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

What is CAM

CAM: Complementary and Alternative CAM: Complementary and Alternative MedicineMedicinea 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: Integrative Medicine: Integrative Medicine is the practice of medicine Integrative Medicine is the practice of medicine

that reaffirms the importance of the relationship that reaffirms the importance of the relationship between practitioner and patient, focuses on the between practitioner and patient, focuses on the whole person, is informed by evidence, and whole person, is informed by evidence, and makes use of all appropriate therapeutic makes use of all appropriate therapeutic approaches, healthcare professionals and approaches, healthcare professionals and disciplines to achieve optimal health and healingdisciplines to achieve optimal health and healing

www.imconsortium.orgwww.imconsortium.org

Gerry A

56 year old man with recent diagnosis of locally 56 year old man with recent diagnosis of locally advanced pancreatic cancer, status post Roux en Y advanced pancreatic cancer, status post Roux en Y surgery, prognosis < 6 monthssurgery, prognosis < 6 months

Presented to CAM clinic to address use of Presented to CAM clinic to address use of Complementary therapies in the setting of cancer care.Complementary therapies in the setting of cancer care.

Planned to follow oncologist’s recommendations but Planned to follow oncologist’s recommendations but also use CAMalso use CAM

““I have a feeling that my mission here is not complete, I have a feeling that my mission here is not complete, I need your help”I need your help”

Why should I address CAM or consider Integrative Medicine High utilization: coordination of careHigh utilization: coordination of care Potential for interactions and side-effects Potential for interactions and side-effects Patient’s trust, partnership and engagementPatient’s trust, partnership and engagement Brings values and culture to health careBrings values and culture to health care Increased patient satisfactionIncreased patient satisfaction Importantly: you may be surprised that many Importantly: you may be surprised that many

benefits can be afforded by safe and effective benefits can be afforded by safe and effective use, enhancing traditional careuse, enhancing traditional care

Gerry’s regimen

A plant centered diet: morning burritos laced in onions, A plant centered diet: morning burritos laced in onions, garlic and spices, meditation, yoga, biking, guided imagery, garlic and spices, meditation, yoga, biking, guided imagery, writing/blogging. No ETOH, smoking, occasional coffee writing/blogging. No ETOH, smoking, occasional coffee with minimal honey/unrefined sugarwith minimal honey/unrefined sugar

No sugar, white flour, animal fat. Multiple servings of plants No sugar, white flour, animal fat. Multiple servings of plants daily (despite low income). Occasional coffeedaily (despite low income). Occasional coffee

Dietary supplement regimen was extensive and changed Dietary supplement regimen was extensive and changed regularly.regularly.

He researched the lay and scientific lit for new studies daily, He researched the lay and scientific lit for new studies daily, followed Drs Weil, Oz and other prominent CAM figuresfollowed Drs Weil, Oz and other prominent CAM figures

Criteria for advice on CAM RecommendRecommend

Evidence supports safety and efficacyEvidence supports safety and efficacy Accept, or discuss as option Accept, or discuss as option AFTER standard of care or AFTER standard of care or

evidence-based treatment offeredevidence-based treatment offered Efficacy is inconclusive, but safety is establishedEfficacy is inconclusive, but safety is established

DiscourageDiscourage Evidence indicates inefficacy or serious riskEvidence indicates inefficacy or serious risk

Discuss FDA approval, risks, document and followDiscuss FDA approval, risks, document and follow Know the evidence, keep personal beliefs in check, you bring the Know the evidence, keep personal beliefs in check, you bring the

evidence-based care, medical knowledge and are responsible for evidence-based care, medical knowledge and are responsible for safety and efficacy and following the standards of care. safety and efficacy and following the standards of care.

Gerry’s Medical Visit ““I read that cancer needs sugar, how about the use of I read that cancer needs sugar, how about the use of

insulin and hypoglycemic therapy”insulin and hypoglycemic therapy” Unsafe and not plausible to be effective, however Unsafe and not plausible to be effective, however

you could eliminate most simple and refined sugars you could eliminate most simple and refined sugars in your dietin your diet

Regarding neuropathy due to cancer treatment, I would Regarding neuropathy due to cancer treatment, I would like to use high dose Vitamin B6like to use high dose Vitamin B6 I think Alpha Lipoic Acid has better data of safety I think Alpha Lipoic Acid has better data of safety

and efficacy for neuropathy and you could use and efficacy for neuropathy and you could use Vitamin B6 at higher than RDA but no higher than Vitamin B6 at higher than RDA but no higher than UL, we will monitor levelsUL, we will monitor levels

