A comparative study to evaluate the therapeutic effects of nutraceuticals in oral leukoplakia:- A randomized clinical trail.

Background: Oral leukoplakia, usually white changes in the oral mucosa, is one of the most common conditions affecting the oral cavity. Oral leukoplakia can occur anywhere in the mouth and is usually asymptomatic. Clinical diagnosis is reliant on visual inspection and manual palpation. It has a global prevalence of 2.6% and a malignant transformation rate of 0.13-34%. In India, OL has a higher prevalence (0.2-5.2%) but a lower a malignant transformation rate (0.13-10%). Methodology: It was a randomized control trial in which study was conducted on clinically diagnosed 300 oral leukoplakia patients. All patients were randomly categorized in three groups of 100 each. Group-A: Patients were given commercially available curcumin 500 mg. daily orally. Group-B: Patients were given 4 mg of oral lycopene daily. Group-C: Patients were treated with 4 mg of lycopene + 500 mg curcumin daily by oral route. After recording the pre-treatment clinical findings, all the participants were evaluated regularly after 30 days, 60 days and 90 days of active treatment and once in a month for another 3 months of post-treatment follow-up and to evaluate concomitant medication, lesion(s), compliance, and adverse events. The clinical response was evaluated by bi-dimensional measurement of the lesions and color photography. Safety assessment measures: Physical examination and laboratory tests were performed at baseline, and every 30 days for 3 months after randomization. Result: Number of participants cured after treatment with oral curcumin was 51%. Participants took lycopene tablets showed 63% cure rate and 72% participants cured after treatment with combination curcumin and lycopene. Conclusion: Results showed that curcumin, lycopene, and a combination of the two are effective in the treatment of oral leukoplakia. When compared, we found that lycopene is a better nutraceutical as compared to curcumin. When both nutraceuticals were given to the participants, they showed better results than single nutraceuticals when the data were analyzed after 90 days of treatment. There is a significant difference in the response of curcumin and combinations of both nutraceuticals, although the difference between lycopene and combinations of curcumin and lycopene is insignificant.