Evaluation of efficacy and safety of curcumin enema in patients with distal ulcerative colitis-a pilot study

Background: Curcumin is an active ingredient of turmeric. It has anti‐infl ammatory properties and was demonstrated to be useful in experimental models of ulcerative colitis (UC). Its efficacy in UC needs to be investigated in clinical studies. Aim: To evaluate the efficacy and safety of curcumin enema in UC patients with distal involvement. Methods: A randomized, double‐blind, single centre pilot trial was conducted in UC patients with distal involvement and mild to moderate disease activity. 45 patients were randomized to receive either curcumin enema combined with oral 5‐ASA or a combination of placebo enema and oral 5‐ASA. Primary end point was reduction in UCDAI score by 3 points at 8 weeks, and the secondary end points were improvement in endoscopic activity and disease remission at 8 weeks. Results: Baseline characteristics were similar in both the groups, except for higher requirement of steroids previously in the curcumin group (p = 0.00). 56.52% in the curcumin group had response to treatment compared to 36.36% (p = 0.175) in the placebo group. At week 8, clinical remission was observed in 43.37% of patients in the curcumin group compared to 22.73% in the placebo group (p = 0.140) and mucosal healing in 52.17% of patients in the curcumin group compared to 36.36% of patients in the placebo group (p = 0.286). Per protocol analysis revealed significantly better outcome in curcumin group, in terms of clinical response (92.85% vs. 50.00%, p value 0.011), clinical remission (71.42% vs. 31.25%, p = 0.028), and mucosal healing (85.71% vs. 50.00%, p = 0.038). Side effects were similar and minor in both the groups. Conclusion: Among patients with mild and moderate distal ulcerative colitis, 8 weeks treatment with curcumin enema resulted in clinical and endoscopic improvement. Role of curcumin as a novel therapeutic agent for treatment of UC should be explored.