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DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994 DEFINITION OF DIETARY SUPPLEMENT is a product (other than tobacco) that is intended to supplement the.

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Presentation on theme: "DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994 DEFINITION OF DIETARY SUPPLEMENT is a product (other than tobacco) that is intended to supplement the."— Presentation transcript:

1 DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994 DEFINITION OF DIETARY SUPPLEMENT is a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients. is intended for ingestion in pill, capsule, tablet, or liquid form. is not represented for use as a conventional food or as the sole item of a meal or diet. is labeled as a "dietary supplement." includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless the Secretary of Health and Human Services waives this provision).

2 SAFETY Under DSHEA a dietary supplement is adulterated if it or one of its ingredients presents "a significant or unreasonable risk of illness or injury" when used as directed on the label, or under normal conditions of use (if there are no directions). A dietary supplement that contains a new dietary ingredient (i.e., an ingredient not marketed for dietary supplement use in the U.S. prior to October 15, 1994) may be adulterated when there is inadequate information to provide reasonable assurance that the ingredient will not present a significant or unreasonable risk of illness or injury The Secretary of HHS may also declare that a dietary supplement or dietary ingredient poses an imminent hazard to public health or safety

3 NUTRITIONAL SUPPORT STATEMENTS Claims may not be made about the use of a dietary supplement to diagnose, prevent, mitigate, treat, or cure a specific disease (For example, a product may not carry the claim "cures cancer" or "treats arthritis." ) Appropriate health claims authorized by FDA--such as the claim linking folic acid and reduce risk of neural tube birth defects and the claim that calcium may reduce the risk of osteoporosis--may be made in supplement labeling if the product qualifies to bear the claim. Manufacturers may describe the supplement's effects on "structure or function" of the body or the "well-being" achieved by consuming the dietary ingredient. To use these claims, manufacturers must have substantiation that the statements are truthful and not misleading and the product label must bear the statement "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

4 Black Cohosh Action: Antispasmodic, regulates menses, astringent, diuretic, cough suppressant, and diaphoretic. Astringent and sedative. Medicinal uses: Delayed painful menstruation and ovarian cramps. Menopausal symptoms Rheumatic pains, muscular and neurological pain. Side effects: low Dose:20-80mg std ext. (2xd) 250-550 mg freeze dried root

5 Chemistry, Functions, Toxicity Steroidal terpenes, cimigoside, acteina, isoflavone, formononetine Vascular and estrogen-like action, suppress LH,(?) Contraindicated during pregnancy (uterine contraction)

6 Herb –Drug Interaction Anesthetics, antihypertensive, sedatives: may increase hypotensive effect Estrogens, hormonal contraceptives: may increase effects. Possible interaction with tamoxifen (Nolvadex)

7 Bilberry Actions: vasoprotective, anti- edema, anti-inflammatory, astringent. Medicinal uses:acute diarrhea and mild inflammation of the mucus membranes. Prevent capillary fragility ( eye disorders, macular degeneration )Varicose veins, thrombosis and angina. Side effects:none Dose: 80-100mg std ext (2xd)

8 Chemistry, Functions, Toxicity Active components:Anthocyanoside, tannins, flavonoids Reduction of vascular permeability and tissue edema, aid in micro vascular blood flow, retina, macular degeneration Hepatic dysfunction (if tannin high)

9 Herb –Drug Interaction Anticoagulants/antiplatelet Don’t take with alcohol Disulfiram-like reactions Don’t take it during breast-feeding

10 Chamomile Actions: Anti-inflammatory, antiseptic, sedative, antispasmodic. Medicinal Uses: Gastrointestinal disorders. Calming and sedative effect general relaxation. Children’s cold, eye wash, skin treatment. Side effects: low Dose: 1-3 teaspoon decoction tincture 1-4 ml in a cup water oil:1-2 drop (1:50 dilution)

