A comparative study to evaluate the efficacy of lycopene and curcumin in oral submucous fibrosis patients: A randomized clinical trial.

Background: : Oral submucous fibrosis (OSMF) is a most prevalent potentially malignant disorder associated with betel quid chewing frequently observed in the Indian population. The present study conducted is much of a keen interest because there is much new information, both in the press and the medical literature, about the benefits of fresh fruits and vegetables and antioxidants (such as lycopene and curcumin) for both prevention and treatment of diseases. As clinicians, we often prescribe medications with significant adverse effects, and certainly, if armed with evidence to support using such antioxidants as safer therapeutic alternatives for treatment of OSMF.

Aims and Objective: The aim of the study was to compare and evaluate the efficacy of lycopene and curcumin given orally in clinically diagnosed OSMF patients.

Materials and Methods: Sixty patients were divided randomly into two groups Group A and Group B. After fulfilling the eligibility criteria, sixty patients were randomly allotted based on fishbowl method into thirty each. This technique eliminated the selection bias arising in the study. Group A individuals were treated with 4 mg of lycopene and Group B individuals were given 300 mg of curcumin thrice daily for 3 months. Both the groups were assessed in terms of mouth opening and burning sensation. The statistical analysis was done using SPSS Version 16.0 statistical Analysis Software.

Results: In Group A, the initial burning sensation was 65.83 ± 3.98%, and in Group B, it was 62.33 ± 5.22% (visual analog scale). After 3 months, there was complete cessation of burning sensation in both the groups. Burning sensation between the groups was statistically nonsignificant (P > 0.05). In Group A, mean mouth opening at baseline (1st visit) observed was 3.17 ± 0.08 cm which improved to 3.52 ± 0.07 cm after 3 months of the treatment period. In Group B, mean mouth opening at baseline (1st visit) observed was 3.32 ± 0.07 cm which improved to 3.52 ± 0.08 cm after 3 months of the treatment period. On comparing intergroup, the difference was statistically nonsignificant (P > 0.05). However, on comparing intergroup, average percent change in mean mouth opening from 1st visit to subsequent time intervals across the time period was found to be statistically significant (P < 0.05). Group A showed 11.1 ± 1.0% improvement in mean mouth opening and Group B showed 6.2 ± 0.4% improvement in the mean mouth opening from the 1st visit till the posttreatment period. The change in the mean mouth opening from 1st visit till posttreatment in Group A was 0.35 ± 0.14, and in Group B, it was 0.20 ± 0.09.

Conclusion: Lycopene showed better results than curcumin in improving mouth opening; both the drugs were equally effective in decreasing burning sensation in OSMF patients.