Placebos and the Placebo Effects What they are and why we should love them © Heidi Most, M. Ac,...

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Placebos and the Placebos and the Placebo Effects Placebo Effects What they are and why we What they are and why we should love them should love them © Heidi Most, M. Ac, L.Ac, Dipl Ac (NCCAOM) © Heidi Most, M. Ac, L.Ac, Dipl Ac (NCCAOM)

Transcript of Placebos and the Placebo Effects What they are and why we should love them © Heidi Most, M. Ac,...

Page 1: Placebos and the Placebo Effects What they are and why we should love them © Heidi Most, M. Ac, L.Ac, Dipl Ac (NCCAOM)

Placebos and the Placebos and the Placebo EffectsPlacebo Effects

What they are and why we What they are and why we should love themshould love them

© Heidi Most, M. Ac, L.Ac, Dipl Ac (NCCAOM)© Heidi Most, M. Ac, L.Ac, Dipl Ac (NCCAOM)

Page 2: Placebos and the Placebo Effects What they are and why we should love them © Heidi Most, M. Ac, L.Ac, Dipl Ac (NCCAOM)

Your body’s ability to Your body’s ability to heal is greater than heal is greater than

anyone has permitted anyone has permitted you to believe.you to believe.

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““Always the purpose of Always the purpose of treatment is only to restore treatment is only to restore

nature’s balance against nature’s balance against disease. There is no recovery disease. There is no recovery unless it comes from the force unless it comes from the force

and fiber of one’s own tissues.” and fiber of one’s own tissues.” Dr. Sherwin Nuland, Yale University School of Medicine, Cliinical Professor of SurgeryDr. Sherwin Nuland, Yale University School of Medicine, Cliinical Professor of Surgery

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Purpose of this lecturePurpose of this lecture

Learn that the context in which Learn that the context in which treatment is given, and the patient’s treatment is given, and the patient’s and the practitioner’s beliefs, play a and the practitioner’s beliefs, play a major role in the patient’s response major role in the patient’s response to treatmentto treatment

Change the question of concern from Change the question of concern from “are placebos ethical?” to “how can “are placebos ethical?” to “how can we make our treatments most we make our treatments most effective.”effective.”

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Why is this important?Why is this important?

We want to be the best clinicians We want to be the best clinicians possiblepossible

Given the crisis in health care costs, Given the crisis in health care costs, we need to be including all possible we need to be including all possible methods of increasing effectiveness methods of increasing effectiveness without increasing cost. without increasing cost.

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Definition of placebo?Definition of placebo?

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What is the placebo What is the placebo effect?effect?

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Working definitionsWorking definitions

Placebo: Placebo: ““An intervention designed to An intervention designed to simulate medical therapy that at the time simulate medical therapy that at the time of use is believed not to be a specific of use is believed not to be a specific therapy for the condition for which it is therapy for the condition for which it is offered.offered.

Placebo Effect: Placebo Effect: ““A change in a patientA change in a patient’’s s illness attributable to the symbolic import illness attributable to the symbolic import of a treatment rather than a specific of a treatment rather than a specific pharmacologic or physiologic property.pharmacologic or physiologic property.

Brody H. Brody H. Placebos and the Philosophy of Medicine. Clinical, Conceptual, and Placebos and the Philosophy of Medicine. Clinical, Conceptual, and Ethical Issues. Ethical Issues. Chicago: University of Chicago Press, 1980Chicago: University of Chicago Press, 1980

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How does the placebo How does the placebo effect occur?effect occur?

