Published in the Journal of

ORAL SURGERY, ORAL MEDICINE
ORAL PATHOLOGY, ORAL RADIOLOGY
and ENDODONTOLOGY (OOOOE)

April 2005, Volume 99, Number 4, Page 429

Studies of Licorice Extract in an Oral Patch on Minor Aphthous Ulcers.  J. T. Haley, M. D. Martin, and J. J. Sherman, Orahealth Corporation and University of Washington , Seattle , Wash.

Objectives.  Minor recurrent aphthous ulcers (RAU) are one of the most common inflammatory conditions of the oral mucosa, affecting approximately 20% of the US population.  RAU typically heal without treatment in 7 to 14 days.  Orahealth Corporation developed a slowly adhering, fully dissolving, time release, oral drug delivery patch for delivery of medication at a spot in the mouth called Oramelts^™.  The aims of this survey were: (1) to determine whether using Oramelts containing Glycyrrhiza herbal water extract in prolonged topical contact with RAU would shorten healing time; and (2) to compare the effectiveness at speeding healing of whole Glycyrrhiza extract (GX), reduced glycyrrhizin extract (DGL), and purified glycyrrhetic acid potassium salt (GAP).

Study Design.    Oramelts were supplied with 18% GX to 20 subjects, with 26% DGL to 147 subjects, and with 7.5% GAP to 40 subjects who were asked to return a report for each ulcer treated.  Subjects were instructed to use the product at least 16 hours per day and asked to report whether the ulcer healed faster than usual, for details on usage if it did not heal within 2 or 3 days, and whether the Oramelt reduced pain while in place.  We received reports of trials on 30 ulcers treated with GX from 15 subjects, 49 ulcers treated with DGL from 46 subjects, and 14 ulcers treated with GAP from 14 subjects.

Results.  Those receiving GX reported healing in 3 days or less on 26 out of 27 ulcers treated where the product was used as directed.  In two other cases where the ulcer did not heal within 3 days, the product was used less than 16 hours per day.  Of those receiving DGL, 32 reported speeding of healing and 2 reported no speeding of healing.  5 reported a failure to heal within 3 days and all 5 used the product less than 9 hours per day.  For GX and DGL combined, 8 of the 9 failures to heal within 3 days (out of 64 healing time reports) resulted from using the product less than 16 hours per day.  With GAP, 9 out of 14 reports found no speeding of healing, in contrast to DGL, while all 14 reported that GAP was effective for relieving pain while in place.  For GX and DGL combined, out of 79 reports, 49 reported pain reduction while the Oramelt was in place, 30 gave no report on pain, and no one reported a failure to reduce pain.

Conclusions.   For most people with minor recurrent aphthous ulcers, complex Glycyrrhiza extract (GX or DGL) in an oral topical time release patch held in constant or frequent contact with a new aphthous ulcer for at least 16 hours per day shortens healing time to 1 - 3 days and relieves pain while in place.  Purified glycyrrhetic acid potassium (GAP) relieves pain but does not reliably speed healing.

Orahealth has chosen GX for the product taken to market as Cankermelts-GX.

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