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Supplements, here, now.

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GRAS, no adverse rpts pregnancy, lactation. Tea prn. Still not sleepy ... 38 deaths Lead: natural Ca, 1994, 2000 -- Azarcon, Rueda Kombucha ... – PowerPoint PPT presentation

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Title: Supplements, here, now.


1

2
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 gt 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 MDs closed minded, dont
    know about DS

3
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.

4
New law, New label
  • 1993 FDA proposal removal of HS from market if
    dont 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.

5
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6
Hey whats 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 ingredientsNSAIDs, steroids
  • 1995 aplastic anemia- Phenylbutazone natural
    cold Rx.

7
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

8
Testing?
  • Consumer Lab testing 6/00
  • Vit C (n26) 15 failed. (lt95 amt claimed)
  • Glucosamine/ Chondroitin (n25) 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, were stuck
  • GRAS/ German Health Authority 1998 Comm. E publ,
    300 HS

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10
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11
URI
  • Echinacea (e. purpura, purple coneflower, 9 spp)
  • Biggest selling HS in US, as it was pre-abx.
  • RCTs 1993, 94, show some ? URI sx, proph. RCTs
    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?

12
Ephedra / Ma Huang
  • Stimulant, weight loss, decongestant
  • Ephedrine sympathomimetic, vasoconstrictive
    effects.
  • gt3 billion products containing sold in US per yr
  • gt1400 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 inhibs life threatening
  • Banned by the NFL, etc.

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14
Weight Loss
  • Metabolife, Herbal Phen-Phen
  • Ephedra, St. Johns Wort, caffeine
  • Phenylpropanolamine- avoid
  • Use with caution per individual ingredients
  • No effect trials Garcinia, Yohimbine,
    creatine, DHEA
  • Unknown effectiveness Cola Acuminata, Dwarf
    Elder, Germander

15
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16
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 rxns ragweed allergy.
  • GRAS, no adverse rpts pregnancy, lactation. Tea
    prn.

17
Still not sleepy?
  • Valerian (Valeriana Officialis root)
  • Effective per 2 small RDBCT. In-vitro binds GABA,
    like benzos
  • 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.

18
?
  • St. Johns 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 ? TCAs, 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

19
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20
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21
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
  • Ø evidence efficacy.
  • Anemia concern binds transferrin
  • gt 600 ?g qd ? RF. Not rec. but probably safe lt
    200 ?g qd

22
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 Ø evidence. Carbo
    load better.

23
Anti-inflammatories
  • Glucosamine/ Chondroitin
  • Meta-analysis (flawed) studies moderate ? sx
    OA.
  • Less SEs than NSAIDS
  • Some RCTs show ? progression OA (unlike NSAIDs)
  • Feverfew (Tanacetum parthenium)
  • Arthritis Ø effect in studies. Conflicting
    evidence for HAs.
  • Parthenolide (-) arachadonic acid, serotonin.
  • Rebound HA, nausea common. Avoid in preganancy, ?
    ctx.
  • Commercial preps weak, placebos.
  • Not recommended

24
Anti-inflammatories to avoid
  • Chaparral / Creosote Bush/ Greasewood
  • (-) cyclooxygenase, lipoxygenase
  • Chronic use assoc hepatitis/ hepatic vein
    occlusions
  • Aconitum
  • Opens cardiac, neuronal Na channels
  • SEs similar to cardiac glycosides, vent
    Dysrhthmias, neuro
  • Arnica
  • Long traditional use but not rec. due reports
    hepatitis, myalgias
  • Homeopathic preps probably safe, low concentration

25
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 gt 25,000 IU/kg ? ICP, hepatotoxic
  • Chronic use gt 4,000 IU/kg neuro, hepatic, derm sx
  • Beta-carotene Slow absorbtion, no Vit A toxicity
  • Skin discoloration
  • Avoid in smokers

26
Antioxidants / Cancer
  • Vitamin E
  • No evidence anticancer effectiveness.
  • CHD Large trials (HOPE, GISSI) now show no
    benefit CAD pts.
  • Physicians 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...

27
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

28
GI
  • Hepatitis Milk Thistle (St. Marys Thistle, Holy
    Thistle)
  • Sylmarin some evid. ? LFTs, 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 doesnt mask.
  • Contraindicated pregnancy, lactation,
    anti-coagulation, sz.
  • See also pregnancy, below

29
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

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31
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

32
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33
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 gt 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.

34
Nausea/ pregnancy
  • Ginger (Zinziber officinale) 7
  • Nausea data mixed, but results similar to
    Reglan.
  • 70 vs. 15 placebo (n27), 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.

35
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
  • Chan Su (Bufo toad)
  • Bufalin aphrodisiac- sx similar to dig toxicity
    (Digibind)

36
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,
  • RDAs need further study for elders per recent
    FDA rpts

37

38
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 lt .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

39
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