Highly Bioavailable Curcumin Derivative Ameliorates Crohn's Disease Symptoms: A Randomized, Double-Blind, Multicenter Study

Background & Aims: The new curcumin derivative Theracurmin (R) has a 27-fold higher absorption rate than natural curcumin powder. Theracurmin (R) is an inhibitor of nuclear factor-kappa B, which mediates the expression of inflammatory cytokines. The effect of Theracurmin (R) on inflammatory bowel disease in humans has not been explored; therefore, we investigated the efficacy and safety of Theracurmin (R) in patients with Crohn's disease. Methods: In this randomized, double-blinded study performed at 5 independent medical centers in Japan, Theracurmin (R) (360 mg/day, n = 20) or placebo (n = 10) was administered to patients with active mild-to-moderate Crohn's disease for 12 weeks. The agent's efficacy was assessed by evaluating clinical and endoscopic remission, healing of anal lesions, and blood levels of inflammatory markers. Results: In theTheracurmin (R) group, a significant reduction in clinical disease activity was observed in week 12 relative to that in week 0 (p = 0.005). On intention-to-treat analysis, clinical remission rates were 35%, 40%, and 40% at weeks 4, 8, and 12, respectively, which were significantly higher than those in the placebo group (all 0%; p = 0.033, p = 0.020, and p = 0.020, respectively). Furthermore, reduction in endoscopic Crohn's disease severity (p = 0.032) was observed at week 12 in the Theracurmin (R) group. The endoscopic remission rates were 15% and 0% in theTheracurmin (R) and placebo groups, respectively. Significant healing of anal lesions (p = 0.017) was observed at week 8 in the Theracurmin (R) group. No serious adverse events were observed in either group throughout the study. Conclusions: Theracurmin (R) shows significant clinical and endoscopic efficacy together with a favorable safety profile in patients with active mild-to-moderate Crohn's disease.