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The Placebo Effect: is achieving trial success all in our minds?

The placebo response, and other closely related phenomena, have been a constant source of fascination since they were first described and although precise, well demarcated definitions of the effects may not exist1–3 the broad related areas of research have never been starved of attention. Over the last decade we have observed a great increase in the amount of dedicated experimental work performed on these processes4,5, and ultimately we have arrived at a consensus that they constitute real psychobiological phenomena with fundamental implications for the pathophysiology and management of medical conditions6–9. In tandem with our evolving understanding of the effect, we have become increasingly reliant on a single experimental design model. The randomised, double-blind, placebo-controlled randomised clinical trial (RDBPCT) has been the gold standard instrument for establishing and comparing the efficacy (active comparators or non-placebo controlled RCTs) of treatments for decades now10. This single study design model has become central to the regulatory approval process for pharmaceuticals and supplements alike. This has led to a massive increase in the number of RDBPCTs conducted globally – expected to be at least 50,000 per year by 2020. Parallel to this trend is the now well documented increase in the magnitude of placebo responses observed in RDBPCTs, especially in trials using relatively subjective outcome measures. This has been a topic of considerable interest in recent years, primarily because adequately differentiating active and placebo groups (i.e. achieving adequate “assay sensitivity”) has become more difficult. In the current paper we describe the trends in more detail, as well as approaches to mitigate the placebo response and investigate whether newer study design models can improve the chances of achieving adequate separation between treatment groups.