Slow Release Oral Formulation and Topical Curcumin in Combination with 5 Aminosalycilate Induce Remission in Patients with Refractory Ulcerative Proctitis in A Randomized Controlled Trial

Abstract

Introduction and Aim: Refractory ulcerative proctitis is defined as the failure of topical and oral 5-aminosalicylate and corticosteroids treatment. Management of refractory proctitis is often challenging. Curcumin was reported to be efficacious in inducing and maintaining remission in patients with ulcerative colitis (UC). We investigated curcumin in patients with refractory ulcerative proctitis, non responder to conventional therapies (rectal 5 aminosalycilate or steroid in combination with oral 5 aminosalycilate, steroid or azathioprine). Methods: In a randomized, placebo controlled trial, 10 patients were randomly assigned to assume curcumin capsules (3g/die), in a slow release oral formulation and curcumin enema (3g/die) for one month. Ten patients assumed an identical placebo for 1 month. Primary outcome was clinical remission at week 4. Endoscopic and biochemical data were also recorded. Results: After one month the number of patients achieving clinical remission was significantly higher in the curcumin treated group (p<0.04; OR, 12,5; 95% CI). After 3 months, 80% of patients treated with curcumin were still in remission vs 10% of patients treated with 5 aminosalycilate (p<0.001; OR, 12; 95% CI). Endoscopic remission (Mayo score <=1 was achieved in 60% of patients treated with curcumin and none in the 5 aminosalycilate group. Conclusion: In this pilot study 3 months topical and oral slow released curcumin therapy in combination with 5 aminosalycilate is efficacious in achieving clinical remission in refractory ulcerative proctitis patients. Results: After one month the number of patients achieving clinical remission was significantly higher in the curcumin treated group (p<0.04; OR, 12,5; 95% CI). After 3 months, 80% of patients treated with curcumin were still in remission vs 10% of patients treated with 5 aminosalycilate (p<0.001; OR, 12; 95% CI). Endoscopic remission (Mayo score <=1 was achieved in 60% of patients treated with curcumin and none in the 5 aminosalycilate group. Conclusion: In this pilot study 3 months topical and oral slow released curcumin therapy in combination with 5 aminosalycilate is efficacious in achieving clinical remission in refractory ulcerative proctitis patients.