Oral and maxillofacial surgery · 2022
Comparative evaluation of the efficacy of Nigella sativa (75% v/v) cream and clobetasol propionate (0.05% w/w) gel in oral lichen planus-a double-blinded randomized control trial.
Рандомизированное исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Kumar S Lokesh, Naik Zameera, Panwar Arun, M Sridhar, Keluskar Vaishali, Kumar Ram Surath
Аннотация
OBJECTIVES: The a im of this study is to evaluate and compare the efficacy of Nigella sativa (75% v/v) cream and clobetasol propionate (0.05% w/w) gel for the management of oral lichen planus (OLP).
STUDY DESIGN: Sixty clinically diagnosed cases of OLP were stratified into moderate cases or severe cases based on burning sensation before getting allocated to group I receiving Nigella sativa cream and group II receiving clobetasol propionate gel, two times a day for 45 days. Patients were examined every 15 days for a change in burning sensation and size of the lesion using the numeric pain rating scale (NRS) and a standard Vernier caliper, respectively. Statistical tests including Mann-Whitney U, Wilcoxon signed-rank, Friedman's, Dunn's post hoc, unpaired t, paired t, one-way repeated measures ANOVA, and Bonferroni's post hoc were applied.
RESULTS: There was a statistically significant reduction in the burning sensation as well as the size of the lesion in both groups (P ≤ 0.05). There was an 87.8% (moderate cases) and 85.7% (severe cases) reduction in the mean NRS scores on the 45th day in group I when compared to the 96.5% (moderate cases) and 93.48% (severe cases) in group II. There was a 92.9% (moderate cases) and 90.7% (severe cases) reduction in the size of the lesion in group I when compared to the 92.6% (moderate cases) and 93.1% (severe cases) in group II.
CONCLUSION: The topical application of Nigella sativa cream was effective and comparable to clobetasol propionate 0.05% gel in the management of OLP, without any side effects. Hence, this study recommends the use of topical Nigella sativa cream therapy in the management of OLP.
CLINICAL RELEVANCE: The current mainstay of treatment for OLP is the administration of topical or systemic corticosteroids, which are known to cause side effects, demanding a search for an alternative. Nigella sativa oil cream could be a safe, promising, cost-effective, adjunctive, or alternative modality. Clinical trial registration number: CTRI/2020/07/026745 (India).
STUDY DESIGN: Sixty clinically diagnosed cases of OLP were stratified into moderate cases or severe cases based on burning sensation before getting allocated to group I receiving Nigella sativa cream and group II receiving clobetasol propionate gel, two times a day for 45 days. Patients were examined every 15 days for a change in burning sensation and size of the lesion using the numeric pain rating scale (NRS) and a standard Vernier caliper, respectively. Statistical tests including Mann-Whitney U, Wilcoxon signed-rank, Friedman's, Dunn's post hoc, unpaired t, paired t, one-way repeated measures ANOVA, and Bonferroni's post hoc were applied.
RESULTS: There was a statistically significant reduction in the burning sensation as well as the size of the lesion in both groups (P ≤ 0.05). There was an 87.8% (moderate cases) and 85.7% (severe cases) reduction in the mean NRS scores on the 45th day in group I when compared to the 96.5% (moderate cases) and 93.48% (severe cases) in group II. There was a 92.9% (moderate cases) and 90.7% (severe cases) reduction in the size of the lesion in group I when compared to the 92.6% (moderate cases) and 93.1% (severe cases) in group II.
CONCLUSION: The topical application of Nigella sativa cream was effective and comparable to clobetasol propionate 0.05% gel in the management of OLP, without any side effects. Hence, this study recommends the use of topical Nigella sativa cream therapy in the management of OLP.
CLINICAL RELEVANCE: The current mainstay of treatment for OLP is the administration of topical or systemic corticosteroids, which are known to cause side effects, demanding a search for an alternative. Nigella sativa oil cream could be a safe, promising, cost-effective, adjunctive, or alternative modality. Clinical trial registration number: CTRI/2020/07/026745 (India).