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Supplements, here, now.

Supplements, here, now. Sales DS about $13 billion in 2000, growing  5% yr Mayo Clinics 5/99: 61% pts said had used DS FDA 1995 survey data > 55% adults 5/00 Texas HMO survey: 40% Use  elderly, females, white, obesity, EtOH Most used per friend,relative, did not ask MD, Pharm

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Supplements, here, now.

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  1. Supplements, here, now. • Sales DS about $13 billion in 2000, growing  5% yr • Mayo Clinics 5/99: 61% pts said had used DS • FDA 1995 survey data > 55% adults • 5/00 Texas HMO survey: 40% • Use  elderly, females, white, obesity, EtOH • Most used per friend,relative, did not ask MD, Pharm • Most felt herbals “safe” and “no side effects”. • 6/99 JFP: most said “MD’s closed minded, don’t know about DS”

  2. Supplement regulation • 1906: FDA to eradicate “misbranding and adulteration” • 1938: FDA requires testing prior to marketing after health elixir kills 105– but allows traditional herbs • 1958 – 1993: GRAS list  250 trad. HS • 1962: Thalidomide. Kefauver-Harris laws require proof safety, efficacy, burden of proof on manufacturers.

  3. New law, New label • 1993: FDA proposal removal of HS from market if don’t meet rules. Congress deluged c protest, $$ ads • 1994 FDA (de) regulations: DSHEA • List ingredients, allowed nutrition claims on labels • Manufacturer responsible for safety • “This product has not been tested or approved by the FDA and makes no claim to diagnose, treat, cure or prevent any disease.” “This product has not been tested or approved by the FDA and makes no claim to diagnose, treat, cure or prevent any disease.”

  4. Hey what’s in that bottle? • Ingredient mixups harvest  bottle • Belgium: ARF: Fang-ji (Stephania tetandra) slimming herbal – consumed: Fang-chi (Aristolochia) • Contamination • 1990 L-tryptophan “E” 1000 eosinophilia, 38 deaths • Lead: “natural” Ca, 1994, 2000 -- Azarcon, Rueda • Kombucha “antioxidant, tonic” yeasts + soil bact (+ anthrax) • Adulteration • Unlisted ingredients–NSAIDs, steroids • 1995 aplastic anemia- Phenylbutazone “natural” cold Rx.

  5. More trouble • Interactions • Dong Quai, Tonka Beans– natural coumarins • Grapefruit Seed – Cyto P450 inhibitor • Overuse, “More is better” dosing (evidence in athletes) • Vit C– mega procarcinogen, calculi • Ginseng overdose syndrome– aggression, manias • Abuse • “Herbal Ecstasy” Ephedra, “Liquid ecstasy” GHB • Artemesia Absinthium (Oil of Wormwood)- thujone, neurotoxin

  6. Testing? • “Consumer Lab” testing 6/00: • Vit C (n=26): 15% failed. (<95% amt claimed) • Glucosamine/ Chondroitin (n=25): 30% failed • Gingko, Saw Palmetto, Methionine… similar. • Products “passed” see ConsumerLab website • Many calls for 3rd party review- FDA hearings, 2000 • NIH Office of Alternative Medicine– underfunded • 1997 Fed Commission on DS: “Rec scientific evidence”. • Meanwhile, we’re stuck • GRAS/ German Health Authority 1998 Comm. E publ, 300 HS

  7. URI • Echinacea (e. purpura, purple coneflower, 9 spp) • Biggest selling HS in US, as it was pre-abx. • RCT’s 1993, 94, show some  URI sx, proph. RCT’s 98, 99 Ø. • Animal Studies:  WBC,  cytokines. • No sig toxicity known. Usual dose 50 drops, or 400 mg tid. • Zinc Gluconate, “Cold Ease” • RCT x 2 1996, ‘98 conflicting. Nausea at effective doses (qid) • Licorice (Glychyrrhiza glabru)For cough. Avoid -  aldosterone • Ephedra / Ma Huang

  8. Ephedra / Ma Huang • Stimulant, weight loss, decongestant • Ephedrine: sympathomimetic, vasoconstrictive effects. • >3 billion products containing sold in US per yr • >1400 rpts to FDA 1999-2001 (HTN, CV, CVA, sz, ) • Poison Cntrl: 876 rpts 1997-99 (ASA 2000 qy) • 12/00 NEJM review 31% “probably” + 31% “possibly” caused • Interactions- MAO inhib’s: life threatening • Banned by the NFL, etc.

