Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to inform patients about intervention risks with patients to preserve their autonomy. Researchers have failed to consider the harm caused by the way in which the information is conveyed. In this paper, I argue that the magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside autonomy when obtaining (ethical) informed consent and communicating intervention risks with patients.

译文

:与安慰剂效应一样,nocebo效应(预期为阴性结果的效应)与其友好表亲几乎不同,几乎被忽略了。与它的存在有关的认识论和伦理学的混淆几乎没有引起人们的注意。与通常所断言的相反,采取安慰剂干预措施后产生的不良事件不一定是nocebo效应。它们可能是由于自然历史而产生的。同时,伦理学上的知情同意书(在临床试验和临床实践中)几乎完全集中在需要告知患者有关患者干预风险以保持其自主权的需要上。研究人员没有考虑到信息传递方式所造成的危害。在本文中,我认为必须使用由未经治疗的患者组成的对照组来衡量Nocebo效应的程度。而且,由于Nocebo效应会产生伤害,因此在获得(道德的)知情同意并与患者交流干预风险时,必须同时考虑非恶意行为的原则和自主权。

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