Self Care

anything patients do on their own to identify, treat, or prevent disease

Pharmacy's role

• improve adherence ot appropriate therapies
• minimize the risk of drug interactions and adverse events
• guide patients to wiser health care decisions

SCHOLAR

Quickly and accurately assess the patient

Mandated safety

Established 2 classes of drugs

• RX
• OTC

• Applied safety AND efficacy for all drugs
• Had grandfather clause

• Phase 1
• Review panel evaluates products
• Phase 2
• Deliberations for Category 2 and 3 ingredients
• Proposed rule or Tentative Final Monograph published
• Phase 3
• Deliberations continue for category 2 or 3
• Final rule or Final monograph published

Phytochemicals

• Plant natural products
• Secondary metabolites which possess complex and highly varied chemical structures sometimes confined to differetn botanical family, genus, and/or species

Aloe vera

• fresh/processed products of Aloe vera other Aloe spp.
• cure-all plant
• contains anthraquinone glycosides used as laxative
• juice used to heal burns and skin protection from UV radiation

Pygeum africanum (prunus africana)

therapeutic: BPH

activity: reduces the excitability of detrusor muscle, increases prostatic secretions

AE: diarrhea, constipation

*demonstrated improvements in urinary flow

vaccinium myrtillus

• effective against diahhrea
• blackberry leaves, blueberry leaves, rasberry leaves
• tannins/other phenolic compounds are active compounds
• phenolic compounds --> antioxidants

Cimicifuga racemosa (actaea racemosa)

• for postmenopausal symptoms
• active ingredients are triterpenoidal glycosides --> structural similarities w/ steroids
• binds estrogen receptors
• toxic in large doses

AE: GI complaints, headache, rash,concern about hepatitis secondary to black cohosh

*no difference in vasomotor symptoms (HALT study)

Bitter Orange

Citrus aurantium

therapeutic: appetite suppressant, treatment of dyspepsia

AE: theoretically by increase BP, HR, can cause CV toxicity due to synephrine and octopamine content

interactions: inhibits activity of drugs through 3A4

Petasites officinales

therapeutic: prevention of migraines, treatment of pain

AE: hepatotoxc, carcinogenic, avoided in lactation and pregnancy, caution with ragweed allergy

Uncaria tomentosa AND Uncaria guianensis

• used locally for various diseases
• U. tomentosa said to have immunostimulants and antiinflammatory agents

Vaccinium macrocarpon

• rich in phenolic compounds --> antioxidant properties
• reduce adhesion to bladder epithelium --> may block E. coli
• therapeutic: prevent and treat UTI
• AE: cranberry tabs may increase kidney stones

Matricicaria reutita

tea to treat common colds

works as a diaphoretic and carminative

Angelica sinensis

Siberian ginseng (Eleuthero)

Eleutherococcus senticosus

lignan derivatives are said to be active ingredients --> activity in humans unconfirmed

Sambucus nigra

has diuretic activity

Ephedra sinica

• Chinese herb for brochial asthma, clod, flu, etc.
• FDA regulates levels of total ingested ephedra alkaloids in herabal prepartions --> max of 8mg per dose and 24md per day
• major active ingredient is ephedrine >sympathomimetic activity

Echinacea spp. (E. purpurea, E. angustifolia, E. pallida)

used as a immunostimulant

AE: mild GI discomfort, headache, pts w/ ragweed allergy should not take this

those with severe illnesses (HIV/AID, MS, TB) not take this

*beneficial in bacteria brochitis, no benefit to prevent URI

Tanacetum parthenium (Chrysantheum parthenium)

• effective against migraines
• active ingredient is parthenolide --> pro apoptotic properties w/ potential anticancer agent
• shown to inhibit serotonin

activity: effects on prostaglandin synthesis, platelet aggregation, macrophage function

AE; minor GI side effects, such as heartburn, nausea, abdominal pain

interactions: warfarin and other platelet active herbs or drugs?

