Amalraj Augustine, Varma Karthik, Jacob Joby, Divya Chandradhara, Kunnumakkara Ajaikumar B, Stohs Sidney J, Gopi Sreeraj
1 R&D Centre, Aurea Biolabs (P) Ltd. , Cochin, India .
2 Agile Pharma Services , Bangalore, India .
J Med Food. 2017 Oct;20(10):1022-1030. doi: 10.1089/jmf.2017.3930. Epub 2017 Aug 29.
Rheumatoid arthritis (RA) is an autoimmune, chronic systemic inflammatory disorder. The long-term use of currently available drugs for the treatment of RA has many potential side effects. Natural phytonutrients may serve as alternative strategies for the safe and effective treatment of RA, and curcuminoids have been used in Ayurvedic medicine for the treatment of inflammatory conditions for centuries. In this study, a novel, highly bioavailable form of curcumin in a completely natural turmeric matrix was evaluated for its ability to improve the clinical symptoms of RA. A randomized, double-blind, placebo-controlled, three-arm, parallel-group study was conducted to evaluate the comparative efficacy of two different doses of curcumin with that of a placebo in active RA patients. Twelve patients in each group received placebo, 250 or 500 mg of the curcumin product twice daily for 90 days. The responses of the patients were assessed using the American College of Rheumatology (ACR) response, visual analog scale (VAS), C-reactive protein (CRP), Disease Activity Score 28 (DAS28), erythrocyte sedimentation rate (ESR), and rheumatoid factor (RF) values. RA patients who received the curcumin product at both low and high doses reported statistically significant changes in their clinical symptoms at the end of the study. These observations were confirmed by significant changes in ESR, CPR, and RF values in patients receiving the study product compared to baseline and placebo. The results indicate that this novel curcumin in a turmeric matrix acts as an analgesic and anti-inflammatory agent for the management of RA at a dose as low as 250 mg twice daily as evidenced by significant improvement in the ESR, CRP, VAS, RF, DAS28, and ACR responses compared to placebo. Both doses of the study product were well tolerated and without side effects.
类风湿性关节炎（RA）是一种自身免疫性慢性全身性炎症性疾病。长期使用目前可用的药物治疗RA有许多潜在的副作用。天然植物营养素可能是安全有效治疗RA的替代策略，姜黄素类化合物在阿育吠陀医学中用于治疗炎症已有数百年历史。在本研究中，评估了一种完全天然姜黄基质中新型、高生物利用度的姜黄素改善RA临床症状的能力。进行了一项随机、双盲、安慰剂对照、三臂平行组研究，以评估两种不同剂量姜黄素与安慰剂在活动性RA患者中的比较疗效。每组12名患者接受安慰剂、250或500毫克姜黄素产品，每日两次，共90天。使用美国风湿病学会（ACR）反应、视觉模拟量表（VAS）、C反应蛋白（CRP）、疾病活动评分28（DAS28）、红细胞沉降率（ESR）和类风湿因子（RF）值评估患者的反应。接受低剂量和高剂量姜黄素产品的RA患者在研究结束时报告其临床症状有统计学上的显著变化。与基线和安慰剂相比，接受研究产品的患者ESR、CPR和RF值的显著变化证实了这些观察结果。结果表明，这种姜黄基质中的新型姜黄素作为一种镇痛和抗炎剂，以低至每日两次250毫克的剂量治疗RA，与安慰剂相比，ESR、CRP、VAS、RF、DAS28和ACR反应有显著改善。研究产品的两种剂量耐受性良好且无副作用。
