Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.
Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Complement Med Res. 2023;30(4):307-316. doi: 10.1159/000530245. Epub 2023 Mar 21.
Few studies have analyzed the consistency between registered acupuncture-moxibustion clinical studies and their published research results as well as their update status of registered information.
We searched for acupuncture-moxibustion clinical studies that were registered at the World Health Organization International Clinical Trials Registry Platform between 2013 and 2015 and collected data regarding their characteristics and update status. Published results of these registered studies were identified and compared with registered information.
A total of 425 registered acupuncture-moxibustion clinical studies were included; 379 (89.2%) of them were interventional studies, and the remaining 46 (10.8%) were observational studies. Forty-six studies (10.8%) were found to have published results, and 51 published articles were identified. Overall, 73.2% (311) of registered studies did not update the research status in time; 46.6% (198) stopped updating before recruiting; 21.6% (92) stopped updating after recruiting; and 4.9% (21) stopped updating after completion. Regarding the 46 studies with published results, 29 (63.0%) were considered to be affected by reporting bias. These reporting biases predominantly involved the omission of some predefined outcomes or endpoints (16 studies), contradictions regarding descriptions of sample sizes (9 studies), discrepancies in treatment measurements or group distribution (7 studies), and inconsistent treatment durations (4 studies). When compared with other studies, significant and various reporting biases could also be commonly found in fields other than acupuncture-moxibustion.
There were many discrepancies between registered information and published reports on acupuncture-moxibustion, which could also be commonly observed in other fields. Moreover, a large proportion of registered studies did not update their research status in time. Efforts should be made to improve the reporting quality and timely updates.
很少有研究分析已注册的针灸临床研究与其已发表的研究结果及其注册信息更新状态之间的一致性。
我们检索了 2013 年至 2015 年期间在世界卫生组织国际临床试验注册平台上注册的针灸临床研究,并收集了这些研究的特征和更新状态的数据。确定了这些已注册研究的已发表结果,并将其与注册信息进行了比较。
共纳入 425 项已注册的针灸临床研究;其中 379 项(89.2%)为干预性研究,其余 46 项(10.8%)为观察性研究。发现 46 项研究(10.8%)有已发表的结果,共确定了 51 篇已发表的文章。总体而言,73.2%(311 项)的已注册研究未及时更新研究状态;46.6%(198 项)在招募前停止更新;21.6%(92 项)在招募后停止更新;4.9%(21 项)在完成后停止更新。对于有已发表结果的 46 项研究,29 项(63.0%)被认为受到报告偏倚的影响。这些报告偏倚主要涉及一些预先设定的结局或终点的缺失(16 项研究),描述样本量的矛盾(9 项研究),治疗措施或组分布的差异(7 项研究),以及治疗持续时间的不一致(4 项研究)。与其他领域相比,在针灸领域也可以经常发现具有显著和不同报告偏倚的研究。
针灸的注册信息与发表报告之间存在许多差异,在其他领域也可以经常发现这些差异。此外,很大一部分已注册的研究没有及时更新其研究状态。应努力提高报告质量和及时更新。