国外SCI研究针刺的两种临床随机对照试验方法的特点分析及评价

Analysis and Evaluation of Characteristics of Two Clinical Randomized Controlled Trials Taken from the SCI Acupuncture Study

目的:为了解国外SCI针刺的发展、研究方法和研究水平及存在的问题,以便于国内针灸学术界及时掌握国际上高水准的针刺研究方法的发展动态。方法:检索web of science,PubMed两大数据库近5年来以"trials and acupuncture"、"RCT and acupuncture"为标题的所有被SCI收录的论文共1581篇,对其内容进行提取并分析试验设计特点和试验质量。结果:国外SCI大部分临床试验采用的是解释性随机对照试验,然其对于解释针刺组疗效优于假针对照组疗效并不理想,也不利国外针刺研究的进一步发展;而实用性随机对照试验在方法学上更适合于复杂干预的针刺临床研究。对于国外SCI的针刺临床试验研究结果显示针刺疗效与假针疗效无差异。结论:通过数据分析,认为国外针刺临床研究中操作者未得针刺"通经络、调气血"之真义才是导致临床研究中针刺疗效不显著的根本原因所在。对于国内研究者来说,今后在选择临床试验设计方案时,应有一个明确的研究目标,无论是选择哪种研究方法,ERCT还是PRCT作为设计方案,重要的是要有一个明确的研究目标,明确研究的目的是探讨针刺的作用机制或针刺特异性还是研究针刺与其他疗法的疗效对比,从而选择最恰当的研究方案。

Objective：The goal of this research was to know the current state of foreign acupuncture through literatures collected by SCI,including methords they used and the existing problems.So we could provide domestic research workers with meaningful information about the development of foreign acupuncture research.Methods：In Web of Science and PubMed database,taking ＂trials and acupuncture＂,＂RCT and acupuncture＂ as title,we finally got 1581 literatures related to acupuncture which were published in Science Citation Index（SCI）Periodicals.We analyzed the characteristics of RCTs involved in the literatures and assess on them.Results：Explanatory randomized controlled trials were used in most literatures.But the result of this kind of RCTs presented poor acupuncture outcome,with a view that acupuncture was not superior to sham acupuncture.While more and more western researchers affirmed that pragmatic randomized controlled trials were more suitable for acupuncture with complex interventions as its feature.The poor outcome that acupuncture was not superior to sham acupuncture had been the result of most SCI clinical studies.While the using of technique of fMRI which presents different mechanisms between acupuncture and sham acupuncture was a new trend in the process of improving the trials protocol,which without any doubt was good news for those promoters.Conclusion：The author of this article thinks that the foreign technicians do not really understand acupuncture with＂smoothing meridians and collaterals and adjusting qi and blood＂as its main effect is the fundamental reason for why the effect of acupuncture in SCI clinical trials is not ideal.For the internal researches,we suggest that ensuring whether to study the mechanism of acupuncture or the comparison clinical effects between acupuncture and other therapies is the most important in future studies.So the most appropriate trial protocol for clinical acupuncture study is available.