October 20, 2015

Positional Therapy Device Improves Nocturnal LPR Symptoms

Device helps hard-to-treat population

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A sleep positioning device that significantly decreases nocturnal gastroesophageal reflux disease (GERD) symptoms is proving successful in quelling symptoms in hard-to-treat patient populations, like patients with laryngopharyngeal reflux (LPR) and pregnant women, according to a Cleveland Clinic study presented at the American College of Gastroenterology 2015 conference.

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Expanding research

Gastroenterologist Scott Gabbard, MD, in Cleveland Clinic’s Digestive Disease Institute, expanded his research into the MedCline Reflux System in patients with laryngopharyngeal reflux (LPR), in which nocturnal symptoms are common. LPR affects the upper esophagus and throat causing hoarseness, voice problems, throat clearing, coughing after laying down, sensations of a lump in the throat and excess mucus.

Recent studies demonstrated use of a positional therapy device (PTD) significantly decreased typical gastroesophageal reflux symptoms, but use of a PTD for LPR symptoms was not studied previously.

“LPR is one of those disease that is very challenging for physicians to treat. The treatment options are so limited,” Dr. Gabbard says, adding that medications and anti-reflux surgery are less effective in treating LPR than in GERD, heartburn and regurgitation. “What we wanted to do was apply the success of the MedCline device to these patients.”

Encouraging results

The study, conducted in conjunction with Cleveland Clinic’s Head & Neck Institute, followed 23 LPR patients at Cleveland Clinic as they used a two-component, wedge-shaped base and a lateral positioning body pillow at least six hours per night for 28 consecutive nights. Patients completed the Nocturnal Gastroesophageal Reflux Symptom Severity and Impact Questionnaire (N-GSSIQ) and Reflux Symptoms Index (RSI) at two weeks and four weeks of PTD use.

The study found that LPR patients reported significant improvement — 75 percent — in symptoms of general nocturnal reflux, as well as LPR reflux symptoms. Patients also reported less concern for their health after four weeks of use. The study reported the strength of these results supports a strong benefit in using the PTD device in patients with nocturnal LPR.

Dr. Gabbard explains the PTD system treats reflux at night through two mechanisms — it elevates the patients’ sleeping at night and positions them on their left side. Both of those positions separately have shown to decrease reflux at night. The combination of adding the left-sided positioning with the elevation factor, he says, significantly increases relief.

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“We wanted to take a very safe, easy-to-use and very well-tolerated therapy and apply it to a difficult-to-treat patient population,” Dr. Gabbard says. Cleveland Clinic Lerner College of Medicine medical student Will Tierney assisted with the LPR study. “PTD is very well-tolerated, with no adverse events in the LPR study.”

Device evolving through research

Since his initial studies into the PTD system, the MedCline system now offers different versions, including a new form-fitting body positioner pillow that Dr. Gabbard has not yet studied. He says he is studying the newer version of the system at Cleveland Clinic in patients with reflux.

The MedCline system is now available for purchase through more insurance companies, although coverage is still determined on a case-by-case basis.

“Clearly, we feel this is going to be a much safer option than surgery, and very likely more cost effective,” Dr. Gabbard says. “The data shows it is very effective for heartburn, regurgitation and now LPR symptoms.”

Safer therapeutic option

Anecdotally, researchers found several patients considering surgery for reflux were able to avoid it or forgo medications and extensive testing as a result of the PTD system.

“Our hope is that with this device we can help some patients avoid pursuing surgery for their reflux, and help some patients avoid the need for further specialized testing, like scopes and PH testing,” Dr. Gabbard says.

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While other sites are studying the MedCline PTD system, Cleveland Clinic has the largest number of patients involved in such studies. Dr. Gabbard is in the preliminary phase of studying the system with actual PH testing in patients with reflux. He also anticipates studying the use of the MedCline system in patients with scleroderma.

“In those patients, whose esophagus muscles are completely dead, they have very severe reflux that doesn’t respond well to medications,” Dr. Gabbard says. “Surgical options are limited and they don’t have some of the options available to other patients. In this population, this is a severe disease with limited therapeutic options.”

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

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