A Randomized Double-Blind Placebo-Controlled Phase IIB Trial of Curcumin in Oral Leukoplakia

Abstract

Oral leukoplakia is a potentially malignant lesion of the oral cavity, for which no effective treatment is available. We investigated the effectiveness of curcumin, a potent inhibitor of NF-kB/COX-2, molecules perturbed in oral carcinogenesis, to treat leukoplakia. Subjects with oral leukoplakia (n ¼ 223) were randomized (1:1 ratio) to receive orally, either 3.6 g/day of curcumin (n ¼ 111) or placebo (n ¼ 112), for 6 months. The primary endpoint was clinical response obtained by bi-dimensional measurement of leukoplakia size at recruitment and 6 months. Histologic response, combined clinical and histologic response, durability and effect of long-term therapy for an additional six months in partial responders, safety and compliance were the secondary endpoints. Clinical response was observed in 75 (67.5%) subjects [95% confidence interval (CI), 58.4-75.6] in the curcumin and 62 (55.3%; 95% CI, 46.1-64.2) in placebo arm (P ¼ 0.03). This response was durable, with 16 of the 18 (88.9%; 95% CI, 67.2-96.9) subjects with complete response in curcumin and 7 of 8 subjects (87.5%) in placebo arm, demonstrating no relapse after 6 months followup. Difference in histologic response between curcumin and placebo was not significant (HR, 0.88, 95% CI, 0.45-1.71; P ¼ 0.71). Combined clinical and histologic response assessment indicated a significantly better response with curcumin (HR, 0.50; 95% CI, 0.27-0.92; P ¼ 0.02). Continued therapy, in subjects with partial response at 6 months, did not yield additional benefit. The treatment did not raise any safety concerns. Treatment of oral leukoplakia with curcumin (3.6 g for six months), thus was well tolerated and demonstrated significant and durable clinical response for 6 months. Cancer Prev Res; 9(8); 683-91. Ó2016 AACR.

Turmeric (Curcuma longa) and its major constituent (curcumin) as nontoxic and safe substances: Review

“…In a study on healthy mature individuals, oral intake of 400 mg curcumin daily for 4 weeks did not show toxicity and it was safe at this dose (Cox, Pipingas, & Scholey, ), as well as no adverse effects were observed in healthy young people who received 200 mg curcumin by mouth within 8 weeks (Oliver et al, ). Curcumin was safe in patients with leukoplakia at the dose of 3.6 g/day orally for 6 months and no severe side effects were reported (Kuriakose et al, ).…”

Head and neck cancers in India

“…83 A recently published phase II RCT on oral leukoplakia, patients who received oral Curcumin showed a clinically significant response at 6 months compared to a placebo (67.5 % vs. 55.3 %). 84…”

“…The Department of Biotechnology, Government of India has supported many studies looking at the potential benefits of curcumin in cancer and other conditions . A recently published phase II RCT on oral leukoplakia, patients who received oral Curcumin showed a clinically significant response at 6 months compared to a placebo (67.5 % vs. 55.3 %) …”

Reduction in Prevalence of Hypertension and Blood Heavy Metals among Curry-Consumed Korean

“…Curcumin [1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6heptadien-3,5-dione] is a major component of curry, and has various physiological activities, including anti-inflammatory, anti-oxidative, and anti-tumor activities (Cao et al 2017;Zhou et al 2017). Higher concentrations of curcumin (1.5-6 g/day) are effective in cancer treatment (Kuriakose et al 2016;Mahammedi et al 2016). Reports indicate curcumin can improve cognitive function and cardiovascular health (Kukongviriyapan et al 2016;Wu et al 2017).…”