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Efficacy and safety of Shaoyang Xibi decoction in patients with knee osteoarthritis:a multi-center,single-blind,randomized controlled trial

查看全文 作　　者：Si [1,2]Yuhao;Ma [3,4,5]Yong;Guo [6]Yang;Pan [6]Yalan;Zheng [6]Suyang;Xu [7,8]Guihua;Da [9]Weiwei;Xu [10]Lili 高影响力作者 机构地区：[1]the First Clinical Medical College,Nanjing University of Chinese Medicine,Nanjing 210023,China;[10]Pre-clinical Medical College,Nanjing University of Chinese Medicine,Nanjing 210023,China;[2]Laboratory for New Technique of Restoration &Reconstruction of Orthopedics and Traumatology,Nanjing University of Chinese Medicine,Nanjing 210023,China;[3]Laboratory for New Techniques of Restoration &Reconstruction of Orthopedics and Traumatology,Nanjing University of Chinese Medicine,Nanjing 210023,China;[4]School of Nursing,Nanjing University of Chinese Medicine,Nanjing 210023,China;[5]Affiliated Hospital of Nanjing University of Chinese Medicine,Nanjing 210029,China;[6]Laboratory for New Techniques of Restora-tion &Reconstruction of Orthopedics and Traumatology,Nanjing University of Chinese Medicine,Nanjing 210023,China;[7]School of Nursing,Nanjing University of Chinese Medicine,Nanjing 210023,China;[8]Institute of Integrated Traditional Chinese and Western Medicine,Nanjing University of Chinese Medicine,Nanjing 210029,China;[9]Yangzhou,Hospital of Traditional Chinese Medicine,Yangzhou 225009,China高影响力机构 出　　处：《Journal of Traditional Chinese Medicine》索引2018年第38卷第5期,共7页高影响力期刊 基　　金：Supported by Natural Science Foundation for Youths of Jiangsu Province,China(No.BK20151007);Postgraduate Research&Practice Innovation Program of Jiangsu Province(No.SJLX16_0383);Jiangsu Province Advantage Disciplines Foundation for School of Nursing of Nanjing University of Chinese Medicine(decree No.37 issued by People's Government of Jiangsu Province Office in 2014) 摘　　要：PURPOSE: To observe the efficacy and safety of Shaoyang Xibi decoction(SYXBD) in patients with knee osteoarthritis(KOA), and to verify that the theory of 'Shaoyang dominating bone' in Traditional Chinese Medicine(TCM) can be applied to KOA treatment.METHODS: Participants were randomly allocated to two groups: SYXBD(treatment group, n = 66)and Meloxicam(control group, n = 66). Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) and 36-Item Short Form Health Survey(SF-36) were used to assess efficacy before the treatment and 8 weeks after the treatment.RESULTS: Baseline data before the treatment between the two groups were similar. The WOMAC scores significantly decreased and the SF-36 scores significantly increased after 8-week treatment in both groups compared with before the treatment(P < 0.05). SYXBD significantly decreased pain scores(P < 0.001), physical function scores(P <0.001) and the total scores(P < 0.001) in WOMAC compared to Meloxicam. SYXBD significantly improved physical function(P = 0.021), bodily pain(P = 0.002) and general health(P = 0.014), with no significant difference in role emotional(P = 0.053),role physical(P = 0.517), vitality(P = 0.241), social function(P = 0.712) and mental health(P = 0.800)in SF-36 compared to Meloxicam. No adverse events were reported in the treatment group while13 adverse events happened in the control group during the study.CONCLUSION: SYXBD, prepared based on the theory of 'Shaoyang dominating bone', has a better curative efficay and safety in patients with KOA compared with Meloxicam. The TCM theory of 'Shaoyang dominating bone' may be useful in KOA treatment. 关 键 词：Osteoarthritis,knee Therapeutic USES Shaoyang dominating BONE Kidney dominating BONE Shaoyang Xibi DECOCTION
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