Scriba P C
Medizinische Klinik Innenstadt, Ludwig-Maximilians-Universität, Ziemssenstr. 1, 80336, München, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2012 Sep;55(9):1113-7. doi: 10.1007/s00103-012-1526-z.
In medicine, placebos are used both in scientific studies and for practical therapeutic purposes. In evidence-based medicine, the efficacy of treatment may be determined as the difference between the effects of the verum (the active study drug) and the placebo, the latter being a substance lacking specific action on the disease under consideration. However, the improvements in patients' conditions under placebo treatment may be substantial and comparable to those with verum. Genuine placebos predominate in clinical studies, while pseudoplacebos prevail in practical therapy. The term pseudoplacebo can also be applied to many procedures in complementary medicine, including homeopathic medicine (Büchel et al., Placebo in der Medizin, 2011). The comprehensive definition of placebo, as used in a report by the German Medical Association (Büchel et al., Placebo in der Medizin, 2011), states that a placebo effect may occur even when treating with verum. The placebo effect is modulated by the context of the treatment, by the expectations of the patients and the doctors, and by the success of the relationship between doctors and patients. A number of unspecific effects, e.g., spontaneous alleviation, statistical effects, variance with time, methodological errors, in addition to the placebo effect make up the total response that is called"placebo reaction." A complete list of the effectiveness of placebo for all important diseases is still lacking. Further, it is not possible to predict which patients will respond to placebo. Which characteristics of doctors are important (competence, empathy, communicative ability and partnership, trust) in order to achieve a placebo effect, particularly in addition to the verum effect measures of evidence-based medicine? Are there doctors who are better in this than others? Could the nocebo effect weaken the efficacy of treatment in evidence-based medicine? Since a placebo effect may occur in almost any standard therapy, information about placebos should be provided during medical education and continuing medical education (CME). The use of placebo in clinical studies is ethically justified and lawful in consenting patients if there is no other effective treatment available with which the test substance could be compared. For daily practical therapeutic purposes, placebos may be ethically acceptable and lawful if there is no effective therapy available, if the complaints are minor, if the patient expressly wishes treatment, and if there is a reasonable likelihood of success. However, an explanation of the expected benefits and risks must be provided to the patients. At present, there are two explanatory theories for the mechanism of action of placebo, namely, the associative and the mentalistic explanation (Büchel et al., Placebo in der Medizin, 2011). Interestingly, effects of placebo and of verum can be localized in the brain by physiological and anatomical techniques. With many open questions remaining, research on placebo is currently very active. These aspect and neurobiological findings in particular may facilitate for "scientifically" educated doctors to accept that ineffective materials, i.e., placebos, are in fact effective.
在医学中,安慰剂既用于科学研究,也用于实际治疗目的。在循证医学中,治疗效果可被确定为真药(活性研究药物)与安慰剂效果之间的差异,后者是一种对所研究疾病缺乏特定作用的物质。然而,安慰剂治疗下患者病情的改善可能相当显著,且与真药治疗的改善效果相当。真正的安慰剂在临床研究中占主导地位,而假安慰剂在实际治疗中更为常见。假安慰剂这一术语也可应用于补充医学中的许多程序,包括顺势疗法(比歇尔等人,《医学中的安慰剂》,2011年)。德国医学协会的一份报告(比歇尔等人,《医学中的安慰剂》,2011年)中所使用的安慰剂的综合定义指出,即使使用真药治疗时也可能出现安慰剂效应。安慰剂效应受治疗背景、患者和医生的期望以及医患关系的融洽程度调节。除了安慰剂效应外,一些非特异性效应,如自发缓解、统计效应、随时间变化、方法学误差等,构成了被称为“安慰剂反应”的总体反应。目前仍缺乏关于安慰剂对所有重要疾病有效性的完整清单。此外,无法预测哪些患者会对安慰剂产生反应。为了产生安慰剂效应,医生的哪些特征(能力、同理心、沟通能力和伙伴关系、信任)很重要,特别是在循证医学的真药效应措施之外?是否有医生在这方面比其他医生更擅长?反安慰剂效应会削弱循证医学中治疗的疗效吗?由于几乎在任何标准治疗中都可能出现安慰剂效应,因此在医学教育和继续医学教育(CME)期间应提供有关安慰剂的信息。在临床研究中,如果没有其他可与受试物质进行比较的有效治疗方法,对同意参与的患者使用安慰剂在伦理上是合理且合法的。对于日常实际治疗目的,如果没有有效的治疗方法、症状较轻、患者明确希望接受治疗且有合理的成功可能性,那么安慰剂在伦理上可能是可接受且合法的。然而,必须向患者解释预期的益处和风险。目前,对于安慰剂作用机制有两种解释理论,即联想解释和心理主义解释(比歇尔等人,《医学中的安慰剂》,2011年)。有趣的是,通过生理和解剖技术可以在大脑中定位安慰剂和真药的效应。由于仍存在许多未解决的问题,目前对安慰剂的研究非常活跃。这些方面,特别是神经生物学发现,可能有助于接受过“科学”教育的医生认识到无效物质,即安慰剂,实际上是有效的。