Department of Endocrinology and Metabolism, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, China.
State Key Laboratory of Traditional Chinese Medicine Syndrome, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China.
Complement Med Res. 2024;31(5):438-448. doi: 10.1159/000540641. Epub 2024 Aug 8.
Moxibustion is clinically used for treating various chronic diseases; however, the reporting quality of current published RCTs of moxibustion is unclear. The objective of this study was to assess the reporting quality of RCTs focusing on moxibustion as a treatment for chronic diseases.
Seven databases were searched to identify relevant RCTs. Criteria for evaluating the reporting quality of standard RCT elements and moxibustion intervention-related information were developed based on the CONSORT statement and its STRICTOM extension, respectively. Multivariate regression models were used to investigate factors impacting reporting quality.
A total of 310 RCTs were included, with 41 (7.6%) published in English journals and 269 (92.4%) in Chinese journals. The median CONSORT and STRICTOM scores of these RCTs, with a maximum score of 100, were 41.2 and 62.9, respectively. RCTs with a later publication year and protocol registration or ethical approval exhibited significantly higher CONSORT and STRICTOM scores. Higher CONSORT scores were also significantly associated with English language publication, funding support, and inclusion of a safety evaluation, while higher STRICTOM scores were additionally associated with an active control design.
The reporting quality of RCTs focusing on moxibustion treatment for chronic diseases is subpar, with gradual but limited improvement over the last 25 years. To enhance the reporting quality of moxibustion RCTs, researchers should develop a comprehensive study protocol and standardize result reporting based on CONSORT and STRICTOM statements. Registration platforms, ethical approval organizations, funders, and journals can also contribute to this improvement by bolstering structured information reporting in the review process.
艾灸在临床上用于治疗各种慢性疾病，但目前艾灸治疗慢性疾病的随机对照试验（RCT）的报告质量尚不清楚。本研究旨在评估艾灸治疗慢性疾病的 RCT 报告质量。
检索了 7 个数据库，以确定相关 RCT。根据 CONSORT 声明及其 STRICTOM 扩展，分别制定了评估标准 RCT 要素和艾灸干预相关信息报告质量的标准。采用多元回归模型调查了影响报告质量的因素。
共纳入 310 项 RCT，其中 41 项（7.6%）发表于英文期刊，269 项（92.4%）发表于中文期刊。这些 RCT 的 CONSORT 和 STRICTOM 中位数评分，最高得分为 100 分，分别为 41.2 分和 62.9 分。发表年份较晚、方案注册或伦理批准的 RCT 的 CONSORT 和 STRICTOM 评分显著较高。更高的 CONSORT 评分还与英文发表、资金支持和包含安全性评估显著相关，而更高的 STRICTOM 评分还与积极对照设计相关。
艾灸治疗慢性疾病的 RCT 报告质量较差，但在过去 25 年中逐渐但有限地得到了改善。为了提高艾灸 RCT 的报告质量，研究人员应根据 CONSORT 和 STRICTOM 声明制定全面的研究方案并规范结果报告。注册平台、伦理批准机构、资助者和期刊也可以通过在审查过程中加强结构化信息报告来促进这一改进。
