Abstract
BackgroundModern 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.MethodsWe 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.ResultsWe 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.ConclusionsIntentionally 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.
Highlights
Modern clinical-research practice favors placebo controls over usual-care controls whenever a credible placebo exists
How use of placebos in research limits their use in clinical practice As we demonstrate below, our common use of placebos in clinical trials may be partly responsible for restricting our ability to use placebos effectively in clinical practice
Recognizing the supremacy of valid research design, we propose a set of questions to help identify the conditions under which a placebo control is clearly appropriate (Table 1)
Summary
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. A colleague described a patient who reported that acupuncture was the best treatment she had found for her chronic low-back pain. Though he knew that, at the time, most placebo (or ‘sham’)-controlled acupuncture trials did not show a benefit of acupuncture relative to placebo, he supported her choice of therapies. The randomized, double-blind clinical trial has been the gold standard for studying the efficacy of medical therapeutics for more than 50 years. As greater understanding of the mechanism of placebo effects evolve, it is likely that there will be greater appreciation of both the specific and non-specific effects of all therapeutic interventions
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