The placebo effect is nothing new, but it can still come as a surprise when it is sizable enough to change treatment decisions. This is what happened when a study published in the New England Journal of Medicine showed that prevention of pediatric migraines with placebo was as effective as amitriptyline or topiramate.
As the authors of the study concluded,
“Given the null outcome in this trial and the adverse events and serious adverse events reported in the amitriptyline and topiramate groups, the data do not show a favorable risk–benefit profile for the use of these therapies in pediatric migraine prevention…”
This was not the first research that demonstrated a powerful placebo effect in children with migraines.
In fact, the pediatric response to placebo for migraines is as high as 50 percent. This makes evaluating pharmaceuticals in a placebo-controlled trial difficult. Much discussion has occurred about how to eliminate the placebo effect in trials. It would help to demonstrate the actual efficacy, if any, of pharmaceutical migraine treatments.
But for the clinician—the practicing neurologist—there is more to consider. There are obvious ethical concerns with giving a sham treatment without patient consent. But research into IBS and ADHD in children has shown a benefit from open-label placebos.
This efficacy combined with the elimination of side effects associated with pharmacotherapy, makes it seem wrong not to use placebo to treat children with migraines.
But how to go about implementing this concept? In an article published in the Journal of Pediatrics, Faria et al, explain that the use of placebo in this population requires a context:
“Importantly, verbally induced suggestions, conditioning, and modeling can be all seen as vehicles through which expectations are acquired.”
The authors went on to provide guidelines for implementing transparent placebo-based treatment in the pediatric migraine clinic. They are predicated on the fact that there are both biological and psychological factors at play in migraines. They suggest that physicians treating migraines take the following steps:
Maximize the therapeutic effects of the doctor-patient encounter.
When this interaction is positive, there is reduced anxiety and increased expectation of relief from pain. These positive feelings may activate the portion of the brain known to be involved in the placebo effect.
Use strong communication skills to boost therapeutic effects.
Make sure the information relayed to patients and parents is “positive, motivational, and understandable.”
Demonstrate care and interest.
A warm, caring interaction has been shown to lead to an improved placebo response compared to a cold, distant interaction.
Consider non-verbal communication and the treatment environment.
Surroundings can affect stress levels in positive or negative ways. Set the stage, both physically and behaviorally, for your patient to have a good experience.
Use the physician-patient relationship to build confidence in the treatment plan.
This can help improve compliance for lifestyle modifications that are known to be beneficial for migraine sufferers.
Adapt this process according to your understanding of the patient.
Individuals respond differently and bring varying expectations to the clinic. Being aware and adapting your use of this approach can help maximize the benefits of placebo.
While much research is needed in order for us to fully understand the placebo effect, we know enough to implement it clinically if it is done in an ethical, transparent manner. There is no cost to patient or provider to take these steps, and it may provide relief and spare adverse events in the children with migraines.