Objective: The aim was to investigate the safety and efficacy of clofazimine for the treatment of recurrent aphthous stomatitis.
Study design: In this randomized controlled partially blind study, 23 patients received clofazimine 100 mg daily for 30 days and then 100 mg every other day. Twenty-three patients received colchicine 0.5 mg 3 times daily. Twenty patients received 1 placebo pill 2 times daily. All subjects received medications for 6 months. The chi-squared or Fisher exact tests were used to assess drug efficacy with respect to objective findings and symptoms.
Results: A greater percentage of individuals in the clofazimine group had no further aphthous episodes (17%-44% compared with <or=6% in the other groups). A significantly greater percentage of treatment interruption occurred in the colchicine group because of gastrointestinal effects (23%-45%). Individuals in the clofazimine group who continued to suffer from aphthous stomatitis presented with better results for the evaluated variables.
Conclusion: Clofazimine should be considered for the treatment of recurrent aphthous stomatitis.