Bone and Cartilage Research Unit, Arthropôle Liège, Institute of Pathology, Level 5, CHU Sart-Tilman, University of Liège, 4000, Liège, Belgium.
Department of Physical Therapy and Rehabilitation, Princess Paola Hospital, Vivalia, Marche-en-Famenne, Belgium.
Arthritis Res Ther. 2019 Jul 27;21(1):179. doi: 10.1186/s13075-019-1960-5.
Comparison of two doses of bio-optimized Curcuma longa extract (BCL) in the management of symptomatic knee osteoarthritis (OA).
A prospective, randomized, 3-month, double-blind, multicenter, three-group, placebo-controlled trial assessing Patient Global Assessment of Disease Activity (PGADA) and serum sColl2-1, a biomarker of cartilage degradation, as co-primary endpoints. Pain on visual analog scale (VAS), Knee injury and Osteoarthritis Outcome Score (KOOS), and paracetamol/non-steroidal anti-inflammatory drug (NSAID) consumption were used as secondary endpoints.
One hundred fifty patients with knee OA were followed for 90 days. Low and high doses of BCL showed a greater decrease of PGADA than placebo. Analysis of sColl2-1 showed in the placebo and BCL low-dose groups, but not in the BCL high-dose group, a transient but non-significant increase of sColl2-1 between T0 and T1. Thereafter, in all groups, sColl2-1 decreased between T1 and T3 (all p < 0.01), but no difference between the groups was found. Pain reduction at day 90 in the low- and high-dose BCL groups (- 29.5 mm and - 36.5 mm) was higher than that in the placebo (- 8 mm; p = 0.018). The global KOOS significantly decreased overtime, but changes were comparable across treatment arms. The ratio of patients with adverse events (AE) related to the product was similar in the placebo and treatment groups, but the number of AE linked to the product was higher in the high-dose BCL group compared to the placebo (p = 0.012).
BCL appeared safe and well-tolerated with no evidence of severe adverse effects. Efficacy analysis suggested positive trends for measurements of PGADA and serum levels of an OA biomarker and showed a rapid and significant decrease of pain in knee OA (Trial registration: ISRCTN, ISRCTN12345678. Registered 21 September 2016-retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02909621?term=osteoarthritis+curcumin&rank=5-Evaluation of FLEXOFYTOL® Versus PLACEBO (COPRA) NCT02909621).
比较两种剂量的生物优化姜黄提取物（BCL）在治疗症状性膝骨关节炎（OA）中的效果。
这是一项前瞻性、随机、3 个月、双盲、多中心、三分组、安慰剂对照试验，评估患者疾病活动的整体评估（PGADA）和血清 sColl2-1，作为共同的主要终点，这是软骨降解的生物标志物。疼痛的视觉模拟量表（VAS）、膝关节损伤和骨关节炎结果评分（KOOS）以及扑热息痛/非甾体抗炎药（NSAID）的使用作为次要终点。
150 名膝骨关节炎患者随访 90 天。BCL 的低剂量和高剂量显示出比安慰剂更大的 PGADA 降低。sColl2-1 的分析显示，在安慰剂和 BCL 低剂量组中，但在 BCL 高剂量组中，sColl2-1 在 T0 和 T1 之间有短暂但无统计学意义的增加。此后，在所有组中，sColl2-1 在 T1 和 T3 之间均下降（均 p<0.01），但组间无差异。低剂量和高剂量 BCL 组在第 90 天的疼痛缓解（-29.5mm 和-36.5mm）高于安慰剂组（-8mm；p=0.018）。全球 KOOS 随时间显著下降，但治疗组之间的变化相当。与产品相关的不良事件（AE）的患者比例在安慰剂和治疗组中相似，但与产品相关的 AE 数量在高剂量 BCL 组高于安慰剂组（p=0.012）。
BCL 似乎安全且耐受良好，没有严重不良事件的证据。疗效分析表明，对 PGADA 测量和 OA 生物标志物血清水平有积极趋势，并显示膝关节骨关节炎疼痛迅速显著下降（试验注册：ISRCTN，ISRCTN12345678。2016 年 9 月 21 日注册-回顾性注册，https://clinicaltrials.gov/ct2/show/NCT02909621？term=osteoarthritis+curcumin&rank=5-Evaluation of FLEXOFYTOL® Versus PLACEBO（COPRA）NCT02909621）。
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