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lecture 9:Placebo Dr.Anna

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The document discusses treatment evaluation and placebo effects, noting that placebos can produce real physiological or psychological effects through mechanisms like expectations, conditioning, and personality factors, even when a person knows they are taking an inert substance. Placebos have been shown to be effective for a wide range of conditions from depression to pain to irritable bowel syndrome. While placebos may be pharmacologically inert, they are not necessarily psychologically or therapeutically inert.

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Dr. Anna Abraham Treatment Evaluation & Placebo Effects
Treatment Evaluation Measuring the Impact of Interventions on Outcomes of Interest BUSINESS LAW Intervention: Participation in a Intervention: Adding hard labour to Leadership Training Program sentences for minor crimes (stealing) Impact: Productivity of a Company Impact: Crime rate for minor crimes
Treatment Evaluation Measuring the Impact of Interventions on Outcomes of Interest MEDICINE BEHAVIORAL TRAINING Intervention: New Drug for Coughs Intervention: Social training in Autism Impact: Cough Symptoms Impact: Social Skills
Treatment Evaluation: EXPERIMENT A means to identify cause-and-effect relationships between events and/or behaviors Follow a set of rules and guidelines that reduce the possibility of errors, biases & chance occurrences Advantages: (1) Less error/bias prone than case studies, surveys or observational methods (2) Most reliable method for identifying cause-and effect relationships Disadvantages: (1) Problems in Generalization: Results from one situation may not apply to another situation
Treatment Evaluation: EXPERIMENT Are there Differences in the Emotional Reactions of Men and Women when watching Thrillers versus Romantic Films? 18 18 18 15 15 15 12 12 12 9 9 9 6 6 6 3 3 3 0 0 0
Treatment Evaluation: EXPERIMENT What Else Could Explain The Results? ACTIVATION OF GENDER STEREOTYPES? Stereotype Susceptibility Study on female Asian-American college students GENDER NEUTRAL ETHNICITY Do you prefer co-ed or single- How satisfied are you with the How many generations of your sex floors for flat-sharing? university telephone service? family have lived in America? MATH TEST Source: M. Shih, T. Pittinsky, & N. Ambady (1999), Psychological Science, 10 (1), 80-83.
Treatment Evaluation: EXPERIMENT What Else Could Explain The Results? ACTIVATION OF GENDER STEREOTYPES? Stereotype Susceptibility Study on female Asian-American college students Accuracy on Math Test 60 55 50 45 40 35 30 FEMALE NEUTRAL ASIAN Source: M. Shih, T. Pittinsky, & N. Ambady (1999), Psychological Science, 10 (1), 80-83.
Treatment Evaluation: EXPERIMENT What Else Could Explain The Results? ! EFFECT OF EXPECTATIONS ! Closely related to the concept of PLACEBO EFFECT which is also expectancy-based
Treatment Evaluation: EXPERIMENT 100 Intensity of Cough 80 Symptoms 60 Is this new cough medicine 40 effective in treating coughs? 20 0 COUGH SYRUP VITAMIN SYRUP 100 Intensity of Cough 80 Symptoms 60 40 20 0 COUGH SYRUP VITAMIN SYRUP COUGH VITAMIN 100 SYRUP SYRUP Intensity of Cough 80 Symptoms 60 40 20 0 COUGH SYRUP VITAMIN SYRUP
Treatment Evaluation: EXPERIMENT What Else Could Explain The Results? ! EFFECT OF EXPECTATIONS ! Closely related to the concept of PLACEBO EFFECT which is also expectancy-based
Treatment Evaluation PLACEBO DEFINITION Any therapy (or that component of any therapy) that is deliberately used for its non-specific psychological or psychophysiological effect, OR that is used for its presumed effect on a patient, symptom, or illness, BUT which, unknown to patient and therapist, is without specific activity for the condition being treated.” (Shapiro, 1971, p. 440)
Treatment Evaluation PLACEBO DEFINITION Any therapy (or that component of any therapy) that is deliberately used for its non-specific psychological or psychophysiological effect, OR that is used for its presumed effect on a patient, symptom, or illness, BUT which, unknown to patient and therapist, is without specific activity for the condition being treated.” (Shapiro, 1971, p. 440)
Treatment Evaluation PLACEBO TREATMENT EFFECT IS NON-SPECIFIC FOR COLDS! SUGAR PILLS ANTIBIOTICS (pure placebo) (impure placebo)
Treatment Evaluation PLACEBO DEFINITION Any therapy (or that component of any therapy) that is deliberately used for its non-specific psychological or psychophysiological effect, OR that is used for its presumed effect on a patient, symptom, or illness, BUT which, unknown to patient and therapist, is without specific activity for the condition being treated.” (Shapiro, 1971, p. 440)
Treatment Evaluation PLACEBO DEFINITION Any therapy (or that component of any therapy) that is deliberately used for its non-specific psychological or psychophysiological effect, OR that is used for its presumed effect on a patient, symptom, or illness, BUT which, unknown to patient and therapist, is without specific activity for the condition being treated.” (Shapiro, 1971, p. 440)
Treatment Evaluation 100 Intensity of Cough 80 Symptoms 60 Is this new cough medicine 40 effective in treating coughs? 20 0 COUGH SYRUP VITAMIN SYRUP 100 Intensity of Cough 80 Symptoms 60 40 20 0 COUGH SYRUP VITAMIN SYRUP COUGH VITAMIN 100 SYRUP SYRUP Intensity of Cough 80 Symptoms 60 40 20 0 COUGH SYRUP VITAMIN SYRUP
