The premise of a randomized controlled trial, or RCT, is simple: In its most basic form, individuals are randomly assigned to one of two groups: treatment, or control. The outcomes of both groups are then compared and quantified.
RCTs are considered the gold standard – and most widely trusted – approach to determining the efficacy of treatment. But several Stanford researchers contend that the RCT ignores both the social and psychological elements that underlay placebo effects and influence treatment. These elements – which include patients’ mindset and the social contexts of treatment – are considered “medically superfluous” in RCTs. But they are, in fact, essential to patient outcomes.
In a recent article in the BMJ, Alia Crum, PhD, and Kari A. Leibowitz, with Stanford's Department of Psychology, and physician Abraham Verghese, MD, point to “growing evidence about the influence” of these psychological and social forces. Patients’ mindsets (or beliefs/expectations) that they will heal “can account for clinically significant benefit in an estimated 60-90 percent of conditions,” they write, while social contexts, which shape mindsets, “include explicit expectations set by the doctor and more subtle social or environmental factors.”
Thus the doctor who declares that a particular medication will help the patient improve is pivotal, including the words he or she chooses to use and the type of white coat worn, as well as certain factors about the medication – such as color, label, and price. Similarly, a recent trial found that greater physician empathy was associated with briefer colds with less severe symptoms.
So how can medicine better understand – and harness – the potential power of these psychosocial elements to improve patient health and speed healing? The authors advocate for interdisciplinary investigation, additional training for physicians, and system-wide reform to “align with and promote effective use of psychosocial elements in healthcare.”
They conclude with a call to use “all the tools at our disposal” to improve patient health and well-being: “Improved understanding of the ability of the social context and patient’s mindsets to evoke healing properties in the body can be an extraordinary resource for health and healing,” they write. “We need to open our minds to that possibility.”