Wang Fei, Shi Lei, Zhang Yaonan, Wang Kunzheng, Pei Fuxing, Zhu Hanmin, Shi Zhanjun, Tao Tianzun, Li Zhihua, Zeng Ping, Wang Xiaobing, Ji Quan, Qin Ling, Xue Qingxun
Department of Orthopedics, Beijing Hospital, National Center of Gerontology, Beijing 100730, China.
Department of Orthopedics, The Second Affiliated Hospital, Medical School of Xi'an Jiaotong University, Xi'an 710004, China.
Evid Based Complement Alternat Med. 2018 Feb 12;2018:1827528. doi: 10.1155/2018/1827528. eCollection 2018.
Evidence of efficacy of a traditional herbal formula Xianlinggubao (XLGB) for treatment of osteoarthritis (OA) is limited. The present study was designed to evaluate the efficacy of XLGB in the management of patients with knee and hand OA. This was a multicenter, stratified, open-label, randomized controlled trial conducted at six centers in China. People aged 40 or above, diagnosed with OA of the knee or hand, were randomly assigned to the XLGB treatment group or watchful waiting control group. Main outcome measures were the changes in the numeric pain rating scales (NPRS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) or the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) scores, from baseline to 6 months. In total 534 patients (272 to XLGB and 262 to control group) received interventions. Participants in the XLGB group exhibited significant improvement in NPRS ( < 0.001) and WOMAC score ( < 0.001) or AUSCAN score ( < 0.001) compared to control group. Treatment with XLGB at current regime significantly reduced pain and improved function of the knee and hand in patients with OA over a 6-month period, implying that XLGB could be suggested as an alternative treatment for patients with knee or hand OA.
传统中药配方仙灵骨葆（XLGB）治疗骨关节炎（OA）的疗效证据有限。本研究旨在评估仙灵骨葆对膝骨关节炎和手骨关节炎患者的治疗效果。这是一项在中国六个中心进行的多中心、分层、开放标签、随机对照试验。年龄在40岁及以上、诊断为膝或手骨关节炎的患者被随机分配到仙灵骨葆治疗组或观察等待对照组。主要观察指标是从基线到6个月时数字疼痛评分量表（NPRS）以及西安大略和麦克马斯特大学骨关节炎指数（WOMAC）或澳大利亚/加拿大手骨关节炎指数（AUSCAN）评分的变化。共有534例患者（272例接受仙灵骨葆治疗，262例接受对照组治疗）接受了干预。与对照组相比，仙灵骨葆组患者的NPRS（<0.001）、WOMAC评分（<0.001）或AUSCAN评分（<0.001）均有显著改善。在6个月的时间里，按照当前方案使用仙灵骨葆治疗可显著减轻骨关节炎患者膝关节和手部的疼痛并改善其功能，这意味着仙灵骨葆可作为膝或手骨关节炎患者的一种替代治疗方法。