Treatment Evaluation Does arthoscopic knee surgery actually relieve knee pain from osteoarthritis? All Patients: Anesthesia & Incisions DEBRIDEMENT: LAVAGE: Shaved off thin Flushed out knee layers of damaged joint & disposed off cartilage unhealthy tissue PLACEBO: No knee surgery was performed
Treatment Evaluation PLACEBO DEFINITION Any therapy (or that component of any therapy) that is deliberately used for its non-specific psychological or psychophysiological effect, OR that is used for its presumed effect on a patient, symptom, or illness, BUT which, unknown to patient and therapist, is without specific activity for the condition being treated.” (Shapiro, 1971, p. 440)
Treatment Evaluation PLACEBO DEFINITION Any therapy (or that component of any therapy) that is deliberately used for its non-specific psychological or psychophysiological effect, OR that is used for its presumed effect on a patient, symptom, or illness, BUT which, unknown to patient and therapist, is without specific activity for the condition being treated.” (Shapiro, 1971, p. 440)
Treatment Evaluation PLACEBO Very long history since the dawn of medicine (Herbs, Preparations, Procedures, Interventions) St John’s Wort Bleeding Royal Touch Animal parts
Treatment Evaluation PLACEBO Very long history since the dawn of medicine (Herbs, Preparations, Procedures, Interventions) Used to treat a wide variety of disorders (Physical Health & Mental Health)
Treatment Evaluation PLACEBO PLACEBO EFFECT DEMONSTRATED IN Depression Anxiety Phobias Asthma Sedation Postoperative Pain Ischemic Pain Chronic Headaches Physiological Arousal Tobacco Addiction Motor Performance Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
Treatment Evaluation PLACEBO PLACEBO EFFECT DEMONSTRATED IN Depression Anxiety Disorders ADHD Asthma, Cough Hypertension Pain Nausea, Swelling Parkinson’s Disease Irritable Bowel Syndrome Tobacco Addiction Language & Behavioral Problems … Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
Treatment Evaluation PLACEBO Very long history since the dawn of medicine (Herbs, Preparations, Procedures, Interventions) Used to treat a wide variety of disorders (Physical Health & Mental Health) Are not always pharmacologically inert (for example, sugar pills versus antibiotics)
Treatment Evaluation PLACEBO SUGAR PILLS ANTIBIOTICS NOT Pharmacologically Pharmacologically Inert Inert
Treatment Evaluation PLACEBO A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
Treatment Evaluation PLACEBO A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
Treatment Evaluation PLACEBO A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
Treatment Evaluation PLACEBO MIND-BODY CONNECTION
Treatment Evaluation PLACEBO CONDITIONING Unconditioned Conditioned response response
Treatment Evaluation PLACEBO: Expectancy vs. Conditioning Source: Shiv, Carmon & Ariely (2005), Journal of Marketing Research, XLII, 383-393.
Treatment Evaluation PLACEBO A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
Treatment Evaluation PLACEBO A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
Treatment Evaluation PLACEBO: Personality When a placebo is administered during a painful experience, altruistic, resilient, and straightforward people show greater activity in brain regions associated with reward and are more likely to enjoy pain relief Thrill-seekers or novelty seeking personality types enjoy a stronger placebo response than people with quiet or reserved personalities Sources: M. Pecina et al. (2012) Neuropsychopharmacology; Schweinhardt et al. (2009) Journal of Neuroscience
Treatment Evaluation PLACEBO A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
Treatment Evaluation PLACEBO A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
Treatment Evaluation PLACEBO Very long history since the dawn of medicine (Herbs, Preparations, Procedures, Interventions) Used to treat a wide variety of disorders (Physical Health & Mental Health) Are not always pharmacologically inert (for example, sugar pills versus antibiotics) The placebo is non-specific in that it with without specific activity for the condition being treated
Treatment Evaluation PLACEBO DEPRESSION 75% of the effectiveness of anti-depressant medication is due to the placebo & other non-specific effects Difference between drug and placebo not clinically significant except in cases of very extreme depression Source: Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, Johnson BT (2008) PLoS Medicine, 5(2):e45
Treatment Evaluation PLACEBO Very long history since the dawn of medicine (Herbs, Preparations, Procedures, Interventions) Used to treat a wide variety of disorders (Physical Health & Mental Health) Are not always pharmacologically inert (for example, sugar pills versus antibiotics) The placebo is non-specific in that it with without specific activity for the condition being treated Can occur even when a person is aware that they are taking a placebo
Treatment Evaluation PLACEBO IRRITABLE BOWEL SYNDROME Enrollment Flowchart Outcomes at the 21-Day Endpoint by Treatment Group Source: Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, et al. (2010) PLoS ONE 5(12): e15591.
Treatment Evaluation PLACEBO IRRITABLE BOWEL SYNDROME Feedback Source: Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, et al. (2010) PLoS ONE 5(12): e15591.