11 Chemistry, Functions, Toxicity Volatile oils: α -bisabolol, chamazulene, ( ↓ inflammation, fever ) flavonoids: apeginin, luteolin, quercetin ( inflammation, sedative, antioxidant) CNS action is through benzodiazepine receptors Orally used to treat diarrhea, anxiety, restlessness, flatulence, teas mainly used for sedation or relaxation. Topically reduce inflammation, induce healing of wounds and burns Toxicity: contact dermatitis, allergic reactions GI; nausea, vomiting Anaphylaxis in case of extreme sensitivity

12 Herb –Drug Interaction Antiplatelet and anticoagulants (warfarin, aspirin, heparin, NSAIDs, clopidogrel, eptifibatide, tirofiban, ticlopidine, dipyridamole and COX-2 inhibitors

13 Dong Quai Actions:adaptogenic, restores menstrual regularity, reduces PMS, prevents anemia, digestive bitter Medicinal uses: Female hormonal balance, high iron content (anemia treatment), promotes circulation and bile secretion. Side effects: low Dose: 125-500 mg std ext(eve) tincture 1-2 teaspoon

14 Chemistry, Functions, Toxicity At least six coumarin derivatives (anticoagulant, vasodilating, antispasmodic activity) N-buthylphtalide, nicotinic acid, safrole, Vitamins; A, E, B12 Weak estrogen-agonist activity, treats blood deficiency, chronic hepatitis and cirrhosis, irregular menstruation. High dose cytotoxic, bleeding tendency,first trimester abortive) don’t use in acute virus infection

15 Herb –Drug Interaction Enhance anticoagulant effect Increased risk of photosensitivity

16 Echinacea Actions: immuno-stimulant, anti-inflammatory, vulnerary, lymphatic. Medicinal Uses: preventive use in case of colds and flu at early stage of infections. Wound and burns. Infections of urinary tract. Inflammation of the mouth and pharynx. Side effects: low Doses: tincture15-30 drops 2-5 times the first day /2x the following days.

17 Chemistry, Functions, Toxicity Alkylamides, caffeic acid derivatives, polysaccharides, essential oils, polyacetylene flavonoids Stimulates phagocytosis, mobility of leucocytes, respiratory cellular activity Allergic reactions, angioedema, urticaria, anaphylaxis

18 Herb –Drug Interaction Alkylating agents : anticancer therapy drugs azathioprine (Imuran) CellCept cyclosporine (Neoral, Sandimmune) Prograf Rapamune Zenapak Liver enzyme influence/clearance Allergy drugs such as Allegra Antifungal drugs such as ketoconazole (Nizoral) and Sporanox Cancer drugs such as etoposide, paclitaxel, vinblastine, or vincristine Drugs for high cholesterol such as lovastatin midazolam (Versed) Oral contraceptives

19 Evening Primrose Actions: Anti-inflammatory, anti-allergic, corrects omega-6 deficiency, hypotensive Medicinal Uses: PMS, atopic dermatitis, rheumatoid arthritis, CFS, ulcerative colitis, IBS, hypertension, mastalgia Side effects: low Doses:250-500 mg/ day 600mg arthritis, hypertension, cardiovascular disorders

20 Chemistry, Functions, Toxicity PUFA, gamma linoleic acid Anti-inflammatory, intestinal Ca absorption, Hypotensive, inhibit gastric mucosal damage Headache, mild nausea, arachidonic acid build up

21 Herb –Drug Interaction Avoid concomitant use with phenothiazines. Contraindicated in : epilepsy

22 Feverfew Actions: Anti-inflammatory, vasodilator, anti-pyretic, antispasmodic, bitter Medicinal Uses: Prophylaxis and treatment of migraine. Cough, colds, febrile diseases, nervous debility, worm infestation, dyspepsia. Side effects: low-medium Doses: 50-200 mg/day tincture 5-20 drops

