基于CONSORT声明壮医药临床随机对照试验报告质量评价

Quality Evaluation of Clinical Randomized Controlled Trial Report of Zhuang Medicine Based on CONSORT Statement

目的:基于临床随机对照试验报告的统一标准(CONSORT)声明评价壮医药临床随机对照试验(RCT)的文献质量。方法:计算机检索自建库以来至2022年9月中国知网(CNKI)、维普中文科技期刊数据库(VIP)、万方数据(WANFANG DATA)和中国生物医学文献服务系统(SinoMed)中有关壮医药的随机对照试验研究。将上述数据库检索到的文献筛选出符合要求的文献,然后设立文献提取表格,内容包括文献基本资料以及CONSORT声明中的7个部分25个条目,再根据文献提取表格对纳入文献逐一评价报告。结果:共检索得到相关文献4430篇,最终纳入RCT研究452篇。根据CONSORT声明,其中109篇(24.1%)文献报告完整的受试者合格标准,109篇(24.1%)文献仅提及诊断标准;仅有6篇(1.3%)文献提到样本量的计算方法;261篇(57.7%)对随机方法进行说明,191篇(42.3%)仅使用“随机”概括随机分配序列的产生;2篇(0.4%)文献提及区组随机化法;25篇(5.5%)提及如何分配隐藏;396篇(87.6%)对统计学方法进行说明;156篇(34.5%)文献通过表格列出组间的基线资料;48篇(10.6%)对脱落情况进行报告;48篇(10.6%)设立随访期;115篇(25.4%)研究报告不良反应;仅1篇(0.2%)研究报告了试验注册号和注册机构名称。结论:目前壮医药相关随机对照试验的文献总体质量较低,应按照CONSORT声明对方案的不足进行修改完善,以确保临床试验数据的完整性和结论的可靠性。

Objective:To evaluate the literature quality of clinical randomized controlled trial(RCT)of Zhuang Medicine based on the statement of the unified standard(CONSORT)of clinical randomized controlled trial reports.Methods:Randomized controlled trials related to Zhuang Pharmaceutical from CNKI,VIP Chinese Science and Technology Journal Database,WANFANG DATA and China Biomedical Literature Service System(SinoMed)were searched by computer from the database establishment to September 2022.The literature retrieved from the above database was screened out to meet the requirements,and then the literature extraction table was set up,including the basic literature information and the 7 parts and 25 items in the CONSORT statement.Then,according to the literature extraction table,the included literature was evaluated and reported one by one.Results:A total of 4430 literatures were retrieved,and 452 were included in the RCT study.According to the CONSORT statement,109(24.1%)reported complete subject eligibility criteria,while 109(24.1%)mentioned only diagnostic criteria;Only 6 literatures(1.3%)mentioned the calculation method of sample size.In 261 papers(57.7%),the random method was explained,and in 191 papers(42.3%),only“random”was used to generalize the generation of random assignment sequences.Block randomization method was mentioned in 2 literatures(0.4%).25(5.5%)mentioned how to allocate hiding;Statistical methods were explained in 396(87.6%).Baseline data between groups were tabulated in 156 literatures(34.5%);48(10.6%)reported the shedding condition;48(10.6%)had a follow-up period;Adverse reactions were reported in 115 studies(25.4%);Only 1 research report(0.2%)test registration number and registration institution name.Conclusion:Currently,the overall quality of literatures on RCTS related to Zhuang medicine is low,and the deficiencies of the protocol should be modified and improved according to the CONSORT statement,so as to ensure the integrity of clinical trial data and the reliability of conclusions.