OBJECTIVE: We investigated the effectiveness and safety of topical application of 5 mg allicin adhesive tablets in the treatment of minor recurrent aphthous ulcerations (MiRAU). MATERIAL AND METHODS: A randomized, double-blinded, placebo-controlled, clinical trial was performed. Tablets containing 5 mg allicin or vehicle only were consecutively applied 4 times per day for 5 days. The size and pain level of ulcers were measured and recorded on days 1, 2, 4, and 6. RESULTS: A total of 96 subjects with MiRAU fulfilled the study. Allicin adhesive tablets significantly reduced ulcer size (P < .005, P < .003, P < .001 for days 2, 4, and 6, respectively) and alleviated ulcer pain score (P < .03, P < .001, P < .05 for days 2, 4, and 6, respectively) compared with vehicle tablets. Minor and major adverse reactions were not observed. CONCLUSIONS:Allicin adhesive tablets were effective in reducing ulcer size and alleviating ulcer pain of the patients in the treatment of MiRAU without significant side effects. Crown Copyright Â
RCT Entities:
OBJECTIVE: We investigated the effectiveness and safety of topical application of 5 mg allicin adhesive tablets in the treatment of minor recurrent aphthous ulcerations (MiRAU). MATERIAL AND METHODS: A randomized, double-blinded, placebo-controlled, clinical trial was performed. Tablets containing 5 mg allicin or vehicle only were consecutively applied 4 times per day for 5 days. The size and pain level of ulcers were measured and recorded on days 1, 2, 4, and 6. RESULTS: A total of 96 subjects with MiRAU fulfilled the study. Allicin adhesive tablets significantly reduced ulcer size (P < .005, P < .003, P < .001 for days 2, 4, and 6, respectively) and alleviated ulcer pain score (P < .03, P < .001, P < .05 for days 2, 4, and 6, respectively) compared with vehicle tablets. Minor and major adverse reactions were not observed. CONCLUSIONS:Allicin adhesive tablets were effective in reducing ulcer size and alleviating ulcer pain of the patients in the treatment of MiRAU without significant side effects. Crown Copyright Â