May 18, 2015

GERD Symptom Improvement Scores Strengthened in Expanded Pillow System Study

Quality of life, symptom relief data support previous findings

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A sleep positioning device not only significantly decreases nocturnal gastroesophageal reflux disease (GERD), but it also dramatically improves quality of life, according to an expanded Cleveland Clinic study presented today at Digestive Disease Week 2015.

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Encouraging Results

Gastroenterologist Scott Gabbard, MD, in Cleveland Clinic’s Digestive Disease Institute, expanded his research into the Medcline Reflux System by increasing the number of patients with nocturnal GERD and on proton pump inhibitors. The sleep positioning device uses a two-component incline base with a wrap-around body pillow shaped like a candy cane.

Previous studies found the sleep positioning device significantly decreased nocturnal GERD symptoms and nocturnal acid reflux in healthy volunteers. Those early results were presented at last year’s American College of Gastroenterology Annual Scientific Meeting.

For this study, Dr. Gabbard increased the number of patients to 25, strengthening symptom improvement scores. This study also included impressive data on how the device significantly improves GERD health-related quality of life.

“Patients filled out a questionnaire that measures how much GERD affects their daily lives, how satisfied they are with their present condition, and symptoms during the day and night,” he says. “We found that, overall, patients had higher GERD-related quality of life while using the pillow. Not only did nighttime symptoms improve, but daytime symptoms and overall quality of life improved.”

An inclined sleep position decreases the chances of regurgitation of stomach acids into the esophagus by using gravity to separate the lower esophageal sphincter from where food and acid layer in the stomach. Left untreated, nocturnal GERD can lead to adenocarcinoma of the esophagus, Barrett’s esophagus, erosive esophagitis, esophageal ulcerations or peptic strictures.

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All patients enrolled in the study had nocturnal GERD symptoms, despite taking medications. While patients continued on their medications during the study, most reported high satisfaction with symptoms while using the pillow system. Dr. Gabbard says some patients even avoided surgery for their reflux after using the pillow system. And he noted that after three months, 91 percent of patients were still using the pillow system. That compares to other studies that showed less than 70 percent of patients are able to continue medications for GERD.

“Patient adherence is much higher for the pillow than for medications,” he says.

Sleep positioning device now available by prescription

Another new development pertains to insurance coverage. Amenity Health Inc. of San Diego, California, which developed the Medcline Reflux System, is now working with insurance companies directly to include coverage of the pillow.

“Our data from Cleveland Clinic have convinced some insurance companies to start covering the system for patients,” Dr. Gabbard says.

Device shows promise for a variety of conditions

Next steps include larger studies to determine cost savings on medications, testing or surgery. Dr. Gabbard and his colleagues also are expanding studies of the sleep positioning system in patients with cough and throat burning at night, pregnant women and lung transplant patients.

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The study with the Head & Neck Institute on laryngopharyngeal reflux (LPR), in particular, is showing dramatic improvement in throat symptoms of GERD, including chronic cough and hoarseness.

“The data is unbelievable for that indication,” Dr. Gabbard says. “There are very limited treatment options for LPR and these findings are just as big.”

The pillow system also has become a standard protocol for GERD patients who undergo lung transplant. Dr. Gabbard says this will be a long-term study that will look at symptom improvement and preserving lung function, while possibly preventing lung transplant.

For more information, please contact Dr. Gabbard at 216.444.6523 or gabbars@ccf.org.

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