Psychological mechanisms which Psychological mechanisms which contribute:contribute: ExpectationsExpectations ConditioningConditioning Therapeutic and Social RelationshipsTherapeutic and Social Relationships MotivationMotivation

Neuro-biological mechanismsNeuro-biological mechanisms Endorphin releaseEndorphin release Brain changesBrain changes

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ExpectancyExpectancy

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ExpectancyExpectancy

Research subjects receive Research subjects receive experimentally induced pain and are experimentally induced pain and are given a topical placebo cream in the given a topical placebo cream in the context of two different cues:context of two different cues:1) the cream is inert and will have no 1) the cream is inert and will have no

effect effect

2) the cream is a powerful pain killer2) the cream is a powerful pain killer

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Verbal cues can Verbal cues can manipulate manipulate

expectations and expectations and mediate placebo mediate placebo

effects:effects: Analgesic effects (both Analgesic effects (both experimentally and clinically)experimentally and clinically)

Changes in motor performance in Changes in motor performance in ParkinsonParkinson’’s disease patientss disease patients

Changes in emotions and brain Changes in emotions and brain responsesresponses

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““Expectancy” research:Expectancy” research:

Research on post-operative pain Research on post-operative pain divided patients into three sectionsdivided patients into three sections

1)1) Received morphine secretlyReceived morphine secretly

2)2) Received morphine and were told they Received morphine and were told they werewere

3)3) Received placebo but told it was a Received placebo but told it was a powerful pain relieverpowerful pain reliever

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Results:Results: Patients who were told they received a pain Patients who were told they received a pain

reliever, whether they actually received it or reliever, whether they actually received it or not, had the same experience as those who not, had the same experience as those who secretly received between six and 8 milligrams secretly received between six and 8 milligrams of morphine.of morphine.

The covert dose had to be increased to 12 The covert dose had to be increased to 12 milligrams to surpass the effect of the placebomilligrams to surpass the effect of the placebo

Levine JD, Gordon NC Levine JD, Gordon NC Analgesic responses to morphine and placebo in Analgesic responses to morphine and placebo in individuals with postoperative pain individuals with postoperative pain Pain, Vol 3, 1981Pain, Vol 3, 1981

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More “Expectancy” More “Expectancy” research:research:

Diazepam has no discernible effect on Diazepam has no discernible effect on anxiety unless a person knows he is anxiety unless a person knows he is taking it. taking it. Luana Colloca, Leonardo Lopiano, Michele Lanotte, Fabrizio Benedetti Luana Colloca, Leonardo Lopiano, Michele Lanotte, Fabrizio Benedetti Overt Overt

versus covert treatment for pain, anxiety, and Parkinson's diseaseversus covert treatment for pain, anxiety, and Parkinson's disease The Lancet Neurology, Volume 3, Issue 11, The Lancet Neurology, Volume 3, Issue 11, November 2004, Pages 679-684November 2004, Pages 679-684

In double blind studies of anti-In double blind studies of anti-depressants, patients often figure out if depressants, patients often figure out if they are getting the “real drug” by side they are getting the “real drug” by side effects. The worse the side effects, the effects. The worse the side effects, the more effective the drug. more effective the drug.

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Classical ConditioningClassical Conditioning

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Classical ConditioningClassical Conditioning

Repeated associations between a Repeated associations between a neutral stimulus and an active drug neutral stimulus and an active drug can result in the ability of the can result in the ability of the neutral stimulus by itself to elicit a neutral stimulus by itself to elicit a response characteristic of the drugresponse characteristic of the drug Responses include changes in hormone Responses include changes in hormone

secretions and immune responsesecretions and immune response

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How does a conscious How does a conscious or unconscious thought or unconscious thought translate into action?translate into action?

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Thinking a thought, Thinking a thought, believing a belief, believing a belief, causes biological causes biological

reactionsreactions

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The Limbic SystemThe Limbic System

Consists of many Consists of many different sub-areas, different sub-areas, with neuronal with neuronal connections to connections to each other and each other and especially to the especially to the hypothalamushypothalamus

Prefrontal cortex Prefrontal cortex has many has many connections to itconnections to it

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The hypothalamus The hypothalamus sends messages to the sends messages to the

rest of the body through rest of the body through the ANS and the the ANS and the

Endocrine system.Endocrine system.

