Evaluation of a granulated formula for the nerve root type and vertebral artery type of cervical spondylosis: a multicenter, single-blind, randomized, controlled, phase III clinical trial
机构:[1]Department of Encephalopathy, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510370, China大德路总院脑病科广东省中医院[2]Faculty of Chinese Medicine, Macau University of Science and Technology, Macau 999078, China[3]Department of Orthopaedics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China深圳市中医院深圳医学信息中心[4]Department of Orthopaedics, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, China大德路总院骨科广东省中医院深圳市中医院深圳医学信息中心[5]Department of Cardiology, The First Affiliated Hospital of Hunan University of Chinese Medicine, Changsha 410007, China[6]Department of Encephalopathy, The First Affiliated Hospital of Hunan University of Chinese Medicine, Changsha 410007, China[7]Department of Orthopaedics, Hubei Provincial Academy of Chinese Medicine, Wuhan 430074, China[8]Research Institution, Shineway Pharmaceutical Group Ltd., Shijiazhuang 051430, China
OBJECTIVE: To evaluate the effectiveness and safety of cervical spondylosis formula granules in reducing the symptoms of patients with the nerve root type and the vertebral artery type of cervical spondylosis. METHODS: This was a multicenter, single-blind, randomized, controlled trial. From April 2002 to November 2003, 499 patients were randomly assigned to either the treatment or the control group. The treatment group was orally administered granules prepared with a formula for cervical spondylosis, while the control group was given Jingfukang granules. The treatment course was 1 month for both groups. RESULTS: In patients With the nerve root type of cervical spondylosis, the total effect rate in the treatment group (87.21%) was significantly higher than that in the control group (80.70%, P < 0.01). After the treatment period in both groups, the treatment group had a significantly greater rate of resolution of pain, numbness of the upper limbs, muscle strength of the upper limbs, and fatigue than the control group (all P < 0.05). In patients with the vertebral artery type of cervical spondylosis, the total effect rate in the treatment group (82.07%) was similar to that in the control group (71.21%, P > 0.05). After the treatment period in both groups, the treatment group had a significantly greater rate of resolution of weakness of the waist and knees than the control group (P < 0.05). CONCLUSION: The cervical spondylosis formula granules significantly improve numbness, muscle strength, and fatigue, and reduce pain in patients with the nerve root type of cervical spondylosis, and improve the weakness of the waist and knees in patients with the vertebral artery type of cervical spondylosis. (C) 2017 JTCM. All rights reserved.
第一作者机构:[1]Department of Encephalopathy, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510370, China[*1]Department of Encephalopathy, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510370, China.
通讯作者:
通讯机构:[1]Department of Encephalopathy, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510370, China[*1]Department of Encephalopathy, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510370, China.
推荐引用方式(GB/T 7714):
Luo Xiaodong,Wang Peng,Li Zhe,et al.Evaluation of a granulated formula for the nerve root type and vertebral artery type of cervical spondylosis: a multicenter, single-blind, randomized, controlled, phase III clinical trial[J].JOURNAL OF TRADITIONAL CHINESE MEDICINE.2017,37(2):193-200.
APA:
Luo Xiaodong,Wang Peng,Li Zhe,Liang De,Huang Feng...&Zhang Huajian.(2017).Evaluation of a granulated formula for the nerve root type and vertebral artery type of cervical spondylosis: a multicenter, single-blind, randomized, controlled, phase III clinical trial.JOURNAL OF TRADITIONAL CHINESE MEDICINE,37,(2)
MLA:
Luo Xiaodong,et al."Evaluation of a granulated formula for the nerve root type and vertebral artery type of cervical spondylosis: a multicenter, single-blind, randomized, controlled, phase III clinical trial".JOURNAL OF TRADITIONAL CHINESE MEDICINE 37..2(2017):193-200