Treatment Evaluation PLACEBO – GENERAL FEATURES Very long history since the dawn of medicine (Herbs, Preparations, Procedures, Interventions) Used to treat a wide variety of disorders (Physical Health & Mental Health) Are not always pharmacologically inert (for example, sugar pills versus antibiotics) The placebo is non-specific in that it with without specific activity for the condition being treated Can occur even when a person is aware that they are taking a placebo
Treatment Evaluation PLACEBO “The problem with the placebo effect is that it is regarded by most people as a nuisance or fake. But it isn't. It is a practical and positive effect that acts by catalyzing the self-healing mechanisms within a patient.” Richard Tonkin, M.D. (Research Council for Complementary Medicine)
Treatment Evaluation PLACEBO PAIN Inject pain-inducing saline Provide pain ratings every solution into jaw 15 seconds (0-100) every four minutes In those who reported less discomfort after the Pain relieving serum placebo, body produced (placebo) endogenous painkilling endorphins People who expected to get relief actually produced it! Source: Zubieta JK, Bueller JA, Jackson LR, Scott DJ, Xu Y, Koeppe RA, Nichols TE, Stohler CS (2005). J Neuroscience 25(34):7754-62
Treatment Evaluation PLACEBO "Any therapeutic meeting between a conscious patient and a doctor has the potential of initiating a placebo effect.“ (Asbjorn Hrobartsson) The word “placebo” comes from the Latin, meaning "I will please" By the 19th century, it was a medicine given "more to please than to benefit the patient" (A.K. Shapiro)
Treatment Evaluation PLACEBO “He cures most successfully in whom the people have the most confidence“ (Galen, AD 129 – AD c. 216) Physicians should provide patients with hope and comfort and “counteract the depressing influence of maladies” (Thomas Percival, 1803)
Treatment Evaluation PLACEBO A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
Treatment Evaluation PLACEBO A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
Treatment Evaluation PLACEBO “The life of a sick person can be shortened not only by the acts, but also the words or the manner of a physician. It is therefore, a sacred duty to guard himself carefully in this respect, and to avoid all things which have a tendency to discourage the patient and depress his spirits.” (AMA – American Medical Association’s first Code of Ethics in 1847) “ … deal honestly with patients” (AMA – American Medical Association’s Code of Ethics in 1980)
Treatment Evaluation PLACEBO INFORMED CONSENT DOCTRINE Focus on patient autonomy. Every person has a right to determine what is done to his own body. Before providing medical treatment, a physician must explain to the patient the nature and purpose of a proposed treatment, the probable risks and benefits, the probability of success, the availability of reasonable alternative courses of action, and, in many cases, the risk of refusing treatment.
Treatment Evaluation PLACEBO: INFLUENCES A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
Treatment Evaluation NOCEBO
Treatment Evaluation NOCEBO Negative consequences (harmful, unpleasant, or undesirable) resulting from the administration of a placebo. Illustrates the role of patient expectations in perceived side effects Unwanted side effects (antipsychotic medication, heart disease, even death)
HOW TO ASSESS/CONTROL FOR PLACEBO EFFECTS? THROUGH EXPERIMENTS
EXPERIMENT A means to identify cause-and-effect relationships between events and/or behaviors Follow a set of rules and guidelines that reduce the possibility of errors, biases & chance occurrences Advantages: (1) Less error/bias prone than case studies, surveys or observational methods (2) Most reliable method for identifying cause-and effect relationships Disadvantages: (1) Problems in Generalization: Results from one situation may not apply to another situation
EXPERIMENT: SCIENTIFIC METHOD Rule 1: Ask Rule 3: Choose Rule 6: Measure  State the question &  Select participants to  Measure how different formulate a hypothesis test the hypothesis treatments (IV) affect (RANDOM SELECTION) behavior (DV) => DATA Rule 2: Identify  how best to test this Rule 4: Assign hypothesis  Participants to  Independent variable different groups Rule 7: Analyze (IV): What a researcher (EXPERIMENTAL group)  Statistical analyses are manipulates or controls (CONTROL group) carried out to determine (TREATMENT) whether the observed  Dependant variable Rule 5: Manipulate differences in the (DV): Participants’  Administer the behaviors (DV) are due to measured behavior different treatments to the treatment effect (IV) (TREATMENT EFFECT) the different groups or due to chance/error
EXPERIMENT: SCIENTIFIC METHOD Rule 1: Ask  State the question & formulate a hypothesis (expectation) QUESTION: Does Coffee Intake Improve your Ability to Concentrate on a Difficult Math Problem? HYPOTHESIS: Coffee Intake Improves the Ability to Concentrate on a Difficult Problem! (because Caffeine is a stimulant)
