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Define placebo in the context of clinical studies.
Interventions designed to simulate medical therapy but not believed to exert a physiological, pharmacological or anatomical effect on the target condition.
Define placebo in the context of clinical care.
any therapy or component of therapy that is deliberately used for its nonspecific, psychological, or psychophysiological effect
Define placebo effect
- Improvement in the patient's illness or symptoms attributable to the psychological and psychophysiological effects of treatment rather than to a specific pharmacological, physiological or anatomical property of the treatment.
- Placebo effect can be produced without administering a placebo.
Define nocebo effect
- Deteriorationg in patient's illness or symptoms attributable to the psychological and psychophysiological effects of the treatment rather than to a specific pharmacological, physiological or anatomical property of the treatment.
- Also known as placebo side effects
When are nocebo effects most likely to become manifest?
- When physician-patient relationship is poor [most important factor]
- Patient expects adverse effects
- Patient has been conditioned by past negative medical encounters to associate medical care with adverse effects
(T/F) Placebos have time-effect curves, peak responses, cumulative effects and carryover effects that mimic those of active medications, as well as dose-response effects.
Effects of cough medication are ___% attributable to placebo and ___% attributable to properties of the medicine.
85% placebo, 15% medication
About __% of panic disorder patients respond to placeo.
(T/F) Responsiveness to placebo declines the longer a patient is clinically depressed.
True (50% patients depressed less than 3 months respond, 30% patients depressed longer than 1 year respond)
What are the most frequently reported nocebo effects?
drowsiness, headaches, nervousness, insomnia, nausea, constipated
What is the "Ultimate Nocebo Effect" or Voodoo death?
Death caused by rapid shifts between sympathetic and parasympathetic activity with cardiac arrest
(T/F) No personality, demographic or other characteristics consistently predict placebo responses.
Placebo effects on pain are mediated by ____
Endogenous opiod peptides (EOPs)
What is the most common factor able to induce a placebo effect?
Presence of a physician. Physicians can use this knowledge to increase placebo effect (i.e. by using the stethoscope, optimistically offering prescriptions or procedures, etc.)
Define the concept of sustained partnership.
- An example of the placebo effect without the placebo. 6 characteristics of a physician that provide superior health outcomes.
- 1. interest in the whole person
- 2. knowing the patient over time
- 3. caring, sensitivity, empathy
- 4. viewed as reliable and trustworthy by the patient
- 5. adapts medical goals of care to the patient's needs and values
- 6. encourages patient to participiate fully in health decision-making
When looking at the Measuring True Treatment Effects graph, how do you measure the true treatment effect and true placebo/nocebo effect?
- True treatment effect: difference between the top of the bar for treatment group and top of the bar of placebo/nocebo group (even if the top of the bar is below 0 like in a nocebo situation)
- True placebo/nocebo effect: difference between the top of the bar of "no treatment" group and top of the bar of placebo/nocebo group.
What is the hidden treatment protocol?
Remove patient's knowledge that a treatment is being given in order to examine the effects of the treatment separate from nonspecific effects. Difficult to use as part of clinical trials.
Which of the following statements is true?
A. A group that does not receive treatment is not the same as a placebo control group.
B. As a physician you must administer an ineffective medication to create a placebo effect.
C. Placebos have no negative side effects.
D. Medical procedures do not produce placebo effects that can significantly influence the course of disease.
E. Placebo effects always are a nuisance in medical practice.
In clinical studies a placebo is defined as a treatment without efficacy against the target condition; in clinical care, however, a placebo is conceived of as a component of treatment that can positively influence outcomes through all of the following pathways or mechanisms EXCEPT:
Which of the following physicians is MOST likely to maximize positive influences on the outcomes of a patient in response to a treatment or medication?
A. Dr. Jones, who values efficiency and always begins and ends the visit abruptly and focuses solely on the symptoms of the patient.
B. Dr. Pheebs, who has nurses interact with patients as much as possible and limits her patient contacts to writing prescriptions whenever possible.
C. Dr. Smith, who discusses both her and the patient's expectations for a given medication or treatment and conveys realistically positive expectations when appropriate.
D. Dr. Robins, who does not maintain lasting relationships with his patients and rarely sees patients more than once.
E. Dr. Bower, who often conveys doubt about the medications he prescribes.
Robert has been in the Army since he was 21. At 41, he is deciding whether or not to retire within the next few months given that he has recently been diagnosed with intractable hypertension that has been medication persistant. Robert's ability to fly airplanes will likely be revoked, unless his hypertension is gotten under control. You see that his condition is worsening as his mood declines and he begins to doubt whether he should continue treatment. You want to help him but are aware that his thoughts may be influencing his physiological response. You decide to institute your power as a physician by creating a placebo response to help Robert to the extent that you are able. Which of the following is MOST likely to explain Robert's subsequent improvment given this change that you make to his treatment regimen:
A. Natural history
B. Regression to the mean
C. Patient expectations
D. True drug effects have a delayed onset
E. Phyisican attention, interest and attitude regarding this case