23 Chemistry, Functions, Toxicity Sesquiterpene lactons: parthenolide, (and derivatives) canin, balchanin, volatile oils, flavonols. Extracts inhibit the release of serotonin from platelets Inhibits platelet aggregation Inhibits arachidonic acid pathway, (prostaglandins and leukotrienes) Inhibits release of granule contents from white blood cells Contraindicated in pregnancy, inflammation of oral mucosa (ulceration)

24 Herb –Drug Interaction None documented potential antithrombic effects Potential interaction with nonsteroidal anti- inflammatory drugs (NSAIDs)

25 Garlic Action: Lipid lowering, Anti- hypertensive, anti-thrombic, anti-oxidant, anti-fungal, anti- bacterial anti-tumor Medicinal Uses: lower serum cholesterol and triglyceride elevate HDL, treatments of infections, high blood pressure, Stroke and cancer of GI tract prevention. Side effects: low-medium Doses: up to 1 g of std ext 2- 5mg allicin.

26 Chemistry, Functions, Toxicity alliin, converted by the enzyme alliinase to allicin. Functions: Antibacterial/Antifungal - Antimycotic/Antiviral - Hypoglycemic - Anticoagulant (antiplatelet aggregating) - Fibrinolytic activity enhancement - Lipid lowering - Antioxidant/Anticancer - Hypotensive - Hepatoprotective - Immunomodulatory Large oral intakes can lead to gastrointestinal symptoms, changes to intestinal flora and allergic reactions. Garlic is contraindicated before surgery

27 Herb –Drug Interaction Acetaminophen and other drugs metabolized by CYP2E1 Anticoagulants, NSAIDs, prostacyclin Antidiabetics Herbs exert anticoagulation, antihyperglycemic effect

28 Gingko Actions: Anti-PAF, anti- oxidant, circulatory stimulant, vasodilation. Medicinal Uses: effective in the management of cerebral insufficiency, dementia and circulatory disorders. Altitude sickness, tinnitus, PMS, headache, migraine, eye problems, allergies Side effects: very low Doses: 120-160mg/day std ext

29 Indications: Traditionally known as an anti-microbial & anti- tubercular agent, new research has shown a profound activity on brain function and cerebral circulation. Clinically it is proving effective in a range of vascular disorders.

30 Precautions and dosage : Few, if any side effects have been documented Gastric disturbance, headache and allergic skin reaction observed after prolonged administration. Dosage: Typical daily dose is 120-160mg. Available in capsules 40,60 or 120 mg of a concentrated (50:1) leaf extract. Tincture: 1-2 ml. Interaction: anticoagulants, antiplatelet (affects) platelet activating factor Insulin and oral hypoglycemic agents: elevated glucose because increased clearance of insulin and sulfunylureas Thiazide diuretics: increased blood pressure Trazodone combination with ginkgo caused coma (in Alzheimer’s)

31 Ginger Actions: Antiemetic, anti- inflammatory, digestive stimulant, antiplatelet, spasmolytic, carminative. Medicinal uses: relieving motion sickness, used in variety of GI disorder, prevent lipid peroxidation, treat parasitic infections, circulatory stimulant (positive inotropic), arthritis Side effects: low Doses:0.5-1g of fresh or dried root 500 mg candy, 1-2ml tincture

32 Chemistry, Functions, Toxicity volatile oils and nonvolatile pungent compounds (zingeberene, curcumene, farnesene, and gingerol, shogaol ) The following functions have been tested experimentally: Anti-emetic activity, Antiserotoninergic activity and gastrointestinal motility effect, Muscular contractility in the gastrointestinal tract. Ability to neutralize toxins and anti-tumor effect. Anti-inflammatory effect. Immune system potentiation Platelet aggregation,Fibrinolysis No toxicity (at pharmacologic dose) don’t use it for morning sickness

33 Herb –Drug Interaction Large doses may increase bleeding time Large doses cardiac arrhythmias, depression

34 Ginseng (Panax) Actions: Adaptogenic, tonic, immunomodulator, cancer preventive. Medicinal Uses: general performance under stress, congestive heart failure, elevates HDL, impotency, non- insulin dependent diabetes, preventive in certain types of cancer. Side effects: low Doses:05-2g dried root 1-5ml tincture

