Behavioral Medicine Behavioral Medicine Meets Complementary, Meets - - PowerPoint PPT Presentation

Behavioral Medicine Behavioral Medicine Meets Complementary, Meets Complementary, Alternative and Alternative and Integrative Medicine: Integrative Medicine: Is there common Is there common ground? ground?

CHIP, UCONN CHIP, UCONN April 24, 2008 April 24, 2008

Complementary, Alternative and Integrative Medicine

Medical and health care practices that are:

• Outside the realm of

conventional medicine

• Yet to be validated

using scientific methods

Complementary: with conventional practices Alternative: in place of conventional practices Increasingly referred to as Integrative Medicine

Integrative Medicine Domains

Parallels in Conventional Medicine

Biologically- Based

Pharmaceuticals

Energy Medicine

ECG, fMRI

Manipulative

Physical therapy

Mind-Body

Psychotherapy

Complementary and Integrative Medicine Use - USA

National Health Interview Survey in 2002 National random sample

• f 31,044 adults

CAM use in last 12 months

– 62%, including prayer for health reasons – 36%, excluding prayer

Barnes et al., CDC ADR, 2004

Most Common

%

Natural products* 19 Deep breathing 12 Meditation 8 Chiropractic 8 Yoga 5 Massage 5 Diet-based therapies** 4

Barnes et al., CDC ADR, 2004

* Omega-3 fatty acids / ** weight loss

Most Common Natural Products

% Echinacea 40 Ginseng 24 Ginkgo biloba 21 Garlic supplements 20 Glucosamine 15

• St. John’s Wort

12 Fish Oils 12

Barnes et al., CDC ADR, 2004

Complementary and Integrative Medicine in US Hospitals

Hospitals offering services

–

8% in 1998

–

17% in 2002

–

27% in 2005

Key reasons

– Patient demand 87% – Reflect mission 62% – Clinical effects 61% – Attract patients 38%

AHA Health Forum, 2006

Services Offered Services Offered

Massage 71% Tai Chi, Yoga 47% Relaxation 43% Acupuncture 39%

AHA Health Forum, 2006

University of Maryland Integrative Medicine Incorporated in

Cancer Center Cardiology Family Medicine VA Hospital Shock Trauma Center

• Pain
• Inflammation
• Traumatic brain injury
• Post-traumatic stress

Growth of the North American Growth of the North American Academic Consortium Academic Consortium

5 10 15 20 25 30 35 40 45 1999 2000 2001 2002 2003 2004 2005 2007 2008 Number of Institutions before consortium formation after consortium formation

Integrative Medicine Prog Integrative Medicine Programs rams Remain Controversial Remain Controversial – – Pressure from Both Sides Pressure from Both Sides

Conventional Conventional Medicine Medicine

The plural of claims is The plural of claims is not not evidence evidence

Safety Efficacy Mechanism

The Answer: Research The Answer: Research

1999 ~ Congressional Mandate for National Institutes of Health to Create the

National Center for Complementary And Alternative Medicine

NCCAM’s Mission

Conduct rigorous

research on CAM practices

Train CAM

researchers

Inform consumers

and health professionals

Biologically Based Practices

Dietary supplements Herbal therapies Animal products Special diets

Dietary Supplements: DSHEA*

Products that supplement diet Contain one or more of

• Vitamin or mineral
• Herb or other botanical
• Amino acid
• Any other dietary substance

For oral intake as a concentrate, metabolite, extract, constituent,

• r combination

* Dietary Supplement Health & Education Act - 1994

Biologically Based Practices - Challenges

Safety is assumed,

not proven

• Lack of product

standardization

• Labeling may not be accurate
• Some products are contaminated

GAIT: Glucosamine/Chondroitin GAIT: Glucosamine/Chondroitin Arthritis Intervention Trial Arthritis Intervention Trial 1583 patients, arthritis knee

5 - arm study

–

1500 mg glucosamine (G)

–

1200 mg chondriotin sulfate (C)

–

G & C

–

200 mg Celecoxib

–

Placebo

28 weeks

(Clegg, et al., NEJM 2006)

Glucosamine/chondroitin Effective Glucosamine/chondroitin Effective for Moderate for Moderate-

• to

to-

• Severe Arthritis

Severe Arthritis

Outcome % pts that report

20% improvement in pain at 24 weeks

Results did not show effectiveness

for Glucosamine and Chondroitin

• verall

GAIT GAIT

All patients WOMAC Pain 301- 400mm WOMAC Pain 125-300mm

Placebo

60%

54% 62%

Celebrex 70% **

69% ¶ 70%*

Glucosamine

64% 66% 64%

Chondroitin

65% 61% 67%

Glucosamine+ chondroitin 67%+

79% # 63% ** p= 0.008 Celeb vs. P

+ p= 0.09 (G+C vs. P)