EXPERIMENT: SCIENTIFIC METHOD Rule 2: Identify  how best to test this hypothesis  Independent variable (IV): What a researcher manipulates or controls (TREATMENT) TREATMENT or INDEPENDENT VARIABLE (IV): 1. Coffee (with caffeine) EXPERIMENTAL 2. Coffee (caffeine-Free) PLACEBO-CONTROL 3. Water NONPLACEBO-CONTROL
EXPERIMENT: SCIENTIFIC METHOD Rule 2: Identify  how best to test this hypothesis  Independent variable (IV): What a researcher manipulates or controls (TREATMENT)  Dependant variable (DV): Participants’ measured behavior (TREATMENT EFFECT) TREATMENT EFFECT or DEPENDENT VARIABLE (DV): 1. Time Taken to complete the Task WHY? Because if you can concentrate better, you should be able to focus on the task better and work faster
EXPERIMENT: SCIENTIFIC METHOD Rule 3: Choose  Select participants to test the hypothesis (RANDOM SELECTION) Sample characteristics: 1. Total number of participants = 1800 2. Equal number of male & female participants 3. Age = Young adults (18-25 years)
EXPERIMENT: SCIENTIFIC METHOD Rule 4: Assign  Participants to different groups (EXPERIMENTAL group) (CONTROL group) Coffee Coffee Water (with caffeine) (without caffeine) (without caffeine) EXPERIMENTAL PLACEBO-CONTROL NON- PLACEBO-CONTROL
EXPERIMENT: SCIENTIFIC METHOD Rule 4: Assign  Participants to different groups (EXPERIMENTAL group) (CONTROL group) RANDOM ASSIGNMENT Coffee Coffee Water (with caffeine) (without caffeine) (without caffeine) EXPERIMENTAL PLACEBO-CONTROL NON- PLACEBO-CONTROL 300 300 300 300 300 300
EXPERIMENT: SCIENTIFIC METHOD Rule 5: Manipulate  Administer the different treatments to the different groups Double - Blind procedure Coffee Coffee Water (with caffeine) (without caffeine) (without caffeine) EXPERIMENTAL PLACEBO-CONTROL NON- PLACEBO-CONTROL 300 300 300 300 300 300
EXPERIMENT: SCIENTIFIC METHOD Rule 6: Measure  Measure how different treatments (IV) affect behavior (DV) => DATA Coffee Coffee Water (with caffeine) (without caffeine) (without caffeine) EXPERIMENTAL PLACEBO-CONTROL NON- PLACEBO-CONTROL 300 300 300 300 300 300
EXPERIMENT: SCIENTIFIC METHOD RESULT: Rule 7: Analyze HYPOTHESIS:  Statistical analyses are Coffee Intake Improves the Experimental group take carried out to determine Ability to Concentrate on a LESS time to solve Math whether the observed Difficult Problem! problem than differences in the (As Caffeine is a stimulant) Placebo control group & behaviors (DV) are due to Non-Placebo control group the treatment effect (IV) or due to chance/error Coffee Coffee Water (with caffeine) (without caffeine) (without caffeine) EXPERIMENTAL PLACEBO-CONTROL NON- PLACEBO-CONTROL 10 10 10 8 8 8 6 6 6 4 4 4 2 2 2 0 0 0
EXPERIMENT: SCIENTIFIC METHOD RESULT: Rule 7: Analyze HYPOTHESIS:  Statistical analyses are Coffee Intake Improves the Experimental group take carried out to determine Ability to Concentrate on a SAME time to solve Math whether the observed Difficult Problem! problem as differences in the (As Caffeine is a stimulant) Placebo-control group behaviors (DV) are due to the treatment effect (IV) or due to chance/error Coffee Coffee Water (with caffeine) (without caffeine) (without caffeine) EXPERIMENTAL PLACEBO-CONTROL NON- PLACEBO-CONTROL 10 10 10 8 8 8 6 6 6 4 4 4 2 2 2 0 0 0
EXPERIMENT: SCIENTIFIC METHOD Rule 1: Ask Rule 3: Choose Rule 6: Measure  State the question &  Select participants to  Measure how different formulate a hypothesis test the hypothesis treatments (IV) affect (RANDOM SELECTION) behavior (DV) => DATA Rule 2: Identify  how best to test this Rule 4: Assign hypothesis  Participants to  Independent variable different groups Rule 7: Analyze (IV): What a researcher (EXPERIMENTAL group)  Statistical analyses are manipulates or controls (CONTROL group) carried out to determine (TREATMENT) whether the observed  Dependant variable Rule 5: Manipulate differences in the (DV): Participants’  Administer the behaviors (DV) are due to measured behavior different treatments to the treatment effect (IV) (TREATMENT EFFECT) the different groups or due to chance/error
Treatment Evaluation: RCT (Randomized Controlled Trial) The key distinguishing feature of the typical RCT is that study subjects, after assessment of eligibility and recruitment, but before the intervention to be studied begins, are randomly allocated to receive one or other of the alternative treatments under study. Random allocation in real trials is complex, but conceptually, the process is like tossing a coin. After randomization, the two (or more) groups of subjects are followed in exactly the same way, and the only differences between the care they receive, for example, in terms of procedures, tests, outpatient visits, follow-up calls etc. should be those intrinsic to the treatments being compared. The most important advantage of proper randomization is that it minimizes allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments. Source: Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG (2010). "CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials". Br Med J 340: c869.
