Fact and Fiction about Herbal Supplements. Buyer Beware

1
Fact and Fiction about Herbal Supplements.
Buyer Beware!

• Dr. Betty J. Larson, LRD, FADA

2
Objectives

• Identify the problems with accuracy of labels on
  herbs and supplements
• Identify the importance of asking your clients if
  they are using herbs or supplements.
• Identify the benefits and risks of the most
  common supplements.

3
Labels on Food

• Nutrition Labeling and Education Act of 1990.
• Labels of all processed foods and most raw foods
  will bear nutrition labels.
• Fresh meat products are covered by FSIS of USDA
  rather than FDA
• Fresh fruits and vegetables must have nutrition
  information available on the 20 most common.
• Only FDA approved health claims about the
  relationship between nutrients of foods and
  diseases can be included on the label.

4
Nutrition Facts Panel on Food

• Defined terms must be used for nutrient content.
• Standardized serving sizes.
• Require ingredient listing in descending order.
• Additives must be on the GRAS list or receive FDA
  approval.
• Daily nutrient content is based on a 2000 Kcal
  diet.
• DIETARY SUPPLEMENTS ARE NOT COVERED BY THE
  NUTRITION LABELING AND EDUCATION ACT OF 1990.
  They are not classified either as food or drugs.

5
1994 Dietary Supplement Act

• The law essentially gives dietary supplement
  manufacturers freedom to market more products as
  supplements and provide information about their
  products benefits.
• FDA does not have the authority for premarket
  approval of supplements like with food.
• FDA has the burden of proof that a supplement is
  unsafe and must provide evidence in federal court
  to remove a supplement.
• www.cfsan.fda.gov

6
Dietary Supplements

• a product (other than tobacco) intended to
  supplement the diet that bears or contains one or
  more of the following ingredients
• Vitamins
• Minerals
• Herb or other botanical
• Amino Acid
• Supplement used by humans to increase nutrient
  intake
• Concentrate metabolite, constituent, extract or
  combination of any ingredient described
  previously

7
Supplements are Big Business

• ConsumerLab.com
• Quackwatch

8
Third Party Certification

• Web site www.safetyalerts.com
• INA is the Institute of Nutraceutical Advancement
• An independent body determines if a product
  complies with a standard in 3rd Party
  Certification
• NSF National Sanitation Foundation
• www.nsf.org
• NNFA National Nutritional Foods Association
• www.nnfa.org
• USP US Pharmacopeia
• www.usp.org

9
ADA Position

• the best nutritional strategy for promoting
  optimal health and reducing the risk of chronic
  disease is to wisely choose a wide variety of
  foods.

10
Interest in Natural Medicine

• Remember the term natural on the label does not
  necessarily equal efficacy, purity or safety.

11
History of botanical medicine

• 200 BC Here, eat this root.
• 1000AD That root is heathen. Here, say this
  prayer.
• 1850 AD That prayer is superstitious. Here drink
  this potion.
• 1940 AD That potion is snake oil. Here swallow
  this pill.
• 1985 AD That pill is ineffective. Here take
  this antibiotic.
• 2000 AD That antibiotic is artificial. Here eat
  this root.

12
Definition of HerbsCrude drugs of vegetable
origin utilized for the treatment of disease
states, often of a chronic nature, or to attain
or maintain a condition of improved health.
13
Nomeclature

• Genus and the species
• Garlic for example is allium sativum
• Ginger is Zingiber officinalis
• In addition the active ingredient may be
  identified. So in garlic the active ingredient
  is allicin.
• In ginger it is gingerols.

14
Types of Herbal Products

• Bulk
• Teas
• Infusions
• Decoctions
• Tinctures
• Capsules
• Proprietary Blend

15
Differences Between Herbs and Drugs

• Herbs are more dilute than the concentrated
  chemicals.
• Herbs often contain other substances such as
  inert starch or other active ingredients.
• It is difficult to standardize the activity of a
  leaf.

16
Herbal Quality

• No standards exist so quality is variable.
• Lack of uniform names.
• Dependent on the reputation of the manufacturer.
• Concentration of active ingredients in different
  lots.
• Environmental conditions
• Lack of therapeutic potency makes herbs more
  useful for chronic complaints than acute.

17
Warning Signs of Paraherbalism

• Claims that a conspiracy by the medical
  establishment discourages the use of herbs.
• Claims that herbs cannot harm, only cure.
• Claims that whole herbs are more effective than
  their isolated active constituents.
• Claims that natural herbs are superior.
• Claims that the Doctrine of Signatures is
  meaningful.

