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
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
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
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
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
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