Assessment of Utility of Lycopene, Selenium, and Vitamin E in Management of Oral Leukoplakia.

Objectives: To assess the utility of lycopene, selenium, and vitamin E in the management of leukoplakia. Materials and
Methods: In this cross-sectional observational prospective study, 52 patients of oral leukoplakia were divided into 2 groups. Group I patients were prescribed 6 mg of lycopene, 400 I.U. of vitamin E, and 200 μg of selenium twice a day. Group II patients were prescribed a placebo capsule. The clinical improvement was recorded in both groups.
Results: The mean pretreatment size of lesion in group I was 9.24 cm2 and in group II was 8.52 cm2. Post treatment size was 1.52 cm2 in group I and 6.28 cm2 in group II. There was a significant reduction in the size of lesion in group I compared to group II (P < 0.05).
Conclusion: The treatment with a combination of lycopene, selenium, and vitamin E is useful and effective in managing the cases of oral leukoplakia. Copyright:

INTRODUCTION

Various tobacco forms are cigarette, bidi, hookah, hookli, cigar, zarda, chaini khaini, pan masala etc. Leukoplakia is one of the potentially malignant diseases manifested as white patches and plaques, which cannot be characterized clinically and pathologically and is not associated with physical use except the use of tobacco.[1]

The best management of cases of leukoplakia is inhibition of tobacco chewing or smoking habit. Antioxidants are also known as free radical scavengers. The function of carotenoids, retinol, retinoid, ascorbic acid, and alpha-tocopherol (vitamin E) as antioxidants is well established.[2] Vitamin E is capable of preventing the conversion of nitrites to a carcinogenic chemical nitrosamine. It also endorses immune system function. Selenium, a micronutrient, induces apoptosis of cells and thus acts as one of the potential antioxidants, especially in leukoplakia.[3] Lycopene is one of the carotenoids and a potential antioxidant, which presents in large amounts in tomatoes.[4]

The present study was conducted to assess the utility of lycopene, selenium, and vitamin E in the management of leukoplakia.

MATERIALS AND METHODOLOGY

This study was conducted in the Department of Oral Pathology. Informed consent was obtained from participants and ethical letter was obtained from institutional ethics committee.

This prospective, crosssectional study was conducted among 52 patients of oral leukoplakia after considering inclusion and exclusion criteria.

Group I patients were prescribed 6 mg of lycopene, 400 I.U. of vitamin E, and 200 μg of selenium twice a day. Group II patients were prescribed a placebo capsule.

In all patients, size of the lesions, clinical improvement such as complete remission (100%), partial improvement (>50%), stable response (<50%), and progression, i.e., appearance of a new lesion, were recorded. Patients were evaluated at baseline, after 2 weeks, and 3 months. Results were tabulated and subjected to statistical analysis using SPSS software version 20 with Oneway ANOVA test. P-value less than 0.05 was considered significant.

RESULTS

Table 1 shows that the mean pretreatment size of lesion in group I was 9.24 cm2 and in group II was 8.52 cm2 and posttreatment size was 1.52 cm2 in group I and 6.28 cm2 in group II. Graph 1 shows that there was an improvement in lesion in group I.

Table 1

Assessment of clinical improvement of lesions in both groups

Parameters (mean±SD) (cm2)	Group I	Group II
Pretreatment	9.24	8.52
Posttreatment	1.52	6.28
Improvement	7.72	1.24
t	6.58	3.40

Graph 1

Clinical improvement in both groups

Table 2 shows that in group I, 8 cases were found to be normal, 10 cases had atypical hyperplasia, and there was more improvement (P < 0.05) in group I than group II (P > 0.05).

Table 2

Assessment of histological improvement in both groups

Histological staging	Group I		Group II
	Pretreatment	Posttreatment	Pretreatment	Posttreatment
Normal	0	8	0	2
Atypical hyperplasia	13	10	10	8
Mild dysplasia	10	8	11	13
Moderate dysplasia	3	0	5	3
Severe dysplasia	0	0	0	0
P	0.01		0.71

DISCUSSION

Leukoplakia is one of the most commonly occurring potentially malignant disorders. It is more prevalent in males.[5] It is clinically manifested as whitish patch, which is usually nonscrapable. An increase in size over the period of time indicates the need of taking biopsy and histopathological examination.[6] Vitamin E causes blockage of N-nitroso compounds and inhibits chemical carcinogenesis in animals.[7]

Patel et al.[8] found a significant improvement in group A (combination of vitamin E selenium and lycopene) group compared to placebo similar to our findings. Singh et al.[9] found that 8 mg lycopene was most effective in bringing down the size of the lesion and improvement in clinincal symptoms as compared to 4 mg/day dosage and lycopene. Uma Maheswari[10] stated that the combination of vitamin A, E, and C was found to be efficient with maximum clinical resolution (90%) recorded and regression of dysplasia recorded as 97.5%.

The shortcoming of the study is a small sample size.

CONCLUSION

The treatment with a combination of lycopene, selenium, and vitamin E is useful and effective in managing cases of oral leukoplakia.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.