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Effect on Acid Reflux Symptoms Occurring during Sleep of an Oral Adhering Disc Containing only Food Ingredients

Jeffrey Alan Burgess, Peter Van Der Ven and Michael Karcher

The aim of this double-blinded, randomized, controlled study was to determine if OraCoat XyliMelts, an over the counter, dissolvable, adhering disc used to reduce excessive day time or night time dry mouth by increasing salivation, would also reduce reflux and heartburn symptoms occurring during sleep among subjects suffering from both GERD and xerostomia. Subjects submitted 14 days of baseline data by answering questions and were then randomized into one of two groups: one receiving a dry mouth gel (control) and a second receiving a disc (product of interest). Neither the identities of the two products nor the manufacturers of the products was revealed to subjects. Answers to the same set of questions were then collected for an additional 14 days as the supplied products were used. The accumulated data were evaluated for pre-post treatment changes within and between groups. Variables included reported heartburn, reflux, reflux taste, hoarseness, dry mouth, and antacid use. The results showed a significant decrease in the severity of the above symptoms of GERD with both disc and gel use, although improvement was greatest for those using the discs. Comparison between the gel and disc groups for most symptoms did not reveal significant differences. For heartburn, subjects using the discs perceived significantly less pain than subjects using the gel. We conclude that the use of certain products intended to reduce dry mouth during sleep, including OraCoat XyliMelts, may be an effective adjunctive remedy for reducing reflux and heartburn symptoms in patients with GERD and xerostomia.

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