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Alternative Healing. Evaluation of Complementary and Alternative Therapies. Presentation Overview. Nature, Use, and Claims of CAM Conducting CAM Research Ethical Issues in CAM. Alternative & Complementary Therapies.

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slide3

Presentation Overview

  • Nature, Use, and Claims of CAM
  • Conducting CAM Research
  • Ethical Issues in CAM
alternative complementary therapies
Alternative & Complementary Therapies
  • Alternative Therapies are used instead of conventional or mainstream medical modalities.
  • Complementary Therapies are used in conjunction with conventional or mainstream medical modalities.
non traditional therapies
Non-traditional Therapies
  • Ever increasing numbers of health care consumers are using nontraditional treatment modalities.
roots of nontraditional therapies
Roots of Nontraditional Therapies
  • Ancient Greece: massage, art therapy, herbal therapy.
  • The Far East: energetic-touch therapies.
  • China: acupuncture, herbalism.
  • India: Ayurvedic medicine.
the shamanistic tradition
The Shamanistic Tradition
  • Shamanism refers to the practice of entering altered states of consciousness with the intent of helping others.
  • The shaman is a folk healer-priest.
modern trends
Modern Trends
  • Mind-Body Medicine and Research.
  • Holism and Nursing Practice.

Modern medicine is looking to non-traditional

medicine for insight into two main areas:

mind body medicine and research
Mind-Body Medicine and Research
  • The traditional medical model is founded on the belief that the mind, body, and spirit are separate entities. A relatively new field of science, however, is called: Psychoneuroimmunology.
psychoneuroimmunology
Psychoneuroimmunology
  • The study of the complex relationship among the cognitive, affective, and physical aspects of humans.
body mind
Body-Mind
  • The inseparable connection and operation of thoughts, feelings, and physiological functions.
holism and nursing practice
Holism and Nursing Practice

As a healing facilitator, the nurse enters into a relationship with the client and can be a:

  • guide.
  • change agent.
  • instrument of healing.
nurse as instrument of healing
Nurse as Instrument of Healing
  • Knowledge base.
  • Intentionality (having conscious direction of goals).
  • Respect for differences.
  • Ability to model wellness.

To serve in this capacity, a nurse should

develop the following attributes:

