Oral medicine
Pilot study on recurrent aphthous stomatitis (RAS): a randomized placebo-controlled trial for the comparative therapeutic effects of systemic prednisone and systemic montelukast in subjects unresponsive to topical therapy

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Background

Recurrent aphthous stomatitis (RAS) is characterized by recurrent painful oral ulcers whose etiology remains largely unknown. Numerous therapeutic protocols have been tried so far, but effectiveness remains an issue.

Objective

To test a new drug for patients with recurrent oral aphthae nonresponsive to local corticosteroid therapy, we compared the therapeutic effectiveness and adverse effects of systemic prednisone and systemic montelukast in a placebo-controlled trial.

Study design

Sixty patients suffering from minor RAS for ≥6 months were studied and randomly assigned to 3 groups of 20 each in a double-blind study. Patients of group A took 25 mg prednisone orally daily for 15 days, 12.5 mg daily for 15 days, 6.25 mg daily for 15 days, then 6.25 mg on alternate days for 15 days. Patients of group B took 10 mg montelukast orally every evening and then on alternate days for the second month. Patients of group C took 100 mg cellulose (placebo) by mouth daily for the first month and on alternate days for the second month. Outcomes assessed were days til pain cessation, days to ulcer healing, and number of aphthae occurring during the follow-up period.

Results

Both prednisone and montelukast were effective in reducing the number of lesions and improving pain relief and ulcer healing when compared with placebo. Prednisone was more effective than montelukast in pain cessation (P < .0001) and in accelerating ulcer healing (P < .0001). However, adverse drug reactions recorded during the entire trial were more common in the prednisone group compared with montelukast (10%) and placebo (10%).

Conclusions

These data suggest that the effectiveness of systemic montelukast is similar to that of systemic prednisone in patients with RAS. The lack of serious side effects makes montelukast a candidate drug to use in cases of RAS where pharmacologic therapy for long periods is needed.

Section snippets

Subjects and Methods

For this trial, one group of physicians served for recruitment of patients (X), and a different group of physicians were involved in evaluation of therapy and outcomes (Y). The diagnosis of RAS was made by evaluating clinical aspects of the oral ulcers19 as well as a detailed history of the periodic recurrence of lesions. A total of 98 patients affected by aphthous lesions were enrolled and met the inclusion and exclusion criteria listed.

Results

During the month preceding the trial, 102 lesions in patients of group A, 98 lesions in group B, and 94 lesions in group C were recorded.

Discussion

In this study, we evaluated the efficacy of systemic montelukast in comparison with systemic prednisone in the control of RAS. Montelukast is an oral leukotriene (LT) receptor antagonist. Leukotrienes (LTs) are a family of paracrine hormones derived from the oxidative methabolism of polyunsaturated fatty acids, particularly arachidonic acid. It is known that these drugs prevent LT binding and the subsequent activation of LT receptors.18 Phospholipid undergoes metabolic degradation to form

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