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

Trials

Alice Pressman¹  Harley Goldberg¹  Karen J Sherman³  Daniel C Cherkin³  Andrew L Avins² 

[1] Northern California Kaiser-Permanente Division of Research, 2000 Broadway, Oakland, CA, 94612, USA;Dept. of Epidemiology & Biostatistics, University of California, 185 Berry Street, Suite 5700, San Francisco, CA, 94107, USA;Group Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA, 98101, USA

关键词: Placebo controls;    Placebo effect;    Placebos;    Masking;    Blinding;    Clinical trials;   

Others  :  1095624
DOI  :  10.1186/1745-6215-13-44

 received in 2011-09-11, accepted in 2012-04-27,  发布年份 2012

【 摘 要 】

Background

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.

Methods

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.

Results

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.

Conclusions

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.

【 授权许可】

   
2012 Avins et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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