4.2 Article

Treatment of aphthous stomatitis with topical Alchemilla vulgaris in glycerine

Journal

CLINICAL DRUG INVESTIGATION
Volume 26, Issue 10, Pages 567-573

Publisher

ADIS INT LTD
DOI: 10.2165/00044011-200626100-00003

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Background and objective: Recurrent aphthous ulceration is the most common oral mucosal disease known. It presents as three types: minor (most prevalent), major and herpetiform. However, there are no well established effective and reliable treatments of this condition. Alchemilla vulgaris (Lady's Mantle) has traditionally been used in oral hygiene and was recently shown to accelerate wound healing when used in combination with glycerine. The objective of this study was to determine whether this combination is effective in the treatment of the most prevalent form of aphthous ulcers. Methods: An open-label study was conducted in 48 otherwise healthy male and female patients aged 4-44 years to determine the putative healing properties and tolerability of a standard 3% extract of A. vulgaris in glycerine (Aphtarine (R)) on common minor oral ulcers. Patients with major or herpetiform ulcers were excluded from the study. Results: Topical application three times daily of Aphtarine (R) gel to minor mouth ulcers relieved discomfort and produced complete healing in the majority of patients (60.4%) within 2 days and in 75% within 3 days, compared with 10.4% and 33.3%, respectively, without treatment and 15% and 40%, respectively, with commonly available treatments. Most patients appreciated the product's ease of application, taste and texture. Aphtarine (R) was well tolerated locally and most patients rated the product good to excellent overall. Conclusion: Aphtarine (R) is a safe, well tolerated and highly effective promising new treatment for healing common mouth ulcers.

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