using alternative complementary therapies
Using Alternative & Complementary Therapies
  • Have a non-judgmental attitude.
  • Ask clients if they use nontraditional therapies.
  • Get instruction in these therapies before trying to administer them.
  • Try one or two basic therapies (e.g. massage or guided imagery).
  • Discuss a therapy with the client before using it.
common elements of alternative complementary interventions
Common Elements of Alternative & Complementary Interventions
  • The whole system is considered.
  • The person is integrated and related to the surroundings.
  • There exists some life force or energy to be used in the healing process.
  • Ritual, prescribed practice and skilled practitioners are vital to holistic healing interventions.
mind body self regulatory techniques
Mind-Body (Self-Regulatory) Techniques
  • Methods by which an individual can, independently or with assistance, consciously control some functions of the sympathetic nervous system (e.g. heart rate, respiratory rate, blood pressure).
leading mind body techniques
Leading Mind-Body Techniques
  • Meditation
  • Relaxation
  • Imagery
  • Bio-feedback
  • Hypnosis
meditation
Meditation
  • Quieting the mind by focusing the attention.
  • Benefits include: stress relief, relaxation, reduced level of lactic acid, efficient & effective oxygen consumption, slowed heart rate, decreased blood pressure, improved functioning of the immune system.
relaxation
Relaxation
  • A therapeutic process incorporating the basic elements of meditation.
  • Basic elements include: a quiet environment, a comfortable position, focused attention, a passive attitude, practice.
imagery
Imagery
  • A technique of using the imagination to visualize a soothing, pleasant image.
  • Benefits include: decreased physical tension, decreased anxiety, and decreasing the adverse effects of chemotherapy.
bio feedback
Bio-feedback
  • The measurement of physiological responses that yields information about the relationship between the body and mind and helps clients learn ways to manipulate those responses through mental activity.
uses of bio feedback
Uses of Bio-feedback
  • A restorative method in rehabilitation settings for clients who have lost sensation and function as result of injury or illness.
  • To relieve tension headaches, migraines and backache.
  • To reduce bruxism (grinding of the teeth).
  • To lower blood pressure.
  • Temperature bio-feedback useful in treating Raynaud’s disease (constriction and spasms of small arteries).
therapeutic hypnosis
Therapeutic Hypnosis
  • Induces an altered state of consciousness or awareness resembling sleep during which the person is more receptive to suggestion.
  • Hypnosis also enhances client’s ability to form images (for guided imagery).
body movement therapies
Body-Movement Therapies
  • Therapies employing techniques of moving or manipulating various body parts to achieve therapeutic outcomes.
leading body movement strategies
Leading Body-Movement Strategies
  • Movement and Exercise
  • Yoga
  • Tai Chi
  • Chiropractic Therapy
energetic touch therapies
Energetic-Touch Therapies
  • Techniques of using the hands to direct or redirect the flow of the body’s energy fields and thus enhance balance within those fields.
leading energetic touch therapies
Leading Energetic-Touch Therapies
  • Therapeutic massage
  • Therapeutic touch
  • Healing touch
  • Shiatsu
  • Acupressure
  • Reflexology
cultural considerations of touch
Cultural Considerations of Touch
  • Ask permission before touching a client.
  • Tell the client what is going to happen.
  • The meaning of touch and the body areas acceptable to touch vary from culture to culture.
leading spiritual therapies
Leading Spiritual Therapies
  • Faith healing.
  • Healing Prayer and Chanting (Kiirtan).
  • Shamanism.

Spiritual therapies can be helpful

modalities in caring for clients. Important

spiritual therapies include:

leading nutritional medicinal therapies
Leading Nutritional/Medicinal Therapies
  • Phytochemicals.
  • Antioxidants and Free Radicals.
  • Macrobiotic Diet.
  • Herbal Therapy.
phytochemicals
Phytochemicals
  • Non-nutritive, physiologically active compounds present in plants in very small amounts.
  • Protect against cancer and prevent heart disease, stroke, and cataracts.
  • Source: fruits and vegetables.
antioxidants and free radicals
Antioxidants and Free Radicals
  • Antioxidants: substances that prevent or inhibit oxidation, a chemical process whereby a substance is joined to oxygen.
  • Free radicals: Antioxidants prevent tissue damage related to these, which are unstable molecules that alter genetic codes and trigger the development of cancer growth.
other important methodologies
Other Important Methodologies
  • Aromatherapy.
  • Humor.
  • Pet Therapy.
  • Music Therapy.
  • Play Therapy.
  • Yogic Dances.
important terms associated with treatment modalities
Important Terms Associated with Treatment Modalities
  • Proven - have been scientifically tested in clinical trials.
  • Experimental - are undergoing regulatory (e.g. FDA) investigations.
  • Untested - have not been investigated by regulatory bodies.
  • Folklore - passed through generations.
  • Quackery - no proven effectiveness, may harm consumer.
what is cam
What Is CAM?

… medical and health care practices outside the realm of conventional medicine, which are yet to be validated using scientific methods

Complementary:togetherwith conventional practices

Alternative:inplaceof conventional practices

cam modalities now in mainstream medicine
Codeine for pain

Digitalis for heart failure

Ipecac for poisoning

Quinine for malaria

Aspirin for fever

Behavioral therapyfor headache

Hypnosis for smoking cessation

Low fat, low cholesterol diets

Exercisefor diabetes

Support groupsfor breast cancer

CAM Modalities Now in Mainstream Medicine
the appeal of cam
The Appeal of CAM
  • Media reports of dramatic results
  • Belief that CAM treatments are natural
  • Patient empowerment
  • Focus on spiritual and emotional well-being
  • Therapist providing “touch, talk, time”
cam use in the united states
CAM Use in the United States
  • 62% of adults 18+ used CAM in the past year
  • More women than men; higher educated; sicker; with more pain
  • Top 10:
    • 43% prayed for self
    • 24% others prayed for you
    • 19% natural products
    • 12% deep breathing exercises
    • 10% participate in prayer group
    • 8% meditation
    • 8% chiropractic
    • 5% yoga
    • 5% massage
    • 4% diet-based therapies

