CONTEXT: Oxidative stress has been implicated in the pathogenesis of lichen planus, and a lower level of lycopene has been reported in erosive and atrophic oral lichen planus (OLP) patients. However, its efficacy in the management of OLP has not been reported. AIM: This study was designed to assess the efficacy of systemic lycopene in the management of OLP. SETTINGS AND DESIGN: This prospective, randomized, double-blind, placebo-controlled study was done in the Oral Medicine Department of a postgraduate teaching dental hospital in India. MATERIALS AND METHODS:Thirty symptomatic OLP patients, randomly divided into two groups of 15 each, were administered lycopene 8 mg/day and an identical placebo, respectively, for 8 consecutive weeks. Burning sensation using visual analogue scale and overall treatment response using Tel Aviv-San Francisco scale were recorded at every visit. The data obtained were analyzed statistically using Wilcoxon Rank test, Mann-Whitney and Fischer's Exact test. RESULTS: A higher (84%) reduction in burning sensation was seen in lycopene than in the placebo group (67%). All 15 (100%) patients in the lycopene group showed 50% or more benefit and 11 (73.3%) patients showed 70-100% benefit, while this number was only 10 and 4 (26.7%), respectively, in the placebo group. CONCLUSION:Lycopene was very effective in the management of OLP, and oxidative stress may have a role in disease pathogenesis.
RCT Entities:
CONTEXT: Oxidative stress has been implicated in the pathogenesis of lichen planus, and a lower level of lycopene has been reported in erosive and atrophic oral lichen planus (OLP) patients. However, its efficacy in the management of OLP has not been reported. AIM: This study was designed to assess the efficacy of systemic lycopene in the management of OLP. SETTINGS AND DESIGN: This prospective, randomized, double-blind, placebo-controlled study was done in the Oral Medicine Department of a postgraduate teaching dental hospital in India. MATERIALS AND METHODS: Thirty symptomatic OLP patients, randomly divided into two groups of 15 each, were administered lycopene 8 mg/day and an identical placebo, respectively, for 8 consecutive weeks. Burning sensation using visual analogue scale and overall treatment response using Tel Aviv-San Francisco scale were recorded at every visit. The data obtained were analyzed statistically using Wilcoxon Rank test, Mann-Whitney and Fischer's Exact test. RESULTS: A higher (84%) reduction in burning sensation was seen in lycopene than in the placebo group (67%). All 15 (100%) patients in the lycopene group showed 50% or more benefit and 11 (73.3%) patients showed 70-100% benefit, while this number was only 10 and 4 (26.7%), respectively, in the placebo group. CONCLUSION:Lycopene was very effective in the management of OLP, and oxidative stress may have a role in disease pathogenesis.