Immunomodulatory effects of novel nano micelle based curcumin in rheumatoid arthritis patients: A double blind randomized clinical trial

Abstract

Background and Objectives: Rheumatoid arthritis (RA) is a well-known systemic autoimmune inflammatory disease. This investigation aimed to assess the effects of Sina-curcumin, a novel nano micelle-based curcumin, on immune system responses of RA patients. Methods: This pilot study is a randomized double blinded, controlled trial. Patients who fulfilled the European League against Rheumatism-American College of Rheumatology (EULAR-ACR) criteria for RA were assigned to receive curcumin or placebo for 12 weeks. The outcomes of this study were comparison of changes in mean value of Disease Activity Score of 28 joints erythrocyte sedimentation rate (DAS28-ESR), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), frequency of T helper 1 and T helper 2 cells population. Results: From 150 RA patients who were assessed for eligibility, data from 30 patients (15 patients in each group) were analyzed. There was no significant difference between the two groups regarding age (P = 0.6441) and body mass index (BMI, P = 0.6016). Our measurement showed a statistically significant reduction in ESR (P < 0.0001), CRP (P < 0.0001) and a non-significant decrease in DAS28-ESR (P = 0.5125) in the curcumin group. Also, the Th1/Th2 ratio favorably decreased in the curcumin group. This finding was due to a significant increase in Th2 cells (P < 0.0001) and a nonsignificant decrease in Th1 cells (P = 0.1532). Conclusion: Our trial findings revealed the immunomodulatory effects of curcumin. It could be used and recommended as adjunctive treatment for RA patients.