MedCline furthers clinical reach to include PPI-refractory, laryngopharyngeal reflux (LPR), post-esophogectomy and gestational GERD patients providing a much-needed solution for those suffering with nocturnal symptoms.

Furthering its commitment to validate its products with compelling clinical data with top researchers nationwide, Amenity Health has widened the clinical applications for its MedCline sleep positioning device to include include PPI-refractory, laryngopharyngeal reflux (LPR), post-esophogectomy and gestational reflux patients. Through 5 clinical trials completed in 2015, MedCline has been shown to be an effective treatment for GERD patients suffering with nocturnal reflux symptoms, including heartburn and regurgitation.

Highlights from these studies include:

• 72% reduction in nocturnal GERD symptom scores
• 95% reported an overall improvement in sleep quality
• 75% reported less difficulty with sliding down at night
• 67% reduction in nocturnal regurgitation scores

The 2015 clinical trials are added to a growing library of clinical data, including the randomized controlled trial conducted by the Medical University of South Carolina published in the June issue of the Journal of Clinical Gastroenterology, which showed:

• 87% reduction in esophageal acid exposure compared to bed wedges
• 38% reduction in reflux episodes than bed wedges
• Nearly 2x more comfortable than bed wedges

This article can be found at: journals.lww.com/jcge/Abstract/publishahead/A_Novel_Sleep_Positioning_Device_Reduces.98453.aspx.

The results of the most recent MedCline clinical trial, “Use of a Sleep Positioning Device Significantly Improves Nocturnal Gastroesophageal Reflux Disease Symptoms in Pregnant Women,” were presented at American College of Gastroenterology’s Annual Scientific Meeting and Postgraduate Course (ACG 2015). The study results show MedCline to be an effective treatment for pregnant women suffering with gestational gastroesophageal reflux disease (GERD).

In this study by Cleveland Clinic, patient’s GERD symptoms were evaluated using two validated questionnaires: (1) Nocturnal GERD Symptom Severity and Impact Questionnaire (N-GSSIQ) and (2) the Pittsburgh Sleep Quality Index (PSQI). Patients completed the questionnaires upon enrollment and then after using MedCline for a minimum of 2 weeks.

The results showed significant patient improvements along all measurements, including:

• 65% reduction in total N-GSSIQ scores
• 70% reduction in nocturnal GERD symptoms scores
• 58% reduction in the morning impact of GERD scores
• 60% reduction in concerns about GERD scores
• 49% reduction in PSQI global scores showing an overall improvement in sleep quality and less sleep disturbances

This study was the first to evaluate MedCline with this patient population. Gestational GERD has been reported to affect up to 80% of pregnancies. GERD in pregnancy is caused by a reduction in lower esophageal sphincter pressure due to an increase in maternal estrogen and progesterone during pregnancy, in addition to mechanical factors. Hormonal changes in pregnancy can also decrease gastric motility, resulting in prolonged gastric emptying time and increased risk of GERD.

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 women suffering with gestational GERD.