¶ p = 0.06 CE vs. P # p = 0.002 (G+C vs. P) * p= 0.04 CE vs. P

Data = % pts that report 20% improvement in pain at 24 wks

(Clegg, et al., NEJM 2006) (Clegg, et al., NEJM 2006)

GAIT GAIT

All patients WOMAC Pain 301- 400mm WOMAC Pain 125-300mm

Placebo

60%

54% 62%

Celebrex 70% ** 69% ¶

70%*

Glucosamine

64% 66% 64%

Chondroitin

65% 61% 67%

Glucosamine+ chondroitin 67%+ 79% #

63% ** p= 0.008 Celeb vs. P

+ p= 0.09 (G+C vs. P)

¶ p = 0.06 CE vs. P # p = 0.002 (G+C vs. P) * p= 0.04 CE vs. P

Data = % pts that report 20% improvement in pain at 24 wks

(Clegg, et al., NEJM 2006) (Clegg, et al., NEJM 2006)

Glucosamine/chondroitin Effective Glucosamine/chondroitin Effective for Moderate for Moderate-

• to

to-

• Severe Arthritis

Severe Arthritis Results did not show

effectiveness for Glucosamine and Chondroitin overall BUT …..

Secondary analyses indicated

benefit for those with “moderate to severe” osteoarthritis

Echinacea to Prevent and Treat Colds

437 students

Complex, 7- arm study

7 days prophylaxis,

rhinovirus challenge, 5 days treatment

900 mg/day

• E. angustifolia vs. placebo

(Turner, et al., NEJM 2005)

Echinacea to Prevent and Treat Colds

Echinacea did not prevent or help treat

symptoms of virus given to participants

Preparation – E. angustifolia Dose – equivalent to 900 mg per day,

may have been too low for this Echinacea species

But the message heard …

Echinacea – “Doesn’t Work”

Complexity: Echinacea

• 3 Species
• E. angustifolia
• E. purpurea
• E. pallida
• Extract, tea or tincture
• Roots, stems or flowers
• Dose ?
• Treatment or prevention ?

Lessons Learned to Optimize Research Obtain well-characterized and

standardized clinical trial materials

Expect very high placebo condition Place greater emphasis on preclinical

and early phase clinical studies –

• Dose

Dose - Response Curve

Manipulative Body-based Practices

Massage

Chiropractic Pilates, Feldenkrais

Massage

Best evidence – when massage is applied to specific conditions

• Low back pain

Massage & exercise, better than

massage alone Challenge – many types of massage

Cherkin, DC, et al, Annals of Internal Med, 2003

Energy Medicine *

All living things possess &

emit energy

• Light therapy
• Electromagnetic fields

“Life force”

• Healing Touch
• Qi gong, Reiki

* “ Biofield Medicine ”

Energy Medicine – NCCAM Position

Must apply same standards

for designing experiments in

• ther scientific disciplines

Need to investigate with

physicists, biophysicists cell biologists, physical chemists, engineers

Whole Medical Systems

• Traditional Chinese

Medicine Acupuncture

• Herbs
• Meditation
• Ayurveda
• Homeopathy

Acupuncture

• Originated in China over 2,000 yrs ago
• Stimulation of anatomical points on

body, most often using needles manipulated by hand or electrical current

• Use by US adults

8.2 million have “ever used” 2.1 million have “used in last 12 mos.”

Acupuncture

• 1996 FDA approved needles for use by

licensed practitioners

• Promising results for chemotherapy

nausea, postoperative dental pain

• Some evidence for use with addiction,

stroke rehab, headache, fibromyalgia, myofascial pain,carpal tunnel, and asthma

Mechanism ? “Western View”

• Acupuncture produces its effects

through impact on the nervous and immune systems

• In particular, the effects on pain are

likely to be achieved by release of endorphins

Acupuncture Treatment of Knee Osteoarthritis

• RCT- Brian Berman

University of Maryland

• Efficacy of acupuncture in

improving function and decreasing pain

• 570 patients, age > 50 years
• Followed 26 months

Acupuncture Treatment of Knee Osteoarthritis

• Treatments:

– Acupuncture – Sham acupuncture – Education

Sham Acupuncture

Acupuncture Treatment of Knee Osteoarthritis

• Treatments:

– Acupuncture – Sham acupuncture – Education

• Outcomes:

– WOMAC index – Function

Acupuncture Treatment of Knee Osteoarthritis

Berman, et al., Annals Internal Med, Dec 2004, 901-911

Domain of Mind-Body Medicine is closely related to Medical Psychology

… …and a topic of and a topic of considerable public interest considerable public interest

Mind-Body Medicine

Research and practices focused on interrelationships

mind, brain, body systems

• endocrine, immune
• nervous systems

behavior

Mind-Body Research: The Placebo Effect

Relieves pain Works through

• pioid system

Anatomically specific Shares the same neuronal

pathways as narcotics

Placebo Effect

How does administering a placebo elicit

physiological change?….expectations?