*freq. of migraines may be reduced, as well as associated symptoms of pain, nausea, vomitting, etc.

Garlic

Allium sativum

contain active ingredient allicin

has sulfur containing compunds:

• lower cholesterol
• prevent platelet aggregation
• antioxidant activity

for: breast cancer, hyperlipidemia, hypertension DM

physiologic: reduces homocysteine levels

Adverse Effects/Contraindications/Precautions

ü  GI side effects as well as bad breath and body odor.

ü  Allergic reactions induced by oral garlic have been reported on rare occasions.

ü  Topical application of garlic cloves and concentrates associated with burns in children.

 Interactions

^ü    Warfarin and other platelet active drugs and herbs?

^ü    Effects on CYP3A4 and CYP2D6

^ü    Docetaxel

no significant effect on LDL's

Panax ginseng (Asian) / P. quinquefolius (American)

• immunostimulating activity
• aphrodisiac
• ginsenosides are active ingredients

Asian --> mental & physical stress, anemia, DM

AE: insomnia, BP changes, headache, anorexia

interactions: phenelzine

Ginkgo biloba

used for memory

therapeutic: Alzheimer's disease, vascular dementias, interminttent claudication

AE: mild GI effects, headache

interactions: warfarin and other platelet active drugs or herbs?

*no benefit shown in test groups

Zingiber officinale

similarity in structure to capsaicin

Hydrastis canadensis

• important source of alkaloid drugs
• mainly used for indigestion, GI and respiratory problems, and skin infections

Aesculus hippocastanum

• for chronic venous insufficiency (used widely in Europe)
• contains beta-aescin and flavonoids --> reduce capillary venous permeability

adverse effects: GI symptoms, pruritis

interactions: warfarin/ other platelet active drugs?

*some efficacy in reducing leg pain

Trifolium pratense

Serenoa repens (Serenoa serrulata)

used for benign prostatic hyperplasia

rich in fatty acids and phytosterols

therapeutic: BPH

activity: inhibit 5-alpha reductase for converting testosterone to dihydrotestoterone

AE: GI complaints

contain at least 85% to 90% standardized FA's

*improved urinary symptom scores compared to placebo

Silybum marianum

therapeutic: liver disease, cirrhosis

activity: silymarin (in seeds and leaves) -->antioxidative and hepatoprotective

AE: nausea, abdominal fullness, allergy to ragweed not take this

standardized to 70-80% flavonolignans

*benefit in delayed progression of liver disease and Hep C infection

Hypericum perforatum

• used in Europe for depression
• contains hyperforin (thought to be active ingredient) --> inhibits uptake of serotonin
• induction of CYP450 enzymes

AE: GI upset, dizziness, allergic reactions, insomnia

w/drawal reaction w/ abrupt d/c

interactions: potent 3A4 inducer, increase risk of serotonin syndrome

Valeriana officinalis (Valeriana exaltata)

• used as sedative/tranquilizer
• no side effects reported

*improved quality of sleep

*less effective than temazepam or diphenhydramine

foods (and/or their extracts) that may provide health benefit beyond basic nutrition

formulated to address specific nutritional deficiencies due to diseases (e.g. DM, osteoporosis) and intended for use by patients under MD supervision

pharamceuticals from botanical sources e.g. taxol, morphine, etc.

