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Compliance In Focus
Posted by Stephani Hulec on Fri, Aug 24, 2012

New Symptom in Clinical Studies: The Nocebo Effect

The Nocebo EffectMost people are familiar with the term placebo effect, in which patients experience beneficial symptoms associated with a specific treatment, even when they are given an ineffectual treatment, or “placebo”.  Recently, this New York Times article discussed the opposite medical phenomena known as the nocebo effect.  The nocebo effect is defined as:

  1. “The induction of a symptom perceived as negative by sham treatment and/or by the suggestion of negative expectations;” or
  2. “A negative symptom induced by the patient’s own negative expectations and/or by negative suggestions from clinical staff in the absence of any treatment” 

In multiple studies noted in the articles above, patients experienced unfavorable side effects when taking a prescribed medication in a randomized study, even though in reality, the patient had received the “control” drug.  Furthermore, as discussed by the NY Times, patients may also report negative symptoms when they are receiving the non-placebo treatment.

The second definition which states that “a negative symptom induced by the patient’s own negative expectations and/or by negative suggestions from clinical staff in the absence of any treatment” is worth taking a closer look.  A physician’s influence has been shown to affect a patient’s behavior or how the patient reacts to a particular treatment.  As the nocebo effect is concerned, an article on PubMed notes how the physician’s disclosure of the potential side effects of a particular treatment during the informed consent process may cause the patient to experience these symptoms.  Also, common clinical jargon used by physicians when communicating with their patients, may actually have unintended negative connotations, which could lead to an increase in nocebo effects.

This may lead to some considerations regarding the way clinical trials are designed.  Is there a way for investigators to move away from this potentially “suggestive” language so that adverse events reported are more accurate?

  • After patients have received a particular treatment, maybe questions could be worded in a more open-ended way (i.e. how are you feeling?), rather than specifically outcome-based questions (i.e. have you experienced pain from your incision site?)
  • How effective are patient questionnaires, such as a patient outcome questionnaire or a quality of life survey, used in medical device trials?  Do these types of questions aid in obtaining accurate data regarding patient’s true symptoms, or could specific inquiries be “leading” towards the reporting of nocebo effects?

How do you think that physicians can effectively and appropriately discuss all potential risks of a treatment or control, without leading to an increase in the adverse symptoms reported by patients?

Do you agree that there are ways that physician-to-patient communication can be improved, as to not influence the patient’s expectations?

Let us know your thoughts, comment below!

Photo Credit: Reigh LeBlanc

Topics: Clinical Studies, The Nocebo Effect, New York Times, New Symptom

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