摘要
目的对健身气功临床试验的注册特征和报告质量进行评价,探讨健身气功临床试验的进展与不足。方法计算机检索中国临床试验注册中心(ChiCTR)和美国临床试验数据库(ClinicalTrials.gov),搜集已注册的健身气功临床试验的信息,检索时限均从建库至2020年10月15日。对已注册的健身气功临床试验的基本信息、经济资助来源、研究内容等方面特征进行分类,并应用世界卫生组织(WHO)试验注册数据集(TRDS)评价健身气功临床试验的注册质量。结果共获得已注册的健身气功临床试验121项。健身气功临床试验近年注册数量逐年增加,2020年达最高(33.06%)。已注册的研究中,八段锦占比最大(65.29%),上海地区注册数量最多(29.75%),研究机构中上海中医药大学附属岳阳中西医结合医院注册数量最多(5.79%)。50.83%的研究经费来源于医院和高校。研究最多的病症是2型糖尿病和慢性阻塞性肺疾病。90.08%研究的试验设计为随机平行对照,样本量在30~100例(71.07%)。受试者年龄集中在40岁及以上(46.15%)。两个中心注册试验平均报告完成度为87.44%。结论目前健身气功临床试验总体趋势较好,但在功法类型、注册地区分布、注册机构分布、经费资源分配、受试年龄段构成等方面存在不均衡特征,在临床试验设计和注册细节方面尚待提高。
Objective To analyze the characteristics and reporting quality of the registered health Qigong-related clinical trials,and to analyze the progress and shortcomings of health Qigong-related clinical trials.Methods Chinese Clinical Trial Registry(ChiCTR)and ClinicalTrials.gov were electronically searched to collect the health Qigong-related clinical trials from inception to October 15 st,2020.Characteristics of trials were analyzed in the aspects of basic information,funding source,study content and more.The quality of registration was evaluated by WHO Trial Registration Data Set(TRDS).Results A total of 121 registered clinical trials were included.The annual registration quantity has been increasing with a peak(33.06%)reached in 2020.Among the registered trials,Baduanjin exerciserelated studies accounted for the highest proportion(65.29%).The quantity of studies registered in Shanghai accounted for the most(29.75%).The largest contribution of registered trials was from Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine(5.79%).50.83%funds in trials were originated from universities and hospitals.Type 2 diabetes,and chronic obstructive pulmonary disease were the most studied diseases in the registered trials.90.08%trials were designed as randomised parallel control studies,and the sample sizes of trials were concentrated between 30 and 100(71.07%),and the age of the subjects was distributed over 40 years old(46.15%).The average quality of registration completion of the two registries was 87.44%.Conclusions At present,the general trend of health Qigong clinical research is positive.However,these trials contain unbalanced attributes such as the research type of health Qigong,distribution of registration area and organization,allocation of funds,and age composition of subjects.The design of clinical trials and registration details are needed to be improved.
作者
周俊
李蓝轩
邓维
唐玥
韩小曼
周奇志
梁繁荣
ZHOU Jun;LI Lanxuan;DENG Wei;TANG Yue;HAN Xiaoman;ZHOU Qizhi;LIANG Fanrong(College of Acupuncture and Massage,Chengdu University ofTCM,Chengdu 610075,P.R.China;College of Clinical Medicine,Chengdu University ofTCM,Chengdu 610075,P.R.China;Chengdu College of Sichuan Foreign Studies University,Chengdu 611844,P.R.China;School of Chinese Martial Arts,Beijing Sports University,Beijing 100084,P.R.China)
出处
《中国循证医学杂志》
CSCD
北大核心
2021年第2期197-203,共7页
Chinese Journal of Evidence-based Medicine
基金
国家自然科学基金项目(编号:81774400、81973958)。
关键词
健身气功
临床试验
注册特征
中国临床试验注册中心
报告质量
Health Qigong
Clinical research
Registration characteristics
Chinese Clinical Trial Registry(ChiCTR)
Reporting quality
