MedCline shown to significantly reduce nocturnal regurgitation and aspiration symptoms in post-esopogectomy patients. Results presented the American College of Surgeons (ACS) Clinical Congress.

The results of the most recent MedCline clinical trial, “Nocturnal Regurgitation after Esophagectomy Before and After Implementation of a Novel Sleep Positioning Device,” were presented at the American College of Surgeons (ACS) 2015 Clinical Congress. Conducted by the Department of Surgery, University of Southern California, Los Angeles California, the study results show MedCline to be an effective treatment for post-esophogectomy patients suffering with nocturnal regurgitation and aspiration symptoms. MedCline™ significantly decreased symptom severity and regurgitation, as well as showed marked improvements across all quality of life measures.

During an esophogectomy, part or all of the esophagus is removed and then reconstructed with organ tissue. Regurgitation and aspiration are common side-effects of the surgery , especially when laying flat, and can be devastating to a patient’s quality of life and clinical outcomes. Prior to the study, 35% of patients were using stacked pillows and 65% were sleeping on a wedge or a hospital bed to achieve an inclined sleep position. Even utilizing these inclining methods, all patients in the study continued to suffer nocturnal symptoms, including getting up frequently at night, episodes of waking up coughing, and regurgitation.

MedCline was shown to increase the maintenance of an inclined position with less difficulty of sliding down at night as reported by patients. Sleeping on MedCline resulted in a 65% reduction in symptom severity scores as measured by the Nocturnal GERD Symptom Severity and Impact Questionnaire (N-GSSIQ) showing notable improvements in getting up during the night, nocturnal coughing, and the severity of regurgitation. Additionally, 95% reported an overall improvement in sleep quality and improved energy throughout the day. The researchers theorized that sleep improvement would translate into an improved health-related quality of life and potentially a reduced frequency of post surgical pulmonary complications.

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 post-esphogectomy patients.

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.

The most recent clinical trial results for the MedCline reflux relief system (Amenity Health, Inc.) were presented at the Gastroenterology Annual Scientific Meeting and Postgraduate Course (ACG) in October 2014. The results showed that MedCline dramatically reduced nighttime acid reflux symptom scores by 77%, as well as showed patient improvement on all health-related quality of life measures, after 2 weeks of use.

After the Cleveland Clinic presentation of results by Dr. Scott Gabbard, news segments nationwide highlighted natural treatment options for acid reflux and heartburn, such as dietary changes, weight loss, and sleep positioning. Though Medcline is not specifically named (referred to as a GERD pillow), the news segments showed a woman using Medcline in its discussion of the benefits of sleeping at an inclined and on the left side for symptom relief. The woman shared that before sleeping on Medcline, she had experienced nighttime acid reflux symptoms four times a week but now with Medcline, she has had reflux only one night over the preceding six-week period.

Examples of the news segment can be seen at:

www.myfoxdetroit.com/story/26835804/sleeping-with-the-right-pillow-could-fix-acid-reflux-for-some

www.wfmz.com/lifestyle/Health-Beat/health-beat-5-natural-remedies-for-gerd/30351564.

As a result of news segments airing nationwide, Amenity Health has received multiple calls from interested individuals showing the demand for natural treatment alternatives for GERD/acid reflux.

Approximately 20-30% of patients with gastroesophageal reflux disease (GERD) continue to suffer moderate to severe heartburn and regurgitation despite regular ProtonPump Inhibitor (PPI) usage. In its most recent clinical study, the MedCline reflux relief system significantly reduced nocturnal reflux symptoms and provided health-related quality of life improvements for these patients, providing much needed relief. The results of the study, “Use of Sleep Positioning Device Significantly Improves Nocturnal Gastroesophageal Reflux Symptoms,” were presented to the medical community by Dr. Scott Gabbard of Cleveland Clinic at the American College of Gastroenterology (ACG) Annual Scientific Meeting and Postgraduate Course 2014.

Upon enrollment into the study, patients completed the Nocturnal GERD Symptom Severity and Impact Questionnaire (N-GSSIQ). This validated questionnaire is comprised of three parts: (a) nocturnal GERD symptoms, (b) morning impact of GERD, and (c) concern about nocturnal GERD. Patients then used MedCline for two weeks for at least 6 hours per night, initiating sleep  on the left side. After two weeks, patients repeated the N-GSSIQ.

The results showed a significant reduction in scores across all measures using MedCline:

• 77% reduction in nocturnal GERDsymptoms

• 67% reduction in morning impact ofGERD

• 61% reduction in concerns about nocturnalGERD

With a 72% reduction in overall N-GSSIQ scores, this study validates MedCline as an effective,at-home nocturnal acid reflux treatment which provides significant nighttime relief for GERD patients who continue to have symptoms despite PPI usage.