The results of the most recent MedCline clinical trial, “Treatment of LPR with a Sleep Positioning Device,” were presented at the 2015 annual meeting of the American Association of Otolaryngology–Head and Neck Surgery. The study results show MedCline to be an effective treatment for laryngopharyngeal reflux (LPR), commonly referred to as “silent reflux.”
This study by Cleveland Clinic was the first to evaluate MedCline with this patient population. LPR occurs when stomach acid travels up to the throat causing symptoms, such as chronic cough, difficulty swallowing, asthma, sinusitis, or a sore throat. Fifty percent of LPR patients do not experience heartburn or regurgitation as commonly experienced with gastroesophageal reflux disease (GERD). LPR is commonly treated with higher doses of proton pump inhibitors medications for prolonged periods of time.
The study included patients diagnosed with LPR. Patients were instructed to sleep on MedCline for at least 6 hours per night for 28 consecutive nights in an at-home setting. Patients were instructed to maintain their current medication regime during the entire study. Symptom data was collected via two validated questionnaires: (1) Nocturnal GERD Symptom Severity and Impact Questionnaire (N-GSSIQ) and (2) Reflux Symptoms Index (RSI) survey. Both questionnaires were completed by patients upon enrollment, after night 14 and after night 28.
The results showed a significant reduction in scores across all measures using Medcline:
- 35% decrease in N-GSSIQ scores by night 14
- 57% decrease in N-GSSIQ scores by night 28
- 16% decrease in RSI scores by night 14
- 51% decrease in RSI scores by night 28
The findings of this study are consistent with previous studies evaluating MedCline for nocturnal GERD patients but extend its possible applications as an effective treatment for LPR patients.
MedCline is a positional therapy device that provides at-home, on-demand relief of nocturnal acid reflux/GERD. It is a Class I Medical Device available by prescription only.
