BACKGROUND: Curcuminoids are components of turmeric (Curcuma longa) that possess anti-inflammatory properties. OBJECTIVE: We sought to study the efficacy of curcuminoids in controlling the signs and symptoms of oral lichen planus, at doses of 6000 mg/d (3 divided doses), and their safety at this dose. METHODS:Twenty consecutive, eligible patients who consented were enrolled into this randomized, double-blind, placebo-controlled clinical trial in 2007 through 2008. Measurement of symptoms and signs of oral lichen planus using the Numerical Rating Scale (NRS) and the Modified Oral Mucositis Index (MOMI), respectively; complete blood counts; liver enzymes; C-reactive protein; and interleukin-6 levels was done at baseline and day 14. Two-sided P values are reported. RESULTS: In the placebo group, the percentage changes from baseline in NRS (median [interquartile range] = 0.00 [-29 to 16.7], P > .99), erythema (0.00 [-10 to 16.7], P = .98), ulceration (0.00 [0.00 to 26.7], P = .63), and total MOMI scores (-3.2 [-13 to 9.09], P = .95) were not statistically significant, whereas they were statistically significant in the curcuminoids group: NRS (-22 [-33 to -14], P = .0078); erythema (-17 [-29 to -8.3], P = .0078), ulceration (-14 [-60 to 0.00], P = .063), MOMI (-24 [-38 to -11], P = .0039). The curcuminoids group showed a greater reduction in clinical signs and symptoms as compared with the placebo group, measured by percentage change in erythema (P = .05) and total MOMI score (P = .03), and proportion showing improvement in NRS (0.8 vs 0.3, P = .02) and total MOMI score (0.9 vs 0.5, P = .05). Adverse effects were uncommon in both groups. LIMITATIONS: The small sample size resulted in limited power, particularly for multivariate analyses. CONCLUSIONS: Curcuminoids at doses of 6000 mg/d in 3 divided doses are well tolerated and may prove efficacious in controlling signs and symptoms of oral lichen planus.
RCT Entities:
BACKGROUND:Curcuminoids are components of turmeric (Curcuma longa) that possess anti-inflammatory properties. OBJECTIVE: We sought to study the efficacy of curcuminoids in controlling the signs and symptoms of oral lichen planus, at doses of 6000 mg/d (3 divided doses), and their safety at this dose. METHODS: Twenty consecutive, eligible patients who consented were enrolled into this randomized, double-blind, placebo-controlled clinical trial in 2007 through 2008. Measurement of symptoms and signs of oral lichen planus using the Numerical Rating Scale (NRS) and the Modified Oral Mucositis Index (MOMI), respectively; complete blood counts; liver enzymes; C-reactive protein; and interleukin-6 levels was done at baseline and day 14. Two-sided P values are reported. RESULTS: In the placebo group, the percentage changes from baseline in NRS (median [interquartile range] = 0.00 [-29 to 16.7], P > .99), erythema (0.00 [-10 to 16.7], P = .98), ulceration (0.00 [0.00 to 26.7], P = .63), and total MOMI scores (-3.2 [-13 to 9.09], P = .95) were not statistically significant, whereas they were statistically significant in the curcuminoids group: NRS (-22 [-33 to -14], P = .0078); erythema (-17 [-29 to -8.3], P = .0078), ulceration (-14 [-60 to 0.00], P = .063), MOMI (-24 [-38 to -11], P = .0039). The curcuminoids group showed a greater reduction in clinical signs and symptoms as compared with the placebo group, measured by percentage change in erythema (P = .05) and total MOMI score (P = .03), and proportion showing improvement in NRS (0.8 vs 0.3, P = .02) and total MOMI score (0.9 vs 0.5, P = .05). Adverse effects were uncommon in both groups. LIMITATIONS: The small sample size resulted in limited power, particularly for multivariate analyses. CONCLUSIONS:Curcuminoids at doses of 6000 mg/d in 3 divided doses are well tolerated and may prove efficacious in controlling signs and symptoms of oral lichen planus.
Authors: Carla Caroline Cunha Bastos; Paulo Henrique Marcelino de Ávila; Edvande Xavier Dos Santos Filho; Renato Ivan de Ávila; Aline Carvalho Batista; Simone Gonçalves Fonseca; Eliana Martins Lima; Ricardo Neves Marreto; Elismauro Francisco de Mendonça; Marize Campos Valadares Journal: Toxicol Rep Date: 2015-10-30
Authors: Muthu K Shanmugam; Grishma Rane; Madhu Mathi Kanchi; Frank Arfuso; Arunachalam Chinnathambi; M E Zayed; Sulaiman Ali Alharbi; Benny K H Tan; Alan Prem Kumar; Gautam Sethi Journal: Molecules Date: 2015-02-05 Impact factor: 4.411