ZBIGNIEW ŻĘGOTA SPECJALISTYCZNY OŚRODEK LECZNICZO-BADAWCZY, OSTRODA, POLAND.
SILMEDIC LTD, KATOWICE, POLAND.
Wiad Lek. 2021;74(9 cz 1):2128-2137.
The aim: In this study, we present a sub-analysis of physical functionality in sufferers of mild knee osteoarthritis (OA) following a clinical assessment of a novel nutraceutical supplement Tregocel® complementary to standard treatment.
Materials and methods: We evaluated the results of a multicenter, open-label, single-arm efficacy and safety evaluation of a polyherbal nutraceutical, performed in subjects with symptomatic, mild knee OA (n = 107, 59.7 ± 10.8 yrs, 68.2% female) over 36 weeks. Physical function was assessed using a standardized walking challenge (6-min walk test), combined with WOMAC indices and leg flexion measurements. Sub-analysis was performed using a linear mixed model that tracked changes in the walking challenge outcomes over time, adjusted for age, gender, and OA duration.
Results: Walking distance was significantly improved with the duration of nutraceutical use, increasing by 0.72 m (95% CI: 0.56, 0.88) per week of product administration. Similarly, there were significant decreases in WOMAC indices per week for stiffness (-1.6, 95% CI: -1.8, 1.4), daily functioning (-13.5, 95% CI: 14.9, 11.9) and global outcome (-19.2, 95% CI -21.3 - -17.1). Furthermore, supine heel-to-high flexion distance was improved relative to the duration of nutraceutical use.
Conclusions: The use of a polyherbal nutraceutical resulted in clinical improvements in several indices of physical functioning in mild knee OA suffers. Trial registration: NCT03636035.
本研究对一种新型营养补充剂 Tregocel®进行了临床评估,发现其对轻度膝骨关节炎(OA)患者的身体功能有改善作用,本研究对此进行了亚分析。
我们评估了一项多中心、开放标签、单臂的疗效和安全性研究,共纳入 107 名症状性、轻度膝 OA 患者(n=107,59.7±10.8 岁,68.2%为女性),随访 36 周。使用标准化的步行挑战(6 分钟步行测试)、WOMAC 指数和腿部弯曲测量来评估身体功能。采用线性混合模型对亚分析进行分析,该模型可追踪随时间变化的步行挑战结果的变化,并根据年龄、性别和 OA 持续时间进行调整。
步行距离随营养补充剂使用时间的延长而显著改善,每周增加 0.72 米(95%CI:0.56,0.88)。同样,每周的 WOMAC 僵硬指数(-1.6,95%CI:-1.8,1.4)、日常功能(-13.5,95%CI:14.9,11.9)和整体结局(-19.2,95%CI:-21.3,-17.1)均有显著下降。此外,仰卧位足跟到最大弯曲距离也随营养补充剂使用时间的延长而改善。
使用草药营养补充剂可改善轻度膝 OA 患者的多项身体功能指标。
NCT03636035。