A Novel Highly Bioavailable Curcumin Formulation Improves Symptoms and Diagnostic Indicators in Rheumatoid Arthritis Patients: A Randomized, Double-Blind, Placebo-Controlled, Two-Dose, Three-Arm, and Parallel-Group Study
A Novel Highly Bioavailable Curcumin Formulation Improves Symptoms and Diagnostic Indicators in Rheumatoid Arthritis Patients: A Randomized, Double-Blind, Placebo-Controlled, Two-Dose, Three-Arm, and Parallel-Group Study
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DOI：
10.1089/jmf.2017.3930
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发表时间：
2017-10-01
影响因子：
2.4
通讯作者：
Gopi, Sreeraj
中科院分区：
文献类型：
--
作者：
Amalraj, Augustine;Varma, Karthik;Gopi, Sreeraj
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。天然植物营养素可作为安全有效治疗RA的替代策略，姜黄素已用于阿育吠陀医学中治疗炎症性疾病数百年。在这项研究中，一种新的，高生物利用度的姜黄素形式在一个完全天然的姜黄基质进行了评估，其改善RA的临床症状的能力。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的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毫克的姜黄素产品，每天两次，持续90天。采用美国流变学学会（ACR）反应、视觉模拟评分（VAS）、C反应蛋白（CRP）、疾病活动性评分28（DAS 28）、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了其临床症状的统计学显著变化。与基线和安慰剂相比，接受研究产品的患者的ESR、CPR和RF值的显著变化证实了这些观察结果。结果表明，姜黄基质中的这种新型姜黄素作为镇痛剂和抗炎剂，以低至250 mg每日两次的剂量用于管理RA，与安慰剂相比，ESR、CRP、VAS、RF、DAS 28和ACR反应的显著改善证明了这一点。两种剂量的研究产品均耐受良好，无副作用。
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 500mg 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 250mg 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.