Barnes et al., CDC ADR, 2004

nccam s mission
NCCAM’s Mission
  • Conduct rigorous research on CAM practices
  • Train CAM researchers
  • Inform consumers and health professionals
who is the practitioner
Who Is the Practitioner?
  • Medical doctors
  • CAM practitioners
  • Traditional healers
cam economics
Americans spend more out-of-pocket for CAM than for all other health care needs

CAM is big business

56% of Americans believe their health plans should cover CAM

Many health insurers and HMOs now cover CAM: Blue Cross of Washington and Alaska, Oxford Health, Prudential, Kaiser Permanente

CAM Economics
slide43

Who uses CAM?

  • More educated
  • In poorer health
  • More affluent
  • Possess a holistic orientation to health
  • Had a ‘transformational experience’
  • Identification with environmentalism, feminism, spirituality
  • Report chronic anxiety, pain, UTI, back problems

(Astin et al. JAMA ,1998)

biological research it s all natural
Biological Research - It’s All “Natural”…!

“People can be induced to swallow anything, provided it is sufficiently seasoned with praise.”

Jean Moliere

dietary supplements dshea definition
Dietary Supplements: DSHEA Definition
  • Product intended to supplement the diet
  • Contains one or more of the following:
    • Vitamin
    • Mineral
    • Herb or other botanical (not tobacco)
    • Amino acid
    • Any other dietary substance
  • For oral intake as a concentrate, metabolite, extract, constituent, or combination
patterns of supplement use the slone survey
Patterns of Supplement Use:The Slone Survey
  • 2590 participants 18 years +
  • Telephone survey, random sampleFeb 1998 - Dec 1999
  • In the preceding week:
    • 14% of population used herbalsand/or supplements
    • 16% of prescription drug users used herbals and/or supplements

JAMA, 2002

slide47

Patterns of Supplement Use:The Slone Survey

Ten Most Commonly Used Herbals / Supplements

  • Ginseng
  • Ginkgo biloba
  • Allium sativum
  • Glucosamine
  • St. John’s wort
  • Echinacea
  • Lecithin
  • Chondroitin
  • Creatine
  • Serenoa repens

JAMA, 2002

slide48

Patterns of Supplement Use:The Slone Survey

Ten Most Common Reasons for taking herbs / supplements

  • General health/good for you (16%)
  • Arthritis (7%)
  • Memory improvement (6%)
  • Energy (5%)
  • Immune booster (5%)
  • Joints (4%)
  • Supplement diet (4%)
  • Sleep aid (3%)
  • Prostate (3%)
  • No reason (2%)
  • All other reasons (45%)

JAMA, 2002

challenges of herbal medicines
Challenges of Herbal Medicines
  • Safety is assumed, not proven
  • Lack of product standardization
  • Contamination with drugs, heavy metals
  • Allergic reactions
  • Inherent toxicity
  • Interactions with drugs
  • Replacing proven therapies
ephedra safety concerns
Ephedra: Safety Concerns
  • Ma huang (Ephedra sineca) – Short-term TCM treatment for asthma, decongestion
  • Contains L-ephedrine, pseudoephedrine
  • Major current use in U.S. in combination with caffeine for weight loss, athletic performance
  • Dozens of reports of severe and life-threatening adverse events in young people
environmental challenges
Environmental Challenges
  • Important public health issues
  • Inconsistent training, credentialing, licensure, access, regulation, reimbursement
  • Highly variable products and product standards
slide52