Treatment Evaluation: RCT (Randomized Controlled Trial) Double - Blind procedure
Dr. Anna Abraham Treatment Evaluation & Placebo Effects

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  • 1. Dr. Anna Abraham Treatment Evaluation & Placebo Effects
  • 2. Treatment Evaluation Measuring the Impact of Interventions on Outcomes of Interest BUSINESS LAW Intervention: Participation in a Intervention: Adding hard labour to Leadership Training Program sentences for minor crimes (stealing) Impact: Productivity of a Company Impact: Crime rate for minor crimes
  • 3. Treatment Evaluation Measuring the Impact of Interventions on Outcomes of Interest MEDICINE BEHAVIORAL TRAINING Intervention: New Drug for Coughs Intervention: Social training in Autism Impact: Cough Symptoms Impact: Social Skills
  • 4. Treatment Evaluation: EXPERIMENT A means to identify cause-and-effect relationships between events and/or behaviors Follow a set of rules and guidelines that reduce the possibility of errors, biases & chance occurrences Advantages: (1) Less error/bias prone than case studies, surveys or observational methods (2) Most reliable method for identifying cause-and effect relationships Disadvantages: (1) Problems in Generalization: Results from one situation may not apply to another situation
  • 5. Treatment Evaluation: EXPERIMENT Are there Differences in the Emotional Reactions of Men and Women when watching Thrillers versus Romantic Films? 18 18 18 15 15 15 12 12 12 9 9 9 6 6 6 3 3 3 0 0 0
  • 6. Treatment Evaluation: EXPERIMENT What Else Could Explain The Results? ACTIVATION OF GENDER STEREOTYPES? Stereotype Susceptibility Study on female Asian-American college students GENDER NEUTRAL ETHNICITY Do you prefer co-ed or single- How satisfied are you with the How many generations of your sex floors for flat-sharing? university telephone service? family have lived in America? MATH TEST Source: M. Shih, T. Pittinsky, & N. Ambady (1999), Psychological Science, 10 (1), 80-83.
  • 7. Treatment Evaluation: EXPERIMENT What Else Could Explain The Results? ACTIVATION OF GENDER STEREOTYPES? Stereotype Susceptibility Study on female Asian-American college students Accuracy on Math Test 60 55 50 45 40 35 30 FEMALE NEUTRAL ASIAN Source: M. Shih, T. Pittinsky, & N. Ambady (1999), Psychological Science, 10 (1), 80-83.
  • 8. Treatment Evaluation: EXPERIMENT What Else Could Explain The Results? ! EFFECT OF EXPECTATIONS ! Closely related to the concept of PLACEBO EFFECT which is also expectancy-based
  • 9. Treatment Evaluation: EXPERIMENT 100 Intensity of Cough 80 Symptoms 60 Is this new cough medicine 40 effective in treating coughs? 20 0 COUGH SYRUP VITAMIN SYRUP 100 Intensity of Cough 80 Symptoms 60 40 20 0 COUGH SYRUP VITAMIN SYRUP COUGH VITAMIN 100 SYRUP SYRUP Intensity of Cough 80 Symptoms 60 40 20 0 COUGH SYRUP VITAMIN SYRUP
  • 10. Treatment Evaluation: EXPERIMENT What Else Could Explain The Results? ! EFFECT OF EXPECTATIONS ! Closely related to the concept of PLACEBO EFFECT which is also expectancy-based
  • 11. Treatment Evaluation PLACEBO DEFINITION Any therapy (or that component of any therapy) that is deliberately used for its non-specific psychological or psychophysiological effect, OR that is used for its presumed effect on a patient, symptom, or illness, BUT which, unknown to patient and therapist, is without specific activity for the condition being treated.” (Shapiro, 1971, p. 440)
  • 12. Treatment Evaluation PLACEBO DEFINITION Any therapy (or that component of any therapy) that is deliberately used for its non-specific psychological or psychophysiological effect, OR that is used for its presumed effect on a patient, symptom, or illness, BUT which, unknown to patient and therapist, is without specific activity for the condition being treated.” (Shapiro, 1971, p. 440)
  • 13. Treatment Evaluation PLACEBO TREATMENT EFFECT IS NON-SPECIFIC FOR COLDS! SUGAR PILLS ANTIBIOTICS (pure placebo) (impure placebo)
  • 14. Treatment Evaluation PLACEBO DEFINITION Any therapy (or that component of any therapy) that is deliberately used for its non-specific psychological or psychophysiological effect, OR that is used for its presumed effect on a patient, symptom, or illness, BUT which, unknown to patient and therapist, is without specific activity for the condition being treated.” (Shapiro, 1971, p. 440)
  • 15. Treatment Evaluation PLACEBO DEFINITION Any therapy (or that component of any therapy) that is deliberately used for its non-specific psychological or psychophysiological effect, OR that is used for its presumed effect on a patient, symptom, or illness, BUT which, unknown to patient and therapist, is without specific activity for the condition being treated.” (Shapiro, 1971, p. 440)
  • 16. Treatment Evaluation 100 Intensity of Cough 80 Symptoms 60 Is this new cough medicine 40 effective in treating coughs? 20 0 COUGH SYRUP VITAMIN SYRUP 100 Intensity of Cough 80 Symptoms 60 40 20 0 COUGH SYRUP VITAMIN SYRUP COUGH VITAMIN 100 SYRUP SYRUP Intensity of Cough 80 Symptoms 60 40 20 0 COUGH SYRUP VITAMIN SYRUP
  • 17. Treatment Evaluation Does arthoscopic knee surgery actually relieve knee pain from osteoarthritis? All Patients: Anesthesia & Incisions DEBRIDEMENT: LAVAGE: Shaved off thin Flushed out knee layers of damaged joint & disposed off cartilage unhealthy tissue PLACEBO: No knee surgery was performed
