Efficacy and Safety of Undenatured Type II Collagen in The Treatment of Osteoarthritis of The Knee: A Randomized, Double-blind, Placebo-controlled Trial
Oentarini Tjandra, Shirly Gunawan, Johan Johan, F. F. Lie, M. E. Rumawas, Agus Limarta
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引用次数: 0
Abstract
BACKGROUND: Available medication for pain and joint stiffness release in osteoarthritis (OA) often gives considerable side effects. Undenatured type II collagen (UC-II) has been considered as a treatment for OA for its ability to prevent the progress of articular cartilage damage. Hence, this study aimed to evaluate the efficacy and safety of UC-II in modulating knee joint function.METHODS: This was a randomized, double-blind, placebo-controlled study involving 102 OA subjects. Subjects were randomized into two groups: receiving an oral daily dose of 40 mg/day UC-II or placebo containing microcrystalline cellulose for 90 days. Efficacy was evaluated by using the Western Ontario McMaster Osteoarthritis Index (WOMAC), Lequesne’s Functional Index (LFI), and Visual Analogue Scale (VAS) score on day-1, -7, -30, -60, and -90. Safety was evaluated by assessing the adverse events (AEs) and abnormal laboratory findings.RESULTS: The WOMAC total score showed a significant difference between the UC-II group vs. the placebo group from day-7 (p<0.05) to day-90 (p<0.01). UC-II was more effective in reducing the WOMAC total scores by 81.6% compared to 19.2% in the placebo group after 90 days. The total LFI and VAS score was significantly reduced in subjects supplemented with UC-II compared to the placebo group (75.8% vs. 7.8%; 67.9% vs. 12.2%, respectively). No significant changes were observed in vital signs and clinical laboratory tests compared to the placebo. The UC-II had a good safety profile with no serious adverse events among participants.CONCLUSION: UC-II significantly improved the knee pain, stiffness, and functional mobility of OA patients and was well-tolerated.KEYWORDS: osteoarthritis, undenatured type II collagen, WOMAC, VAS, LFI
背景:用于骨关节炎(OA)疼痛和关节僵硬缓解的现有药物通常会产生相当大的副作用。未变性II型胶原(UC-II)因其防止关节软骨损伤进展的能力而被认为是OA的治疗方法。因此,本研究旨在评价UC-II调节膝关节功能的有效性和安全性。方法:这是一项随机、双盲、安慰剂对照的研究,涉及102名OA受试者。受试者被随机分为两组:接受每日口服剂量40毫克/天的UC-II或含有微晶纤维素的安慰剂,持续90天。采用Western Ontario McMaster Osteoarthritis Index (WOMAC)、Lequesne’s Functional Index (LFI)和Visual Analogue Scale (VAS)评分,分别于第1天、第7天、第30天、第60天和第90天进行疗效评价。通过评估不良事件(ae)和异常实验室结果来评估安全性。结果:UC-II组与安慰剂组的WOMAC总分从第7天到第90天差异有统计学意义(p<0.05)。90天后,UC-II在将WOMAC总分降低81.6%方面更有效,而安慰剂组则为19.2%。与安慰剂组相比,补充UC-II的受试者的总LFI和VAS评分显著降低(75.8% vs. 7.8%;67.9% vs. 12.2%)。与安慰剂相比,在生命体征和临床实验室检查中未观察到显著变化。UC-II具有良好的安全性,在参与者中没有严重的不良事件。结论:UC-II可显著改善OA患者的膝关节疼痛、僵硬和功能活动能力,且耐受性良好。关键词:骨关节炎,未变性II型胶原蛋白,WOMAC, VAS, LFI