Sara L. Warber, MDSara L. Warber, MD

Co-Director, UM Integrative Co-Director, UM Integrative MedicineMedicine

Assist Prof, Dept of Family Assist Prof, Dept of Family MedicineMedicine

Herbs and Health:Herbs and Health:Real World BasicsReal World Basics

ContextContext

Historical Context

Physical evidence dates Physical evidence dates back 60,000 years back 60,000 years

All cultures have traditions All cultures have traditions of herb use for healingof herb use for healing

2000 BC - First known 2000 BC - First known materia medica materia medica in in SumeriaSumeria

1st Century AD - Chinese 1st Century AD - Chinese Materia MedicaMateria Medica

Cultural Context

In China, 40-50% of meds used are In China, 40-50% of meds used are traditional herbstraditional herbs

In Africa, 80% of population uses In Africa, 80% of population uses herbal medicine for primary careherbal medicine for primary care

In Germany, 90% of adults use herbs In Germany, 90% of adults use herbs in lifetimein lifetime

Ethnic populations in US very likely to Ethnic populations in US very likely to be using herbsbe using herbs

25% of prescription drugs from plants 25% of prescription drugs from plants

Pediatric Herbal Pediatric Herbal RemediesRemedies

Aloe veraAloe vera 43%43% Chamomile teaChamomile tea29%29% EchinaceaEchinacea28%28% GarlicGarlic 11%11% GingerGinger 11%11% Tea tree oilTea tree oil 8%8%

GoldensealGoldenseal 7%7% GinsengGinseng 5%5% Ginkgo bilobaGinkgo biloba 4%4% St John’s wortSt John’s wort 4%4% FeverfewFeverfew 4%4%

Ottolini MC. Ambulatory Peds Mar-Apr 2001

Asking about herbsAsking about herbs

Do we really need to ask?

458 VA patients (Pittsburgh, LA) 43% taking herbs/supplements plus

medications 2% at risk for serious adverse event 42-48% at risk for minor adverse

events 59-88% never asked by physicians

about use

Glassman P. quoted in Family Practice News. June 15, 2000.

RegulationsRegulations

Federal Trade Commission (FTC)Federal Trade Commission (FTC) Food & Drug Administration (FDA)Food & Drug Administration (FDA)

Role of FTC

FTC governs the advertising and FTC governs the advertising and promotion of herbs and dietary promotion of herbs and dietary supplements. It can:supplements. It can:– Outlaw unfair or deceptive practicesOutlaw unfair or deceptive practices– Stop unsubstantiated advertisingStop unsubstantiated advertising– Investigate complaints and seek civil Investigate complaints and seek civil

penalties for violations of trade penalties for violations of trade regulationsregulations

Role of FDA

Stop the marketing of toxic or unsanitary Stop the marketing of toxic or unsanitary productsproducts

Stop the marketing of products with false Stop the marketing of products with false or unsubstantiated claimsor unsubstantiated claims

Take action against a product which Take action against a product which poses “ a significant unreasonable risk of poses “ a significant unreasonable risk of illness or injury”illness or injury”

Prohibit claims that a product cures or Prohibit claims that a product cures or treats a diseasetreats a disease

Stop the marketing of a new (post 1994) Stop the marketing of a new (post 1994) dietary ingredient if safety data is lackingdietary ingredient if safety data is lacking

Case study: Ephedra

EphedraEphedra HWLDS - 0.95 kg lost/mo HWLDS - 0.95 kg lost/mo Ephedrine alone - 0.5 kg lost/moEphedrine alone - 0.5 kg lost/mo Ephedrine/caffeine combo - 1.0 kg Ephedrine/caffeine combo - 1.0 kg

lost/molost/mo

Ephedrine/caffeine modest dose Ephedrine/caffeine modest dose response effect over multiple trialsresponse effect over multiple trials

Rand Meta-analysis

Ephedra/Ephedrine Safety

RCTs - no serious adverse effectsRCTs - no serious adverse effects Sentinel events: MI, CVA, Sentinel events: MI, CVA,

seizures, & psychiatric cases.seizures, & psychiatric cases. Adverse events reportsAdverse events reports

– EphedraEphedra - 21 sentinel serious - 21 sentinel serious adverse events (including 2 deaths)adverse events (including 2 deaths)

– Ephedrine - 11 sentinel events Ephedrine - 11 sentinel events (including 3 deaths)(including 3 deaths)

Rand Meta-analysis

Expertise – Who has it?Expertise – Who has it?

