Effect of the Novel Low Molecular Weight Hydrolyzed Chicken Sternal Cartilage Extract, BioCell Collagen, on Improving Osteoarthritis-Related Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial

Effect of the Novel Low Molecular Weight Hydrolyzed Chicken Sternal Cartilage Extract, BioCell Collagen, on Improving Osteoarthritis-Related Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial
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DOI:
10.1021/jf205295u
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发表时间:
2012-04-25
影响因子:
6.1
通讯作者:
Clewell, Amy
Clewell, Amy
中科院分区:
农林科学1区
文献类型:
--
作者:
Schauss, Alexander G.;Stenehjem, Jerome;Clewell, Amy

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骨关节炎(OA)是疼痛和残疾的重要来源。目前的医疗和手术治疗可能是昂贵的,并有严重的副作用。这项随机、双盲、安慰剂对照试验的目的是研究BioCell胶原蛋白(BCC)(一种由水解鸡胸骨软骨提取物组成的低分子量膳食补充剂)治疗OA症状的耐受性和疗效。研究中的患者(n = 80)在其髋关节和/或膝关节中具有经医生证实的进行性OA证据。入组时关节疼痛已持续3个月或更长时间,根据医生总体评估评分评估,基线时疼痛水平为4或更高。受试者被分为两组,并给予2g BCC或安慰剂70天。其他结局测量包括疼痛视觉模拟量表(VAS)和第1、35和70天的西安大略和麦克马斯特大学关节炎指数(WOMAC)评分。治疗组的耐受性特征与安慰剂相当。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),在第35天(p = 0.017)和第70天(p < 0.001)WOMAC评分显著降低。在第35天(p = 0.007)和第70天(p < 0.001),BCC组与安慰剂组相比经历了身体活动的显著改善。BCC耐受性良好,并在研究期间有效管理OA相关症状,从而改善患者的日常生活活动。BCC可以被认为是当前OA治疗的潜在补充。
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.