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2. Herbal Medicines Dragana Skokovic-Sunjic, RPh, BScPhm Pharmacist and Consultant on Herbal Products NAMS Credentialed Menopause Practitioner Dell Pharmacies

3. Problems with natural and herbal products • High popular demand • Potentially very lucrative and profitable market • Non-satisfactory quality control and lack of regulations • Misconceptions about safety • Dangerous self-medication • Adulterated or mislabeled products

4. HOW TO AVOID HERBAL FRAUD • If it sounds too good to be true, it probably is! • Be cautious of testimonials claiming amazing results. • Watch out for claims such as : • “scientific breakthrough” • “miraculous cure” • “exclusive product” • “secret ingredient”

5. Update on Regulations • Natural Health ProductsRegulations published in the CanadaGazette,Part II on June 18, 2003 • Came into force on January 1, 2004, with transition period ranging from 2-6 years

6. When and how will the new regulations be implemented? • By the end of 2 years, all manufacturers, importersand labelers with good manufacturing practice (GMP) issued site licences • By the end of 4 years, any new NHP on the market should have a NHP licence or NPN (natural product number) • By the end of 6 years, all products that currently have DIN will have NHN or a DIN-HM (homeopathic medicine)

7. How will the consumer know when a NHP has been authorized for sale by Health Canada? • The product label will bear an 8 digitproduct licence number, proceeded by the letters “NPN” • NPN will indicate that the product has been reviewed by Health Canada for safety, quality and health claims

8. How will NHP be labeled under the new regulations? • The label will include: • Appropriate and truthful, recommended use and purpose • Route of administration, dose, duration • Side effects, contraindications, cautions, warnings • Medicinal and non-medicinal ingredients • Storage, lot number , expiry date • Name, address, phone number of the manufacturer

9. How is this going to affect us? • No more magic… • No more guessing game… • Just read the label !

10. “Herbs” used in the treatment of cancer • Canadian Yew ( Taxus Canadiensis) • Periwinkle ( Vinca sp.) Many alkaloids derived from plants are commonly used in the treatment of cancer (etoposide, vincristine, vinblastine). These potent alkaloids are not common, health food store variety!

11. Geranium oil ( Pelargonium sp.) Active constituents : citronellol and geraniol • clinically tested in post-herpetic neuralgia • pain relief dose-dependent (10-100% conc. tested), onset in 5-15 min, return to baseline in 24 hours • skin irritation equal to placebo (mineral oil) • Marketed in Canada as : Neuragen

12. Ginger (Zingiber officinale) • Evidence for efficacy in motion sickness and nausea in pregnancy • Preliminary evidence for inhibitory effect on thromboxane synthesis • May decrease nausea associated with radiation or chemo and help with the gastric emptying delays seen with cisplatin • Not as effective as 5-HT3 receptor antagonists

13. Ginger ( Zingiber officinale) • Major benefits: • no drowsiness as S/E • it is relatively inexpensive • Dose : 250-500mg BID-QID (max 4g/day) • Caution: monitor platelet count, do not use Ginger if platelets < 60,000 • Ginger may have anti-platelet effect

14. Marigold (Calendula officinalis) • Flowers used in the form of infusion (tea), tincture, extract, oil or ointment, • Promotes the granulation and facilitates healing of the skin and mucosal inflammations, wounds, burns or eczema • Active principles are volatile oils and xanthophylls present in high concentrations in the herb

15. Calendula - Official indications(German Commission E) • Inflammation of the oral and pharyngeal mucosa (prepared as tea and used as a mouthwash or a gargle) • Poorly healing wounds • Ulcus cruris (venous stasis ulcer)

16. Valerian ( Valeriana officinalis) • Indications: insomnia and anxiety and nervous disorders • Increases GABA levels by blocking reuptake (same neurotransmitter affected by benzodiazepines) • Dose: extract standardized for 0.8% of valerenic acid 100mg prn for anxiety 500-1,000 mg HS for insomnia

17. Valerian ( Valeriana officinalis) Side Effects: - no daytime sedation, - not addictive - large regular doses over time may cause headache, heaviness and stupor; Caution: not to be used with other sedatives or alcohol

18. Black Elderberry(Sambucus nigra) • Fruit contains flavonoids, anthocyan and cyanogenic glycosides • Raw and unripe fruit cause nausea, vomiting, severe diarrhea • Uncooked juice can cause weakness, dizziness, numbness

19. Black elderberryfruit extract • In several clinical studies have shown consistent results in the treatment of the flu in different populations (children, frail elderly ) • Inhibits hemagglutinin activity and replication of several strains of influenza viruses A and B • Recent in vitro studies have shown high effectiveness of black elderberry extract against bird flu virus; animal studies are underway • available in a liquid form (“Sambucol”)

