Open AccessRandomized controlled trial to evaluate the efficacy of oral lycopene in combination with vitamin E and selenium in the treatment of oral leukoplakia
Author(s) -
Jyotsna Sandeep Patel,
Hemant R Umarji,
Amol Dhokar,
Rashmi Sapkal,
Sandeep G. Patel,
A.K. Panda
Publication year - 2014
Publication title -
journal of indian academy of oral medicine and radiology
Language(s) - English
Resource type - Journals
eISSN - 0975-1572
pISSN - 0972-1363
DOI - 10.4103/0972-1363.155630
Subject(s) - medicine , lycopene , placebo , randomized controlled trial , leukoplakia , vitamin e , gastroenterology , selenium , oral leukoplakia , vitamin , surgery , dentistry , carotenoid , antioxidant , food science , pathology , cancer , biochemistry , chemistry , materials science , metallurgy , alternative medicine
Aims and Objectives: A randomized controlled study was carried out to evaluate the efficacy of lycopene in combination with vitamin E and selenium in the treatment of oral leukoplakia in patients visiting the Government Dental College and Hospital, Mumbai. Materials and Methods: Forty-one patients of leukoplakia were randomly categorized (irrespective of size and severity of the lesions) in two groups: Group A and B. Group A consisting of 21 patients were administered combination of lycopene (3 mg), vitamin E (200 I.U.) and selenium (100 mcg) twice daily and group B consisting of 20 patients were given placebo capsules once daily for a period of 3 months. Post-treatment follow-up period was 3-4 months. The product used in the study was LYC-O-MATO soft gels, manufactured by Mano pharmaceuticals, Chennai, India. The treatment outcome was evaluated both clinically and histologically and the results were statistically evaluated using Student′s unpaired ′t′ test. Results: The results showed that the patients receiving lycopene in combination with vitamin E and selenium have statistically significant improvements both clinically and histologically as compared to those receiving placebo and with no side effects. Conclusion: The study results proved the efficacy and safety of lycopene along with selenium and vitamin E in the management of oral leukoplakia