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P289. Evaluation of efficacy and safety of induction therapy with curcumin enema in ulcerative colitis patients with mild to moderate proctitis

V. Ahuja, V. Singla, B. Choudhury, P. Verma, V. Tiwari, S. Kumar, S. Sharma

All India Institute of Medical Sciences, New Delhi, India

Aim: To evaluate the efficacy and safety of eight weeks curcumin enema induction therapy in ulcerative colitis patients with proctitis.

Methods: A randomized, double-blind, single centre pilot trial studied the efficacy and safety of curcumin enema plus oral 5ASA, compared with placebo enema plus oral 5ASA in 43 ulcerative colitis patients with mild and moderate proctitis as defined by UCDAI score >3. Clinical activity index and endoscopic score were assessed at baseline, 4 weeks and 8 weeks. The primary end point was reduction in UCDAI score >3 points at 8 weeks, and the secondary end points were improvement in endoscopic activity and disease remission at 4 weeks and 8 weeks of therapy.

Results: Of 43 randomized patients, 22 received curcumin and 5 ASA, 21 received placebo and 5ASA. The mean age was 32.8 years (10 male) and 35.8 years (8 male) in curcumin and placebo groups respectively. The baseline UCDAI score was 6.05 and 6.1 in curcumin and placebo group respectively. There was higher number of previous relapses requiring steroid therapy in patients in curcumin group (p < 0.001). Both the treatments were well tolerated, 5 patients were lost to follow up (3 in curcumin group and 2 in placebo group), and treatment was stopped in 9 patients because of failure of therapy. A per protocol analysis of 29 patients (14-curcumin, 15-placebo group) who completed the therapy was performed. The clinical response rates at 4 weeks were (71.3% vs 46.6%, p = 0.176), at 8 weeks were (92.8% vs 53.3%, p = 0.017); remission rates at 4 weeks were (64.2% vs 20%, p = 0.016) at 8 weeks were (78.5% vs 40%, p = 0.03); mucosal healing at 4 weeks (78.5% vs 40%, p = 0.035) and at 8 weeks were (85.6% vs 53.3%, p = 0.06) in curcumin + oral 5ASA versus placebo +oral 5ASA groups respectively. A subgroup analysis showed that in patients who had never received steroids in the past curcumin enemas produced significantly higher response as well as remission rates at 8 weeks (p = 0.038 and p = 0.045).

Conclusions: Curcumin enemas with oral 5ASA are significantly better than oral 5ASA and placebo in achieving better clinical response as well as higher remission rates following 8 weeks of therapy in patients with mild to moderate ulcerative proctitis.