  • 18. Treatment Evaluation PLACEBO DEFINITION Any therapy (or that component of any therapy) that is deliberately used for its non-specific psychological or psychophysiological effect, OR that is used for its presumed effect on a patient, symptom, or illness, BUT which, unknown to patient and therapist, is without specific activity for the condition being treated.” (Shapiro, 1971, p. 440)
  • 19. Treatment Evaluation PLACEBO DEFINITION Any therapy (or that component of any therapy) that is deliberately used for its non-specific psychological or psychophysiological effect, OR that is used for its presumed effect on a patient, symptom, or illness, BUT which, unknown to patient and therapist, is without specific activity for the condition being treated.” (Shapiro, 1971, p. 440)
  • 20. Treatment Evaluation PLACEBO Very long history since the dawn of medicine (Herbs, Preparations, Procedures, Interventions) St John’s Wort Bleeding Royal Touch Animal parts
  • 21. Treatment Evaluation PLACEBO Very long history since the dawn of medicine (Herbs, Preparations, Procedures, Interventions) Used to treat a wide variety of disorders (Physical Health & Mental Health)
  • 22. Treatment Evaluation PLACEBO PLACEBO EFFECT DEMONSTRATED IN Depression Anxiety Phobias Asthma Sedation Postoperative Pain Ischemic Pain Chronic Headaches Physiological Arousal Tobacco Addiction Motor Performance Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
  • 23. Treatment Evaluation PLACEBO PLACEBO EFFECT DEMONSTRATED IN Depression Anxiety Disorders ADHD Asthma, Cough Hypertension Pain Nausea, Swelling Parkinson’s Disease Irritable Bowel Syndrome Tobacco Addiction Language & Behavioral Problems … Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
  • 24. Treatment Evaluation PLACEBO Very long history since the dawn of medicine (Herbs, Preparations, Procedures, Interventions) Used to treat a wide variety of disorders (Physical Health & Mental Health) Are not always pharmacologically inert (for example, sugar pills versus antibiotics)
  • 25. Treatment Evaluation PLACEBO SUGAR PILLS ANTIBIOTICS NOT Pharmacologically Pharmacologically Inert Inert
  • 26. Treatment Evaluation PLACEBO A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
  • 27. Treatment Evaluation PLACEBO A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
  • 28. Treatment Evaluation PLACEBO A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
  • 29. Treatment Evaluation PLACEBO MIND-BODY CONNECTION
  • 30. Treatment Evaluation PLACEBO CONDITIONING Unconditioned Conditioned response response
  • 31. Treatment Evaluation PLACEBO: Expectancy vs. Conditioning Source: Shiv, Carmon & Ariely (2005), Journal of Marketing Research, XLII, 383-393.
  • 32. Treatment Evaluation PLACEBO A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
  • 33. Treatment Evaluation PLACEBO A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
  • 34. Treatment Evaluation PLACEBO: Personality When a placebo is administered during a painful experience, altruistic, resilient, and straightforward people show greater activity in brain regions associated with reward and are more likely to enjoy pain relief Thrill-seekers or novelty seeking personality types enjoy a stronger placebo response than people with quiet or reserved personalities Sources: M. Pecina et al. (2012) Neuropsychopharmacology; Schweinhardt et al. (2009) Journal of Neuroscience
  • 35. Treatment Evaluation PLACEBO A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
  • 36. Treatment Evaluation PLACEBO A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
  • 37. Treatment Evaluation PLACEBO Very long history since the dawn of medicine (Herbs, Preparations, Procedures, Interventions) Used to treat a wide variety of disorders (Physical Health & Mental Health) Are not always pharmacologically inert (for example, sugar pills versus antibiotics) The placebo is non-specific in that it with without specific activity for the condition being treated
  • 38. Treatment Evaluation PLACEBO DEPRESSION 75% of the effectiveness of anti-depressant medication is due to the placebo & other non-specific effects Difference between drug and placebo not clinically significant except in cases of very extreme depression Source: Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, Johnson BT (2008) PLoS Medicine, 5(2):e45
  • 39. Treatment Evaluation PLACEBO Very long history since the dawn of medicine (Herbs, Preparations, Procedures, Interventions) Used to treat a wide variety of disorders (Physical Health & Mental Health) Are not always pharmacologically inert (for example, sugar pills versus antibiotics) The placebo is non-specific in that it with without specific activity for the condition being treated Can occur even when a person is aware that they are taking a placebo
  • 40. Treatment Evaluation PLACEBO IRRITABLE BOWEL SYNDROME Enrollment Flowchart Outcomes at the 21-Day Endpoint by Treatment Group Source: Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, et al. (2010) PLoS ONE 5(12): e15591.
  • 41. Treatment Evaluation PLACEBO IRRITABLE BOWEL SYNDROME Feedback Source: Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, et al. (2010) PLoS ONE 5(12): e15591.
