High dose Curcuminoids are efficacious in the reduction in symptoms and signs of oral lichen planus.
J Am Acad Dermatol. 2012; 66(5):752-60.
Previous study with the 2000 mg/day dose of Curcuminoids in patients with OLP was ended for futility. Also the earlier study suggested the need of trial with higher dose of Curcuminoids for effective results.
- To evaluate the efficacy, safety and tolerability of Curcuminoids at a dose of 6000 mg/day in patients with OLP.
- To evaluate the association of serum C-reactive protein (CRP) and serum interleukin (IL)-6 with clinical severity of OLP at baseline and overtime.
- To evaluate the effect of Curcuminoids on CRP, IL-6 in patients with OLP.
A phase II, randomized, double-blind, placebo controlled study was planned with 20 patients. Patients were divided into two groups of 10 each and were administered 6000 mg/day of Curcuminoids or placebo for two weeks. In accordance with the above objectives; OLP signs and symptoms were measured by using Numerical Rating Scale (NRS) and Oral Mucositis Index (MOMI).
Complete blood count, liver enzymes, CRP and IL-6 levels were also measured. Primary outcome measure was change in symptom scores from baseline to 2-week follow-up, secondary outcome measures were changes in clinical signs, CRP and IL-6 from baseline and occurrence of adverse effects.
Results and Discussion:
- The Curcuminoids group showed greater reduction in OLP symptoms as compared to placebo group, as measured by NRS (p=0.09), erythema (p=0.05), ulceration (p=0.08), and total MOMI score (p=0.03).
- Curcuminoids were well tolerated at dose level of 6000 mg/day and there was no difference between the side effects observed between both Curcuminoids and placebo group.
- The association of CRP and (IL)-6 with clinical severity of OLP was nonsignificant at baseline and overtime.
- Most participants at baseline had low CRP and IL-6 levels and difference in changes in these markers after administration of Curcuminoids as compared to placebo was non-significant.
This study was the first study to show that Curcuminoids are not only the effective agent to reduce symptoms and signs of OLP but the dose level of 6000 mg/day Curcuminoids was well tolerated in patients with OLP. Therefore, considering the safety profile of Curcuminoids, it is suggested from above study that Curcuminoids can be an effective agent for treating the patients of OLP and their efficacy in other autoimmune diseases should also be tested