The results of the most recent MedCline clinical trial, “Treatment of LPR with a Sleep Positioning Device,” were presented at the annual meeting of the American Association of Otolaryngology – Head and Neck Surgery showing MedCline to be an effective treatment for Silent Reflux/LPR.
The results of the most recent MedCline clinical trial, “Treatment of LPR with a Sleep Positioning Device,” were presented at the annual meeting of the American Association of Otolaryngology – Head and Neck Surgery, the world's largest organization of specialists who treat the ear, nose, throat and related structures of the head and neck. 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. Silent Reflux/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 Silent Reflux/LPR patients do not experience heartburn or regurgitation as commonly experienced with Gastroesophageal Reflux Disease (GERD). Silent Reflux/LPR is commonly treated with higher doses of PPI medications for prolonged periods of time.
The study included patients diagnosed with Silent Reflux/LPR. Patients were instructed to sleep on MedCline™ for at least six 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 Silent Reflux/LPR patients.