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A Randomized Placebo-controlled Double Blind Clinical Trial of Quercetin for Treatment of Oral Lichen Planus.

ABSTRACT: Background and aims. Standard treatment of oral lichen planus (OLP) includes topical or systemic corticosteroids that have many adverse effects. A trend toward alternative natural or herbal drugs has attended recently. This study was conducted to evaluate the effect of quercetin in treatment of erosive-atrophic OLP. Materials and methods. Thirty patients participated in this randomized clinical trial from April 2010 to June 2010 (TRIAL REGISTRATION NUMBER: NCT01375101). Patients were randomly allocated in two groups. Both groups received the standard treatment (dexamethasone mouthwash and nystatin suspension). Experimental group received oral 250 mg quercetin hydrate capsules (bid) and the control group received placebo capsules. The pain and severity of the lesions were recorded at the initial visit and the follow-ups. All recorded data were analyzed with chi-square, Mann-Whitney, t-test, Wilcoxon and Friedman tests using SPSS 11.5. Results. There were no significant differences between the two groups in severity of the lesions and pain in the follow-ups.According to the Friedman test, there was a significant reduction in pain (P = 0.01) and severity indices (P = 0.00) in the case group. These differences were not observed in the control group(P = 0.26,SI; and P = 0.86, PI). No adverse effect of quercetin was reported. Conclusion. According to the results, no significant therapeutic effect can be considered for quercetin in treatment of OLP.

SUBMITTER: Amirchaghmaghi M

PROVIDER: S-EPMC4417489 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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A Randomized Placebo-controlled Double Blind Clinical Trial of Quercetin for Treatment of Oral Lichen Planus.

Amirchaghmaghi Maryam M Delavarian Zahra Z Iranshahi Mehrdad M Shakeri Mohammad Taghi MT Mosannen Mozafari Pegah P Mohammadpour Amir Hushang AH Farazi Fatemeh F Iranshahy Milad M

Journal of dental research, dental clinics, dental prospects 20150304 1

Background and aims. Standard treatment of oral lichen planus (OLP) includes topical or systemic corticosteroids that have many adverse effects. A trend toward alternative natural or herbal drugs has attended recently. This study was conducted to evaluate the effect of quercetin in treatment of erosive-atrophic OLP. Materials and methods. Thirty patients participated in this randomized clinical trial from April 2010 to June 2010 (TRIAL REGISTRATION NUMBER: NCT01375101). Patients were randomly al ...[more]

PMID: 25973150

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Project description:INTRODUCTION:Oral lichen planus (OLP) is an idiopathic chronic mucocutaneous disease with a wide range of clinical manifestations, including white reticular patches, erosive/ulcerative and atrophic lesions, both associated with intense symptomatology. Topical corticosteroids are commonly used as standard therapy. However, patients frequently present relapses after the discontinuation of treatment as well as developing resistance to corticosteroid therapy. Photobiomodulation (PBM) has been shown to be a potential therapeutic tool to treat inflammatory disorders, including OLP. The aim of this study was to compare the efficacy of PBM (660?nm) with corticosteroid therapy with clobetasol propionate 0.05% for the treatment of OLP. METHODS AND ANALYSIS:Forty-four patients with symptomatic and histopathological diagnosis of OLP will be randomised into two experimental groups in a double-blind manner: control group (n=22): clobetasol propionate 0.05%+placebo PBM, and experimental group (n=22): PBM (?=660?nm, power 100?mW, radiant exposure: 177?J/cm2 and 0.5J per point)+placebo?gel. Laser will be applied 2×/week for 1?month and clobetasol propionate three times a day for 30 days and the same for placebo treatments. The primary variable (pain) and the secondary variables (clinical score, evaluation of functional scores, clinical resolution, OLP recurrence, quality of life and anxiety and depression) will be evaluated at the baseline, once a week during treatment (depending on the variables) and after 30 days and 60 days of follow-up. Pain will be evaluated using visual analogue scale and clinical characteristics will be scored using the Thongprasom Index. The quality of life and anxiety and depression will be evaluated by Oral Health Impact Profile-14 questionnaire and by Hospital Anxiety and Depression Scale for anxiety scale, respectively. The serum and salivary levels of interleukin (IL)-6, IL-10, IL-1?, INF-? and tumour necrosis factor-? will be evaluated by ELISA at baseline and at the end of treatment. ETHICS AND DISSEMINATION:This protocol was approved (#2.375.410) by the Nove de Julho University (UNINOVE) Research Ethics Committee. The data gathered using this protocol will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER:NCT03320460.

Project description:BackgroundOral lichen planus (OLP) is a mucocutaneous autoimmune disease with T-cell mediation. Corticosteroids are considered as a first choice in OLP and should be used for a long period with a subsequent increase in dose since the disease has a chronic and recalcitrant nature. There have been efforts to use alternative therapies due to the Corticosteroid's side effects. Curcumin is a non-toxic natural product with different effects on various oral diseases. It demonstrates antioxidant, anti-inflammatory, antimicrobial, and anticarcinogenic activities. It seems that Curcumin can be used as a proper alternative for Corticosteroid treatments. To overcome limitations in the bioavailability of Curcumin, the therapeutic effect of oral Nano-Curcumin was evaluated for the first time.MethodsSixty OLP patients were included in this double-blinded randomized clinical trial. The patients were randomly divided into two groups and received either 'Nano-Curcumin 80 mg' or 'Prednisolone 10 mg' treatments for 1?month. The patients should take one capsule after having their breakfast. The VAS scale was used to analyze pain severity and burning sensation. To assess lesion size the Thongprasom scale was employed. Repeated measures and independent t-tests, as well as LSD paired-test, were used to analyze the data.ResultsData from 57 patients were analyzed. The level of pain, burning sensation, and OLP lesions decreased in both groups of Curcumin and Prednisolone and no statistically significant difference was observed between the two groups.ConclusionDespite many studies conducted to find an effective approach for managing OLP, the results have often been unsatisfactory. In comparison with previous studies, current results clarify the importance of Nano-Curcumin bioavailability in therapeutic effects. Pain VAS and lesion size were decreased with oral Curcumin. The results have shown that oral Curcumin can be used as an alternative therapy for OLP in patients with the contraindicated Corticosteroids or should be used with caution. Oral Curcumin can be used in preventing the recurrence of OLP lesions after the treatment and initial control. Moreover, the amount of Curcumin dose is more important than its use duration in improving OLP.Trial registrationIRCT, IRCT20100101002950N5. Registered 9 February 2019, https://www.irct.ir/trial/36704 .

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A Randomized Placebo-controlled Double Blind Clinical Trial of Quercetin for Treatment of Oral Lichen Planus.

Publications

A Randomized Placebo-controlled Double Blind Clinical Trial of Quercetin for Treatment of Oral Lichen Planus.

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