  9. Weight Loss • “Metabolife”, “Herbal Phen-Phen”… • Ephedra, St. John’s Wort, caffeine • Phenylpropanolamine- avoid • Use with caution per individual ingredients • “No effect” trials: Garcinia, Yohimbine, creatine, DHEA • Unknown effectiveness: Cola Acuminata, Dwarf Elder, Germander

  10. Sedatives / Hypnotics • Melatonin • Pineal hormone, normal trigger bright light • Irregular sleep cycles of blind pts improve c melatonin • Studies: Ø effect nl patients sleep latency, quality • Usually safe, if pure product. • Chamomile • Apigenin, binds benzo receptors, mice: mild sedative • Cross rxn’s ragweed allergy. • GRAS, no adverse rpts pregnancy, lactation. Tea prn.

  11. Still not sleepy? • Valerian (Valeriana Officialis root) • Effective per 2 small RDBCT. In-vitro binds GABA, like benzo’s • Some pts paradoxical effects. Not rec pregnancy. • GRAS, long hx use, no sig toxicity. 400 mg qhs. • Kava-Kava (Piper methysticum) • Some evidence better than placebo,  Oxazepam 15 mg • Very heavy use: reports of adverse sx. • Generally safe, intermittent use no known toxicity. • Mistletoe, Catnip, Gutu kola, Hops, Lavendar, Skullcap Passionflower… No evidence.

  12. • St. John’s Wort (Hypericum perforatum) • 2nd most popular HS. Effective per 1996 meta-analysis. • MAO (-) ?, SSRI. Interactions, photosensitivity • Avoid pregnancy-  ctx. Case reports thrombocytopenia. • 300 mg tid  TCA’s, amytriptilene 75mg qd • NIH currently studying vs. fluoxetine. • Gingko ( G. biloba) • Dementia, memory. Some evidence  intracerebral circulation • Gingkolides: (-) PAF, bleeding rpts. • Germany: (Egb 761), US trials: similar to tacrine, donezepil. • Gingko seed: neurotoxin. Egb 761 (leaf extract) 80 mg bid

  13. Athletics I • Creatine: Big sales, Big stars • Precursor to creatine phosphate, ADPATP • Small  wt bodybuilders (? H20). ? Weight lifters, sprinters. • Ø effect rowers, swimmers, cyclers, runners • Elderly Ø effect. Serum creatinine can . • Caffeine blocks ( - phosphocreatine resynthesis) • Probably safe : 20g qd x 1 wk, then 5g qd. (Diet  1-2 g qd) • Chromium • Øevidence efficacy. • Anemia concern: binds transferrin • > 600 g qd  RF. Not rec. but probably safe < 200 g qd

  14. Athletics II • Androstenedione, DHEA • Testosterone precursors,  oxytestosterone. Estrone may • Studies: Ø effect performance or muscle mass but  HDL ~ 5. • GHB (gammahydroxybutyrate) • “Growth hormone releaser” No evidence effective. • “GHB intoxication” syndrome: MS , coma,13% intubated • Banned FDA for OTC, but still available internet • GBL (gammabutyrolactone) available, similar toxicity • Amino acids, muscle tonics: Øevidence. Carbo load better.

  15. Anti-inflammatories • Glucosamine/ Chondroitin • Meta-analysis (flawed) studies : moderate  sx OA. • Less SE’s than NSAIDS • Some RCTs show  progression OA (unlike NSAIDs) • Feverfew (Tanacetum parthenium) • Arthritis: Ø effect in studies. Conflicting evidence for HA’s. • Parthenolide (-) arachadonic acid, serotonin. • Rebound HA, nausea common. Avoid in preganancy,  ctx. • Commercial prep’s weak, “placebos”. • Not recommended

  16. Anti-inflammatories to avoid • Chaparral / Creosote Bush/ Greasewood • (-) cyclooxygenase, lipoxygenase • Chronic use assoc hepatitis/ hepatic vein occlusions • Aconitum • Opens cardiac, neuronal Na channels • SE’s similar to cardiac glycosides, vent Dysrhthmias, neuro • Arnica • Long traditional use but not rec. due reports hepatitis, myalgias • Homeopathic preps probably safe, low concentration

  17. Antioxidants / Cancer • Selenium • Intracellular metalloid assoc with glutathione peroxidase • Selenosis in overdose amounts- similar to arsenic • No evidence effectiveness. • Vitamin A • Frequent toxicity reports • Megadose levels > 25,000 IU/kg  ICP, hepatotoxic • Chronic use > 4,000 IU/kg neuro, hepatic, derm sx • Beta-carotene: Slow absorbtion, no Vit A toxicity • Skin discoloration • Avoid in smokers

  18. Antioxidants / Cancer • Vitamin E • No evidence anticancer effectiveness. • CHD: Large trials (HOPE, GISSI) now show no benefit CAD pts. • Physician’s Study 2001, Vit E  CV death rate. • Extreme doses– anti-coagulation, but wide safety margin. • Vit C: • Studied more than any other DS but no proof definitive benefit • Procarcinogenic, nephrolithiasis in some studies hi doses • MANY-- Green Tea, Glutathione, Gingko, Grape Seed, n-acetylcysteine, Melatonin, Bilberry, curcumin, Laetrile...

