The Placebo Response in Pediatric Clinical Trials

Marcia L. Buck, Pharm.D., FCCP, FPPAG


Pediatr Pharm. 2012;18(3) 

In This Article

Understanding the Placebo Response

In the November 2011 issue of Clinical Pharmacology and Therapeutics, Rief and colleagues published a thought-provoking article describing the mechanisms involved in both placebo and nocebo response (the positive as well as negative effects of inactive substances).[18] The authors propose that these effects are mediated through multiple interrelated mechanisms, including the patient's expectations of treatment benefit, the doctor-patient relationship, and associative learning or conditioning. They provide examples of the impact of placebos on psychological outcomes like perception of pain relief, as well as biologic parameters such as pulmonary function testing in patients with asthma, and discuss the potential benefits of optimizing these effects. While some investigators have argued for elimination of placebo controls in pediatric studies or alterations in study design in order to eliminate their influence, these authors support the role of placebos and provide recommendations for further study.


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