Presentation Overview

  • Nature, Use, and Claims of CAM
  • Conducting CAM Research
  • Ethical Issues in CAM
nccam s strategic areas
NCCAM’s Strategic Areas
  • Investing in research
  • Training CAM investigators
  • Expanding outreach
  • Facilitating integration
nccam s unique scientific challenge conducting rigorous research
Broad spectrum of CAM practices

Inconsistent product and practice standards

Few CAM practitioners experienced in research

Market disincentives

Dearth of credible scientific information

NCCAM’s Unique Scientific Challenge: Conducting Rigorous Research
challenges of natural products research
Challenges of Natural Products Research
  • Safety is assumed, not proven
  • Products are not standardized
  • Contamination with drugs and heavy metals
  • Allergic reactions
  • Some are toxic
  • Interactions with drugs
  • Replacing proven therapies
prioritizing studies
Prioritizing Studies
  • Public health needs
  • Preliminary data exist
  • Good products available
  • Feasible studies
  • Ethical studies

Systematic Reviews

fmri pinpoints central effects of acupuncture
fMRI Pinpoints Central Effects of Acupuncture

Hui, K. et al., MGH, NMR Center

the placebo
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
this is your brain on placebo
This Is Your Brain on Placebo

rostral anterior cingulate cortex

Placebo and Opioid Analgesia - Imaging a Shared Neuronal Network

Petrovic, PP et al. Science Express Reports, 2002

grantee research studying cellular mechanisms of ginkgo biloba
Grantee Research: Studying Cellular Mechanisms of Ginkgo Biloba

A recent trio of studies determined that Ginkgo extract:

  • Increases stress resistance and extends the lifespan of C.elegans

J Smith, et al., Cellular and Mol Biol, 2002

  • Protects cultured neural cells from undergoing apoptosis

Z Wu, J Smith, et al., Cellular and Mol Biol, 2002

  • Inhibits beta-amyloidaggregration

Y Luo, J Smith, et al., Proc Natl Acad Sci USA, 2002

women s health better management of menopausal transition
Women’s Health: Better Management of Menopausal Transition
  • Supporting research on CAM modalities for hot flashes, other menopausal symptoms
  • Convened workshop to assess existing tools for measurement of hot flashes (January 2004)
  • With NIH, NIBIB, & ORWH, issued RFA for SBIR applications to improve objective measures of hot flashes (September 2004)
  • Cosponsoring, with NIA, state-of-the-science conference on Management of the Menopausal Transition (March 2005)
  • Clinical trials to follow
nccam is active in major trans nih initiatives
NCCAM Is Active in Major Trans-NIH Initiatives
  • Osteoarthritis
  • Obesity
  • Neuroscience Blueprint
  • NIH Roadmap for Medical Research
iom study on cam
IOM Study on CAM
  • NCCAM and 16 NIH ICs and AHRQ commissioned the study in 2002
  • Panel asked to address a wide range of CAM science, policy, and practice issues
  • Study released on January 12, 2005
iom study on cam1
IOM Study on CAM

Key Conclusions

  • Same principles and standards of evidence of treatment effectiveness should apply to all conventional and CAM interventions
  • Emphasize health services research and consider ethical, legal, and social implications of CAM research and integrated medicine
  • Ensure rigor in CAM studies
slide70

Key Principles of CAM Research

  • Use the same designs and outcome instruments as for definitive studies of conventional practices
  • Randomized, double-blind controlled trials are the ‘gold standard’
  • Some modalities can not be blinded
  • Studies of whole CAM ‘systems’ require creativity and flexibility
  • CAM experts and patient advocates should be included in study design and oversight
slide71

Designing CAM Studies

  • Individual botanical or nutritional supplements can be tested in randomized, double-blind controlled trials.
  • Combinations of agents, especially if custom-tailored for each subject are harder to blind.
  • Complex CAM systems and physical modalities, among others, can not be blinded
  • It is hard to study the approach of an individual practitioner
slide72

