Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.
Department of Traditional Chinese Medicine, Beijing Puren Hospital, Beijing, 100062, China.
Chin J Integr Med. 2024 Jun;30(6):551-558. doi: 10.1007/s11655-023-3711-3. Epub 2023 Nov 21.
OBJECTIVE: To assess the use of evidence-based research (EBR) approach in randomized controlled trials (RCTs) of acupuncture-related therapies for primary dysmenorrhea (PD). METHODS: PubMed, EMBASE, Cochrane Library, China National Knowledge Infrastructure, Wanfang Database, Chinese Biomedical Database, and China Science and Technology Journal Database were searched from January 2013 to December 2022 for RCTs of acupuncture on PD. The full text and references of each RCT were read to assess whether systematic reviews (SRs) or other types of studies with similar research questions and end-users' perspectives were cited to justify and design the trial. In addition, the discussion section were analyzed to evaluate whether trials placed the new result in the existing SRs to draw a conclusion. Multivariable logistic regression was used to find variables that associated with 3 aspects of EBR approach: (1) citing clinical studies for justification, (2) citing relevant studies that obtain the perspectives of end users, and (3) citing clinical studies for results discussion. RESULTS: Of 473 RCTs included, 45.67% (216) of the trials cited relevant similar studies, 21.56% (102) referenced to the studies that collected end-users' perspectives, and 10.99% (52) placed result in the context of the previous research. Few RCTs appropriately applied EBR approach. Among all the included studies, 3.17% (15) of the trials used SRs to inform study questions but none of them used updated SRs with acceptable quality; 1.05% (5) of the trials cited SRs of end-user's perspectives in the justification and design of the study, and only 1 trial added results in existing SR to draw a conclusion. Year of publication, language, funding, registration, ethical approval and number of sites were significantly associated with 1 of the 3 aspects of EBR approach. CONCLUSIONS: Few RCTs in acupuncture-related therapies for PD used the EBR approach to minimize research redundancy. Researchers, research institutes, funding agencies, ethics committees, journals and peer reviewers in acupuncture should make efforts to use and promote the EBR approach to ensure the value of new trials.
目的：评估针灸相关疗法治疗原发性痛经（PD）的随机对照试验（RCT）中基于证据的研究（EBR）方法的应用。
方法：检索 2013 年 1 月至 2022 年 12 月发表的针灸治疗 PD 的 RCT，包括 PubMed、EMBASE、Cochrane 图书馆、中国知网、万方数据库、中国生物医学文献数据库和中国科技期刊数据库。阅读每个 RCT 的全文和参考文献，以评估是否引用系统评价（SR）或其他具有相似研究问题和最终用户视角的研究类型来证明和设计试验。此外，分析讨论部分以评估试验是否将新结果置于现有 SR 中得出结论。采用多变量逻辑回归分析与 EBR 方法的 3 个方面相关的变量：（1）引用临床研究进行论证，（2）引用获得最终用户观点的相关研究，（3）引用临床研究进行结果讨论。
结果：共纳入 473 项 RCT，其中 45.67%（216 项）的试验引用了相关的相似研究，21.56%（102 项）参考了收集最终用户观点的研究，10.99%（52 项）将结果置于先前研究的背景下。很少有 RCT 适当地应用了 EBR 方法。在所纳入的所有研究中，3.17%（15 项）的试验使用 SR 来指导研究问题，但没有一项试验使用具有可接受质量的更新 SR；1.05%（5 项）的试验在研究的论证和设计中引用了最终用户观点的 SR，只有 1 项试验将结果添加到现有 SR 中得出结论。发表年份、语言、资金、注册、伦理批准和纳入的研究地点与 EBR 方法的 3 个方面中的 1 个显著相关。
结论：针灸相关疗法治疗 PD 的 RCT 中很少使用 EBR 方法来最小化研究冗余。针灸领域的研究人员、研究机构、资助机构、伦理委员会、期刊和同行评审员应努力使用和推广 EBR 方法，以确保新试验的价值。
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