Comparative Study of the Efficacy of Lycopene Versus Prednisolone in the Management of Oral Lichen Planus- A Randomized, Double Blind Clinical Trial.

Abstract

Oral lichen planus (OLP) is a chronic inflammatory, immunologically mediated mucocutaneous disorder. Numerous topical and systemic therapies have been used in the treatment of OLP. Most of the current available treatments are palliative rather than curative. Corticosteroids are considered as the main treatment drugs. Unfortunately, some patients may develop refractory or resistance to corticosteroids therapy. This study aims to evaluate and compare the efficacy of lycopene and prednisolone in the management of OLP. This was a double-blind randomized comparative study in which clinically and histopathologically proven symptomatic OLP patients were enrolled and divided into two groups. Lycopene group received oral lycopene 4 mg/day (n=13) and prednisolone group received oral prednisolone 40 mg/day (n=15) for eight consecutive weeks. Assessments were made at baseline and after 2, 4, 6 and 8 weeks of treatment, based on the Numerical Rating Scale (NRS) and the Piboonniyom REU (Reticular, Erythematous and Ulceration) severity score. From the results obtained, the reduction of NRS burning sensation scores was statistically significant after two weeks of treatment in both groups. REU severity scores were decreased by 74% (p=0.005) and 91% (p=0.001) in lycopene and prednisolone groups respectively. Complete remission (EI=100%) of lesion was observed in two (15.4%) patients treated with lycopene and ten (66.7%) patients treated with prednisolone. However, the overall treatment response was

Serum 8-isoprostane levels in patients with resistant oral lichen planus before and after treatment with lycopene: a randomized clinical trial

“…In this trial, the test group received 10 mg of lycopene for eight consecutive weeks. In OLP, previous clinical trials tested lycopene as a therapeutic agent [7,[37][38][39][40]. The length of treatment followed in the present study was based on the trials by Saawarn et al [37], Shekhawat et al [38] and Kushwaha et al [7] that used LYC for eight weeks.…”

“…(a) Participants of the lycopene (test) group were administered 10 mg of lycopene soft gel capsules as a single morning dose for eight consecutive weeks [7,28]. The active ingredient in each capsule consists of 10 mg lycopene from natural tomato extract.…”

“…(b) Participants of the corticosteroids (control) group were administered 40 mg (2 tablets) of oral Predni-solone as a single morning dose for four consecutive weeks and the dose was tapered along another four weeks. Incremental reduction of 10 mg each week for the first three weeks, followed by 5 mg reduction in the last week, was the tapering protocol in this study [7,13,29]. Each tablet's active ingredient consists of Prednisolone metasulfobenzoate sodium 31.44 mg, which is equivalent to 20 mg of Prednisolone.…”

“…Reactive oxygen species (ROS) and free radicals are unstable molecules that, when released in numerous amounts, are capable of inducing inflammatory and immune responses [6,7]. They hereby are said to put cells in a state of oxidative stress [8].…”

“…The biological properties of lycopene mark its role in various diseases, particularly oral mucosal diseases [16]. For all those reasons, along with considering the implication of oxidative stress in OLP pathology, lycopene is believed to exert significant effects in the treatment of OLP and the prevention of its malignant transformation [7].…”