35 Chemistry, Functions, Toxicity Ginsenosides, biotin, B1,B2, B12, panthotenic acid, nicotinic acid, Increase T-cell activity, stimulates interferon, HDL production, accelerate nuclear RNA production Ginseng abuse syndrome (increased motor activity, diarrhea, nervousness, insomnia, hypertension, edema)

36 Herb –Drug Interaction Anticoagulants (warfarin) Antidiabetics, insulin; increases hypoglycemic effect Drugs metabolized by CYP3A4 (inhibits the enzyme system) MAO inhibitors, phenelzine, hypericin (tremor, headache, mania)

37 Goldenseal Actions: antispasmodic, weak antibiotic, expectorant, laxative, bitter hepatic. Medicinal Uses: stimulate bile secretion, inflammatory conditions of the mucous membranes (respiratory, GI,) external applications Side effects:low-medium Doses: 250-300 mg fd ext. 05- 1g dried root (capsule)

38 Chemistry, Functions, Toxicity Alkaloids, berberine, hydrastine, volatile oils, chlorogenic acid Anti-inflammatory, antihemorrhagic, immunomodulatory, muscle relaxant, hydrastin causes peripheral vasoconstriction, berberine antibacterial CNS depression, paralysis, seizures Asystole, bradycardia, respiratory depression Abdominal cramp nausea, diarrhea Anemia, leukoppenia Contact dermatitis

39 Herb –Drug Interaction Anticoagulants, sedatives, proton pump inhibitors (H2 antagonists), allergic drugs, antidepressants Unpredictable: ACE inhibitors such as captopril, enalapril, lisinopril, and Monopril Beta blockers such as atenolol, metoprolol, and propranolol Calcium channel blockers such as nifedipine, Norvasc, and verapamil Diuretics such as Dyazide, furosemide, and hydrochlorothiazide

40 Hawthorn Actions: Cardio tonic, cardioprotective, antioxidant, hypotensive antiarrhytmic Medicinal Uses: traditional drug to treat heart problems, hypertension, diuretic for kidney problems Side effects: none Doses: 1-3g flower leaves or berry, by infusion fluid extract 3-6 ml, tincture: 1-2 ml (3xd)

41 Chemistry, Functions, Toxicity Flavonoids and procyanidins primarily responsible for action cAMP phosphodiesterase inhibition, slowly developing actions. The combined pharmacological effects are positively inotropic, chronotropic and dromotropic. Its negative bathmotropic effect makes this herb unique among anti- arrhythmic drugs, plus antilipidemic. No toxicity has been noted

42 Herb –Drug Interaction Antiarrhytmics ; the herb action is similar to class III antiarrhytmics Antihypertensive nitrates; increased risk of hypotension Cardiac glycosides; increased risk of cardiac toxicity.

43 Kava-kava (Piper methysticum) Parts used : roots, rhizomes Properties: bitter, pungent, warming herb, diuretic, relieves pain, relaxes spasm, stimulant effect on circulatory and nervous system Constituents: kava lactones / pyrones, kavain, dihydro-kavain methysticin, yangonine, Medicinal use: nervous anxiety, stress, restlessness, insomnia The sedative effect of kava-pyrones might be mediated via the GABA-A receptor.

44 Precautions and dosage : Patients should not use kava without first obtaining medical advice, and doses should not exceed 300 mg/day. In one clinical trial using WS 1490, the occurrence of adverse effects was rare. Only two reports (stomach upset in both cases) were rated as “possibly related.” The most commonly reported adverse effect of kava usage is kava dermopathy—a yellow, scaly, leprosy-like eruption of the skin and inflammation of the eyes. The drug contraindicated during pregnancy or nursing. It is also contraindicated in patients with endogenous depression because it increases the danger of suicide. Daily dose: equivalent of 60 to 120 mg kava lactones.