Consumer/patientConsumer/patient Clerk in storeClerk in store Herbalist – what tradition? How certified? Herbalist – what tradition? How certified? Chiropractor (DC)Chiropractor (DC) Nutritionist (RD)Nutritionist (RD) Pharmacist (PharmD, PhD)Pharmacist (PharmD, PhD) Naturopathic Doctor (ND)Naturopathic Doctor (ND) Board Certified Holistic Physician (MD, Board Certified Holistic Physician (MD,

DO)DO) Fellowship-trained Integrative Physician Fellowship-trained Integrative Physician

EvidenceEvidence

Traditional useTraditional use Basic scienceBasic science Clinical scienceClinical science

Traditional useTraditional use

Often based on Often based on hundreds to thousands hundreds to thousands of years of observationof years of observation

60-70% of traditionally 60-70% of traditionally used herbs are used herbs are pharmacologically pharmacologically activeactive

German Commission EGerman Commission E

Traditional preparations

Infusion - flowers and leaves Infusion - flowers and leaves steeped in hot water, ie, teas steeped in hot water, ie, teas

Decoction - bark, roots or seeds Decoction - bark, roots or seeds boiled in waterboiled in water

Tincture – extraction with alcohol Tincture – extraction with alcohol or vinegar or glycerin and wateror vinegar or glycerin and water

More preparationsMore preparations Capsules Capsules

– dried and ground herbs in a gelatin dried and ground herbs in a gelatin or vegetable capsuleor vegetable capsule

– dried extract of plant partdried extract of plant part Salve - an oil and beeswax/lanolin Salve - an oil and beeswax/lanolin

mixture used topicallymixture used topically

Basic ScienceBasic Science

Mechanism of actionMechanism of action Pharmacokinetics, etcPharmacokinetics, etc ToxicityToxicity

Often done AFTER clinical studiesOften done AFTER clinical studies

Clinical ScienceClinical Science

Federally funded studiesFederally funded studies

1.1. Echinacea Echinacea 19192.2. Ginseng Ginseng 22223.3. Gingko biloba Gingko biloba 884.4. Garlic Garlic 48485.5. SJW SJW 28286.6. Peppermint Peppermint 007.7. Ginger Ginger 998.8. Soy Soy >200>2009.9. Chamomile Chamomile 1110.10. Kava kava Kava kava 66

ProblemsProblems

Toxicity Interactions Adverse reactions

ToxicityToxicity

Renal toxicity Renal toxicity – Stephania Stephania

(Fang ji)(Fang ji)– Aristolochia Aristolochia

(Fang chi)(Fang chi)

LobeliaLobelia

YohimbeYohimbe

Liver toxicityLiver toxicity– ChaparralChaparral– ComfreyComfrey– GermanderGermander– Jin Bu HuanJin Bu Huan

Physician Actions

Avoid products with multiple herbs Consider following LFT’s, BUN, Cr Consider herbs in differential Obtain samples when problems

suspected Report to MedWatch 1-800-332-

1088

InteractionsInteractions

St John’s wortSt John’s wort– Studies - digoxin, Studies - digoxin,

protease inhibitors, protease inhibitors, TCAsTCAs

– Case reports - Case reports - cyclosporine, cyclosporine, warfarin, oral warfarin, oral contraceptives, contraceptives, theophylline, SSRIs theophylline, SSRIs

– Theoretical - ironTheoretical - iron

Adverse Reactions

52 y.o. male for R knee replacement52 y.o. male for R knee replacement Surgery went well, some oozing of Surgery went well, some oozing of

bloodblood Continued bleeding post operativelyContinued bleeding post operatively Smart medical student saves the daySmart medical student saves the day

– Ginkgo biloba, garlic, green teaGinkgo biloba, garlic, green tea

Product Quality

Genetics, growing conditions, Genetics, growing conditions, harvest time, product harvest time, product preparationpreparation

Misidentification, Misidentification, contamination, adulterationcontamination, adulteration

Quality Solutions

StandardizationStandardization Independent testingIndependent testing

– www.consumerlab.cwww.consumerlab.comom

– www.nsf.orgwww.nsf.org

Searching for answers:Searching for answers:real world workreal world work

Health Health Professional’s ActionsActions HHonor your patients reasons for usageonor your patients reasons for usage EEncourage open communicationncourage open communication RRead about herbal remediesead about herbal remedies BBe honest about what you learne honest about what you learn AAvoid criticismvoid criticism LList herbal remedies in the patient ist herbal remedies in the patient

chartchart

Weigand JM et al, FP Recertification, 22(9):45-62