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

Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Feb;115(2):212-7. doi: 10.1016/j.oooo.2012.09.009. Epub 2012 Dec 12.

Abstract

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Adult
  • Berberine / administration & dosage
  • Berberine / therapeutic use*
  • Chi-Square Distribution
  • China
  • Double-Blind Method
  • Female
  • Gelatin / administration & dosage
  • Gelatin / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Pain Measurement
  • Placebos
  • Recurrence
  • Statistics, Nonparametric
  • Stomatitis, Aphthous / drug therapy*
  • Treatment Outcome

Substances

  • Placebos
  • Berberine
  • Gelatin