Efficacy and safety of Xinfeng capsule in the treatment of osteoarthritis:a multicenter, randomized, double-blinded, controlled trial  

作　　者：Liu Jian Wang Yuan Sun Yue Huang Chuanbing Chen Xi Zhang Wandong He Liyun James Cheng-Chung Wei 

机构地区：[1]Department of Rheumatism Immunity,The First Affiliated Hospital,Anhui University of Chinese Medicine,Hefei 230031,China [2]the Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China [3]Division of Allergy,Immunology and Rheumatology,Chung Shan Medical University Hospital,Institute of Medicine,Chung Shan Medical University,Graduate Institute of Integrated Medicine,China Medical University,Taichung,Taiwan China

出　　处：《Journal of Traditional Chinese Medicine》2020年第2期284-295,共12页中医杂志（英文版）

基　　金：Supported by the Science and Technology Projects of Anhui Province Evidence-based Clinical Study of Xin'an Capsule in the Treatment of Knee Osteoarthritis with Protecting the Spleen(1301042211)。

摘　　要：OBJECTIVE: To evaluate the efficacy and safety of Xinfeng capsule(XFC) in patients with osteoarthritis(OA).METHODS: This was a multicenter, double-blinded,randomized, controlled, clinical trial. Patients with OA were assigned to the XFC group [treated with XFC and a glucosamine(GS) placebo, n = 129] or the GS group(treated with GS and an XFC placebo,n = 126). Both groups were treated for 4 weeks. The primary endpoint was the difference between the two groups in the Western Ontario and Mc Master Universities OA(WOMAC) index total score at 4 th week. The secondary endpoints were the visual analogue scale for pain, Lequesne index, function influence index rating, quality of life as assessed by the Short Form-36, erythrocyte sedimentation rate,and C-reactive protein concentration at baseline and at second week and 4 th week. Bone mineral density were checked by X ray absorptiometry at baseline and 4 th week.RESULTS: After 4 weeks of treatment, all patients in both groups showed similar significant improvements compared with baseline. There were no significant differences between groups regarding pain relief, bilateral femoral bone mineral density, and laboratory indices such as erythrocyte sedimentation rate and C-reactive protein concentration.Both groups had a significantly lower function influence index rating score and curative effect for each sign/symptom in week 4 than in week 0, and these changes did not significantly differ between groups. XFC was superior to GS in improving the WOMAC index total score, WOMAC scores for function and stiffness, integrated symptoms, physiological function, energy, emotional function, mental health, and health changes. Fourteen adverse reactions were reported, and the incidence of adverse reactions did not significantly differ between groups. The most common adverse reactions were hepatic impairment, kidney functional damage,gastrectasia, and facial skin allergy. The types of adverse reactions did not differ between groups.CONCLUSION: XFC is effective and safe in the treatment o

关 键 词：OSTEOARTHRITIS GLUCOSAMINE Quality of life Treatment outcome Randomized controlled trial Xinfeng capsule 

分 类 号：R274.9[医药卫生—中西医结合]