Effects of berberine gelatin on recurrent aphthous stomatitis: a randomized, placebo-controlled, double-blind trial in a Chinese cohort.

OBJECTIVE

Recurrent aphthous stomatitis (RAS) is a common oral mucosal disease, yet effective therapeutic approaches are lacking. This study aimed to determine the effects of application of berberine gelatin in the treatment of minor RAS (MiRAS).

METHODS

A randomized, double-blind, placebo-controlled, clinical trial was performed. The gelatin containing berberine (5 mg/g) or vehicle only was applied 4 times per day for 5 days. Clinical evaluation included pain level, size, erythema, and exudation of certain ulcers on days 1, 2, 4, and 6.

RESULTS

A total of 84 subjects fulfilled the study without obvious side effects. Berberine gelatin treatment reduced the ulcer pain score compared with placebo gelatin (P < 0.05). Ulcer size was significantly reduced (P < 0.05) and lower erythema (P < 0.05) and exudation (P < 0.05) levels were associated with berberine treatment.

CONCLUSIONS

Berberine gelatin may be a safe and effective treatment for MiRAS.