Highly bioavailable curcumin derivative ameliorates Crohn's disease symptoms: A randomized, double-blind, multicenter study
Abstract
Background & aims: The new curcumin derivative Theracurmin® has a 27-fold higher absorption rate than natural curcumin powder. Theracurmin® is an inhibitor of nuclear factor-κB, which mediates the expression of inflammatory cytokines. The effect of Theracurmin® on inflammatory bowel disease in humans has not been explored; therefore, we investigated the efficacy and safety of Theracurmin® in patients with Crohn's disease.
Methods: In this randomized, double-blinded study performed at 5 independent medical centers in Japan, Theracurmin® (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 the Theracurmin® 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® group. The endoscopic remission rates were 15% and 0% in the Theracurmin® and placebo groups, respectively. Significant healing of anal lesions (P=0.017) was observed at week 8 in the Theracurmin® group. No serious adverse events were observed in either group throughout the study.
Conclusions: Theracurmin® shows significant clinical and endoscopic efficacy together with a favorable safety profile in patients with active mild-to-moderate Crohn's disease.