A CLINICAL-TRIAL OF ANTIOXIDANT SUPPLEMENTS IN THE TREATMENT OF ORAL LEUKOPLAKIA

Seventy-nine patients with oral leukoplakia that was histologically ve rified as either hyperkeratosis or epithelial dysplasia with hyperkera tosis were enrolled in an antioxidant supplementation program for the treatment of the oral lesions. The patients received 30 mg of beta-car otene, 1000 mg of ascorbic acid, and 800 IU of alpha-tocopherol per da y for 9 months. Clinical improvement of the oral lesion was noted in 5 5.7% of the patients and was more likely to occur in patients who redu ced their use of alcohol or tobacco (p = 0.0056). Although risk-factor reduction was important, approximately half of the patients who did n ot alter their exposure to either alcohol or tobacco showed clinical i mprovement. The antioxidant supplementation significantly increased se rum and tissue levels of beta-carotene, ascorbic acid, and alpha-tocop herol, but these changes did not correlate strongly with clinical impr ovement.