World Health Organization (WHO) Collaborating Centre for Traditional Medicine, Discipline of Chinese Medicine, School of Health Sciences, RMIT University, Bundoora, Victoria, Australia.
J Altern Complement Med. 2010 Mar;16(3):301-12. doi: 10.1089/acm.2009.0293.
As an alternative medical system, Traditional Chinese Medicine (TCM) has been increasingly used over the last several decades. Such a consumer-driven development has resulted in introduction of education programs for practitioner training, development of product and practitioner regulation systems, and generation of an increasing interest in research. Significant efforts have been made in validating the quality, effectiveness, and safety of TCM interventions evidenced by a growing number of published trials and systematic reviews. Commonly, the results of these studies were inconclusive due to the lack of quality and quantity of the trials to answer specific and answerable clinical questions.
The methodology of a randomized clinical trial (RCT) is not free from bias, and the unique features of TCM (such as individualization and holism) further complicate effective execution of RCTs in TCM therapies. Thus, data from limited RCTs and systematic reviews need to be interpreted with great caution. Nevertheless, until new and specific methodology is developed that can adequately address these methodology challenges for RCTs in TCM, evidence from quality RCTs and systematic reviews still holds the credibility of TCM in the scientific community.
This article summarizes studies on TCM utilization, and regulatory and educational development with a focus on updating the TCM clinical evidence from RCTs and systematic reviews over the last decade. The key issues and challenges associated with evidence-based TCM developments are also explored.
作为一种替代医学体系,中医药在过去几十年中得到了越来越多的应用。这种由消费者驱动的发展导致了从业者培训教育项目的引入、产品和从业者监管系统的发展,以及对研究的兴趣日益增加。大量努力已经用于验证中医药干预措施的质量、有效性和安全性,这一点可以从越来越多的已发表试验和系统评价中得到证明。通常,由于缺乏能够回答具体可回答的临床问题的高质量和数量的试验,这些研究的结果并不确定。
随机临床试验(RCT)的方法并非没有偏倚,而中医药的独特特征(如个体化和整体性)进一步使中医药疗法中 RCT 的有效实施复杂化。因此,需要谨慎解释来自有限 RCT 和系统评价的数据。然而,在为中医药 RCT 开发出能够充分解决这些方法学挑战的新的特定方法学之前,来自高质量 RCT 和系统评价的证据仍然在科学界为中医药提供可信度。
本文总结了中医药利用、监管和教育发展方面的研究,重点介绍了过去十年中 RCT 和系统评价中中医药临床证据的更新。还探讨了与循证中医药发展相关的关键问题和挑战。