Transcript Herbal Medicines - Multiple Myeloma Support Group

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Herbal Medicines
Dragana Skokovic-Sunjic, RPh, BScPhm
Pharmacist and Consultant on Herbal Products
NAMS Credentialed Menopause Practitioner
Dell Pharmacies
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
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”
Update on Regulations
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?

-
-
-
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
How is this going to affect us?
 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!
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
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
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
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
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)
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
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
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
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”)
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
Milk thistle
What it does?
 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
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
UPDATE
ON SOME OF THE
MOST COMMON HERBALS
Echinacea
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
Co-A reductase inhibitors or “statins”, tamoxifen;
2) CYP1A2 substrates are : diazepam, haloperidol,
methadone, olanzapine, ondansteron, propranolol;
3) CYP2C9 substrates are : phenytoin, tolbutamide,
NSAIDs;
MSM
Methylsulfonylmethane
 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
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
HELPFUL WEBSITES
( quality assurance )
 www.consumerlab.com
 www.supplementwatch.com
 www.healthwatcher.ca
More questions, need
references...?
Go to : www.dellpharmacy.com
Or e-mail :
[email protected]