Should we reconsider the routine use of placebo controls in clinical research?

Should we reconsider the routine use of placebo controls in clinical research?
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DOI:
10.1186/1745-6215-13-44
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发表时间:
2012-04-27
期刊:
影响因子:
2.5
通讯作者:
Pressman A
Pressman A
中科院分区:
医学4区
文献类型:
--
作者:
Avins AL;Cherkin DC;Sherman KJ;Goldberg H;Pressman A

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现代临床研究实践中,只要存在可信的安慰剂,就倾向于安慰剂对照而非常规护理对照。这种偏好的一个未被认识到的后果是,临床医生在临床实践中提供安慰剂非特异性愈合作用获益的能力更加有限。我们研究了在安慰剂和常规护理对照之间进行选择的问题。我们考虑了为什么安慰剂对照对临床医生的限制和选择对照组的权衡。我们发现,对于某些研究,研究者应该考虑常规护理对照,即使有足够的安慰剂。采用常规护理控制将是最有价值的实用性试验评估治疗,以改善临床护理,并为内部效度的威胁,可以充分管理没有安慰剂对照条件。即使存在令人满意的安慰剂,有意识地选择常规护理对照,也会使临床医生获得所有干预措施共同的非特异性治疗益处的价值。其结果可能是更有效的,以病人为中心的护理,使最好地利用医疗干预的具体和非具体的好处。
Modern clinical-research practice favors placebo controls over usual-care controls whenever a credible placebo exists. An unrecognized consequence of this preference is that clinicians are more limited in their ability to provide the benefits of the non-specific healing effects of placebos in clinical practice. We examined the issues in choosing between placebo and usual-care controls. We considered why placebo controls place constraints on clinicians and the trade-offs involved in the choice of control groups. We find that, for certain studies, investigators should consider usual-care controls, even if an adequate placebo is available. Employing usual-care controls would be of greatest value for pragmatic trials evaluating treatments to improve clinical care and for which threats to internal validity can be adequately managed without a placebo-control condition. Intentionally choosing usual-care controls, even when a satisfactory placebo exists, would allow clinicians to capture the value of non-specific therapeutic benefits that are common to all interventions. The result could be more effective, patient-centered care that makes the best use of both specific and non-specific benefits of medical interventions.
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