  • 42. Treatment Evaluation PLACEBO – GENERAL FEATURES Very long history since the dawn of medicine (Herbs, Preparations, Procedures, Interventions) Used to treat a wide variety of disorders (Physical Health & Mental Health) Are not always pharmacologically inert (for example, sugar pills versus antibiotics) The placebo is non-specific in that it with without specific activity for the condition being treated Can occur even when a person is aware that they are taking a placebo
  • 43. Treatment Evaluation PLACEBO “The problem with the placebo effect is that it is regarded by most people as a nuisance or fake. But it isn't. It is a practical and positive effect that acts by catalyzing the self-healing mechanisms within a patient.” Richard Tonkin, M.D. (Research Council for Complementary Medicine)
  • 44. Treatment Evaluation PLACEBO PAIN Inject pain-inducing saline Provide pain ratings every solution into jaw 15 seconds (0-100) every four minutes In those who reported less discomfort after the Pain relieving serum placebo, body produced (placebo) endogenous painkilling endorphins People who expected to get relief actually produced it! Source: Zubieta JK, Bueller JA, Jackson LR, Scott DJ, Xu Y, Koeppe RA, Nichols TE, Stohler CS (2005). J Neuroscience 25(34):7754-62
  • 45. Treatment Evaluation PLACEBO "Any therapeutic meeting between a conscious patient and a doctor has the potential of initiating a placebo effect.“ (Asbjorn Hrobartsson) The word “placebo” comes from the Latin, meaning "I will please" By the 19th century, it was a medicine given "more to please than to benefit the patient" (A.K. Shapiro)
  • 46. Treatment Evaluation PLACEBO “He cures most successfully in whom the people have the most confidence“ (Galen, AD 129 – AD c. 216) Physicians should provide patients with hope and comfort and “counteract the depressing influence of maladies” (Thomas Percival, 1803)
  • 47. Treatment Evaluation PLACEBO A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
  • 48. Treatment Evaluation PLACEBO A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
  • 49. Treatment Evaluation PLACEBO “The life of a sick person can be shortened not only by the acts, but also the words or the manner of a physician. It is therefore, a sacred duty to guard himself carefully in this respect, and to avoid all things which have a tendency to discourage the patient and depress his spirits.” (AMA – American Medical Association’s first Code of Ethics in 1847) “ … deal honestly with patients” (AMA – American Medical Association’s Code of Ethics in 1980)
  • 50. Treatment Evaluation PLACEBO INFORMED CONSENT DOCTRINE Focus on patient autonomy. Every person has a right to determine what is done to his own body. Before providing medical treatment, a physician must explain to the patient the nature and purpose of a proposed treatment, the probable risks and benefits, the probability of success, the availability of reasonable alternative courses of action, and, in many cases, the risk of refusing treatment.
  • 51. Treatment Evaluation PLACEBO: INFLUENCES A PLACEBO MAY BE PHARMACOLOGICALLY INERT BUT NOT PSYCHOLOGICALLY OR THERAPEUTICALLY INERT Expectancies Conditioning Personality Motivation Persuasion Goal Activation Physician-Patient Interactions Circumstances of Treatment Source: M. Choliz & A. Capafons (2012), Theory Psychology, 22, 513.
  • 53. Treatment Evaluation NOCEBO Negative consequences (harmful, unpleasant, or undesirable) resulting from the administration of a placebo. Illustrates the role of patient expectations in perceived side effects Unwanted side effects (antipsychotic medication, heart disease, even death)
  • 54. HOW TO ASSESS/CONTROL FOR PLACEBO EFFECTS? THROUGH EXPERIMENTS
  • 55. EXPERIMENT A means to identify cause-and-effect relationships between events and/or behaviors Follow a set of rules and guidelines that reduce the possibility of errors, biases & chance occurrences Advantages: (1) Less error/bias prone than case studies, surveys or observational methods (2) Most reliable method for identifying cause-and effect relationships Disadvantages: (1) Problems in Generalization: Results from one situation may not apply to another situation
  • 56. EXPERIMENT: SCIENTIFIC METHOD Rule 1: Ask Rule 3: Choose Rule 6: Measure  State the question &  Select participants to  Measure how different formulate a hypothesis test the hypothesis treatments (IV) affect (RANDOM SELECTION) behavior (DV) => DATA Rule 2: Identify  how best to test this Rule 4: Assign hypothesis  Participants to  Independent variable different groups Rule 7: Analyze (IV): What a researcher (EXPERIMENTAL group)  Statistical analyses are manipulates or controls (CONTROL group) carried out to determine (TREATMENT) whether the observed  Dependant variable Rule 5: Manipulate differences in the (DV): Participants’  Administer the behaviors (DV) are due to measured behavior different treatments to the treatment effect (IV) (TREATMENT EFFECT) the different groups or due to chance/error
  • 57. EXPERIMENT: SCIENTIFIC METHOD Rule 1: Ask  State the question & formulate a hypothesis (expectation) QUESTION: Does Coffee Intake Improve your Ability to Concentrate on a Difficult Math Problem? HYPOTHESIS: Coffee Intake Improves the Ability to Concentrate on a Difficult Problem! (because Caffeine is a stimulant)