18
Warning Signs Continued

• Claims that reducing the dose of a medicine
  increases its therapeutic activity.
• Claims that astrological influences are
  significant
• Claims that physiological tests in animals are
  not of value for humans.
• Use of anecdotal evidence.
• Claims that herbs are Gods cure for disease.

19
Storage

• Keep all forms in a cool, dark, place away from
  heat and strong light.
• Fresh herbs should be used right away. Dried
  herbs may be kept one to two years in an airtight
  container or frozen for long-term.
• Color is often a determinant of freshness.
• Capsules and tablets have the longest shelf life.
  But do not freeze these forms.
• Teas should be used the day theyre prepared.
• Infusions and decoctions can be stored in the
  refrigerator and used within 24 hours.

20
Drug/Herb Interactions

• St. Johns Wort indinavir, antiretrovirals,
  antidepressants, MAO inhibitors
• Gingko biloba anticoagulants and antiplatelet
  agents such as aspirin, warfarin, ticlopidine,
  clopidogrel, dipyridamole
• Ginseng warfarin
• Kava sedatives, sleeping pills, antipsychotics,
  alcohol
• Brewer Yeast MAO inhibitors, antimycotics

21
Drug/Herb Interactions

• Saw Palmetto oral contraceptives, estrogen
  replacement products, hormone based products such
  as tamoxifen, toremifene, testosterone, or
  anabolic steroids
• Echinacea steroids, cyclosporine, immune system
  suppressants
• Evening primrose oil antiseizure medications,
  antiepileptics, chlorpromazine, fluphenazine,
  mesoridazine, perphenazine, prochlorperazine,
  promethazine, thioridzaine, trifluoperazine,
  triflupromazine.

22
Dangerous Herbs

• Chaparral
• Comfrey
• Lobelia
• Germanium
• Yohimbe

23
Ephedra (Ma Huang)

• Claims are made that it is useful for asthma,
  nasal
• decongestant and CNS stimulant.
• While it does produce bronchial dilation there is
  no
• evidence that it is safe for weight control.
• Caution because it is a CNS stimulant, it raises
• blood pressure, causes nervousness, headaches,
• insomnia, dizziness, vomiting, and is a
  precursor
• for illegal drugs (speed).

24
Ephedra (ma huang)

• Thermadrene
• Ripped Fuel
• Stacker 2
• Metabolife 356
• Ultimate Xphoria
• Xenedrine
• Hydroxy-Cut

25
KavaPiper methysticum

• Activity is believed to be due to kava lactones
  though more than one mode of action is involved.
• Traditionally, used to treat nervous tension,
  anxiety. Jan 1, 2002, Annals of Internal
  Medicine, Ernst reported that Kava appeared to be
  an efficacious short term treatment for anxiety.
• Inhibition of limbic system reduces emotional
  excitability and enhances mood

26
Kava

• Human studies have shown that kava
• Promotes mild euphoria without effecting thoughts
  or memory
• Produces analgesia, sedation, and
  muscle-relaxation
• Has anti-psychotic activity
• Some reduction in seizure activity
• (Fellow, et al. Complimentary Alternative
  Medicine. September, 1999).

27
Kava

• Germany removed Kava from the market in June of
  2002. Previously, it had been used there for
  conditions of nervous anxiety, stress and
  restlessness.
• In March, 2002, FDA released an advisory warning
  of severe liver toxicity from Kava.

28
Saw Palmetto

• A dietary supplement used in the US to improve
  urinary flow and reduce the frequency and urgency
  of urination in men with prostate enlargement.
  Also, used to treat bladder inflammation
  (cystitis), chronic bronchitis, among other
  conditions.
• January 2002, FDA released an advisory that
  certain brands contained prescription drugs.

29
Tomatoes as Disease Fighters

• Lycopene, one of natures most powerful
• antioxidants is found almost exclusively in
• tomatoes.
• Harvard researchers showed a decreased risk of
• cancer with increased intake of tomato
  products.
• North Carolina researchers have shown an
• increase in tomato products may reduce risk of
• CHD

30
Benefits of Soy

• Populations that consume more soy have reduced
  rates of certain cancers.
• Isoflavones in soy are weak estrogens. Weak
  estrogens are believed to function as
  antiestrogens because they can compete with
  endogenous estrogen for binding to estrogen
  receptors. In doing so, they block the more
  potent endogenous estrogens from asserting
  effects. Since high estrogen levels cause breast
  cancer, soy may be preventive.