Gerry A - follow up I knew him for over 5 years I knew him for over 5 years He went through 3 recurrencesHe went through 3 recurrences He died in his sleep presumably due to GI He died in his sleep presumably due to GI

bleeding at anastomotic sitebleeding at anastomotic site He came to CAM clinic every month and He came to CAM clinic every month and

discussed treatment and CAM usediscussed treatment and CAM use He rode his bike to clinicHe rode his bike to clinic He spoke with my medical students regularly and He spoke with my medical students regularly and

with other patientswith other patients

Complementary and Alternative Medicine Program Developed in 1996, launched in 1998Developed in 1996, launched in 1998 Collaboration with Family Medicine and Pharm Collaboration with Family Medicine and Pharm

D program D program Close collaboration with licensed CAM providersClose collaboration with licensed CAM providers Focus on evidence-based practice, safety and Focus on evidence-based practice, safety and

efficacy, standards of care, education and efficacy, standards of care, education and researchresearch

Learning from patientsLearning from patients

CAM/Integrative Medicine

Focus on:Focus on: Cancer careCancer care Chronic painChronic pain Preference for CAMPreference for CAM Dietary supplement use/PolyherbacyDietary supplement use/Polyherbacy All areas of Internal Medicine, occasional All areas of Internal Medicine, occasional

pediatric consultationspediatric consultations

Education

CCOM curriculumCCOM curriculum Residency educationResidency education Elective rotationElective rotation Education of Public and Health care Education of Public and Health care

providers, CAM providersproviders, CAM providers

Research

NIH P-50 Botanical center grant for 5 years, NIH P-50 Botanical center grant for 5 years, over 6 million dollars, renewed in collaboration over 6 million dollars, renewed in collaboration with Iowa State Universitywith Iowa State University

HCCC grantHCCC grant CCOM educational grantCCOM educational grant Other collaboration with Dentistry, Audiology, Other collaboration with Dentistry, Audiology,

HCCC, PsychologyHCCC, Psychology Multiple publications on peer reviewed literatureMultiple publications on peer reviewed literature

Mrs. Forgetful

Patient with history of breast Patient with history of breast cancer and CAD with recent cancer and CAD with recent pulmonary embolism on pulmonary embolism on warfarin and baby asa and warfarin and baby asa and many other medications many other medications develops some forgetfulness.develops some forgetfulness.

She plans to use Gingko She plans to use Gingko Biloba to help.Biloba to help.

PT/INR checked sequentially PT/INR checked sequentially are stable between 2-3. Is it are stable between 2-3. Is it safe?safe?

Mrs. Busy Mom

Mother of 4 comes in Mother of 4 comes in to refill BCP. She is to refill BCP. She is feeling a bit feeling a bit overwhelmed and has overwhelmed and has read that SJW can help read that SJW can help her mood.her mood.

No other medications No other medications are used. Is it safe?are used. Is it safe?

Mr. Sneezy

Mr. Sneezy comes in Mr. Sneezy comes in Mid October to Mid October to purchase his Echinacea purchase his Echinacea for the winter. He for the winter. He comments on his comments on his terrible ragweed allergy terrible ragweed allergy this fall, as he picks up this fall, as he picks up Claritin and Echinacea. Claritin and Echinacea.

Is it safe?Is it safe?

Dietary Supplement Regulation

Dietary Supplement Health and Education Act of 1994Dietary Supplement Health and Education Act of 1994 Definition of dietary supplement*Definition of dietary supplement* “…“…..not evaluated by the FDA. ….not intended to ..not evaluated by the FDA. ….not intended to

diagnose, treat, cure, or prevent…..”diagnose, treat, cure, or prevent…..” Remove product only when hazardousRemove product only when hazardous Office of Dietary SupplementsOffice of Dietary Supplements No claims of efficacyNo claims of efficacy

NCCAM/ODSNCCAM/ODS

Definition of Dietary Supplement

Is intended to supplement the diet Is intended to supplement the diet Contains one or more dietary ingredients Contains one or more dietary ingredients

(including vitamins, minerals, herbs or other (including vitamins, minerals, herbs or other botanicals, amino acids, and certain other botanicals, amino acids, and certain other substances) or their constituents substances) or their constituents

Is intended to be taken by mouth, in forms such as Is intended to be taken by mouth, in forms such as tablet, capsule, powder, softgel, gelcap, or liquid tablet, capsule, powder, softgel, gelcap, or liquid