  • 58. EXPERIMENT: SCIENTIFIC METHOD Rule 2: Identify  how best to test this hypothesis  Independent variable (IV): What a researcher manipulates or controls (TREATMENT) TREATMENT or INDEPENDENT VARIABLE (IV): 1. Coffee (with caffeine) EXPERIMENTAL 2. Coffee (caffeine-Free) PLACEBO-CONTROL 3. Water NONPLACEBO-CONTROL
  • 59. EXPERIMENT: SCIENTIFIC METHOD Rule 2: Identify  how best to test this hypothesis  Independent variable (IV): What a researcher manipulates or controls (TREATMENT)  Dependant variable (DV): Participants’ measured behavior (TREATMENT EFFECT) TREATMENT EFFECT or DEPENDENT VARIABLE (DV): 1. Time Taken to complete the Task WHY? Because if you can concentrate better, you should be able to focus on the task better and work faster
  • 60. EXPERIMENT: SCIENTIFIC METHOD Rule 3: Choose  Select participants to test the hypothesis (RANDOM SELECTION) Sample characteristics: 1. Total number of participants = 1800 2. Equal number of male & female participants 3. Age = Young adults (18-25 years)
  • 61. EXPERIMENT: SCIENTIFIC METHOD Rule 4: Assign  Participants to different groups (EXPERIMENTAL group) (CONTROL group) Coffee Coffee Water (with caffeine) (without caffeine) (without caffeine) EXPERIMENTAL PLACEBO-CONTROL NON- PLACEBO-CONTROL
  • 62. EXPERIMENT: SCIENTIFIC METHOD Rule 4: Assign  Participants to different groups (EXPERIMENTAL group) (CONTROL group) RANDOM ASSIGNMENT Coffee Coffee Water (with caffeine) (without caffeine) (without caffeine) EXPERIMENTAL PLACEBO-CONTROL NON- PLACEBO-CONTROL 300 300 300 300 300 300
  • 63. EXPERIMENT: SCIENTIFIC METHOD Rule 5: Manipulate  Administer the different treatments to the different groups Double - Blind procedure Coffee Coffee Water (with caffeine) (without caffeine) (without caffeine) EXPERIMENTAL PLACEBO-CONTROL NON- PLACEBO-CONTROL 300 300 300 300 300 300
  • 64. EXPERIMENT: SCIENTIFIC METHOD Rule 6: Measure  Measure how different treatments (IV) affect behavior (DV) => DATA Coffee Coffee Water (with caffeine) (without caffeine) (without caffeine) EXPERIMENTAL PLACEBO-CONTROL NON- PLACEBO-CONTROL 300 300 300 300 300 300
  • 65. EXPERIMENT: SCIENTIFIC METHOD RESULT: Rule 7: Analyze HYPOTHESIS:  Statistical analyses are Coffee Intake Improves the Experimental group take carried out to determine Ability to Concentrate on a LESS time to solve Math whether the observed Difficult Problem! problem than differences in the (As Caffeine is a stimulant) Placebo control group & behaviors (DV) are due to Non-Placebo control group the treatment effect (IV) or due to chance/error Coffee Coffee Water (with caffeine) (without caffeine) (without caffeine) EXPERIMENTAL PLACEBO-CONTROL NON- PLACEBO-CONTROL 10 10 10 8 8 8 6 6 6 4 4 4 2 2 2 0 0 0
  • 66. EXPERIMENT: SCIENTIFIC METHOD RESULT: Rule 7: Analyze HYPOTHESIS:  Statistical analyses are Coffee Intake Improves the Experimental group take carried out to determine Ability to Concentrate on a SAME time to solve Math whether the observed Difficult Problem! problem as differences in the (As Caffeine is a stimulant) Placebo-control group behaviors (DV) are due to the treatment effect (IV) or due to chance/error Coffee Coffee Water (with caffeine) (without caffeine) (without caffeine) EXPERIMENTAL PLACEBO-CONTROL NON- PLACEBO-CONTROL 10 10 10 8 8 8 6 6 6 4 4 4 2 2 2 0 0 0
  • 67. EXPERIMENT: SCIENTIFIC METHOD Rule 1: Ask Rule 3: Choose Rule 6: Measure  State the question &  Select participants to  Measure how different formulate a hypothesis test the hypothesis treatments (IV) affect (RANDOM SELECTION) behavior (DV) => DATA Rule 2: Identify  how best to test this Rule 4: Assign hypothesis  Participants to  Independent variable different groups Rule 7: Analyze (IV): What a researcher (EXPERIMENTAL group)  Statistical analyses are manipulates or controls (CONTROL group) carried out to determine (TREATMENT) whether the observed  Dependant variable Rule 5: Manipulate differences in the (DV): Participants’  Administer the behaviors (DV) are due to measured behavior different treatments to the treatment effect (IV) (TREATMENT EFFECT) the different groups or due to chance/error
  • 68. Treatment Evaluation: RCT (Randomized Controlled Trial) The key distinguishing feature of the typical RCT is that study subjects, after assessment of eligibility and recruitment, but before the intervention to be studied begins, are randomly allocated to receive one or other of the alternative treatments under study. Random allocation in real trials is complex, but conceptually, the process is like tossing a coin. After randomization, the two (or more) groups of subjects are followed in exactly the same way, and the only differences between the care they receive, for example, in terms of procedures, tests, outpatient visits, follow-up calls etc. should be those intrinsic to the treatments being compared. The most important advantage of proper randomization is that it minimizes allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments. Source: Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG (2010). "CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials". Br Med J 340: c869.
  • 69. Treatment Evaluation: RCT (Randomized Controlled Trial) Double - Blind procedure
  • 70. Dr. Anna Abraham Treatment Evaluation & Placebo Effects