This was a randomised, double-blind, placebo-controlled trial.
One tablet was taken each day before sleep for 6 months. The test group received sublingual vitamin B12 tablets (1000 mcg of vitamin B12) whereas the control group took a placebo of the same shape, size, colour and flavour. Participants met with staff monthly.
Duration (days) of an aphthous stomatitis episode, monthly number of aphthous ulcers, and severity of pain according to the Numerous Rating Scale (NRS), were recorded in a diary.
Fifty-eight people suffering from recurrent aphthous stomatitis (RAS) participated: 31 were allocated to the intervention group and 27 to the control group. The duration of outbreaks, the number of ulcers, and the level of pain were reduced significantly (P <0.05) at 5 and 6 months of treatment with vitamin B12, regardless of initial vitamin B12 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 <0.01).
Vitamin B12 treatment, which is simple, inexpensive and low-risk, seems to be effective for patients suffering from RAS, regardless of the serum vitamin B12 level.