Botanical Drugs

FDA approved, prescribed by MD

Kava Kava

Piper methysticum

sedative or psychotropic effects

major ingredients, pyrones, have analgesic effects

Symphytum officinale

• used for wide range of ailments (skin, ulcers, arthritis)
• contains hepatotoxic pyrrolizidine alkaloids
• now labeled for "external use" only

Camellia sinensis

green tea-->weight loss and enhance cognitive performance; also used to prevent cancer, CVD

AE: N/V, abdominal pain, increased risk of hepatotoxicity

*most evidence is enhancing mental alertness, standardized green tea have 25%ECGC which may have modest effects on obese pts

• fermented with Monascus species
• contains polyketides (monacolins), pigments, fatty acids
• major monacolin K in crystallized form is Mevacor --> lipid lowering drug
• bioavailabilty enhanced w/ grapefruit juice

unhealthy acids

• palmitic acids
• stearic acids

single double bond

• olive oil
• linseed oil

multiple double bonds

• omega-3 fatty acids
• fish oils

Polyphenols, flavonoids, bioflavonoids

• antioxidants
• quench harmful radicals or dangereous oxidants in body

phenolic rich --> tea (green and black); grape seed and extract; red wine and resvertrol

Phytoestrogens

abundantly in legumes

popular sources:

• soy
• red clover
• black cohosh

used for PMS, BPH, mastalgia

AE: GI complaints, rashes, migraines

Interactions: red clover base enhance warfarin; red clover base inhibit activity of CYP1A2, 2C9, 2C19, 3A4

*Genistein(market name)shown counteract tamoxifen; also shown to have improvements in women for BMD

good radical quenchers (found in plants)--> antioxidant and phytoestrogen effects

found in:

• flax and sesame seeds
• burdock roots
• Siberian ginseng

describe compounds which stimulate the immune system in general; many help lympocyte production, phagocytosis, and sometimes immunoglobulin production

e.g. echinacea, medcinal mushrooms

• structurally defined by basic nitrogen atom
• bitter taste
• have pharacological effects as medications and recreational drugs

e.g. cocaine, morphine, quinine

many plant alkaloids toxic are toxic

cytochrome elicitors

found in higher plants

furancourmarins in grapefruit --> CYP 3A4 elicitor

plant sterols and stanols

• very close to cholesterol structurally
• widely used in supplements and functional foods for heart health
• work competitively to human sterols and steroid hormone receptors

• hydrophobic molecules and hydrophillic sugars
• act like soaps and are hemolytic
• immunopotentiating and considered tonics (e.g. ginseng, yucca, etc.)
• used in cosmetics

Cyanide glycosides

in presence of beta-glucosidase enzyme lose their sugar portion to form cyanohydrin which can then undergo hydrolysis to form benzaldehyde and hydrogen cyanide (HCN)

• e.g. amygdalin in Prunus spp. (apricots, peaches, cherries, plums)

cruciferous vegetables contain glucosinolates which is converted by enzyme myrosinase into isothiocyantates --> may induce phase II enzymes --> claims of detoxification and anti-carcinogenic properties

Curcuman longa

• Indian curry spice
• active compounds are curumoinoids
• anti-inflammatory effects

natural extract of plant waxes and is usually a mixture of fatty acids

Borago officinalis

• used as astringent and demulcent
• contains pyrrolizidine alkaloids ->carcinogenic, hepatotoxic
• no proof of efficacy

Arnica montana --> compositae plant

• alcohol tinture extract used topically as counter irritant
• antiinflammotory compounds

Calendula

Calendula officinalis  

• European drug --> ester
• treat wounds and skin problems
• antiinflammatory effect of extract reported

Nepeta cataria

used as a sedative (in humans)

Harpagophytum procumbens

• cure wide variety of ailments --> rheumatism and cancer
• no proof evident

Cratagenas monogyna

claimed to have hypotensive and cardiotonic activities

Viscum album 

• hemi-parasitic plants
• folkloric uses in Europe for diseases such as hyptertension
• quite toxic

Mentha puligeum

curing effects ranging from cold to PMS

Phyolacca americana

• treatment of rheumatism and other ailments (efficacy not confirmed)
• plant contains toxic saponins

Arctostaphylos uva-ursi

diuretic and urinary disinfectant

active ingredient arbutin

mucopolysaccharides --> effective against cancer

"sharks don't get cancer"

Chondroitin sulfate

inter-cellular material in connective tissues and joints

• combnation with glucosamine works against osteoarthritis
• not only works as an antiinflammatory but also regenerates tissues