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Therapeutic and Social Therapeutic and Social RelationshipsRelationships

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Therapeutic and Social Therapeutic and Social RelationshipsRelationships

Results of two randomized control Results of two randomized control trials with asthma patients and with trials with asthma patients and with rheumatoid arthritis patientsrheumatoid arthritis patients

Active group: patients described a Active group: patients described a significantly difficult conflict or secret significantly difficult conflict or secret about past traumas to the clinicianabout past traumas to the clinician

Control group, patients talked about Control group, patients talked about superficial things superficial things Smyth, J., Stone, A., Hurewitz, A & Kaell, A. 1999 Smyth, J., Stone, A., Hurewitz, A & Kaell, A. 1999

Effects of writing about stressful experience on symptom reduction…JAMA 281 1304-1309Effects of writing about stressful experience on symptom reduction…JAMA 281 1304-1309

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ResultResult

At the 4 month follow-up, asthma At the 4 month follow-up, asthma patients who were in the active patients who were in the active group showed significant group showed significant improvements in forced expiratory improvements in forced expiratory volume, and those with arthritis volume, and those with arthritis showed significant improvements in showed significant improvements in pain, when compared with their pain, when compared with their control groups.control groups.

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More relationship More relationship researchresearch

Large RCT showed that a positive Large RCT showed that a positive consultation by a physician produced consultation by a physician produced 20-25% greater improvements in 20-25% greater improvements in functional conditions compared with functional conditions compared with a negative consultation. Amount of a negative consultation. Amount of time spent in consultation was equal.time spent in consultation was equal.

Extensive summaries of this Extensive summaries of this research: research: Chez, R.A & Jonas, W. 2005 Developing healing Chez, R.A & Jonas, W. 2005 Developing healing relationships: J. Altern. Complementary Med. 11, S1-S2 and relationships: J. Altern. Complementary Med. 11, S1-S2 and Safran, D., Miller, W. & Beckman H. 2006 Organizational Safran, D., Miller, W. & Beckman H. 2006 Organizational dimensions of relationship-centered care: …J. Gen. Intern Med. dimensions of relationship-centered care: …J. Gen. Intern Med. 21, S9-S15.21, S9-S15.

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Neuro-biological Neuro-biological mechanismsmechanisms

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Neurobiological Neurobiological mechanismsmechanisms

Placebo analgesia: The suggestion Placebo analgesia: The suggestion that a substance will reduce pain that a substance will reduce pain increases the release of endorphins, increases the release of endorphins, which make patients feel less painwhich make patients feel less pain

When given Naloxone, which lock up When given Naloxone, which lock up key opioid receptors, the pain comes key opioid receptors, the pain comes back back Fields HL, Levine JD. Placebo analgesia- a role for endorphins. Trends in Fields HL, Levine JD. Placebo analgesia- a role for endorphins. Trends in

Neuroscience 1984; 7:271-73Neuroscience 1984; 7:271-73

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Other biological effects:Other biological effects:

Placebo analgesic effects are Placebo analgesic effects are inhibited by the peptide CCKinhibited by the peptide CCK

Several studies have demonstrated Several studies have demonstrated highly specific endogenous opioid-highly specific endogenous opioid-mediated placebo analgesic mediated placebo analgesic responses, such as increased opioids responses, such as increased opioids in cerebrospinal fluidin cerebrospinal fluid

PET and fMRI show placebo induced PET and fMRI show placebo induced brain changes mirror those found in brain changes mirror those found in opioid drug administration.opioid drug administration.

