Efficacy of lycopene in the management of oral submucous fibrosis.

OBJECTIVES

To evaluate the efficacy of oral lycopene therapy in patients with oral submucous fibrosis and to compare these effects with a placebo.

STUDY

DESIGN

Fifty-eight patients with oral submucous fibrosis formed the population for the study and were randomly divided into 3 groups, evaluated weekly over a 2-month period. Patients of group A (n = 21) received 16 mg of lycopene, those of group B (n = 19) received 16 mg of lycopene along with biweekly intralesional steroid injections, and those of group C (n = 18) were given a placebo. Paired and unpaired t tests were used for statistical evaluation.

RESULTS

Mouth-opening values for the patients showed an average increase of 3.4 mm, 4.6 mm, and 0.0 mm for patients in groups A, B, and C, respectively. These values were statistically found to be highly significant.

CONCLUSIONS

The observed effects suggest that lycopene can and should be used as a first line of therapy in the initial management of oral submucous fibrosis.