Evaluation of penicillin G potassium troches in the treatment of minor recurrent aphthous ulceration in a Chinese cohort: a randomized, double-blinded, placebo and no-treatment–controlled, multicenter clinical trial

ObjectiveThe aim of this study was to explore the effectiveness and safety of topical application of 50 mg penicillin G potassium troches in the treatment of minor recurrent aphthous ulcerations (MiRAU) in a Chinese cohort.Material and methodsA randomized, double-blinded, placebo and no-treatment–controlled, multicenter clinical trial was performed. Troches were consecutively applied 4 times per day for 4 days. The size and pain level of ulcers were measured and recorded on days 0, 3, 4, 5, and 6.ResultsA total of 258 subjects with minor recurrent aphthous ulcerations (86 subjects in penicillin G potassium group, 88 subjects in placebo control group, and 84 subjects in no-treatment control group) fulfilled the study. Penicillin G potassium significantly reduced ulcer size (P < .00001 for days 3, 4, 5, and 6) and alleviated ulcer pain (P < .00001 for days 3, 4, 5, and 6). No severe adverse reactions were observed. Only 4 subjects experienced mild adverse reaction.ConclusionsPenicillin G potassium troches are effective in reducing ulcer size and alleviating ulcer pain of the patients in the treatment of a single episode of MiRAU in this Chinese cohort. Few adverse effects were observed with this therapeutic approach.