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目的评价当前中医药非劣效/等效性随机对照试验(RCT)的报告质量。方法计算机检索中医药研究中采用非劣效/等效性试验设计的RCT报告,参照CONSORT声明扩展版——非劣效和等效性随机对照试验的报告标准对纳入的报告进行质量评价。结果共纳入中医药非劣效/等效性RCT报告13篇。报告质量除存在一般RCT常见问题以外,非劣效/等效性试验相关的一些内容报告不够充分:①文题不能反映文献的最重要内容;②背景的介绍比较简单,未明确非劣效/等效性试验的理论基础、参照处理(阳性对照)的有效性等;③全部文献均未说明非劣效/等效性试验的受试者、干预措施和结局是否与既往确立参照处理有效性的试验中用到的相似或相同;④大部分文献未确定非劣效/等效性界值,未进行样本含量的估算;⑤仅半数文献对非劣效/等效性检验方法有所描述;⑥部分文献存在误下非劣效/等效性结论的问题。结论研究者对非劣效/等效性试验理论基础的认识仍需深入,参照CONSORT声明的扩展——非劣效和等效性随机对照试验的报告标准,有助于研究者明确非劣效/等效性RCT设计、实施和报告的重点,重视非劣效/等效性试验报告的相关内容,从根本上提高此类临床试验报告的质量。
Objective To evaluate the current reporting quality of RCTs in Chinese medicine non-inferiority / equivalence. Methods Computer-based RCTs reporting non-inferiority / equivalence in TCM studies were used to assess the quality of the included reports based on the reporting criteria of the CONSORT statement Extended Edition - Noninferiority and Equivalence Randomized Controlled Trials. Results A total of 13 non-inferiority / equivalence RCT reports were included in the study. Report Quality In addition to common RCT common problems, non-inferiority / equivalence test related to some of the contents of the report is not sufficient: ① the topic does not reflect the most important content of the literature; ② background is relatively simple, not clear non-inferior / The theoretical basis of equivalence test, the validity of the reference treatment (positive control), etc .; ③ The whole literature does not indicate whether the subjects, interventions and outcomes of the non-inferiority / equivalence test are validated with the previous reference treatment ; ④ most of the literature did not establish the non-inferiority / equivalence cut-off value and did not estimate the sample content; only half of the literature described non-inferiority / equivalence test methods ; ⑥ Some documents have the problem of non-inferiority / equivalence conclusion. Conclusions The researchers’ understanding of the theoretical basis of noninferiority / equivalence trials still needs to be further explored. Referring to the CONSORT statement of reporting criteria for noninferiority and equivalence randomized controlled trials, it is helpful for investigators to identify noninferiority / Equivalent The RCT focuses on the design, implementation, and reporting, and emphasizes the relevance of non-inferiority / equivalence test reports to fundamentally improve the quality of such clinical trial reports.