Lewith George, Barlow Fiona, Eyles Caroline, Flower Andrew, Hall Sue, Hopwood Val, Walker Jan
Primary Medical Care, University of Southampton, Southampton, UK.
Forsch Komplementmed. 2009 Dec;16(6):404-12. doi: 10.1159/000259371. Epub 2009 Dec 4.
Calls for placebo-controlled randomised trials in complementary and alternative medicine (CAM) are entirely reasonable. However, they present major methodological problems, particularly when we understand so little about the underlying biological mechanisms involved for many of these therapies. Designing a placebo in CAM is frequently dependent on unsubstantiated assumptions about the specificity of a particular CAM intervention. In this paper we address the development and application of placebos to clinical trials of homeopathy, acupuncture, kinesiology, Chinese herbal medicine and healing. Each therapy-based vignette is authored by a researcher from the Complementary and Integrated Medicine Research Unit at the University of Southampton who has specific expertise in the field. The essential research question within this review is; can we legitimately claim to have placebos for these particular CAM interventions? In some areas of CAM the debate has become very involved and sophisticated, for instance in acupuncture but for other areas, such as healing, our understanding of placebos is currently limited and very naïve. For instance, if acupuncture is not point specific, then many so-called 'placebo-controlled' acupuncture trials are both misconceived and misleading. We have addressed this debate in what we hope is a thoughtful and rigorous manner with a view to developing realistic, reliable and credible placebos for randomised controlled studies when and where possible. However, our conclusions suggest that we are some way from developing valid, credible and reliable placebos for most CAM therapies.
要求在补充和替代医学(CAM)中开展安慰剂对照随机试验是完全合理的。然而,它们存在重大的方法学问题,尤其是当我们对许多此类疗法所涉及的潜在生物学机制了解甚少时。在CAM中设计安慰剂往往依赖于对特定CAM干预特异性的未经证实的假设。在本文中,我们探讨了安慰剂在顺势疗法、针灸、运动机能学、中药和自然疗法临床试验中的开发与应用。每个基于疗法的案例均由南安普顿大学补充与整合医学研究单位的一名研究人员撰写,该研究人员在该领域具有特定专长。本综述中的核心研究问题是:对于这些特定的CAM干预措施,我们能否合理地声称拥有安慰剂?在CAM的某些领域,争论已经变得非常复杂和深入,例如在针灸方面,但对于其他领域,如自然疗法,我们目前对安慰剂的理解有限且非常幼稚。例如,如果针灸不是穴位特异性的,那么许多所谓的“安慰剂对照”针灸试验都是错误构想且具有误导性的。我们以一种我们希望是深思熟虑且严谨的方式来探讨这场争论,以期在可能的情况下为随机对照研究开发出现实、可靠且可信的安慰剂。然而,我们的结论表明,对于大多数CAM疗法,我们距离开发出有效、可信且可靠的安慰剂还有一段路要走。