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The effects are not The effects are not limited to analgesialimited to analgesia

Increase in respiratory functioningIncrease in respiratory functioning Decreased heart rateDecreased heart rate Dopamine release and changes in Dopamine release and changes in

basal ganglia and thalamic neuron basal ganglia and thalamic neuron firing in Parkinson patientsfiring in Parkinson patients

Can see changes in metabolic activity Can see changes in metabolic activity in the brain in depression and in the brain in depression and expectation manipulation with expectation manipulation with addictionaddiction

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Albuterol TrialAlbuterol Trial

Double-blind crossover study of Double-blind crossover study of 46 patients with asthma 46 patients with asthma Wechsler, M, Kelley J, Wechsler, M, Kelley J,

Boyd, OE, Dutile, S, Marigowda G, Kirsch I, Israel E. Kaptchuk, T. “Active Albuterol Boyd, OE, Dutile, S, Marigowda G, Kirsch I, Israel E. Kaptchuk, T. “Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma, N Engl J Med or Placebo, Sham Acupuncture, or No Intervention in Asthma, N Engl J Med 2011;365:119-262011;365:119-26

4 arms4 arms Active treatment (albuterol inhaler)Active treatment (albuterol inhaler) Placebo inhalerPlacebo inhaler Sham acupunctureSham acupuncture No interventionNo intervention

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MethodsMethods

Administered one each of the four Administered one each of the four interventions in random order during four interventions in random order during four sequential visits (3-7 days apart).sequential visits (3-7 days apart).

Procedure repeated in 2 more blocks of Procedure repeated in 2 more blocks of visits for total of 12 visits for each patientvisits for total of 12 visits for each patient

Spirometry was performed repeatedly Spirometry was performed repeatedly over a period of 2 hours, and patients’ over a period of 2 hours, and patients’ self-reported improvement ratings were self-reported improvement ratings were recordedrecorded

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ResultsResults

Albuterol resulted in a 20% increase Albuterol resulted in a 20% increase in FEV1, as compared to 7% with in FEV1, as compared to 7% with each of the other three interventionseach of the other three interventions

Patients reported equal and Patients reported equal and substantial improvement with the substantial improvement with the inhaled albuterol, inhaled sham and inhaled albuterol, inhaled sham and the sham acupuncture. the sham acupuncture.

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QuickTime™ and a decompressor

are needed to see this picture.

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Page 35: Placebos and the Placebo Effects What they are and why we should love them © Heidi Most, M. Ac, L.Ac, Dipl Ac (NCCAOM)

DiscussionDiscussion

Findings consistent with meta-Findings consistent with meta-analysis involving multiple analysis involving multiple conditions, where placebos, as conditions, where placebos, as compared with no-intervention compared with no-intervention controls had no significant effect on controls had no significant effect on objective measures but did have objective measures but did have significant effects on subjective significant effects on subjective outcomes. outcomes. Hrobjartsson A, Gotzshe PC. Is the Placebo powerless? An analysis Hrobjartsson A, Gotzshe PC. Is the Placebo powerless? An analysis

of clinical trials comparing placebo with no treatment. N.Engl J Med 2001;344;1594-602of clinical trials comparing placebo with no treatment. N.Engl J Med 2001;344;1594-602

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Discussion cont’dDiscussion cont’d

Findings do not contradict recent lab Findings do not contradict recent lab studies showing that placebo studies showing that placebo treatment elicits quantifiable treatment elicits quantifiable changes in neurotransmitters and changes in neurotransmitters and regionally specific brain activity that regionally specific brain activity that influence symptoms. influence symptoms.

Bifurcation of effects may represent Bifurcation of effects may represent difference between treating disease difference between treating disease and treating illness. and treating illness.

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When is there no placebo When is there no placebo effect?effect?

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Loss of placebo Loss of placebo mechanisms reduce mechanisms reduce therapeutic efficacytherapeutic efficacy In an open-hidden design in In an open-hidden design in

Alzheimer’s disease, the placebo Alzheimer’s disease, the placebo component was correlated with component was correlated with cognitive status and functional cognitive status and functional connectivity between brain regions. connectivity between brain regions.

The lower the cognition and The lower the cognition and connectivity the less the analgesic connectivity the less the analgesic effect, to the point where an increase effect, to the point where an increase in dose was required for same level of in dose was required for same level of analgesia. analgesia. Benedetti F, Arduino C, Costa S, Vighetti S, Tarenzi L, Rainero I, et al. Benedetti F, Arduino C, Costa S, Vighetti S, Tarenzi L, Rainero I, et al.