20. Milk Thistle (Silybum marianum) • Seed contains a mixture of active principles called silymarin (flavolignan complex composed of silibinin,silidianin and silichristin) • Dose: 200mg (containing min. 70% silymarin) 3xday (note: silymarin is poorly soluble in water) • Has a long history of traditional use , clinical studies since early 1960s

21. Milk thistle What it does? • Actively protects the liver by strengthening the outer membrane of liver cells and preventing toxins from penetrating • Stimulates an enzymaticaction that in turn increases protein synthesis, enables the liver to form new cells and repair itself

22. Milk thistle What it does? • Protects the liver against toxins (amanitin, phaloidin, DL-ethionine, carbon tetra-chloride, thioacetamide, acetaminophen) • Improves liver function in patients with alcohol-induced cirrhosis (lowers mortality rate) • Reduces hepatotoxicity of neuroleptic drugs • Hepatitis (chronic and acute)-IV administration • Reduces likelihood of liver and kidney damage by some medications used in chemotherapy

23. UPDATE ON SOME OF THE MOST COMMON HERBALS

24. EchinaceaE. purpurea, E. pallida, E. angustifolia Do we know when and how to use it ? Recent studies show no benefits in taking Echinacea as a prevention against common cold or flu; Seems to be effectiveonly if taken at the onset of symptoms.

25. EchinaceaWho should not be taking it? Allergic reactions - who is at risk? Patients with hayfever, allergy to plants from the same family ( Asteraceae ) Case reports of anaphylactic shock after ingestion of echinacea extracts (capsule or liquid)

26. EchinaceaWho should not be taking it? Patients with severe systemic disease - pulmonary disease - neoplastic disease - immunosupression - AIDS, HIV infection - tuberculosis - multiple sclerosis - rheumatoid arthritis - systemic lupus erythematosus - asthma and COPD…

27. EchinaceaWho should not be taking it? • Patients with renal or hepatic impairment • Patient with diabetes : • Use in - infants and small children - frail elderly not recommended

28. EchinaceaWho should not be taking it? 1. Anti-neoplastic agents 2. Corticosteroids 3. Immuno-suppressants

29. Good News - recent studies confirm its efficacy in the treatment of mild to moderate depression - side effects profile excellent in comparison with other antidepressants St. John’s WortHypericum Perforatum

30. Bad News - effect on liver enzyme systems (CYP3A4 and other hepatic cytochrome P450 enzymes) - effect on p-glycoprotein St. John’s WortHypericum Perforatum

31. St.John’s WortUpdate on drug-herb interactions - SSRIs - “serotonin syndrome” - Sympathomimetics ( pseudoephedrine, xylometazoline, psycostimulants) - Levodopa (can lead to cathecholamine excess at neuronal site) - General anesthetics (prolongation of effect) - Digoxin ( due to induction of p-glycoprotein intestinal drug transporter) - Warfarin - due to induction of CYP4A4 and CYP2C9 which results in decreased warfarin concentrations - Protease inhibitors - induction of CYP3A4 -significant reduction in plasma conc. (treatment failure) - Estrogen and oral contraceptives – treatment failure - Cyclosporine and other immunosuppressive agents - significant reductions in plasma conc. (acute transplant rejections)

32. St.John’s WortUpdate on drug-herb interactions Some of the potential interactions include : 1) CYP3A4 substrates include : azole antifungals, calcium-channel blockers, carbamazepine, clarithomycin, cyclophosphamide, dopenezil, erythromycin, fentanyl, HMG Co-A reductase inhibitors or “statins”, tamoxifen; 2) CYP1A2 substrates are : diazepam, haloperidol, methadone, olanzapine, ondansteron, propranolol; 3) CYP2C9 substrates are : phenytoin, tolbutamide, NSAIDs;

33. MSMMethylsulfonylmethane • Promoted as a miracle cure for almost everything ( RA, allergies, GI upset, PMS, obesity, hypertension, diabetes, fibromyalgia, cancer, yeast infections, etc.) • Insufficient reliable information available to support any of those claims • Few case reports of prolonged bleeding time and significant drop in platelet count

34. HELPFUL WEBSITES( botanical information ) • www.herbalgram.com • www.herbs.org • www.amfoundation.org/herbmed • www.onhealth.net • www.naturaldatabase.com • www.cochrane.hcn.net.au

35. HELPFUL WEBSITES( quality assurance ) • www.consumerlab.com • www.supplementwatch.com • www.healthwatcher.ca

36. More questions, need references...? Go to : www.dellpharmacy.com Or e-mail : dskokovicsunjic@dellpharmacy.com