45 Possible interaction between kava-lactones and pharmaceutical drugs. The drug may enhances the effectiveness of barbiturates and other psychopharmacological agents. Kava lactons inhibit Cytochrome P-450 Drug clearance is slowing down, extended effect or toxicity Deficiency of CYP2D6 (7-9% of Caucasian population) People should avoid kava predisposed to liver problem or already taking drugs that have adverse effect on the liver.

46 Milk thistle Actions: hepatoprotective, antioxidant, cholerectic Medicinal Uses: regeneration of hepatocytes, cirrhosis, poisonous, alcoholic liver damage, fatty liver, expelling gallstone. Side effects:none –low Doses: 140 mg (2xd std for sylimarine) 1-5ml tincture

47 Chemistry, Functions, Toxicity Silymarin may stimulate the action of nucleolar polymerase A, resulting in an increase in ribosomal protein synthesis, thereby stimulating the regenerative ability of the liver and the formation of new hepatocytes. Silybin, the active constituent of silymarin has been reported to work as an antioxidant, scavenging free radicals.

48 Herb –Drug Interaction Aspirin: improve clearance in patients with cirrhosis Cisplatin: prevent kidney damage Disulfiram: drugs containing alcohol may cause disulfiram like reactions Tacrine: reduces adverse cholinergic effects Hepatotoxic drugs: prevent liver damage caused by butyrophenones, phenothiazines, phenytoin, acetaminophen, and halothane.

49 Saw Palmetto Actions: Diuretic, urinary antiseptic, anti-inflammatory, spasmolytic, endocrine agent Medicinal Uses: treat mild to moderate BPH, inflammation of respiratory and genitourinary tract Side effects: none-low Doses:160 mg (2xd std lipophylic ext) or 2-4 ml tincture

50 Chemistry, Functions, Toxicity It contains sterols, flavonoids, water-soluble polysacharides and fatty oil. Antiandrogenic, antiestrogenic and anti-inflammatory actions The oily fraction inhibits in vitro testosterone 5a- reductase activity, an enzyme in male hormone metabolism. 5 a-reductase converts testosterone to dihydrotestosterone. The overproduction of dihydrotestosterone is responsible for prostate enlargement. No toxic or health hazard, occasional stomach complaints

51 St. John’s Wort Actions: Antiviral, nervine, antidepressant, antiseptic Medicinal Uses: treatment for mild to moderate depression, neuralgia, sciatica, muscular rheumatism, menopausal anxiety, bruises, shingles Side effects: low Doses: 300 mg std ext 0.3% hypericin 3xd 3-6 ml liquid ext

52 Herb-Drug Interaction St. John's wort may interact with oral contraceptives protease inhibitors (such as indinavir and ritonavir, which are used to treat HIV infectionindinavir ritonavir MAOIs and other antidepressants immunosuppressant cyclosporinecyclosporine Cardiac glycosides digoxindigoxin iron supplements the anticoagulant warfarin warfarin

53 Uva-ursi Actions: Astringent, antibacterial, mild diuretic, urinary antiseptic. Medicinal Uses: urinary tract infections including cystitis, nephritis, urethritis, yeast infection early stage of genital herpes Side effects:low-medium Doses: 1 tsp in 0.5 L water boiled for 15 min. 1-4 ml tincture in a glass of water.

54 Chemistry, Functions, Toxicity Leaves contain: hydroquinone derivatives; arbutin, methylarbutin, ericolin, ursone, gallic acid ellagic acid, tannin (5-7%) Arbutin is hydrolyzed to hydroquinone which acts as a mild astringent and antimicrobial in alkaline urine. Ursolic acid is contributing to the diuretic effect. Adverse reactions: seizures, tinnitus, nausea, irritation of the bladder and UT mucous membrane, hepatotoxicity.