Is labeled as being a dietary supplement Is labeled as being a dietary supplement NCCAM/DSHEA’94NCCAM/DSHEA’94

Dietary Supplements

Vitamins/MineralsVitamins/Minerals Essential fatty acidsEssential fatty acids Enzymes/coenzymes (ex. Coenzyme Q10)Enzymes/coenzymes (ex. Coenzyme Q10) Plant-derived (Herbs)Plant-derived (Herbs) Animal-derived (ex. Glucosamine)Animal-derived (ex. Glucosamine) Bacteria (ex. Lactobacilli acidophilus)Bacteria (ex. Lactobacilli acidophilus) Glandular products (ex. Adrenal extracts)Glandular products (ex. Adrenal extracts) Hormonal (ex. Melatonin)Hormonal (ex. Melatonin)

NCCAM/ODSNCCAM/ODS

Labeling Requirements

Statement of identityStatement of identity Supplement Facts panelSupplement Facts panel

Suggested serving sizeSuggested serving size Net quantity of ingredientsNet quantity of ingredients Dietary supplements and their RDAs (if known)Dietary supplements and their RDAs (if known) Herbs identified by common plant name and Herbs identified by common plant name and

specify what part of plant was usedspecify what part of plant was used Klepser, T/NCCAM/ODSKlepser, T/NCCAM/ODS

New Requirements

Manufacturers are expected to follow "good Manufacturers are expected to follow "good manufacturing practices" (GMPs) to ensure that dietary manufacturing practices" (GMPs) to ensure that dietary supplements are processed consistently and meet quality supplements are processed consistently and meet quality standards. Requirements for GMPs went into effect in standards. Requirements for GMPs went into effect in 2008 for large manufacturers and are being phased in for 2008 for large manufacturers and are being phased in for small manufacturers through 2010. small manufacturers through 2010.

Adverse event reporting: FDA's MedWatch hotline Adverse event reporting: FDA's MedWatch hotline number: 1-800-FDA-1088 or website number: 1-800-FDA-1088 or website http://www.fda.gov/medwatch/report/hcp.htm. .

Reporting now mandatory to manufacturers and Reporting now mandatory to manufacturers and distributors of supplementsdistributors of supplements

Dietary Supplement Use National Surveys 2007: 38 percent of American adults and 2007: 38 percent of American adults and

12 of children had used some form of 12 of children had used some form of CAM, with 20% using a "natural products" CAM, with 20% using a "natural products" (i.e., dietary supplements other than (i.e., dietary supplements other than vitamins and minerals) in the past 12 vitamins and minerals) in the past 12 months. (National Health Interview Survey)months. (National Health Interview Survey)

$33.9 billion out of pocket$33.9 billion out of pocketNCCAMNCCAM

National Health Interview Survey (NHIS)2002 Supplement on Alternative Medicine

PracticePractice %ever used%ever used %last yr%last yrNatural herbsNatural herbs 2525 1919AcupunctureAcupuncture 4 4 1 1ChelationChelation 0.1 0.1 0.1 0.1““Folk medicine”Folk medicine” 0.6 0.6 0.1 0.1Tai chiTai chi 2 2 1 1Guided imageryGuided imagery 3 3 2 2Deep breathing exer.Deep breathing exer. 1515 1111

NCCAMNCCAM

Why patients use AM

Conventional care Conventional care perceived as:perceived as:

ineffectiveineffective too expensivetoo expensive too focused on too focused on

curing vs curing vs maintaining healthmaintaining health

Fox, JAMA 1997Fox, JAMA 1997

CAM perceived as:CAM perceived as:

less authoritarian, less authoritarian, empoweringempowering

congruent with congruent with patient’s values and patient’s values and personal beliefspersonal beliefs

Astin, JAMA 1998Astin, JAMA 1998

Basic requirements: Health Care Provider guidance

Completed diagnostic evaluation. Completed diagnostic evaluation. Offer standards of care first, alwaysOffer standards of care first, always Create goals for CAM treatment and follow up with Create goals for CAM treatment and follow up with

monitoring of side-effects and timeline for symptom monitoring of side-effects and timeline for symptom improvement improvement

Seek licensed providers, reputable dietary supplement Seek licensed providers, reputable dietary supplement companies, companies, www.Consumerlab.com

Communicate with licensed CAM providerCommunicate with licensed CAM provider Report Adverse Drug Reactions and drug interactionsReport Adverse Drug Reactions and drug interactions Document in Medical RecordsDocument in Medical Records

