机构:[1]The Second Affiliated Hospital of Guangzhou University of ChineseMedicine, Guangzhou, Guangdong Province, China[2]The Second ClinicalCollege, Guangzhou University of Chinese Medicine, Guangzhou,Guangdong Province, China[3]Ultrasonography Department, The SecondAffiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou,Guangdong Province, China[4]Acupuncture Department, The SecondAffiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou,Guangdong Province, China深圳市中医院深圳医学信息中心[5]Shenzhen Bao’an Research Centre forAcupuncture and Moxibustion, Shenzhen, China
Background: Carotid atherosclerosis disease (CAD) is generally associated with the occurrence of cardiovascular and cerebrovascular accidents. However, CAD has not been taken seriously enough in the clinic, which, coupled with the single treatment and prevention of CAD, has led to a generally low level of patient compliance. Therefore, acupuncture is expected to be a safe and effective therapy that can be maintained in the long term for patients with CAD. The study objective is to evaluate the efficiency and reliability of acupuncture to relieve CAD and provide a new therapeutic idea for the clinical treatment of CAD. Methods: This is a three-arm randomized clinical trial in China. Three groups (TA, SA, and MC) will be randomly allocated at a 1:1:1 ratio. The study will enrol 105 cervical atherosclerosis plaque patients in total on a voluntary basis, with 35 patients in each group. The treatment will last for 12 weeks, with two treatments per week for twenty-four treatments in total. Results: Two 3D ultrasound indicators will be measured as the primary outcomes: the total plaque volume (PV) of the carotid artery on each side and the grey-scale median (GSM). The secondary outcomes will include intima-media thickness (IMT), lipid levels, apolipoprotein A-IV level, platelet count (PLT), fibrinogen (FIB), and platelet aggregation rate (PAR). All the outcomes will be assessed before treatment, after treatment, and after a 12-week follow-up period. This study will utilize per-protocol (PP) and intention-to-treat (ITT) analysis principles. Conclusions: This trial is to evaluate the efficacy and reliability of acupuncture in relieving carotid atherosclerotic plaques by establishing acupuncture (TA), sham acupuncture (SA), and medication (MC) groups. Ethics and dissemination: This study was approved by the Institutional Ethics Committee of Guangdong Provincial Hospital of Traditional Chinese Medicine (no. YF2018-107-01). All data and findings will be provided by the principal investigator via email.
基金:
Sanming Project of Medicine in Shenzhen; Shenzhen Bao'an Research Centre for Acupuncture and Moxibustion [SZSM201806077]
第一作者机构:[1]The Second Affiliated Hospital of Guangzhou University of ChineseMedicine, Guangzhou, Guangdong Province, China
通讯作者:
通讯机构:[2]The Second ClinicalCollege, Guangzhou University of Chinese Medicine, Guangzhou,Guangdong Province, China[4]Acupuncture Department, The SecondAffiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou,Guangdong Province, China
推荐引用方式(GB/T 7714):
Junhe Zhou,Lin Zhao,Lingcui Meng,et al.Acupuncture treatment for carotid atherosclerotic plaques: study protocol for a pilot randomized, single blinded, controlled clinical trial[J].TRIALS.2020,21(1):doi:10.1186/s13063-020-04709-0.
APA:
Junhe Zhou,Lin Zhao,Lingcui Meng,Huitao Liang,Ting Zhou...&Wenbin Fu.(2020).Acupuncture treatment for carotid atherosclerotic plaques: study protocol for a pilot randomized, single blinded, controlled clinical trial.TRIALS,21,(1)
MLA:
Junhe Zhou,et al."Acupuncture treatment for carotid atherosclerotic plaques: study protocol for a pilot randomized, single blinded, controlled clinical trial".TRIALS 21..1(2020)