Results from a pilot study published in Journal of Clinical Gastroenterology suggest that low-dose add-on therapy with a novel, hydrophilic, bioenhanced form of curcumin may improve remission rates for ulcerative colitis (UC) in patients receiving the maximum dose of mesalamine.
The chronic and remitting nature of UC necessitates the development of novel therapies. While prior studies have assessed the efficacy of curcumin as add-on treatment, its low bioavailability has produced inconsistent results. Researchers developed a bioenhanced version of curcumin using a combination of surfactant, co-surfactant, oil, and solubilizers. In the gut, this form of bioenhanced curcumin (BEC) disperses to form a microemulsion, which improves uptake and increases bioavailability.
To test the feasibility of BEC as an add-on therapy, investigators conducted a randomized, double-blind, placebo-controlled pilot study at a gastroenterology clinic in Telangana, India (ClinicalTrials.gov Identifier: NCT02683733). Patients with mild to moderately active UC on a standard dose of mesalamine were randomly assigned 1:1 to either BEC or placebo. BEC was administered twice daily in capsule form at 50 mg doses.
Clinical response, defined as a ≥2 point reduction in partial Mayo score, was assessed at 6 weeks and 3 months. Clinical remission (partial Mayo score ≤1) and endoscopic remission (endoscopic Mayo score ≤1) were also evaluated at these timepoints. Patients who displayed clinical response at 3 months were followed-up at 6 and 12 months for maintenance of remission.
A total of 69 patients were randomly assigned: 34 to BEC and 35 to placebo. Demographic characteristics and baseline disease activity were comparable between study groups. In the total cohort, median age was 38 years and 62% were men.
At week 6, clinical and endoscopic remission were observed in 44.1% and 35.3% of the BEC group, respectively, compared with 0% each in the placebo group (both P <.01). Clinical response at 6 weeks was also significantly more common in the BEC group compared with the placebo group (52.9% vs 14.3%; P =.001).
At 3 months, the BEC group had significantly greater rates of clinical remission (55.9% vs 5.7%), clinical response (58.8% vs 28.6%), and endoscopic remission (44% vs 5.7%) compared with placebo (all P ≤.01). At 6 and 12 months 95% and 84% of BEC responders maintained clinical remission, respectively. Just 2 patients who responded to placebo were followed-up at 6 months; neither patient maintained remission. BEC was not associated with any significant side effects.
Results from this pilot study suggest that low-dose BEC as add-on therapy was superior to placebo for inducing sustained clinical and endoscopic response in mild to moderate UC. However, further research is necessary to confirm the potential benefits of BEC, as the small patient cohort and single study center limited data generalizability.
“The encouraging results highlight the need for larger multicentric trials with larger number of participants including severe disease and multiple dosing algorithms with a properly designed maintenance phase study to externally validate the results,” investigators wrote. “[C]urcumin is a safe low-cost treatment option especially in resource-limited settings. As the global burden of IBD increases, curcumin may present a cost-effective alternative for the management of UC,” they concluded.
Banerjee R, Pal P, Penmetsa A, et al. Novel bioenhanced curcumin with mesalamine for induction of clinical and endoscopic remission in mild-to-moderate ulcerative colitis: a randomized double-blind placebo-controlled pilot study. J Clin Gastroenterol. 2021;55(8):702-708. doi: 10.1097/MCG.0000000000001416