55 Herb –Drug Interaction Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Corticosteroids: Arbutin increases the inhibitory action of prednisolone and dexamethazone on contact dermatitis, allergic-type hypersensitivity and arthritis. Diuretics: enhanced effects

56 Valerian Actions: Anxiolytic, mild sedative, hypnotic, spasmolytic Medicinal Uses: insomnia, nervous unrest, stress and neuralgia, depression and anxiety Side effects:low Doses: 400-500 mg liquid ext capsules of 100, 250, 380, 400, 445, 475, 500, 1000 mg tablets 160 mg 550 mg

57 Chemistry, Functions, Toxicity Sesquiterpenes (volatile oils) and valepotriates (iridoid triesters ). Acts via a central adenosine mechanism (partial agonist) Inhibits cAMP accumulations No clearly identified toxicities in humans Possible adverse reactions: CNS: headache, morning drowsiness, restlessness. CV: cardiac disturbances GI: GI complaints Withdrawal symptoms

58 Drug-herb Interaction No drug interactions have been reported in humans Potential reaction with barbiturates and benzodiazepines Contraindicated while undergoing treatment with barbiturates May be helpful in easing withdrawal from benzodiazepines.

59 Vitex Actions: prolactin inhibitor, dopamine agonist, exert progesteronic effect in women and anti-androgenic in men Medicinal Uses: PMS, menstrual irregularities, menopausal symptoms and fibroids, increase lactation, impotence, BPH Side effects: none-low Doses: 150-330 std ext (0.5% agnuside) (2xd)

60 Chemistry, Functions, Toxicity Iridoid glucosides: agnuside, aucubin luteolin like flavonoids, triterpenoids, alkaloid vitricine. Antiandrogenic, anti-inflammatory, progesteronic effect Female endocrine, reproductive disorders and hormonal imbalance, ovarian insufficiency inadequate lactation, PMS Headache, increased menstrual flow

61 Drug-herb Interaction Antihypertensive (antagonistic effect) Beta-blockers: possible risk of hypertensive crisis

62 Stress Every living organism is maintaining a complex dynamic equilibrium or homeostasis. Stress is a mutual actions of forces that take place across any section of the body and it is a state of threatened homeostasis. The human body reacts to stress by activating complex behavioral and physiologic responses. (Hans Selye)

63 Herbal Stress Management Daily mild Lemon balm (Melissa officinalis) Tilia europea Skullcap (Scutellaria sp) Chamomile (Matricaria recutita) Mugwort (Artemissa vulgaris) Oat (Avena sativa) Lavender (Lavendula officinalis) Short term extreme Passionflower (passiflora incarnata) Valerian (Valeriana officinalis) Skulcap (Scutellaria sp) Wild lettuce (Lactuca virosa) Long standing Ginseng (Panax, Quintifolum, Eleutherococcus)

64 Herbs used in depression: Mugwort (Artemissa vulgaris) California Poppy (Eschscholtzia californica) St. John’s Wort (Hypericum perforatum) Lemon Balm (Melissa officinalis) Basil (Ocimum basilicum) Passion Flower (Passiflora incarnata) Marijuana (Cannabis sativa) Kava-kava (Piper methysticum)

65 Herbs used in anxiety and headache AnxietyHeadache Black CohosCatnip Hopsblack pepper Jamaican dogwoodgreen tea Kava-kavadamiana Lemon balmfeverfew Mugwortgingko St. John’s wortmeadosweet Valeriansaffron rosemary wild ginger yerba mate willow

66 Herbs used in Common Cold AniseBayberryBurdockCatnip CinnamonColtsfootEchinaceaEphedra GarlicHyssopLindenLicorice OnionPau d’arcoPennyroyalPeppermint Rose hipSaw palmettoSweet violetVervain WillowYarrowYerba santa Meadowsweet

67 Herbs used in kidney and bladder disorders AsparagusBlackthornBorage BuchuCapsicumCelery CorianderCorn silkDevil’s claw HorsetailJuniperMarshmallow ParsleyPau d’arcoSarsaparilla SchisandraSoapwortStone root Uva ursi

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