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

Abstract

<jats:title>Abstract</jats:title> <jats:sec> <jats:title>Background &amp; Aims</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>Theracurmin® shows significant clinical and endoscopic efficacy together with a favorable safety profile in patients with active mild-to-moderate Crohn’s disease.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical trial UMIN registration ID</jats:title> <jats:p>UMIN000015770.</jats:p> </jats:sec>

Curcumin and Its Modified Formulations on Inflammatory Bowel Disease (IBD): The Story So Far and Future Outlook

“…The clinical reduction observed at 4, 8, and 12 weeks was 35%, 40%, and 40%, respectively, which was considerably higher than in the placebo group. Theracurcumin also exhibited a decrease in the severity of CD and stronger endoscopic reduction levels in the theracurcumin group (15% compared to 0% in the placebo-treated groups), suggesting the potential of using theracurcumin to ameliorate the CD [ 130 ].…”

A Systematic Review Assessing Clinical Utility of Curcumin with a Focus on Cancer Prevention

“…In the prevention setting, from the 15 studies that met all five quality criteria, 10 had positive clinical outcomes. These outcomes related directly to efficacy [12] , symptom improvement [15,20,25,28] , durability of clinical response [22] , clinical remission [23,29,30] , and assessment by biomarker changes. [26] This provides encouraging information to suggest potential for positive patient benefit within the oral lichen planus, oral leucoplakia, ulcerative colitis, Crohn's disease, and oral submucous fibrosis settings.…”

(Poly)phenols in Inflammatory Bowel Disease and Irritable Bowel Syndrome: A Review

“…The Crohn's disease activity index (CDAI) is a seven-criteria disease activity index including frequency of liquid stools, abdominal pain, general wellbeing, presence of complication, use of medication for diarrhoea, abdominal mass, haematocrit, and deviation from standard weight [81]. Administration of Theracurmin, which has increased bioavailability in comparison with standard curcumin, resulted in a significant reduction in CDAI [54] compared with a non-significant reduction with standard curcumin [43]. One study found no change in CDAI in CD or ulcerative colitis clinical activity index (UCAI) in UC with moderate red wine consumption [53].…”

“…Extra virgin olive oil administration resulted in a significant reduction in reports of constipation [47]. One study explored individual gastrointestinal symptoms in CD and found supplementation with Theracurmin significantly reduced stool frequency and demonstrated a trend in reduced abdominal pain [54].…”

“…The endoscopic component of the UCDAI score reduced in subjects with UC who demonstrated an overall reduction in UCDAI following green tea EGCG supplementation [45]. In CD, 360 mg of curcumin (Theracurmin) significantly reduced simple endoscopic score for Crohn's disease (SESCD) and anal lesions, although there was no difference in endoscopic remission rates defined at SESCD ≤ 4 [54].…”