BCM-95® (CURCUGREEN®), 24 Mar 2016
Published on : August 2016

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

Moni Abraham Kuriakose, Kunnambath Ramdas, Bindu Dey, Subramanya Iyer, Gunaseelan Rajan, Kalavathy K. Elango, Amritha Suresh, Divya Ravindran, Rajneesh R. Kumar, Prathiba R, Surya Ramachandran, Nisha Asok Kumar, Gigi Thomas, Thara Somanathan, Hiran K. Ravindran, Kannan Ranganathan, Sudhakar Babu Katakam, Shivashankar Parashuram, Vijayvel Jayaprakash and M. Radhakrishna Pillai

DOI: 10.1158/1940-6207.CAPR-15-0390 Published August 2016

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-κB/COX-2, molecules perturbed in oral carcinogenesis, to treat leukoplakia. Subjects with oral leukoplakia (n = 223) were randomized (1:1 ratio) to receive orally, either 3.6 g/day of curcumin (n = 111) or placebo (n = 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 = 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 follow-up. Difference in histologic response between curcumin and placebo was not significant (HR, 0.88, 95% CI, 0.45–1.71; P = 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 = 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. ©2016 AACR.


  • bcm
  • BCM-95
  • bcm95
  • clinical study
  • curcugreen
  • Curcumin
  • leukoplakia
  • oral leukoplakia
  • turmeric
  • turmeric extract

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