Loss of expectation-related mechanisms in Alzheimer’s disease makes analgesic therapies less Loss of expectation-related mechanisms in Alzheimer’s disease makes analgesic therapies less effective. effective. Pain 2006 MarPain 2006 Mar

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So far, what do we So far, what do we know?know?

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Limitations in current Limitations in current researchresearch

Most have involved lab experiments over Most have involved lab experiments over short durations with healthy subjectsshort durations with healthy subjects

Longer term placebo response has been Longer term placebo response has been studied in RCTs; but these rarely include studied in RCTs; but these rarely include no treatment groups to control for no treatment groups to control for natural history and regression to the natural history and regression to the meanmean

More research is needed from a basic More research is needed from a basic science, clinical trial and ethical science, clinical trial and ethical perspectivesperspectives

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Some specific placebo Some specific placebo researchresearch

3 week single blind RCT with IBS patients 3 week single blind RCT with IBS patients (n=262)looked at sham acupuncture, (n=262)looked at sham acupuncture, sham acupuncture plus supportive sham acupuncture plus supportive patient-practitioner relationship patient-practitioner relationship compared to no treatment control. compared to no treatment control. 62% adequate relief (AR) with acu + support62% adequate relief (AR) with acu + support 44% AR acu alone44% AR acu alone 28% AR no treatment28% AR no treatmentKaptchuk Tj, Kelley JM, Conboy,LA, Davis RB, Kerr CE, Jacobson EE, et al. Kaptchuk Tj, Kelley JM, Conboy,LA, Davis RB, Kerr CE, Jacobson EE, et al. Components of placebo effect; Components of placebo effect;

randomised controlled trial in patients with IBS. randomised controlled trial in patients with IBS. BMJ 2008 May 3 BMJ 2008 May 3

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Different vehicles of Different vehicles of placebo ritual produce placebo ritual produce

different effectsdifferent effects Sham acu more effective than pills in Sham acu more effective than pills in

ability to functionability to function Depending on complaint and length Depending on complaint and length

of time administered, different of time administered, different placebos had different effectsplacebos had different effects

Different nocebo effects also Different nocebo effects also observed observed

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Alternative therapies Alternative therapies with elaborate rituals with elaborate rituals

have clinically have clinically significant placebo significant placebo

effectseffects Large acu trials in Germany compared acu, Large acu trials in Germany compared acu, sham acu, usual care, and no treatment for sham acu, usual care, and no treatment for migraine, tension HA, chronic LBP, and OA migraine, tension HA, chronic LBP, and OA of the kneeof the knee

Verum and sham acu resulted in Verum and sham acu resulted in substantially greater symptom improvement substantially greater symptom improvement than no treatment and usual care. than no treatment and usual care.

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More on the German More on the German studiesstudies

Positive expectations influenced Positive expectations influenced analgesic responses, doubling the analgesic responses, doubling the likelihood of positive outcomes. likelihood of positive outcomes.

Results lasted one year.Results lasted one year.

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Other interesting Other interesting findings:findings:

The larger the pill, the stronger the The larger the pill, the stronger the placebo effectplacebo effect

Two pills are better than oneTwo pills are better than one Brand name pills are better than Brand name pills are better than

genericsgenerics Capsules are more effective than pillsCapsules are more effective than pills Injections produce more pronounced Injections produce more pronounced

effect that capsules or pillseffect that capsules or pills

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More interesting More interesting findings:findings:

Colored pills are more likely to Colored pills are more likely to relieve pain than white pillsrelieve pain than white pills

Blue pills help people sleep better Blue pills help people sleep better than red pillsthan red pills

Green capsules work best for anxiety Green capsules work best for anxiety medicationmedication

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Surgery is an extremely Surgery is an extremely powerful placebopowerful placebo

Treatment for coronary artery disease Treatment for coronary artery disease in the 1950s in the 1950s (bilateral internal mammary artery ligation (bilateral internal mammary artery ligation

BIMAL) BIMAL) was found to be no better than was found to be no better than placebo surgery (relief from angina placebo surgery (relief from angina was significant in 70-80% of patients was significant in 70-80% of patients in both active and sham treatmentin both active and sham treatment

At same time as this research, heart At same time as this research, heart lung bypass machine was developed, lung bypass machine was developed, allowing for coronary artery bypass allowing for coronary artery bypass surgery.surgery.

