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 of 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 45 40 Number of Institutions 35 30 25 20 15 10 5 0 1999 2000 2001 2002 2003 2004 2005 2007 2008 before consortium formation after consortium formation
Integrative Medicine Programs rams Integrative Medicine Prog Remain Controversial – – Remain Controversial Pressure from Both Sides Pressure from Both Sides Conventional Conventional Medicine Medicine
The plural of claims is not not The plural of claims is evidence evidence
The Answer: Research The Answer: Research � Safety � Efficacy � Mechanism
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, or 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- -to to- -Severe Arthritis Severe Arthritis for Moderate � Outcome % pts that report 20% improvement in pain at 24 weeks � Results did not show effectiveness for Glucosamine and Chondroitin overall
GAIT GAIT WOMAC Pain 301- WOMAC Pain All patients 400mm 125-300mm 60% Placebo 54% 62% Celebrex 70% ** 69% ¶ 70%* Glucosamine 64% 66% 64% Chondroitin 65% 61% 67% Glucosamine+ 67% + 79% # 63% chondroitin ¶ p = 0.06 CE vs. P ** p= 0.008 Celeb vs. P # p = 0.002 * p= 0.04 CE vs. P + p= 0.09 (G+C vs. P) (G+C 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 WOMAC Pain 301- WOMAC Pain All patients 400mm 125-300mm 60% Placebo 54% 62% Celebrex 70% ** 69% ¶ 70%* Glucosamine 64% 66% 64% Chondroitin 65% 61% 67% Glucosamine+ 67% + 79% # 63% chondroitin ¶ p = 0.06 CE vs. P ** p= 0.008 Celeb vs. P # p = 0.002 * p= 0.04 CE vs. P + p= 0.09 (G+C vs. P) (G+C 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- -to to- -Severe Arthritis Severe Arthritis for Moderate � 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 …
“Doesn’t Work” Echinacea –
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 Challenge – many types of massage � Best evidence – when massage is applied to specific conditions - Low back pain � Massage & exercise, better than massage alone 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 other 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
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