Issues in Studies of CAM Treatments

  • Complex and multi-modal
  • Individualized regimens
  • Intra- and inter-practitioner consistency
  • Acceptability of randomization
  • Test materials of highly variable potency
  • Use of placebo and sham treatment arms
training cam investigators
Training CAM Investigators
  • Tailor programs to reflect evolving needs
  • Foster a culture of research
  • Provide resources to build careers in CAM research
nccam training opportunities
NCCAM Training Opportunities

The Challenge: Finding Good Mentors

integrating cam education into conventional medical curricula
Integrating CAM Education into Conventional Medical Curricula
  • Goal: Integrate information on CAM practices into academic curricula
  • Settings: 15 medical, nursing, pharmacy, osteopathy, dental schools
  • Funding: Up to $300K per year each for 5 years through R25 grants
cam research results in mainstream publications
CAM Research Resultsin Mainstream Publications
  • Funded over 800 projects
  • Over 700 scientific publications
  • Publications have appeared in journals such as JAMA, Lancet, NEJM, Annals of Internal Medicine and PNAS
  • Grantee bibliography available on NCCAM Web site
slide77

CAM on PubMed

  • Launched: February 2001
  • Contains nearly 300,000 citations
  • Access via NCCAM Web site: Click on icon
  • Access via NLM’s PubMed: Complementary Medicine Subset
communications information and outreach
Communications Information and Outreach
  • NCCAM Web Site

More than 1.5 million visitors a year

  • Information Clearinghouse

Inquiries by phone, email, fax, letters

  • Newsletter, E-Bulletin

More than 11,000 subscribers

  • CAM on PubMed

5,800 user sessions per month

  • Patient Recruitment

800-number, promotion, patient ed pamphlets

  • Public Education

More than 90 fact sheets, reports, alerts, andother information products

  • Town Meetings, Exhibits, Lectures

Events nationwide

slide79

Presentation Overview

  • Nature, Use, and Claims of CAM
  • Conducting CAM Research
  • Ethical Issues in CAM
requirements for ethical research
Requirements for Ethical Research
  • Social value
  • Scientific validity
  • Fair subject selection
  • Favorable risk:benefit ratio
  • Independent review
  • Informed consent
  • Respect study subjects

Emmanuel, Wendler & Grady, JAMA, 2000

ethical issues posed by cam
Ethical Issues Posed by CAM

Social value

  • Extensive public use without proof
  • Emerging evidence questions traditional assumptions of safety and efficacy

Scientific validity

  • The literature is dominated by under-powered, poorly designed studies, conducted by people with limited scientific credentials
slide82

The plural of anecdote

is not evidence

critique of ongoing cam research
Critique of Ongoing CAM Research
  • Sets a higher standard than for conventional practices – few allopathic practices are proven with double-blind RCTs
  • Is too reductionistic – CAM is multi-modal
  • Does not test the approach as traditionally delivered – wrong herb; wrong dose; wrong needling point …
  • The investigators have no expertise in CAM
ethical issues posed by cam1
Ethical Issues Posed by CAM

Fair subject selection

  • Advocates and skeptics refuse enrollment, comply poorly and withdraw prematurely
  • These biases risk the generalizability of the study findings

Risk:benefit ratio

  • Lack of formal preclinical and clinical data challenges assumptions of safety, optimal dose and schedule
ethical issues posed by cam2
Ethical Issues Posed by CAM

Independent review

  • IRBs may oppose or lack expertise in CAM

Informed consent

  • Undermines expectations of healing
  • Difficult to inform where objective data on potential risks and benefits are lacking

Respect for subjects

  • Cannot ethically study everything to which a person is willing to be subjected
slide86

Unethical Studies

  • Practices or placebo arm would displace life-saving therapies
  • Irreproducible products
  • Unsafe practicesor products
slide87

Summary

  • Nature, use, and claims of CAM
  • Conducting CAM Research
  • Ethical Issues in CAM