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Results:Results:

Coronary artery bypass surgery has Coronary artery bypass surgery has never been tested in a placebo-never been tested in a placebo-controlled trialcontrolled trial

Its effectiveness in treating angina is Its effectiveness in treating angina is approximately the same as the old approximately the same as the old treatment: 70-80%treatment: 70-80%

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More placebo surgery More placebo surgery researchresearch

Placebo-controlled study of 298 Placebo-controlled study of 298 patients with class III or IV heart patients with class III or IV heart failure underwent high-dose laser failure underwent high-dose laser treatment, low-dose laser treatment treatment, low-dose laser treatment or placebo (catheter inserted but the or placebo (catheter inserted but the laser was never turned on)laser was never turned on)

Equally significant improvement in Equally significant improvement in all groups which lasted over 6 all groups which lasted over 6 months. months. Johnson A. 1994 Surgery as placebo. Lancet 344, 1140-1142Johnson A. 1994 Surgery as placebo. Lancet 344, 1140-1142

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More placebo surgery More placebo surgery researchresearch

The placebo “debridement” of The placebo “debridement” of osteoarthritis with arthroscopic osteoarthritis with arthroscopic surgery showed just as good pain surgery showed just as good pain relief as actual debridement for the relief as actual debridement for the same procedure.same procedure.

Two control conditions: Two control conditions: Only laparoscopic lavage was usedOnly laparoscopic lavage was used Skin incision made without insertion of Skin incision made without insertion of

laparoscopelaparoscope

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Results:Results:

Pain relief lasted over 2 years and Pain relief lasted over 2 years and was equal in all groups. was equal in all groups. Moseley, J., O’Malley, K., Moseley, J., O’Malley, K.,

Petersen, N., Menke, T., Brody, B., Kykendall, D., Hollingsworth, J., Ashton, C., and Wray, N. 2002 Petersen, N., Menke, T., Brody, B., Kykendall, D., Hollingsworth, J., Ashton, C., and Wray, N. 2002 A controlled trial of arthroscopic surgery for OA of the knee. N. England J. Med 347, 81-88A controlled trial of arthroscopic surgery for OA of the knee. N. England J. Med 347, 81-88

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Placebo effects are Placebo effects are inherent in clinical inherent in clinical practice, even w/o practice, even w/o

placeboplacebo Hidden administration of 5 Hidden administration of 5

commonly used painkillers were commonly used painkillers were markedly less effective than open markedly less effective than open administration administration Colloca L, Lopiano L, Lnotte M, Benedetti F. Colloca L, Lopiano L, Lnotte M, Benedetti F. Overt versus covert Overt versus covert

treatment for pain, anxiety, and Parkinson’s disease. treatment for pain, anxiety, and Parkinson’s disease. La cet Neurology 2004; 3; Amanzio M, Pollo A, Maggi G, La cet Neurology 2004; 3; Amanzio M, Pollo A, Maggi G, Benedetti F. Benedetti F. Response variability to analgesics: a role for non-specific activation of endogenous opiods. Response variability to analgesics: a role for non-specific activation of endogenous opiods. Pain 2001; Pain 2001;

Similar results have been Similar results have been reproduced for drug admin for reproduced for drug admin for anxiety and deep brain stimulation anxiety and deep brain stimulation for Parkinson’s Diseasefor Parkinson’s Disease

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Another open-hidden Another open-hidden paradigm studyparadigm study

CCK antagonist proglumide was shown to be CCK antagonist proglumide was shown to be better than placebo, which was in turn better better than placebo, which was in turn better than no-treatment for post-operative pain. than no-treatment for post-operative pain.

