Investigators are exploring methods to incorporate the placebo effect into normal treatment regimens. Benefits of a new placebo protocol include less medication, lower cost and fewer dangerous side effects with equally effective care.
Researchers used this method to successfully treat psoriasis patients with one quarter to one half of their usual dose of a widely used steroid medication, according to an early study published online the journal Psychosomatic Medicine.
Early results in human patients suggest that the new technique could improve treatment for several chronic diseases that involve mental state or the immune system, including asthma, multiple sclerosis and chronic pain.
By designing treatment regimens that mix active drug and placebo, researchers at the University of Rochester Medical Center hope to maximize drug benefits, reduce side effects, increase the number of patients who take their medicine and extend the use of drugs otherwise limited by addiction risk or toxicity.
Using a fraction of the usual drug dose to get the same effect could also make possible a dramatic and timely reduction in health care costs, according to the authors.
The publication is a product of decades of research in the emerging field of “psychoneuro-immunology,” which holds that the ability of the human immune system to fight disease is closely linked with a person’s mind. Thoughts and moods are captured in neurochemicals that cause the release of hormones which interact with disease-fighting cells.
The current research team chose psoriasis for their first human experiments because it is chronic, gets worse when patients feel stress and involves the immune system. The condition causes pain and disability in four million Americans as inherited traits and irritants cause the immune system to trigger the too fast production of skin cells, resulting in red, scaly patches of dead skin.
“Our study provides evidence that the placebo effect can make possible the treatment of psoriasis with an amount of drug that should be too small to work,” said Robert Ader, Ph.D., M.D.(hc), distinguished university professor in the University of Rochester School of Medicine & Dentistry.
“While these results are preliminary, we believe the medical establishment needs to recognize the mind’s reaction to medication as a powerful part of many drug effects, and start taking advantage of it,” said Ader, principal investigator of the study.
“The placebo effect, obviously, cannot help unconscious patients, or replace substances that the body itself is unable to produce,” he added. In the absence of functioning islet cells, for example, placebos cannot stimulate the release of insulin in a Type l diabetic.
A description of the current findings requires expanding the definition of placebo effects to include phenomena that are not fully understood by modern medicine, Ader said. Although placebos, “dummy pills” that have no therapeutic effect by themselves, are prescribed by many physicians today, their use still carries a stigma. It’s as if the effect of a pill containing no medication is not “real,” part magic and part deception.
To accurately define and study the placebo effect, Ader and colleagues chose to frame it as an example of a well established psychological phenomenon: the conditioned response. Nineteenth century Russian physiologist Ivan Pavlov was the first to study the phenomenon of conditioning. By ringing a bell (a conditioned stimulus) each day before giving his dogs food (an unconditioned stimulus), Pavlov found that the dogs would eventually salivate (a conditioned response) at the sound of the bell alone.
In the current study, Ader and colleagues sought to determine if a drug’s therapeutic effect could be triggered by qualities associated with the drug, like its shape, color, smell and packaging, as well as by its administration by an authority figure in a white lab coat.
These repeated associations, Ader argues, create conditioned responses, drug-like therapeutic effects of treatment caused not by a drug’s ingredients alone, but elicited by stimuli associated with the effects of active drug treatment.
The results provide the first evidence that conditioned responses might be harnessed to influence the design of drug regimens in humans.
“The pharmaceutical industry may choose to ignore the conditioning component of drug treatment regimens,” Ader said.
“Alternatively, they may now consider exploring ways to exploit conditioning in the design of drug treatment protocols, especially in chronic conditions where patients acquire conditioned responses over time. I believe industry will eventually support this approach because it promises to increase safety and reduce production costs.”