Introduction
At Caritas Neuro Solutions, we take a unique approach to clinical trials and patient care. We emphasise the health and wellness of our patients and advocate this to be put at the centre of the trial alongside the investigational product (IP). We believe that by nourishing both the mind and body of the patient through mechanisms of wellness techniques, our clinical trial results can excel. We know the power of the mind through witnessing the placebo effect. A placebo is any form of treatment that does not contain an active treatment, usually tested as the comparison treatment, to see if the active treatment helps the health condition in question. The placebo can be a sugar pill, saline injection or any administered ‘fake’ treatment, given to patients. The placebo effect does not necessarily come from the placebo. It is born from the belief that the patient is receiving an active treatment that will alter their current condition (Dispenza, 2014). The placebo effect is the response felt by a patient after receiving the placebo treatment, this can be a positive or negative change in the patient’s condition or symptoms. Where a negative effect is experienced, this is called a ‘nocebo’ effect (Le Pera, 2021). The placebo effect illustrates that the mind and body are inextricably connected, demonstrating that one’s beliefs and thoughts translate from the mind to the body. When our body expects to get better, it sends out signals to generate the healing process. Thus, this raises the question, can we harness the power of the placebo effect to enhance our trial results, by merging the power of the mind with our effective treatments?
The Placebo Effect
If a patient believes they are taking an active product under investigation, their thoughts can alchemise into biochemical effects that translate into healing. Price et al acknowledges that the placebo has ‘neurological underpinnings’ and is down to environmental factors, more so than the chemical component of the placebo treatment administered (Price, Finniss, & Benedetti, 2008). Such environmental influencers may be the clinical setting, receiving patient care, quality of treatment and other elements that may affect the patients’ thoughts, emotions and beliefs. Every time one has a thought, a neurotransmitter is fired, and the brain makes a small protein chemical called neuropeptide. This sends a message to the body, through the activation of multiple different hormonal centres (Dispenza, 2014). The body reacts by having a feeling, and the cycle continues. Feelings have biochemical reactions in the body, and this affects our health. Neurobiologists have found that the placebo effect causes a decrease in activity in the regions of the brain that are ‘known to process anxiety and pain’ and an increase in activity in the region of the brain known for emotional regulation (Price, Finniss, & Benedetti, 2008). Price et al highlights that the placebo effect is a by-product of the brain’s function of ‘reward or aversion and associated neuro-circuitry.’ Thus, the placebo effect and its response in the brain is real and can be measured in the brain through medical instruments like functional magnetic resonance imaging (fMRI).
The Placebo Effect in the Body
Placebo analgesia is the phenomenon of the placebo effect of pain relief, which Wanger et al found to be due to the reduced activity in the brain which processes pain through measuring patients’ neurobiological responses with fMRI technology (Wager, et al., 2004). Such pain reductions were seen in neural activity, located in the regions of the thalamus, anterior insular cortex, and anterior cingulate cortex during the placebo condition, as compared with the baseline condition. The magnitude of such decreases in activity paralleled the reduction of pain experienced (Wagner et al., 2004). Physiological changes are found in the body too, just as neurobiological changes are found in the brain, during a placebo response. The University of Glasgow conducted a study on 15 healthy runners, who were administered a saline injection under the impression this was a doping drug called OxyRBX, and then asked to run a race. The runners race times increased significantly despite merely being administered a placebo (Ross, Gray, & Gill, 2015). In addition to healing illnesses, the placebo effect can enhance the performance of healthy individuals and athletes.
The Power of the Mind
Incredibly, comparable results were found in absence of a placebo disguised as medication, but through social and environmental factors. In 1979, a Harvard psychologist Ellen Langer conducted a study looking at aging and mindset, now known as the ‘Counter-Clockwise Study’ (Langer, 2009). Langer recruited elderly men from nursing homes and placed them in monastery that resembled an environment of the men’s past. The subjects were split into two groups, one group was told to verbally reminisce about the past through conversation while staying in the present, and the other group was told to live as they were twenty years ago, as their younger selves (Dispenza, 2014; LaPera, 2021). They were told to discuss topical events of the era in 1959, such as the moon landing and the cold war. All mirrors in the monastery were replaced with old portraits of the men as their younger selves in the investigational group, and in the control group the portraits were of the men as their present selves. The men lived in the monastery for a week and reported significant changes in their physiology and cognition. Their posture was better, they experienced increased flexibility, better joint health, their hearing and eyesight improved, and they even looked younger. The group of men who lived as they would decades before, experienced a more significant improvement compared with the group who were reminiscing about the past. Some even gave up their walking sticks (Dispenza, 2014). Yet still, both groups felt dramatically healthier. Neurologically, the men may have activated the circuits in their brain which reminded them of who they once were, which translated in their bodies to physiological changes. This again, alongside the placebo effect, demonstrates the power of the mind. We know that medicine has effective responses from patients too, but what if we can harness the healing mechanisms of our mind that work to produce ‘the placebo effect’ together with the power of a medicine? The Langer experiment of 1979 saw elderly men feel younger and healthier without an active trial product, but with prescribed behaviours, conversations, and thoughts. Such findings illustrate the potential of the mind to catalyse healing along with an active treatment.
Conclusion
The Placebo effect is a perfect illustration as to how mind over matter works. There are quantifiable neurological and physiological changes in our bodies that translate from our thoughts, feelings and beliefs. Our mind can play a pivotal role in our own healing, and if we pair the power of the mind with pharmaceutical drugs- the possibilities are magnificent. Current mindful practices in medical therapies and clinical trials are rooted in psychological talking therapies or Buddhist traditions- which center around breathing exercises and presence. A popular method of this is CBT administered alongside antidepressant drugs, which Hollon, Garber and Shelton found to be significant in easing symptoms of depression (2005). At Caritas Neuro Solutions, we encourage mindful practices to be administered alongside the IP where possible, at varying degrees. We believe this patient centered approach is the missing element in current clinical trials and will truly revolutionize research into mental and physical illnesses.
Bibliography
Dispenza, J. (2014). You Are The Placebo: Making Your Mind Matter. Carlsbad: Hay House Inc.
Hollon, S. D., Garber, J., & Shelton, R. C. (2005). Treatment of Depression in Adolescents With Cognitive Behaviour Therapy and Medications: A Commentary on the TADS Project. Cognitive and Behavioural Practise, 12(2), 149-155.
Langer, E. (2009). Counter-Clockwise: Mindful Health and the Power of Possibility. New York: Ballantine Books. Chapter 1.
Le Pera, N. (2021). How to Do The Work: Recognise Your Patterns, Heal From Your Past and Create Your Self. London: The Orion Publishing Group Ltd.
Price, D. D., Finniss, D. G., & Benedetti, F. (2008). A Comprehensive Review of the Placebo Effect: Recent Advances and Current Thought. Annual Review of Psychology, 59, 565-590.
Ross, R., Gray, C. M., & Gill, J. M. (2015). Effects of an Injected Placebo on Endurance Running Performance. Medicine and Science in Sports and Exercise, 47(8), 1672-1681.
Wager, T. D., Rilling, J. K., Smith, E. E., Sokolik, A., Casey, K. L., Davidson, R. J., Cohen, J. D. (2004). Placebo-Induced Changes in fMRI in the Anticipation and Experience of Pain. Science, 303(5661), 1162-1167.