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PC SPES
Dietary supplement of chrysanthemum, licorice, ginseng, saw palmetto, scutellaria, and three other herbs
Used for advanced prostate cancer Small Phase I/II studies suggest safety,
improved quality of life, reduction of pain, and lower PSA levels (Pfeifer, BJU Int., 2000)
Loss of libido, breast tenderness, and lower PSA levels associated with potent estrogenic activity (DiPaola, NEJM, 1998)
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PC SPES for Prostate Cancer
P.I. Adrian S. Dobs, MD, MHS, Johns Hopkins University
Background Multiple, small pre-clinical and clinical studies
Enrollment 100 men with hormone-refractory disease, rising PSAs
Design Double-blind, randomized controlled trial vs. estradiol
Sites Johns Hopkins and Singapore
Endpoints Disease progression, PSA, quality of life, safety
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Identification of PC SPES-Regulated Genes in Prostate Epithelial Cells
Nelson, 2001
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Dietary Supplement Research
Effectiveness
Mechanisms
Interactions
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CAM Domains
Biologically Based Systems
Manipulative and Body-Based Systems
Mind-Body Medicine
Alternative Medical Systems
Energy Therapies
Diets Herbals
Homeopathy Naturopathy
Yoga Prayer
Meditation
Massage Chiropractic
Reiki Magnets Qi qong
CommonCAM
Practices
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What Is Hypnosis?
Intense focus on a suggested response leads to involuntary changes in perception, mood, memory, or physiology
Subject of great controversy and popular misunderstandings since developed by Mesmer in 18th C. France
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Hypnosis Alters Color Processing in the Brain
8 hypnotizable subjects viewed identical patterns in color or gray scale during PET scanning
Randomly told to see color or gray scale
Blood flow to cortical color processing regions increased when asked to perceive color and decreased when told to see gray scale, regardless of what they were actually shown
Kosslyn SM, Thompson, WL, Spiegel D, et al. Am J Psychiatry 2000;157:1279-84
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Kosslyn SM, Thompson, WL, Spiegel D, et al. Am J Psychiatry 2000;157:1279-84
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Kosslyn SM, Thompson, WL, Spiegel D, et al. Am J Psychiatry 2000;157:1279-84
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Kosslyn SM, Thompson, WL, Spiegel D, et al. Am J Psychiatry 2000;157:1279-84
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The Placebo
Historically, an inactive or innocent management contrivance to encourage healing in the absence of specific therapeutics
Relied upon to “control” for nonspecific effects that might confound calculation of the true benefits of a novel intervention
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The Placebo – A ‘Pious Fraud’
“One of the most successful physicians I have ever known has assured me that he used more bread pills, drops of coloured water, and powders of hickory ashes, than all other medicines put together.”
Thomas Jefferson (1743-1826)
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‘The Powerful Placebo’
Analysis of the aggregate percentage of patients satisfactorily relieved by a placebo across multiple clinical trials
1082 patients in 15 controlled trials
35.2 ± 2.2% “average significant effectiveness”
HK Beecher, JAMA, 1955
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‘The Powerless Placebo’
Systematic review of outcomes for 8525 subjects in 116 controlled trials
No overall benefit attributable to placebo
Significant differences only for continuous subjective outcomes
27% (95% CI of 15-40%) reduction in pain associated with placebo
Hrobjartsson & Gotzche, NEJM, 2001
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“Such a report can hardly negate an experienced physician’s awe at a phenomenon that might impress even a dispassionate biometrician, should he ever venture within the range of a real patient.”
S.B. Nuland, The American Scholar, 2001
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Placebo Analgesia: Spatially Specific and Mediated by
Endogenous Opioid Systems
Pain induced in all 4 limbs with capsaicin
Patients told they were to receive a powerful local anesthetic
Placebo cream applied to 1 limb
Analgesia achieved only in the treated limb
Analgesia abolished by IV naloxone
Benedetti et al., J Neurosci, 1999
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0
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Benedetti et al. 1999
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This Is Your Brain on Placebo
Petrovic, PP et al. February 7 2002; 10.1126/science.1068836, Science Express Reports
Placebo and Opioid Analgesia - Imaging a Shared Neuronal Network
rostral anterior
cingulate cortex
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The Placebo Effect
Relieves pain
Works through the opioid system
Anatomically specific
Shares the same neuronal pathways as narcotics
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BMJ BooksMarch 6, 2002
Edited by:Harry A. GuessArthur KleinmanJohn W. KusekLinda W. Engel
RFAs Elucidation of the Underlying
Mechanisms of Placebo Effect
The Placebo Effect in Clinical Practice
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Evidence Leads to Understanding
Potential benefits of dietary supplements may be offset by untoward drug interactions.
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The mind-body dialogue yields powerful, even surprising, physiological responses.
Evidence Leads to Understanding
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Understanding Leads to Acceptance
CAM will be integrated with conventional medicine as science affords a fuller understanding of its benefits and risks.
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Charles Rosenberg, Ph.D.Professor of the History of Science
Harvard University July 18, 2002
Alternative to What? Complementary to Whom? On Some Aspects of Medicine's Scientific Identity
Arthur Kleinman, M.D.Professor of Social Anthropology
Harvard UniversityLillian Presley Professor of Medical
Anthropology and PsychiatryHarvard Medical School
November 7, 2002The Global Transformation of Health Care: Cultural and Ethical Challenges to Medicine
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N a t i o n a l C e n t e r f o r C o m p l e m e n t a r y a n d A l t e r n a t i v e M e d i c i n e