Żęgota Zbigniew, Goździk Joanna, Głogowska-Szeląg Joanna
Zbigniew Żęgota Specjalistyczny Ośrodek Leczniczo-Badawczy, Ostróda, Poland.
Silmedic Ltd., Katowice, Poland.
Adv Orthop. 2021 May 7;2021:5589597. doi: 10.1155/2021/5589597. eCollection 2021.
This study aimed to provide clinical information on general and joint performance from individuals taking Tregocel® (containing curcuminoid and extracts of the herbs , , and ) alongside a standard therapy of symptomatic mild knee osteoarthritis (OA).
This was a multicenter, open-label, prospective, single-arm study, in which Tregocel® was supplemented for 36 weeks. Participants with symptomatic mild knee OA requiring pharmacologic treatment for pain were enrolled. Physical performance (6-minute walk test, WOMAC-pain and functional domain, and heel-thigh distance flexion test), general performance (WOMAC questionnaire), and VAS (Visual Analogue Scale) assessment of knee pain, as well as anti-inflammatory and analgesic medication consumption, were assessed.
Between January and April 2019, 107 participants were enrolled and analysed in per protocol population. Mean age was 59.7 (SD 10.8) years, and there were 68.2% women. Mean observation time was 291.1 (SD 7.7) days. Mean increase in 6MWT result observed at the end of the study was 26.0 (SD 30.4) m ( < 0.001). Median VAS score decreased from 60.0 (IQR 50-72) mm at the beginning of the study to 21.0 (IQR 14-30) mm after 36 weeks of product administration ( < 0.001). Regular knee OA medications were taken in 99.1% of subjects at baseline decreasing to 55.1% at the end of the Tregocel® supplementation.
During Tregocel® supplementation, participants observed improved functional capacity confirmed in the distance in 6MWT and in the heel-thigh distance flexion test, decreased level of pain, and improved WOMAC scores for all domains.
本研究旨在提供服用Tregocel®（含有姜黄素以及草药、和的提取物）并接受症状性轻度膝骨关节炎（OA）标准治疗的个体的一般和关节功能的临床信息。
这是一项多中心、开放标签、前瞻性、单臂研究，其中Tregocel®补充治疗36周。纳入需要药物治疗疼痛的症状性轻度膝OA患者。评估身体功能（6分钟步行试验、WOMAC疼痛和功能领域以及足跟-大腿距离屈曲试验）、一般功能（WOMAC问卷）、膝关节疼痛的视觉模拟量表（VAS）评估以及抗炎和止痛药物的使用情况。
在2019年1月至4月期间，107名参与者按方案人群进行登记和分析。平均年龄为59.7（标准差10.8）岁，女性占68.2%。平均观察时间为291.1（标准差7.7）天。研究结束时观察到的6分钟步行试验结果平均增加26.0（标准差30.4）米（<0.001）。VAS评分中位数从研究开始时的60.0（四分位间距50 - 72）毫米降至产品给药36周后的21.0（四分位间距14 - 30）毫米（<0.001）。99.1%的受试者在基线时服用常规膝OA药物，在Tregocel®补充治疗结束时降至55.1%。
在补充Tregocel®期间，参与者的功能能力得到改善，这在6分钟步行试验的距离和足跟-大腿距离屈曲试验中得到证实，疼痛水平降低，所有领域的WOMAC评分均有所改善。
