Oral medicine
Treatment of recurrent aphthous stomatitis with clofazimine

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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 ≤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.

Section snippets

Materials and Methods

We carried out a randomized, controlled, and partially blind study in consecutive patients with recurrent aphthous stomatitis who were seen in the Stomatology Outclinic of the Federal University of São Paulo between 2000 and 2003. The protocol was reviewed by the Committee of Ethics in Research of the institution, and each subject in the project signed a detailed informed consent form. The study compared the effects of clofazimine, colchicine, and placebo. This study included 15- to 60-year-old

Results

Regarding race, clinical form, and gender, there were no significant differences among the groups (P = .430; P = .542; and P = .317; respectively). In the total study sample, 70% of the subjects were caucasian. Eighty percent presented with the minor clinical form, 12% presented with the major form, and 8% presented with the herpetiform. Sixty-eight percent of the subjects were men. The average age was 38 years (SD 2.4 years) for the clofazimine group, 34 years (SD 2.6 years) for the colchicine

Discussion

Despite the many therapeutic options available for the management of recurrent aphthous stomatitis, no treatment is specific and definitive. Colchicine, thalidomide, levamisole, and pentoxifylline have been used to treat severe cases, but they are not always effective, long-term adverse effects are a restriction factor, and recurrence occurs once the drug is discontinued.7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 We decided to use clofazimine in patients with aphthous stomatitis

Conclusions

Clofazimine is effective in the prevention of recurrent aphthous stomatitis and the amelioration of symptoms related to aphthous lesions. It is a well tolerated and relatively safe drug in the doses used in this study. Adverse effects were mild and transient, and there were no changes in the results of the ophthalmologic exams, complete blood cell counts, and liver and renal tests. Clofazimine should be considered as a treatment option for recurrent aphthous stomatitis, and it may be of benefit

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