Guiding Patients on Safe and Effective Use of Complementary Medicine and Integrative Medicine

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Guiding Patients on Safe and Effective Use of
Complementary Medicine and Integrative Medicine
Nicole Nisly, M.D.
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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.

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Integrative Medicine

• Integrative Medicine
• 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

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Gerry A

• 56 year old man with recent diagnosis of locally
  advanced pancreatic cancer, status post Roux en Y
  surgery, prognosis lt 6 months
• Presented to CAM clinic to address use of
  Complementary therapies in the setting of cancer
  care.
• Planned to follow oncologists recommendations
  but also use CAM
• I have a feeling that my mission here is not
  complete, I need your help

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Why should I address CAM or consider Integrative
Medicine

• High utilization coordination of care
• Potential for interactions and side-effects
• Patients 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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Gerrys regimen

• 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

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Criteria for advice on CAM

• 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.

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Gerrys Medical Visit

• 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

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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

• Focus on
• Cancer care
• Chronic pain
• Preference for CAM
• Dietary supplement use/Polyherbacy
• All areas of Internal Medicine, occasional
  pediatric consultations

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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

• 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?

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Mrs. Busy Mom

• 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?

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Mr. Sneezy

• 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?

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Dietary Supplement Regulation

• 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

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Definition of Dietary Supplement

• 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/DSHEA94

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Dietary Supplements

• 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

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Labeling Requirements

• 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

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New Requirements

• 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

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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 ever used last yr
• Natural herbs 25 19
• Acupuncture 4 1
• Chelation 0.1 0.1
• Folk medicine 0.6 0.1
• Tai chi 2 1
• Guided imagery 3 2
• Deep breathing exer. 15 11
• NCCAM

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Why patients use AM

• Conventional care perceived as
• ineffective
• too expensive
• too focused on curing vs maintaining health
  
• Fox, JAMA 1997

• CAM perceived as
• less authoritarian, empowering
• congruent with patients values and personal
  beliefs
• Astin, JAMA 1998

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Basic requirements Health Care Provider guidance

• 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

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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_A
  ll.html
• UIHC Micromedex, Natural Standards database

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St. Johns Wort (Hypericum perforatum)

• Originates in the Old World.
• Indications Mild to Moderate Depression.
• Dose 300 mg tid.
• Concerns Drug interactions, photosensitivity,
  Pregnancy, Children.
• Other uses Antiviral, Cancer.

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St. Johns 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

• 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
• 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. N181. Doses 600-1800 mg, all
  had benefit

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The alphabet soup

• 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

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Vitamin D facts

• 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

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Vitamin D and Cancer Care

• Levels in ng/mL lt20 insufficient 20-50 optimal
  _at_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 30-50ng/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

• Carcinogens
• Borage
• Calamus
• Coltsfoot
• Comfrey
• Life root
• Sassafras

• Hepatotoxicity
• Chaparral
• Germander
• Life root
• Miscellaneous
• Licorice
• Ma Huang
• Pokeroot (Children)
• -Varro Tyler

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Document and Discuss!

• 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/medwatch/report/hcp.htm
  

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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 parkinsons 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

• Acupuncture, among the oldest healing practices
  in the world, is part of traditional Chinese
  medicine. In Acupuncture practitioners stimulate
  specific points on the bodymost 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.

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Indications for acupuncture

• 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 painAcupuncture appears to
  be effective for osteoarthritis, particularly in
  the area of knee pain..
• Chemotherapy related nausea

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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?