What factors interfere with these effects?

Placebo Effect

262 patients with irritable bowel syndrome Randomized to one of 3 groups: Wait list Placebo Placebo Acupuncture Acupuncture Only Augmented Improvement Scores 3.8 4.3 5.0 (p<.001) Patients w/ Relief 28% 44% 66% (p<.001)

Kaptchuk, BMJ, 8 April, 2008

Placebo Effect

How does administering a placebo elicit physiological change? ….expectations? What factors interfere with these effects? Can understanding these effects be harnessed to enhance conventional and alternative therapies? What other demographic characteristics, personal or socio-environmental attributes,

• r behaviors influence expectancies?

Mind-Body Research

Explore the value of mind- body therapies* * Meditation to reduce the burden of stress- related chronic illnesses

Meditation Approaches

Relaxation Response : Herbert Benson Transcendental Meditation (TM): Maharishi

Mahesh Yogi

Mindfulness meditation:

Jon Kabat-Zin

RCT of TM on Metabolic Syndrome

• 103 subjects with stable CHD
• 16 weeks TM vs. health education

Paul Labrador, et al, Arch Intern Med, 166, 1218-1224, 2006

RCT of TM on Metabolic Syndrome

TM Educ. BP

• 3.4

2.8 p =.04 p =.01

• 0.50

Insulin Resistance

• 0.75

Labrador, et al, Arch Intern Med, 166, 1218-1224, 2006

Yoga for Chronic Low Back Pain

101 adults chronic low back pain Randomized to 12-week program

Yoga Conventional exercise class Self-help book

Outcome:

Roland disability index Back pain

Sherman et al., Ann Intern Med, 143: 849-857, 2005

Yoga Reduces Disability & Pain

At 12 weeks

Yoga > Book Disability - 3.4 (p < .001) Yoga > Exercise Disability - 1.8 (p = .03)

At 26 weeks

Yoga > Book Disability - 3.6 (p < .001) Yoga > Book Pain

• 2.2 (p < .001)

Sherman et al., Ann Intern Med, 143: 849-857, 2005

Mind-Body Research

Explore the ability of CAM

therapies to enhance resilience, positive affect and coping in

• rder to prevent or slow disease

progression, treat disease, and improve health and well-being

Coping Effectiveness Training for HIV Coping Effectiveness Training for HIV Enhancing Well Enhancing Well-

• being

being

• Increase awareness and share positive experiences
• Plant flowers, watch sunset
• When facing unchangeable stress…
• Look for lessons learned
• Identify positive moments
• Reframe with understanding, forgiveness, new goals
• Use humor
• Use “positive accounting” at the end of the day
• Keep track of those events that went “right”
• Identify sources of positive meaning in life and

everyday activities

CHANgES Project

HIV+ Men

(N=199)

CET-E

(N=68)

Coping Effectiveness Training +

(3 mo – 12 sessions)

Enhanced Maintenance

(9 mo – 18 sessions)

CET-S

(N=66)

Coping Effectiveness Training +

(3 mo – 12 sessions)

Standard Maintenance

(9 mo – 6 sessions)

MCC

(N=65)

Minimal Contact Control

(12 months)

Day-Long CET Workshop

(in month 13)

Intervention Groups Control Group

Personal Growth Scale Items Personal Growth Scale Items

• I learned to be myself and not try to be

what others want me to be

• I learned to communicate more honestly

with others

• I learned to be open to new information

and ideas

• I learned to find more meaning in life

0 = Not at all 1 = Somewhat 2 = A Great Deal

* * * * * *

Park, 2000

3 12

Months

5 10 15 20

Negative Morale Negative Morale

CET MCC

3 12

Months

5 10 15 20 25

Burnout Burnout

MCC CET

3 12 Months

10 12 14 16 18 20

Growth Growth

MCC CET

3 12 Months 3 6 9 12 15 PSOM PSOM CET MCC

Integrative Medicine

Facilitate integration of

effective health, intervention prevention strategies to create

• Comprehensive care that …
• Is based on the best science

available ….

Integrative Medicine

• Comprehensive care that …
• Recognizes the importance
• f compassion and caring

Integrative Medicine

• Comprehensive care that …
• Recognizes the importance
• f compassion and caring
• And encourages people to

actively participate in choices to enhance their resilience, prevent illness and Improve the quality of their lives.

Integrative medicine

Center for Integrative Medicine University of Maryland, School of Medicine Baltimore, Maryland http://www.compmed.umm.edu/ mchesney@compmed.edu Center for Integrative Medicine University of Maryland, School of Medicine Baltimore, Maryland http://www.compmed.umm.edu/ mchesney@compmed.edu