Multivitamin therapy for recurrent aphthous stomatitis: a randomized, double-masked, placebo-controlled trial

Abstract

Background: Recurrent aphthous stomatitis (RAS) is a painful condition of unknown etiology, affecting more than 2.5 billion people worldwide. Vitamin deficiencies have been implicated as a possible cause.

Methods: The authors conducted a single-center, randomized, parallel-arm, double-masked, placebo-controlled study to examine the effect of daily multivitamin supplementation on the number and duration of RAS episodes. The authors randomly assigned 160 adults who had a validated history of at least three episodes of idiopathic minor RAS within the previous 12 months to one of two groups: the first group (n = 83) received a once-daily multivitamin containing 100 percent of the U.S. reference daily intake (RDI) of essential vitamins, and the second group (n = 77) received once-daily placebo for up to 365 days.

Results: The results showed no significant difference in the mean number of new RAS episodes between the multivitamin (4.19 episodes) and placebo (4.60 episodes) arms during the study period (P = .69). The mean duration of new RAS episodes also was similar for the multivitamin (8.66 days) and placebo (8.99 days) arms (P = .60). Furthermore, the authors found no differences between the two arms with regard to mouth pain, normalcy of diet or compliance with the study medication regimen.

Conclusion: Daily multivitamin supplementation, with the RDI of essential vitamins, did not result in a reduction in the number or duration of RAS episodes.

Clinical implications: Clinicians should not recommend multi-vitamin supplementation routinely as prophylaxis for RAS.

Trial registration: ClinicalTrials.gov NCT00527306.