Puigdellivol Jordi, Comellas Berenger Carme, Pérez Fernández Miguel Ángel, Cowalinsky Millán Juan M, Carreras Vidal Christian, Gil Gil Inés, Martínez Pagán Julio, Ruiz Nieto Borja, Jiménez Gómez Francisco, Comas Figuerola Francesc X, Aguilar Hernández María E
a Centre for Sports Medicine, Traumatology and Rehabilitation , Clinic Sant Josep , Manresa, Barcelona , Spain.
b Trauma Salut SL , Sabadell, Barcelona , Spain.
J Diet Suppl. 2019;16(4):379-389. doi: 10.1080/19390211.2018.1461726. Epub 2018 Apr 27.
This observational, open, multicenter clinical trial with a single treatment group aimed to evaluate the effectiveness of a dietary supplement whose main ingredients are hydrolyzed gelatin, chondroitin sulfate, glucosamine sulfate, and devil's claw and bamboo extracts for pain reduction and improvement of functional capacities in patients with osteoarthritis (OA) of the knee and/or hip (REDART study). In all, 130 patients with OA recruited from Spanish hospitals received the dietary supplement for 6 months. The primary outcome was the patients' global assessment of pain in the affected joint as measured with a visual analogue scale (VAS). Other outcome measurements included the Lequesne Functional Index (subindexes for pain/discomfort, distance walked, and daily living) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC; subindexes for pain, stiffness, and physical function). Scores were taken at months 3 and 6 of the treatment. Patients ( = 78) showed a reduction of pain of 3.77 ± 1.77 points after 6 months ( < .0001) in the VAS. The total reduction in the Lequesne Functional Index was 6.30 ± 4.08 points after 6 months ( < .0001), with significant reductions in all subindexes of the scale. A similar pattern was found for the WOMAC index, with an overall reduction of 22.49 ± 14.03 points after 6 months ( < .0001) and significant reductions in all subindexes. No major adverse events were noted during the treatment. This exploratory study shows that treatment with the dietary supplement significantly reduces pain and improves locomotor function in patients with OA of the knee and/or hip.
这项观察性、开放性、单治疗组多中心临床试验旨在评估一种膳食补充剂的有效性,该补充剂的主要成分包括水解明胶、硫酸软骨素、硫酸葡萄糖胺、魔鬼爪提取物和竹子提取物,用于减轻膝关节和/或髋关节骨关节炎(OA)患者的疼痛并改善其功能能力(REDART研究)。共有130名从西班牙医院招募的OA患者接受了该膳食补充剂治疗6个月。主要结局是用视觉模拟量表(VAS)测量患者对患关节疼痛的整体评估。其他结局指标包括勒凯斯内功能指数(疼痛/不适、行走距离和日常生活的子指数)以及西安大略和麦克马斯特大学骨关节炎指数(WOMAC;疼痛、僵硬和身体功能的子指数)。在治疗的第3个月和第6个月进行评分。6个月后,患者( = 78)的VAS疼痛评分降低了3.77±1.77分( <.0001)。勒凯斯内功能指数在6个月后的总降低值为6.30±4.08分( <.0001),该量表的所有子指数均显著降低。WOMAC指数也呈现类似模式,6个月后的总体降低值为22.49±14.03分( <.0001),所有子指数均显著降低。治疗期间未观察到重大不良事件。这项探索性研究表明,该膳食补充剂治疗可显著减轻膝关节和/或髋关节OA患者的疼痛并改善其运动功能。