Recurrent aphthous stomatitis (RAS) is usually episodic and self-limiting but can produce severe ulcers that interfere with eating speaking and swallowing. Minor RAS (MiRAS) is the most common form. The aim of this trial was to investigate the efficacy and safety of berberine (an isoquinoline alkaloid originally isolated from medicinal herbs) in the treatment of MiRAS
Adult patients (18-50 yrs of age) with a history of RAS for a minimum of 6 months with an average of 1 to 2 outbreaks per month and 1 to 5 minor aphthae per outbreak were recruited within 48 hrs of ulceration onset. Those with ulceration as as a manifestation of systemic disease were excluded. Outcomes included pain level, size, erythema, and exudation of certain ulcers on days 1, 2, 4, and 6. Patients recorded pain on a visual analog scale (VAS) . Patients were randomised to receive either the active agent ( berberine) or placebo of similar shape colour and flavour.
- 84 out of the 87 randomised patients completed the trial (2 drop outs in berberine group 1 in placebo)
- There were significant reductions in both pain score and ulcer size in the berberine group
- Reduction in pain scores were greater in the on
- day 2 ( 16.1% vs 6,56% in control )
- day 4 ( 44.57% vs 22.6%
- day 6 (76.65% vs 60.87%)
- Reduction in ulcer size
- day 2 (35.63%, vs 14.14%)
- day 4, (54.07%, vs 37.66%,)
- day 6, (70.56% vs 54.35%)
- No adverse events were reported.
The authors concluded
The present study findings demonstrate that the topical application of berberine gelatin could decrease pain intensity and promote ulcer healing with minimal safety concerns. Therefore, in clinical practice, berberine gelatin could be a well-tolerated and safe addition to the treatment armamentarium for MiRAS
This appears to be the first published study that has looked at using berberine for the treatment of RAS so the effects will need to be confirmed in other populations to see if similar positive effects can be demonstrated. Recently Brocklehurst et al published a Cochrane review on systemic treatments for RAS (Dental Elf Sept 14th 2012 ) and found that no single systemic approach was effective. A Cochrane review on topical treatments is planned as a number of different topical agents have been tried over the years. In May last year (Dental Elf 8th & 9th May 2012) we highlighted two other trials looking at dexamethasone and multivitamins for RAS.
Jiang XW, Zhang Y, Zhu YL, Zhang H, Lu K, Li FF, Peng HY. 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. 2012 Dec 12. doi:pii: S2212-4403(12)01522-2. 10.1016/j.oooo.2012.09.009. [Epub ahead of print] PubMed PMID: 23246229.