Marco Carrozzo1. 1. Department of Oral Medicine, School of Dental Sciences, University of Newcastle upon Tyne, Newcastle upon Tyne, UK.
Abstract
DESIGN: This was a randomised, double-blind, placebo-controlled trial. INTERVENTION: 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. OUTCOME MEASURE: 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. RESULTS: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). CONCLUSIONS: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.
RCT Entities:
DESIGN: This was a randomised, double-blind, placebo-controlled trial. INTERVENTION: 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. OUTCOME MEASURE: 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. RESULTS: 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). CONCLUSIONS: 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.
Authors: L Baccaglini; R V Lalla; A J Bruce; J C Sartori-Valinotti; M C Latortue; M Carrozzo; R S Rogers Journal: Oral Dis Date: 2011-08-04 Impact factor: 3.511