However, a hidden injection of proglumide was However, a hidden injection of proglumide was completely ineffective, showing the drug completely ineffective, showing the drug achieved a response by interacting with and achieved a response by interacting with and enhancing the expectancy pathways. enhancing the expectancy pathways.

Its effectiveness was dependent on the placebo Its effectiveness was dependent on the placebo mechanisms inherent in the clinical encounter. mechanisms inherent in the clinical encounter. Benedetti F, Amanzio M, Maggi G. Benedetti F, Amanzio M, Maggi G. Potentiation of placebo analgesia by proglumide. Potentiation of placebo analgesia by proglumide. Lancet 1995d Lancet 1995d

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The placebo effect is not The placebo effect is not always presentalways present

Placebos are not magicPlacebos are not magic They have not been proven to be They have not been proven to be

effective in reducing tumors, effective in reducing tumors, changing the course of fatal changing the course of fatal diseases, reducing extremely high diseases, reducing extremely high levels of pain…levels of pain…

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ANDANDwe can improve many we can improve many

therapies through therapies through using the placebo using the placebo

effect. effect.

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A short term experiment in 2001, post-A short term experiment in 2001, post-operative pain patients took 33% less operative pain patients took 33% less active analgesic if they believed they were active analgesic if they believed they were also receiving intravenous analgesia.also receiving intravenous analgesia. Pollo A, Amanzio Pollo A, Amanzio

M, Arslanian A, Casadio C, Maggi G, Benedetti F. M, Arslanian A, Casadio C, Maggi G, Benedetti F. Response expectancies in placebo analgesia and their clinical relevance. Response expectancies in placebo analgesia and their clinical relevance. Ain 2001; Ain 2001; 93 (1)93 (1)

In IBS study, patients exposed to a painful In IBS study, patients exposed to a painful stimulus under two conditions: local stimulus under two conditions: local anesthetic and placebo. In one study they anesthetic and placebo. In one study they were told that they “may receive an active were told that they “may receive an active or a placebo agent” and in the second or a placebo agent” and in the second they were told that “the agent you have they were told that “the agent you have been given is known to significantly reduce been given is known to significantly reduce pain in some patients”. Placebo responses pain in some patients”. Placebo responses were larger in the second study.were larger in the second study.

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We have seen We have seen expectation and belief expectation and belief

strongly influence strongly influence therapeutic outcomes.therapeutic outcomes.

In what other In what other unconscious ways is our unconscious ways is our

behavior influenced?behavior influenced?

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Other ways our Other ways our behavior is behavior is

unconsciously unconsciously influenced:influenced: Marketing (wine labeled from CA tastes Marketing (wine labeled from CA tastes

better than wine labeled from IN, even better than wine labeled from IN, even though it is the same wine)though it is the same wine)

Embodied cognition: our rationality is Embodied cognition: our rationality is influenced by our bodies (women who influenced by our bodies (women who wore bikinis did worse on math tests)wore bikinis did worse on math tests)

Enclothed cognition (the clothes we Enclothed cognition (the clothes we wear influence how we experience the wear influence how we experience the world)world)

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How can we maximize How can we maximize the therapeutic effects the therapeutic effects

of our treatments?of our treatments?

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The definition of The definition of treatment needs to be treatment needs to be

broadenedbroadened Drugs Drugs SurgerySurgery What we sayWhat we say How we conduct ourselvesHow we conduct ourselves The environment in which we work The environment in which we work

and see patientsand see patients Therapeutic relationshipsTherapeutic relationships

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Reminder: Reminder: Placebo is an Placebo is an

intervention designed intervention designed to simulate medical to simulate medical

therapy that therapy that at the time at the time of useof use is believed not to is believed not to be a specific therapy for be a specific therapy for the condition for which the condition for which

it is offered.it is offered.

