High-dose curcuminoids are efficacious in the reduction in symptoms and signs of oral lichen planus

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.