Deciding on the use of CAM: Patient Identify key symptoms or problemsIdentify key symptoms or problems Maintain a symptom diaryMaintain a symptom diary Understand their preferences and expectationsUnderstand their preferences and expectations Review issues of safety and efficacy and FDA Review issues of safety and efficacy and FDA

approved indicationsapproved indications Understand access and cost issuesUnderstand access and cost issues Write down recommendations and need for Write down recommendations and need for

follow up follow up

Resources for Health Care Practitioners NCCAMNCCAMhttp://nccam.nih.gov/http://nccam.nih.gov/ Dietary Supplement label databaseDietary Supplement label databasehttp://dietarysupplements.nlm.nih.gov/dietary/ CAM on PubMedCAM on PubMedhttp://nccam.nih.gov/research/camonpubmed/ Medline Plus on SupplementsMedline Plus on Supplementshttp://www.nlm.nih.gov/medlineplus/druginfo/herb_All.html UIHC: Micromedex, Natural Standards databaseUIHC: Micromedex, Natural Standards database

St. John’s Wort (Hypericum perforatum)

Originates in the Old Originates in the Old World.World.

Indications: Mild to Indications: Mild to Moderate Depression.Moderate Depression.

Dose: 300 mg tid.Dose: 300 mg tid. Concerns: Drug Concerns: Drug

interactions, interactions, photosensitivity, photosensitivity, Pregnancy, Children.Pregnancy, Children.

Other uses: Antiviral, Other uses: Antiviral, Cancer.Cancer.

St. John’s Wort

Drug Interactions Drug Interactions (P450 1A2, 2C9, (P450 1A2, 2C9, 3A4)3A4)

Activates a receptor, named PXR, Activates a receptor, named PXR, in the liver and intestine, which in the liver and intestine, which accelerates drug metabolism. accelerates drug metabolism.

It may interact with over It may interact with over 80%80% of of drugs available in the U.S. market.drugs available in the U.S. market.

Examples of important SJW/ drug interactions

DECREASED LEVELS OF:DECREASED LEVELS OF: Anti-retrovirals such as Indinavir and NevirapineAnti-retrovirals such as Indinavir and Nevirapine Cancer drugs such as IrinotecanCancer drugs such as Irinotecan Immunosuppressant agents such as Immunosuppressant agents such as

Cyclosporine Cyclosporine Cardiac drugs such as DigoxinCardiac drugs such as Digoxin Bronchodilator such as TheophyllineBronchodilator such as Theophylline Oral ContraceptivesOral Contraceptives Warfarin (decreased INR)Warfarin (decreased INR)SSRI: serotonin syndromeSSRI: serotonin syndrome

Alpha Lipoic Acid

Indications: diabetic neuropathy and neuropathic Indications: diabetic neuropathy and neuropathic painpain

What is it: Sulfur containing fatty acid, antioxidantWhat is it: Sulfur containing fatty acid, antioxidant Sources: made in the body, liver, yeastSources: made in the body, liver, yeast Dose: 100-200 mg TID. Dose: 100-200 mg TID. Side-effects: sedationSide-effects: sedation Siegler D, 2006. N=181. Doses 600-1800 mg, all Siegler D, 2006. N=181. Doses 600-1800 mg, all

had benefithad benefit

The alphabet soup

A, beta carotene and smokersA, beta carotene and smokers B6 and neuropathyB6 and neuropathy C is neutral but watch that kidneyC is neutral but watch that kidney D and the Midwest, too little and too muchD and the Midwest, too little and too much E less than 400 IUE less than 400 IU Multi and prostate cancerMulti and prostate cancer NHANES and is more even better?NHANES and is more even better? Zinc needs copperZinc needs copper

Vitamin D facts Fat soluble vitamin, the sunshine vitaminFat soluble vitamin, the sunshine vitamin Produced endogenously when ultraviolet sunrays Produced endogenously when ultraviolet sunrays

strike skin and trigger Vitamin D synthesisstrike skin and trigger Vitamin D synthesis It must be metabolized first in the liver to make 25-It must be metabolized first in the liver to make 25-

OH vitamin D and then kidney to make 1,25 OH OH vitamin D and then kidney to make 1,25 OH vitamin Dvitamin D

Besides calcium absorption it modulates cell growth, Besides calcium absorption it modulates cell growth, neuromuscular and immune function and reduces neuromuscular and immune function and reduces inflammationinflammation

25-OH vitamin D best indicator of nutritional status25-OH vitamin D best indicator of nutritional status