  19. General Tonics • Garlic (Allium sativum) • HTN: maybe  5%, cholesterol: probably Ø • Allicin degraded by crushing, heat, acid. • GRAS, rec dose: 1 clove qd. Commercial tabs 93% Ø allicin. • Comfrey tea • “Wound healing” no evid. but may be carcinogenic, hepatotoxic • Esp. avoid pregnancy (DNA damage in vitro), lactation. • Ginseng (Panax ginseng)  “Siberian g” (E. Senticosis) • Mild stimulant, no other proven. • Ginsenosides: wide variation of content • GRAS, rare mastalgia, PMP bleed. “Ginseng abuse syndrome”

  20. GI • Hepatitis: Milk Thistle (St. Mary’s Thistle, Holy Thistle) • Sylmarin: some evid.  LFT’s, esp in EtOH cirrhosis • Europe uses IV,  mortality 50%, mushroom poisoning cases • GRAS: Long used safely as food in Mideast • Diarrhea: Goldenseal (Hydrastis canadensis) • Berberine: intraluminal antidiarrheal (E. Coli, Vibrio studies) • Drug screens: doesn’t mask. • Contraindicated: pregnancy, lactation, anti-coagulation, sz. • See also pregnancy, below

  21. CAD: Is Merlot a Vitamin? • EtOH and cardiac dz: • 490,000 pts: 1 qd  21% overall mortality, 30-40% CHD. • Evidence 2-6 drinks qw  34-53% CHD mortality, overall  28%. • But: heavier drinkers  51% overall mortality. • Other agents • Omega-3  CVA, MI in post-MI pts. (GISSI prevention trial) (850mg eicos + 750 mg decos qd) • Folate, Vit B6  homocysteine, unk. effect on CHD. • Diet works: low Na, DASH and Ornish…& exercise

  22. Female • Pennyroyal (Hedoma pulegioides) • Birth control,  ctx. Hepatoxicity, neurotoxic, deaths. Teratogen. • Pulegone – effects similar acetomin toxicity, TD 10ml. Avoid. • Blue / Black Cohosh • Midwives: cervical ripening, labor,menopause. Does seem ctx. • Possible teratogenic effects, in-vitro coronary artery constrict. • Soy / isoflavones (Many formulations, inconsistent dosing) • Ob/Gyn 2000 review: Some  menopause sx, prob safe. • Evening Primrose Oil- Some evidence breast sx relief, GRAS

  23. Pregnancy • UCSF 1999-00 150 pts, 13% used, 75% reported • Similar stats: 2000 N. Carolina midwives study • Echinacea 9%, • Not rec. By German Commmission E > 8 weeks • Recent study 5-7 d, 206 women all trimesters: no malformations • Pregnancy Tea 9% • Spearmint, raspberry, strawberry, nettle, rosehip, lemon verbena, alfalfa “uterine toner”. No data x use.

  24. Nausea/ pregnancy • Ginger (Zinziber officinale) 7% • Nausea: data mixed, but results similar to Reglan. • 70% vs. 15% placebo (n=27), other RCDBT also good results. • Contraindicated in bleeding disorders. (- Thrombox synth) • GRAS, rec. dose ¼ to 1 g powder qid. • B6 / pyridoxine 2% • Nausea/ hyperemesis: some evidence helpful • No known toxicity, 50mg po tid rec.

  25. Male • Saw Palmetto (Serenoa Repens) • BPH some evidence  sx, (flow, nocturia) • In-vitro 5- R (-), similar to finasteride, not effective as 1(-) • Few side effects (HA, GI). Usual dose 160 mg bid. • Yohimbine (Pausinystalia yohimbe bark)- • ED: central adrenergic feedback inhib– HTN, emesis • Ch’an Su (Bufo toad) • Bufalin aphrodisiac- sx similar to dig toxicity (Digibind)

  26. Elderly • “Aggressive marketing tactics” • Atrophic Gastritis • Affects 1/3 elder adults -- past h.pylori usually •  Absorbtion Fe, Folate, Ca, Vit K, Vit B-12 • Intolerance of lactose/dairy further  Ca. • Overall small intestine, pancreatic fxn stays intact • Nutritional health most affected mobility, diet, $ • RDA’s need further study for elders per recent FDA rpts

  27. Kids • Avoid all but the safest DS • Fluoride – Effective preventer tooth decay. • Public Health Service Rec [.7-1.2 mg/ L]. Seattle 2001 [1mg/L] • Supplementation Recs per AAP if H20 < .6 ppm. • No evidence current levels carcinogen, etc. • Flouride Overdosing? • Poisonings: 1992 Alaska, ‘93 Hawaii, ’98 Miss. All  200 mg/L •  Fluorosis: Usually small opaque areas tooth, can be brown • Avoid excess flouride/ toothpast in kids- rice sized glob enough

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