Ken Sugimoto1, Kentaro Ikeya2, Shigeki Bamba3, Akira Andoh4, Hiroshi Yamasaki5, Keiichi Mitsuyama6, Masanao Nasuno7, Hiroki Tanaka7, Ai Matsuura2, Masaichi Kato2, Natsuki Ishida1, Satoshi Tamura1, Ryosuke Takano1, Shinya Tani8, Satoshi Osawa8, Jun Nishihira9, Hiroyuki Hanai2. 1. The First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan. 2. Centre for Gastroenterology & IBD Research, Hamamatsu South Hospital, Hamamatsu, Japan. 3. Division of Clinical Nutrition, Shiga University of Medical Science, Otsu, Japan. 4. Division of Gastroenterology, Shiga University of Medical Science, Otsu, Japan. 5. Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan. 6. Inflammatory Bowel Disease Centre, Kurume University School of Medicine, Kurume, Japan. 7. IBD Centre, Sapporo Kosei General Hospital, Sapporo, Japan. 8. Department of Endoscopic and Photodynamic Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan. 9. Department of Medical Management and Informatics, Hokkaido Information University, Ebetsu, Japan.
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. CLINICAL TRIAL UMIN REGISTRATION ID: UMIN000015770.
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. CLINICAL TRIAL UMIN REGISTRATION ID: UMIN000015770.
Authors: Barbara De Conno; Marcella Pesce; Martina Chiurazzi; Marta Andreozzi; Sara Rurgo; Chiara Corpetti; Luisa Seguella; Alessandro Del Re; Irene Palenca; Giuseppe Esposito; Giovanni Sarnelli Journal: Foods Date: 2022-04-04
Authors: Mohammed Ghiboub; Charlotte M Verburgt; Bruno Sovran; Marc A Benninga; Wouter J de Jonge; Johan E Van Limbergen Journal: Nutrients Date: 2020-09-17 Impact factor: 5.717