Vitamin D and Cancer Care

Levels: in ng/mL <20 insufficient; 20-50 Levels: in ng/mL <20 insufficient; 20-50 optimal; @50 potentially associated with optimal; @50 potentially associated with improved outcomesimproved outcomes

Amount needed for non obese adults who are Amount needed for non obese adults who are younger than 70: 600-800 IU dailyyounger than 70: 600-800 IU daily

Upper Tolerable Intake 4,000 IU dailyUpper Tolerable Intake 4,000 IU daily Measure and target levels between 30-Measure and target levels between 30-

50ng/mL (IOM/NCCAM)50ng/mL (IOM/NCCAM)

Melatonin

Natural hormone produced in the body, rises in Natural hormone produced in the body, rises in the evening and lowers in the morningthe evening and lowers in the morning

Most studied for jet lag, delayed sleep phase Most studied for jet lag, delayed sleep phase dz, shift work, ADHD (breast and brain dz, shift work, ADHD (breast and brain cancer)cancer)

Prolonged release melatonin may be most Prolonged release melatonin may be most helpful. Dose 5-10 mg 20 min before bedtimehelpful. Dose 5-10 mg 20 min before bedtime

Unsafe Herbs

CarcinogensCarcinogens BorageBorage CalamusCalamus ColtsfootColtsfoot ComfreyComfrey Life rootLife root SassafrasSassafras

HepatotoxicityHepatotoxicity ChaparralChaparral Germander Germander Life rootLife root

MiscellaneousMiscellaneous LicoriceLicorice Ma HuangMa Huang Pokeroot (Children)Pokeroot (Children)

-Varro Tyler-Varro Tyler

Document and Discuss!

DocumentDocument! Dietary ! Dietary supplement counseling or supplement counseling or useuse

ReportReport suspectedsuspected adverse adverse reactions to FDA's reactions to FDA's MedWatch hotline MedWatch hotline number: 1-800-FDA-1088 number: 1-800-FDA-1088 or website or website http://www.fda.gov/medwatch/report/hcp.htm

Non supplement care NCCAM funded research shows that following NCCAM funded research shows that following

techniques can reduce craving/use:techniques can reduce craving/use: Yoga, meditation, guided imageryYoga, meditation, guided imagery

Hot flashes can be alleviated by:Hot flashes can be alleviated by: Yoga, tai-chi, acupuncture, meditation and high fiber Yoga, tai-chi, acupuncture, meditation and high fiber

diet. No benefit from black cohosh, red clover, diet. No benefit from black cohosh, red clover, DHEA, soy isoflavones (although soy consumption DHEA, soy isoflavones (although soy consumption may help*)may help*)

Tai-Chi can help to prevent falls in patients with Tai-Chi can help to prevent falls in patients with parkinson’s diseaseparkinson’s disease

Acupuncture

Who can practice legally in IowaWho can practice legally in Iowa Acupuncture forms: traditional, medical, Acupuncture forms: traditional, medical,

moxa, ear or scalp acupuncturemoxa, ear or scalp acupuncture Indications: nausea, tennis elbow, Indications: nausea, tennis elbow,

addictions, labor and deliveryaddictions, labor and delivery Contra-indications and complicationsContra-indications and complications

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 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 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 IowaWho can practice in Iowa Forms: Deep tissue massage, Reflexology, Forms: Deep tissue massage, Reflexology,

Shiatsu, Swedish massageShiatsu, Swedish massage HistoryHistory Research: Touch Research InstituteResearch: Touch Research Institute IndicationsIndications Contra-indicationsContra-indications

A Word on Diet VegetarianVegetarian VeganVegan MediterraneanMediterranean Gluten Free/PaleoGluten Free/Paleo Anti InflammatoryAnti Inflammatory PLANT CENTERED, AVOID WEIGHT LOSSPLANT CENTERED, AVOID WEIGHT LOSS CAUTION WITH GARLIC, GINGER, CAUTION WITH GARLIC, GINGER,

TURMERIC, Green Tea, GrapefruitTURMERIC, Green Tea, Grapefruit

Healing Touch

Energy Medicine technique or Biofield therapyEnergy Medicine technique or Biofield therapy ““improve flow of energy”improve flow of energy” Other forms include Reiki, Therapeutic TouchOther forms include Reiki, Therapeutic Touch Healing Touch InternationalHealing Touch International Improved NK cells, immune function Improved NK cells, immune function

(Lutgendorf, S 2007)(Lutgendorf, S 2007)

Questions?