AIBMR Life Sciences, Inc., Puyallup, Washington 98373, United States.
J Agric Food Chem. 2012 Apr 25;60(16):4096-101. doi: 10.1021/jf205295u. Epub 2012 Apr 16.
Osteoarthritis (OA) is a significant source of pain and disability. Current medical and surgical treatments can be costly and have serious side effects. The aim of this randomized, double-blind, placebo-controlled trial was to investigate the tolerability and efficacy of BioCell Collagen (BCC), a low molecular weight dietary supplement consisting of hydrolyzed chicken sternal cartilage extract, in the treatment of OA symptoms. Patients (n = 80) in the study had physician-verified evidence of progressive OA in their hip and/or knee joint. Joint pain had been present for 3 months or longer at enrollment, and pain levels were 4 or higher at baseline as assessed by Physician Global Assessment scores. Subjects were divided into two groups and administered either 2 g of BCC or placebo for 70 days. Other outcome measurements included visual analogue scale (VAS) for pain and Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores taken on days 1, 35, and 70. The tolerability profile of the treatment group was comparable to that of the placebo. Intent-to-treat analysis showed that the treatment group, as compared to placebo, had a significant reduction of VAS pain on day 70 (p < 0.001) and of WOMAC scores on both days 35 (p = 0.017) and 70 (p < 0.001). The BCC group experienced a significant improvement in physical activities compared to the placebo group on days 35 (p = 0.007) and 70 (p < 0.001). BCC was well tolerated and found to be effective in managing OA-associated symptoms over the study period, thereby improving patient's activities of daily living. BCC can be considered a potential complement to current OA therapies.
骨关节炎(OA)是疼痛和残疾的重要来源。目前的医学和手术治疗可能费用高昂,并伴有严重的副作用。这项随机、双盲、安慰剂对照试验的目的是研究 BioCell 胶原(BCC)的耐受性和疗效,BCC 是一种低分子量膳食补充剂,由水解鸡胸骨软骨提取物组成,用于治疗 OA 症状。研究中的患者(n=80)有医生证实的髋关节和/或膝关节进行性 OA 证据。在入组时,关节疼痛已经存在 3 个月或更长时间,并且基线时疼痛水平为 4 或更高,通过医生整体评估评分评估。受试者分为两组,分别给予 2 g BCC 或安慰剂,持续 70 天。其他结果测量包括视觉模拟量表(VAS)疼痛和西安大略和麦克马斯特大学关节炎指数(WOMAC)评分,在第 1、35 和 70 天进行。治疗组的耐受性与安慰剂组相当。意向治疗分析显示,与安慰剂相比,治疗组在第 70 天 VAS 疼痛显著降低(p < 0.001),第 35 和 70 天 WOMAC 评分也显著降低(p=0.017 和 p < 0.001)。与安慰剂组相比,BCC 组在第 35 和 70 天(p=0.007 和 p < 0.001)的身体活动方面有显著改善。BCC 耐受性良好,在研究期间发现对管理 OA 相关症状有效,从而改善了患者的日常生活活动能力。BCC 可以被认为是目前 OA 治疗的潜在补充。