Guiding Patients on Safe and
Effective Use of Complementary
Medicine and Integrative Medicine –
Nicole Nisly, M.D.
What is CAM

CAM: Complementary and Alternative
Medicine
 a group of diverse medical and health
care systems, practices, and products
that are not generally considered part
of conventional medicine.
 CAM practices are often grouped into
broad categories, such as natural
products, mind and body medicine.
Integrative Medicine

Integrative Medicine:
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Integrative Medicine is the practice of medicine
that reaffirms the importance of the relationship
between practitioner and patient, focuses on the
whole person, is informed by evidence, and
makes use of all appropriate therapeutic
approaches, healthcare professionals and
disciplines to achieve optimal health and
healing
 www.imconsortium.org
Gerry A
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56 year old man with recent diagnosis of locally
advanced pancreatic cancer, status post Roux en Y
surgery, prognosis < 6 months
Presented to CAM clinic to address use of
Complementary therapies in the setting of cancer
care.
Planned to follow oncologist’s recommendations
but also use CAM
“I have a feeling that my mission here is not
complete, I need your help”
Why should I address CAM or
consider Integrative Medicine
High utilization: coordination of care
 Potential for interactions and side-effects
 Patient’s trust, partnership and engagement
 Brings values and culture to health care
 Increased patient satisfaction
 Importantly: you may be surprised that
many benefits can be afforded by safe and
effective use, enhancing traditional care
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Gerry’s regimen
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A plant centered diet: morning burritos laced in onions,
garlic and spices, meditation, yoga, biking, guided
imagery, writing/blogging. No ETOH, smoking,
occasional coffee with minimal honey/unrefined sugar
No sugar, white flour, animal fat. Multiple servings of
plants daily (despite low income). Occasional coffee
Dietary supplement regimen was extensive and changed
regularly.
He researched the lay and scientific lit for new studies
daily, followed Drs Weil, Oz and other prominent CAM
figures
Criteria for advice on CAM
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Recommend
 Evidence supports safety and efficacy
Accept, or discuss as option AFTER standard of
care or evidence-based treatment offered
 Efficacy is inconclusive, but safety is established
Discourage
 Evidence indicates inefficacy or serious risk
Discuss FDA approval, risks, document and follow
Know the evidence, keep personal beliefs in check,
you bring the evidence-based care, medical
knowledge and are responsible for safety and
efficacy and following the standards of care.
Gerry’s Medical Visit
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“I read that cancer needs sugar, how about the use
of insulin and hypoglycemic therapy”
 Unsafe and not plausible to be effective,
however you could eliminate most simple and
refined sugars in your diet
Regarding neuropathy due to cancer treatment, I
would like to use high dose Vitamin B6
 I think Alpha Lipoic Acid has better data of
safety and efficacy for neuropathy and you
could use Vitamin B6 at higher than RDA but
no higher than UL, we will monitor levels
Gerry A - follow up
I knew him for over 5 years
 He went through 3 recurrences
 He died in his sleep presumably due to GI
bleeding at anastomotic site
 He came to CAM clinic every month and
discussed treatment and CAM use
 He rode his bike to clinic
 He spoke with my medical students
regularly and with other patients
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Complementary and Alternative
Medicine Program
Developed in 1996, launched in 1998
 Collaboration with Family Medicine and
Pharm D program
 Close collaboration with licensed CAM
providers
 Focus on evidence-based practice, safety
and efficacy, standards of care, education
and research
 Learning from patients
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CAM/Integrative Medicine
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Focus on:
 Cancer care
 Chronic pain
 Preference for CAM
 Dietary supplement use/Polyherbacy
 All areas of Internal Medicine, occasional
pediatric consultations
Education
CCOM curriculum
 Residency education
 Elective rotation
 Education of Public and Health care
providers, CAM providers
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Research
NIH P-50 Botanical center grant for 5 years,
over 6 million dollars, renewed in
collaboration with Iowa State University
 HCCC grant
 CCOM educational grant
 Other collaboration with Dentistry,
Audiology, HCCC, Psychology
 Multiple publications on peer reviewed
literature
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Mrs. Forgetful
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Patient with history of
breast cancer and CAD
with recent pulmonary
embolism on warfarin and
baby asa and many other
medications develops
some forgetfulness.
She plans to use Gingko
Biloba to help.
PT/INR checked
sequentially are stable
between 2-3. Is it safe?
Mrs. Busy Mom
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Mother of 4 comes in
to refill BCP. She is
feeling a bit
overwhelmed and has
read that SJW can help
her mood.
No other medications
are used. Is it safe?
Mr. Sneezy
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Mr. Sneezy comes in
Mid October to
purchase his
Echinacea for the
winter. He comments
on his terrible ragweed
allergy this fall, as he
picks up Claritin and
Echinacea.
Is it safe?
Dietary Supplement Regulation
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Dietary Supplement Health and Education Act of
1994
 Definition of dietary supplement*
 “…..not evaluated by the FDA. ….not intended
to diagnose, treat, cure, or prevent…..”
