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

 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

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

 Natural Health Products Regulations published in the Canada Gazette , Part II on
June 18, 2003
 Came into force on January 1, 2004, with transition period ranging from 2-6 years

When and how will the new regulations be implemented?
 By the end of 2 years, all manufacturers, importers and 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)

How will the consumer know when a
NHP has been authorized for sale by
Health Canada?
 The product label will bear an 8 digit product 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

How will NHP be labeled under the new regulations ?
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 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

 No more magic…
 No more guessing game…
 Just read the label !

“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!

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

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

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

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

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)

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

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

 Fruit contains flavonoids, anthocyan and cyanogenic glycosides
 Raw and unripe fruit cause nausea, vomiting, severe diarrhea
 Uncooked juice can cause weakness, dizziness, numbness

Black elderberry fruit 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”)

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

 Actively protects the liver by strengthening the outer membrane of liver cells and preventing toxins from penetrating
 Stimulates an enzymatic action that in turn increases protein synthesis, enables the liver to form new cells and repair itself

 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

E. 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 effective only if taken at the onset of symptoms.

Echinacea
Who 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)

Echinacea
Who 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…

Echinacea
Who should not be taking it?
 Patients with renal or hepatic impairment
 Patient with diabetes :
 Use in
infants and small children
- frail elderly not recommended

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

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

St.John’s Wort
Update 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 )

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

 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

 www.herbalgram.com
 www.herbs.org
 www.amfoundation.org/herbmed
 www.onhealth.net
 www.naturaldatabase.com
 www.cochrane.hcn.net.au

 www.consumerlab.com
 www.supplementwatch.com
 www.healthwatcher.ca

Go to : www.dellpharmacy.com
Or e-mail : dskokovicsunjic@dellpharmacy.com