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Important to recognize Important to recognize what we don’t knowwhat we don’t know

We do not know the limits of our We do not know the limits of our knowledge, of our own mindsknowledge, of our own minds

““The scientist knows that in the history of The scientist knows that in the history of ideas, magic always precedes science, ideas, magic always precedes science, that the intuition of phenomena that the intuition of phenomena anticipates their objective knowledge.anticipates their objective knowledge.”” Gauguelin 1974Gauguelin 1974

““Advance in detail is permitted: Advance in detail is permitted: fundamental novelty is barred. This fundamental novelty is barred. This dogmatic common sense is the death of dogmatic common sense is the death of philosophical adventure.philosophical adventure.”” Alfred North Whitehead (1948)Alfred North Whitehead (1948)

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What we think of as What we think of as placebos might in fact placebos might in fact be proven in the future be proven in the future

to have specific to have specific therapeutic effects.therapeutic effects. AcupunctureAcupuncture

ReikiReiki Therapeutic touchTherapeutic touch Bio-feedbackBio-feedback

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What else do we know What else do we know of that strongly of that strongly

influences therapeutic influences therapeutic outcomes?outcomes?

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Mindfulness-based Mindfulness-based Stress ReductionStress Reduction

Conscious relaxation reduces the Conscious relaxation reduces the cascade of stress responses, reducing cascade of stress responses, reducing our heart rate, blood pressure, our heart rate, blood pressure, relaxing our bowels, improving relaxing our bowels, improving digestion, reducing pain in chronic digestion, reducing pain in chronic disease, makes learning easierdisease, makes learning easier

Our immune system responses are Our immune system responses are improved, we get less colds, miss improved, we get less colds, miss fewer days of workfewer days of work

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What are the ethical What are the ethical considerations?considerations?

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If treatments have not If treatments have not been successful, or as been successful, or as

successful as you would successful as you would like, is it ethical to:like, is it ethical to:

Recommend Recommend acupuncture?acupuncture? meditation?meditation? herbal preparations?herbal preparations? Bio-feedback?Bio-feedback? Crystal therapy?Crystal therapy?

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What level of What level of information do you information do you

need to make a need to make a recommendation?recommendation?

Double blind RCTs? How many?Double blind RCTs? How many? Other forms of research?Other forms of research? Good friends, family members who Good friends, family members who

have benefited?have benefited? What level of information is What level of information is

enough?enough?

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SummarySummary

A patient’s expectations, beliefs, A patient’s expectations, beliefs, conditioning and anxiety can conditioning and anxiety can strongly effect treatment efficacystrongly effect treatment efficacy

As practitioners, we can strongly As practitioners, we can strongly affect those expectations through affect those expectations through our words, and behavior.our words, and behavior.

We can use the evidence from We can use the evidence from placebo research in a way that is placebo research in a way that is ethically acceptable and effective.ethically acceptable and effective.

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Recommendations Recommendations Wayne JonasWayne Jonas

Replace the term Placebo Effect with Replace the term Placebo Effect with concepts such as “meaning and concepts such as “meaning and context’ response components in context’ response components in researchresearch

Create optimal healing environments Create optimal healing environments for all of our clinical carefor all of our clinical care

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Acknowledgements:Acknowledgements:

““Placebo Effects: Biological, Clinical Placebo Effects: Biological, Clinical and Ethical Advances” Damien G and Ethical Advances” Damien G Finniss, Ted J. Kaptchuk, Franlin Finniss, Ted J. Kaptchuk, Franlin Miller and Fabrizio Benedetti, Miller and Fabrizio Benedetti, Lancet. 2010 February 20; Lancet. 2010 February 20;

““Reframing Placebo in Research and Reframing Placebo in Research and Practice” Wayne B. Jonas, Practice” Wayne B. Jonas, Philosophical Transactions of the Philosophical Transactions of the Royal Society 2011Royal Society 2011