs –2.3±6.4; p=0.04). Overall, symptom response was achieved by 35 percent of patients after phase I and by 55 percent after phase II.

Compared to nonresponders, participants who successfully achieved symptom response to the PPI + device intervention had significantly lower body mass index (p=0.02) and higher baseline salivary pepsin concentration (p=0.01). Baseline RSI was likewise significantly lower in responders (p<0.01).

The PPI + device intervention had a significantly stronger impact on responders vs nonresponders in terms of the following questions in the RSI: throat clearing; excessive threat mucus; troublesome or annoying coughs; and heartburn, chest pain, indigestion, or stomach acid coming up (p<0.01 for all).

The UES device was likewise safe, with only one mild adverse event (collar bone discomfort) deemed related to its use, which subsequently resolved without sequelae. No serious side effects were documented. After 3 months, 14 of 21 participants (67 percent) available for follow-up were still using the external UES compression device.

Seven participants had discontinued use due to intolerance, rashes, and lack of symptom control.

“Given paucity of previous clinical trial data surrounding the external UES compression device, this study was designed as a single-arm proof-of-concept trial where participants served as their own controls with the intention to assess the device in a randomized sham-controlled trial design if results from this current study were positive,” the researchers said.

“Particular factors may increase likelihood of treatment response, such as higher baseline salivary pepsin concentration, lower BMI, and smaller defect at the antireflux barrier, highlighting the need for personalized approaches to LPR,” they added.