 Remove product only when hazardous
 Office of Dietary Supplements
 No claims of efficacy
NCCAM/ODS
Definition of Dietary Supplement
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Is intended to supplement the diet
Contains one or more dietary ingredients
(including vitamins, minerals, herbs or other
botanicals, amino acids, and certain other
substances) or their constituents
Is intended to be taken by mouth, in forms such as
tablet, capsule, powder, softgel, gelcap, or liquid
Is labeled as being a dietary supplement
NCCAM/DSHEA’94
Dietary Supplements
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Vitamins/Minerals
Essential fatty acids
Enzymes/coenzymes (ex. Coenzyme Q10)
Plant-derived (Herbs)
Animal-derived (ex. Glucosamine)
Bacteria (ex. Lactobacilli acidophilus)
Glandular products (ex. Adrenal extracts)
Hormonal (ex. Melatonin)
NCCAM/ODS
Labeling Requirements
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Statement of identity
Supplement Facts panel
 Suggested serving size
 Net quantity of ingredients
 Dietary supplements and their RDAs (if
known)
 Herbs identified by common plant name and
 specify what part of plant was used
Klepser, T/NCCAM/ODS
New Requirements
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Manufacturers are expected to follow "good manufacturing
practices" (GMPs) to ensure that dietary supplements are
processed consistently and meet quality standards.
Requirements for GMPs went into effect in 2008 for large
manufacturers and are being phased in for small
manufacturers through 2010.
Adverse event reporting: FDA's MedWatch hotline
number: 1-800-FDA-1088 or website
http://www.fda.gov/medwatch/report/hcp.htm.
Reporting now mandatory to manufacturers and
distributors of supplements
Dietary Supplement Use National
Surveys
2007: 38 percent of American adults and
12 of children had used some form of CAM,
with 20% using a "natural products" (i.e.,
dietary supplements other than vitamins and
minerals) in the past 12 months. (National
Health Interview Survey)
 $33.9 billion out of pocket
 NCCAM
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National Health Interview Survey (NHIS)
2002 Supplement on Alternative Medicine
Practice
Natural herbs
Acupuncture
Chelation
“Folk medicine”
Tai chi
Guided imagery
Deep breathing exer.
%ever used %last yr
25
19
4
1
0.1
0.1
0.6
0.1
2
1
3
2
15
11
NCCAM
Why patients use AM
Conventional care
perceived as:
 ineffective
 too expensive
 too focused on
curing vs
maintaining health
CAM perceived as:
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less authoritarian,
empowering
congruent with
patient’s values
and personal
beliefs
Fox, JAMA 1997
Astin, JAMA 1998
Basic requirements: Health Care
Provider guidance
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Completed diagnostic evaluation.
Offer standards of care first, always
Create goals for CAM treatment and follow up
with monitoring of side-effects and timeline for
symptom improvement
Seek licensed providers, reputable dietary
supplement companies, www.Consumerlab.com
Communicate with licensed CAM provider
Report Adverse Drug Reactions and drug
interactions
Document in Medical Records
Deciding on the use of CAM: Patient
Identify key symptoms or problems
 Maintain a symptom diary
 Understand their preferences and
expectations
 Review issues of safety and efficacy and
FDA approved indications
 Understand access and cost issues
 Write down recommendations and need for
follow up
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Resources for Health Care
Practitioners
NCCAM
http://nccam.nih.gov/
 Dietary Supplement label database
http://dietarysupplements.nlm.nih.gov/dietary/
 CAM on PubMed
http://nccam.nih.gov/research/camonpubmed/
 Medline Plus on Supplements
http://www.nlm.nih.gov/medlineplus/druginfo/herb_
All.html
 UIHC: Micromedex, Natural Standards database
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St. John’s Wort (Hypericum
perforatum)
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Originates in the Old
World.
Indications: Mild to
Moderate Depression.
Dose: 300 mg tid.
Concerns: Drug
interactions,
photosensitivity,
Pregnancy, Children.
Other uses: Antiviral,
Cancer.
St. John’s Wort
Drug Interactions (P450 1A2, 2C9, 3A4)
 Activates a receptor, named PXR, in the
liver and intestine, which accelerates
drug metabolism.
 It may interact with over 80% of drugs
available in the U.S. market.
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Examples of important SJW/
drug interactions
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DECREASED LEVELS OF:
 Anti-retrovirals such as Indinavir and
Nevirapine
 Cancer drugs such as Irinotecan
 Immunosuppressant agents such as
Cyclosporine
 Cardiac drugs such as Digoxin
 Bronchodilator such as Theophylline
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Oral Contraceptives
Warfarin (decreased INR)
 SSRI: serotonin syndrome
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Alpha Lipoic Acid
Indications: diabetic neuropathy and
neuropathic pain
 What is it: Sulfur containing fatty acid,
antioxidant
 Sources: made in the body, liver, yeast
 Dose: 100-200 mg TID.
