Effectiveness of vitamin B12 in treating recurrent aphthous stomatitis: a randomized, double-blind, placebo-controlled trial.
Volkov, I., Rudoy, I., Freud, T., Sardal, G., Naimer, S., Peleg, R., and Press, Y.J Am Board Fam Med – 01-JAN-2009; 22(1): 9-16.
Objectives: Recurrent aphthous stomatitis is the most common oral lesion seen in primary care practice and occurs in an estimated 25% of the general population. The objective of the current study was to validate and confirm previous observations on the benefits of Vitamin B12 for the treatment of this patient population.
Methods: 58 patients were randomly divided into a treatment group (N=31) and a control (placebo) group (N=27). The treatment group received 1000mcg of sublingual Vitamin B12 for 6 months. The control group received placebo for the same time period. Clinicians were blinded to group assignment. Clinical parameters measured were pain, number of ulcers, outbreak frequency, and duration of outbreak. 87% of the treatment group and 93% of the control group completed the study.
Results: During the last 2 months of the study, 15 patients (55.6%) from the treatment group and 4 patients (16%) from the control group were clinically determined to have reached the endpoint “no aphthous ulcers status” (P < .01). The treatment group also had fewer outbreaks (P < .0001), less painful lesions (P < .0001) and shorter duration of outbreak (P < .0001).
Conclusions: Sublingual B12 at 1000mcg/d is an effective, safe and inexpensive treatment of recurrent aphthous stomatitis.