Clinical Health Updates

Vitamin B12 effective in treatment of recurrent aphthous stomatitis

Clinical Question:
Is vitamin B12 effective in the treatment of adults with recurrent aphthous stomatitis?

Bottom Line:
Compared with placebo, sublingual vitamin B12 significantly reduced the average duration of recurrent aphthous stomatitis, the number of aphthous ulcers, and the subjective level of pain. Treatment was only effective after 5 months, so shorter treatment courses may not be effective.

Volkov I, Rudoy I, Freud T, et al. Effectiveness of vitamin B12 in treating recurrent aphthous stomatitis: A randomized, double-blind, placebo-controlled trial. J Am Board Fam Med 2009;22(1):9-16.

Study Design:
Randomized controlled trial (double-blinded)


Outpatient (primary care)


The frequency of recurrent aphthous stomatitis (RAS), the most common oral mucosa lesions seen in primary care, is up to 25% in the general population. However, there has been no optimal therapeutic approach. The objective was to confirm the previous clinical observation of the beneficial treatment of RAS with vitamin B(12). They did a randomized, double-blind, placebo-controlled trial was done using primary care patients. A sublingual a dose of 1000 mcg of vitamin B(12) was used in patients in the intervention group for 6 months. In total, 58 patients suffering from RAS participated in the study: 31 were included in the intervention group and 27 were included in control group. All parameters of RAS among patients in the intervention group were recorded and compared with the control group. The duration of outbreaks, the number of ulcers, and the level of pain were reduced significantly (P < .05) at 5 and 6 months of treatment with vitamin B(12), regardless of initial vitamin B(12) levels in the blood. During the last month of treatment a significant number of participants in the intervention group reached “no aphthous ulcers status” (74.1% vs 32.0%; P < .01).