AE: GI discomfort, alopecia

interactions: theoretically may enhance warfarin effect

building block of various skeletal and connective tissue

reported effective against osteoarthritis

activity: stimulates synthesis of glycosaminoglycan, proteoglycan and hyaluronic acid

AE: avoid w/ selfish allergy

• for insomnia and jet lag
• claims to prevent cancer slow aging
• is a natural endogenous hormone (close to serotonin)

AE: N/V, HA, tachycardia, mood and BP changes

Interactions: theoretical ones with fluvoxamine, MAOI, BZDP and valproate

*prevent jet lag when crossing 5+ time zones taken 10pm-12am

*consistent efficacy in improving sleep

• important function to quench harmful radicals in the body --> anticancer claim
• quite toxic in large doses

• powerful antioxidant
• protects vitamin E
• maintain CV health

generally well tolerated, some nausea, insomnia, anorexia

interactions: warfarin and other platelet active drug

*efficacy in reducing statin-induced myopathy is limited

*efficacy in reducing [LDL] is slight

1994 Dietary Supplement and Health Education Act

the term "dietary supplement" referest to roal product contatin a "dietary ingredient" such as vitamins, minerals, herbs or other botanicals, amino acids, dietary substances used to supplement the diet by increasing the total deitary intake, or a concentrate, metabolite, constituent, extract or combinations of these ingredients

mandates any adverse effect to be reported to the FDA

intended to place more structure on regulating DS

Medwatch reporting by consumers

• 10-29% of daily recommended amount --> good source
• <20% of daily recommended amount --> excellent source

consumers, healthcare officials fund studies

*National Institute of Health

does not fund studies, has pt related information

*National Institute of Health

encourages non-allopathic professionals to document products used, success and failure; natural products and cancer information available

*National Institute of Health

active ingredient: docosahexaenoic acid (DHA), eicosapentaenoic acid(EPA)

therapeutic uses: prevent CVD, decrease TG's by 10-33% (dose dependent)

also for inflammatory conditions like RA

interactions: theoretically large doses of fish oil may inhibit platelet agregation, actual effect on bleeding risk unknown

DART --> EPA and DHA DS reduce all cause mortality and CVD outcomes

therapeutic uses: hyperlipidemia, intermittent claudication, MI

activity: waxy alcohols from sugar cane

AE: generally well tolerated, isolated effects of migraines, insomnia, somnolence, etc.

*not much efficacy in lowering LDL

Cinnamon

active ingredient: procyanidin typ-A polymer

therapeutic: lower [BG] w/ C. cassia

adverse effects: none

*efficacy dose dependent

Ginger

active ingredient: 6-gingerol, 6-shogaol, 8-gingerol

therapeutic: relieve nausea, motion sickness, morning sickness

AE: heartburn

interactions: warfarin and other platelet active drugs or herbs?

SAMe (S-adenosyl methionine)

therapeutic: osteoarthritis, HD, depression

AE: N/V, diarrhea, heartburn, risk of

interactions: other antidepressents, meperidine, DM b/c of SAMe's serotonergic activity

*small studies in depression and osteoarthritis suggest efficacy

therapeutic: treatment of obesity, hypercholesterolemia

AE: GI upset, flatulence, nausea

pts w/ selfish allergy should use product w/ caution

*thought to work similarly like orlistat to block GI absorption of fat

therapeutic: use for weight loss, enhance athletic performance

AE: side effects reflect caffeine content and include insomnia, tachycardia, nervousness

3.6-5.8% of caffeine -->potential drug-drug-herb interactions due to high caffeine content

therapeutic: appetite suppressant

AE: unknown

therapeutic uses: dementia, increase memory

activity: peripherally and centrally acting acetylcholinesterase inhibitor

AE:sweating, blurred vision, N/V

interactions: concurrent use of anticholinergic drugs