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A two-piece positional therapy device (PTD) significantly reduces nocturnal gastroesophageal reflux disease (GERD) symptoms and improves overall sleep quality in pregnant women, according to a Cleveland Clinic study presented at the American College of Gastroenterology 2015 conference.
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Gastroenterologist Scott Gabbard, MD, in Cleveland Clinic’s Digestive Disease Institute, recruited 17 women from an outpatient obstetrics clinic in their second trimester of pregnancy who reported frequent moderate to severe nocturnal heartburn and regurgitation.
Recent studies demonstrated use of a PTD significantly decreased typical GERD symptoms and nocturnal GERD in patients with laryngopharyngeal reflux (LPR). The PTD system elevates the sleep position and places patients on their left side.
Dr. Gabbard notes there are limited studied in pregnant patients. None of the acid medications or proton pump inhibitors, in fact, are approved for use in pregnancy because they are Class C medications that may carry some risk for pregnancy.
“Invariably, all patients develop reflux at the end of pregnancy and also have very disrupted sleep,” Dr. Gabbard says.
The women completed the Nocturnal GERD Symptom Severity and Impact Questionnaire (N-GSSIQ) and the Pittsburgh Sleep Quality Index (PSQI) to assess their sleep quality and disturbances at enrollment and again after two weeks of using the PTD, which consists of a wedge pillow and a lateral-positioned body pillow.
The study found reflux symptoms including nocturnal GERD, morning impact of nocturnal GERD and concern about nocturnal GERD improved by 65 percent and sleep quality improved by 49 percent after just two weeks of use of the PTD system.
The study is continuing to enroll participants and is following patients through delivery. The MedCline system is now available for purchase through most insurance companies, although coverage is still considered on a case-by-case basis.
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“This is one of the first therapies that has shown efficacy for pregnant patients, both with reflux and with sleep quality. We’re very excited about this,” Dr. Gabbard says.
This study was conducted in conjunction with the Ob/Gyn & Women’s Health Institute. Third-year Internal Medicine Resident Adam Kichler, DO, assisted with the study.
For more information, please contact Dr. Gabbard at 216.444.6523 or gabbars@ccf.org.
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