 Side-effects: sedation
 Siegler D, 2006. N=181. Doses 600-1800
mg, all had benefit
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The alphabet soup
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A, beta carotene and smokers
B6 and neuropathy
C is neutral but watch that kidney
D and the Midwest, too little and too much
E less than 400 IU
Multi and prostate cancer
NHANES and is more even better?
Zinc needs copper
Vitamin D facts
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Fat soluble vitamin, the sunshine vitamin
Produced endogenously when ultraviolet sunrays
strike skin and trigger Vitamin D synthesis
It must be metabolized first in the liver to make
25-OH vitamin D and then kidney to make 1,25
OH vitamin D
Besides calcium absorption it modulates cell
growth, neuromuscular and immune function and
reduces inflammation
25-OH vitamin D best indicator of nutritional
status
Vitamin D and Cancer Care
Levels: in ng/mL <20 insufficient; 20-50
optimal; @50 potentially associated with
improved outcomes
 Amount needed for non obese adults who
are younger than 70: 600-800 IU daily
 Upper Tolerable Intake 4,000 IU daily
 Measure and target levels between 3050ng/mL (IOM/NCCAM)
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Melatonin
Natural hormone produced in the body,
rises in the evening and lowers in the
morning
 Most studied for jet lag, delayed sleep phase
dz, shift work, ADHD (breast and brain
cancer)
 Prolonged release melatonin may be most
helpful. Dose 5-10 mg 20 min before
bedtime
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Unsafe Herbs
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Carcinogens
 Borage
 Calamus
 Coltsfoot
 Comfrey
 Life root
 Sassafras
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Hepatotoxicity
 Chaparral
 Germander
 Life root
Miscellaneous
 Licorice
 Ma Huang
 Pokeroot (Children)
-Varro Tyler
Document and Discuss!
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Document! Dietary
supplement counseling or
use
Report suspected adverse
reactions to FDA's
MedWatch hotline
number: 1-800-FDA-1088
or website
http://www.fda.gov/med
watch/report/hcp.htm
Non supplement care
NCCAM funded research shows that following
techniques can reduce craving/use:
 Yoga, meditation, guided imagery
 Hot flashes can be alleviated by:
 Yoga, tai-chi, acupuncture, meditation and high
fiber diet. No benefit from black cohosh, red
clover, DHEA, soy isoflavones (although soy
consumption may help*)
 Tai-Chi can help to prevent falls in patients with
parkinson’s disease
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Acupuncture
Who can practice legally in Iowa
 Acupuncture forms: traditional, medical,
moxa, ear or scalp acupuncture
 Indications: nausea, tennis elbow,
addictions, labor and delivery
 Contra-indications and complications
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Acupuncture Use in Pain
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Acupuncture, among the oldest healing practices in the world, is part of
traditional Chinese medicine. In Acupuncture practitioners stimulate
specific points on the body—most often by inserting thin solid needles
through the skin. In traditional Chinese medicine theory, this regulates
the flow of qi (vital energy) along pathways known as meridians.
In the 2007 National Health Interview Survey, 1.4 percent of respondents
(an estimated 3.1 million Americans) said they had used acupuncture in
the past year.
Analysis of acupuncture data found that pain or musculoskeletal
complaints accounted for 7 of the top 10 conditions for which people use
acupuncture. Back pain was the most common, followed by joint pain,
neck pain, severe headache/migraine, and recurring pain.
Indications for acupuncture
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Carpal tunnel syndrome, Fibromyalgia, Myofascial pain: mixed limited
data
Headache/migraine: A 2009 review found that acupuncture may help
tension headaches, however with migraines no difference found.
Low-back pain: According to clinical practice guidelines issued by the
American Pain Society and the American College of Physicians in 2007,
acupuncture is one of several CAM therapies physicians should consider
when patients with chronic low-back pain do not respond to conventional
treatment. RCT in 2009 found that actual acupuncture and simulated
acupuncture were equally effective and both were more effective than
conventional treatment for relieving chronic low-back pain.
Menstrual cramps, Neck pain, Tennis Elbow, Post-op dental pain:
promising but not definitive
Osteoarthritis/knee pain—Acupuncture appears to be effective for
osteoarthritis, particularly in the area of knee pain..
Chemotherapy related nausea
Massage therapy
Who can practice in Iowa
 Forms: Deep tissue massage, Reflexology,
Shiatsu, Swedish massage
 History
 Research: Touch Research Institute
 Indications
 Contra-indications
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A Word on Diet
Vegetarian
 Vegan
 Mediterranean
 Gluten Free/Paleo
 Anti Inflammatory
 PLANT CENTERED, AVOID WEIGHT
LOSS
 CAUTION WITH GARLIC, GINGER,
TURMERIC, Green Tea, Grapefruit
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Healing Touch
Energy Medicine technique or Biofield
therapy
 “improve flow of energy”
 Other forms include Reiki, Therapeutic
Touch
 Healing Touch International
 Improved NK cells, immune function
(Lutgendorf, S 2007)
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Questions?