1. 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)

2. 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

3. Identification of PC SPES-Regulated Genes in Prostate Epithelial Cells
Nelson, 2001

4. Dietary Supplement Research
Effectiveness
Mechanisms
Interactions

5. Yoga Prayer Meditation Homeopathy Naturopathy
CAM Domains
Manipulative and Body-Based Systems
Biologically Based Systems
Diets Herbals
Massage Chiropractic
Common
CAM
Practices
Yoga Prayer Meditation
Reiki Magnets Qi qong
Mind-Body Medicine
Energy Therapies
Homeopathy Naturopathy
Alternative Medical Systems

6. 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

7. 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:

8. Kosslyn SM, Thompson, WL, Spiegel D, et al
Kosslyn SM, Thompson, WL, Spiegel D, et al. Am J Psychiatry 2000;157:

9. Kosslyn SM, Thompson, WL, Spiegel D, et al
Kosslyn SM, Thompson, WL, Spiegel D, et al. Am J Psychiatry 2000;157:

10. Kosslyn SM, Thompson, WL, Spiegel D, et al
Kosslyn SM, Thompson, WL, Spiegel D, et al. Am J Psychiatry 2000;157:

11. 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

12. 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 ( )

13. ‘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

14. ‘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

15. “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

16. 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

17. Right Hand Left Hand Placebo Placebo Right Foot Left Foot expectation10 10
pain
pain 15 15
minutes
minutes
Left Hand
Right Hand
expectation
Placebo
Placebo
expectation
Left Foot
Right Foot 10 10
pain
pain 15 15
minutes
minutes
Benedetti et al. 1999

18. Naloxone Right Hand Left Hand Placebo Placebo Right Foot Left Foot10 10
pain
pain 15 15
minutes
minutes
Left Hand
Right Hand
Placebo
expectation
Naloxone
Placebo
expectation
Left Foot
Right Foot 10 10
pain
pain 15 15
minutes
minutes

19. This Is Your Brain on Placebo
rostral anterior cingulate cortex
Placebo and Opioid Analgesia - Imaging a Shared Neuronal Network
Petrovic, PP et al. February ; /science , Science Express Reports

20. The Placebo Effect Relieves pain Works through the opioid system
Anatomically specific
Shares the same neuronal pathways as narcotics

21. BMJ Books March 6, 2002 RFAs Edited by: Harry A. Guess Arthur Kleinman
John W. Kusek
Linda W. Engel
RFAs
Elucidation of the Underlying Mechanisms of Placebo Effect
The Placebo Effect in Clinical Practice

22. Evidence Leads to Understanding
Potential benefits of dietary supplements may be offset by untoward drug interactions.

23. Evidence Leads to Understanding
The mind-body dialogue yields powerful, even surprising, physiological responses.

24. Understanding Leads to Acceptance
CAM will be integrated with conventional medicine as science affords a fuller understanding of its benefits and risks.

29. Professor of the History of Science Harvard University July 18, 2002
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 University
Lillian Presley Professor of Medical Anthropology and Psychiatry
Harvard Medical School
November 7, 2002
The Global Transformation of Health Care: Cultural and Ethical Challenges to Medicine

30. 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