Abstract
The study was designed to evaluate the efficacy and safety of an herbal extract of Yunnan Baiyao formulated in toothpaste as an alternative therapy for minor RAS. A randomized, double-blind, placebo-controlled clinical trial (from March 2010 to March 2011) was conducted on a cohort of 227 minor RAS patients. The toothpaste containing Yunnan Baiyao was used twice daily as part of the patient's routine oral hygiene for 5 days. An assessment of ulcerative size and pain was recorded on day 0 (baseline), day 3, and day 5. Any noted adverse reactions were recorded. All data were analyzed using the SAS software 8.0. As a result, the toothpaste containing Yunnan Baiyao began to present noticeable effectiveness on ulcer healing (ulcer size) by day 3 (27.5% versus 15.8%, P < 0.05), which further improved by day 5 when compared to the placebo (66.4% versus 50.0%, P = 0.01). A significant difference in alleviating pain was noted on day 5 for those who used the toothpaste containing Yunnan Baiyao (66.4% versus 51.8%, P < 0.05). No side effects were noted as a result of the Yunnan Baiyao. Therefore, Yunnan Baiyao may provide an alternative therapy for minor ulcers by promoting healing.
Highlights
Recurrent aphthous stomatitis (RAS) is a common oral disorder with prevalence of 25% [1], characterized by recurrent ulcers on unkeratinized oral mucosa
We suggest that an herbal medicine approach may offer an alternative therapy for minor RAS
If we paired efficacy index (EI) = 100% and EI = 70–100% categories as considered significant improvement of ulcer and EI = 0–30% and EI = 30–70% as nonsignificant improvement, an obvious between-group difference was identified in the rate of significant improvement relative to the size of the ulcer, as displayed by 27.4% in the experimental group compared to 15.8% in the placebo group (P < 0.05)
Summary
Recurrent aphthous stomatitis (RAS) is a common oral disorder with prevalence of 25% [1], characterized by recurrent ulcers on unkeratinized oral mucosa. Topical agents including corticosteroids, antimicrobials, and analgesics make up the first choice for RAS patients due to the minimum serious adverse effects [4]. Topical corticosteroids such as triamcinolone acetonide, prednisolone, and betamethasone [5] are the major remedies that are available and have helped in reducing local inflammation and hastening the healing process. Yunnan Baiyao is a well-known traditional Chinese medicine, formulated in a powder or capsule form. Evidence-Based Complementary and Alternative Medicine a randomized, double-blind, placebo-controlled clinical trial that included 227 patients with minor RAS to assess its efficacy and safety when formulated in toothpaste
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