31
Ginger

• Researchers have shown it superior to
  dimenhydrinate in reducing the symptoms of motion
  sickness.
• Also, may be useful for indigestion and nausea
• Active constituent may be a volatile oil that is
  also responsible for its odor.
• Usually taken as hard gelatin capsules

32
Echinacea(Purple Cone Flower)

• Beneficial effects in the treatment of infections
  are brought about by its ability to act as an
  immunostimulant.
• Promotes activity of the lymphocytes
• Increases phagocytosis.
  
• Increases production of interferon
• Increases body resistance to bacteria.
• DO NOT TAKE FOR PROLONGED TIME PERIODS.

33
St. Johns WortHypericum perforatum

• Popular remedy for depression probably due to
  contained MAO inhibitors.
• Concern over its possible mutagenic nature and
  potential carcinogenicity.
• Increases photosensitivities.

34
St Johns Wort Continued

• In 1996, meta-analysis of 23 randomized, clinical
  trials involving 1757 patients with depression
  found St. Johns Wort to be superior to placebo
  for mild-to-moderate depression. (Linde, K. et
  al. BMJ 1996 313253-58)
• German MDs prescribe St. Johns Wort 41 over
  Prozak for depression.
• The newer products are standardized to 4-5
  hyperforin and are the preferred preparation
  The dose is 300 mg TID for at least 6 weeks.

35
St. Johns Wort Continued

• Side effects include GI disturbances, headache,
  and insomnia.
• Possibility of photosensitivity. Do not use with
  protease inhibitors or cyclosporine.
• Mechanism of action still unclear
• MAO does not occur to any considerable extent
  in-vivo. (Chavez Hosp Parm 1997 321621-32)
• The extract does inhibit serotonin re-uptake but
  at much higher doses than used to treat
  depression. (Arzneim Forsch 1995 451145-48.)

36
Ginkgo

• Most of the research has been conducted on the
  standardized extract EGb761.
• The German authorities have concluded that it is
  a safe and effective treatment for circulatory
  disturbances, including cerebrovascular
  insufficiency.
• In 1997, a 52 week, multi-center randomized,
  double blind, placebo-controlled trial was
  conducted in the US with EGB761.
• 309 patients with mild to severe multi-infarct
  dementia or Alzheimers dementia were give 120 mg
  extract or placebo.

37
GINKGO Continued

• A small but statistically significant improvement
  was noted in cognitive and social functioning.
  (LeBars, PL, et al. JAMA 1997 2781327-32)
• Mechanism of action is not completely understood
  but the physiologic effects appear to be due to
  arterial vasodilation, reduction in blood
  viscosity, inhibition of platelet activating
  factor (Nemez, et al. US Parmacist. Sept. 1997
  22144-51).

38
Ginkgo Continued

• Dose in clinical trials ranged from 60-240 mg of
  standardized extract per day.
• Standardized products should contain 24
  ginkgoflavones and 6 terpenes.
• Caution patients taking anti-platelet and/or
  anti-coagulant medications.
• Side effects mild GI disturbances and headaches.

39
Ginsengs

• Chinese have used Ginseng to increase mental
  health and physical vitality in the elderly.
• Engels and Wirth reported their randomized
  double-blind placebo controlled trial with 36 men
  taking 200-400 mg Panax Ginseng had no impact to
  improve aerobic exercise performance.
• Wayne State researcher reported no psychological
  benefit for 200-400 mg compared to placebo.
• Side effects include hypertension, nervousness,
  and irritability.
• Consumer Reports researchers found none of the
  brands contained the amount on the label.

40
Blackberry, Blueberry, and Raspberry Leaves

• Teas from these leaves can be used to control
  diarrhea.
• The teas from these leaves may also be used
  effectively as a mouthwash, gargle for sore mouth
  and inflammation of the mucous membranes of the
  throat.

41
Green Tea

• Green tea may reduce the incidence of esophageal
  cancer.
• Benefit may be from polyphenols that are found in
  green tea.
• Polyphenols have been shown in animals to halt
  enzymes that produce cancer-causing substances.
• Green tea has also been shown to lower
  cholesterol.

42
Licorice

• Careful that it is licorice rather than licorice
  flavored.
• Useful in the treatment of peptic ulcers and is a
  distinct anti-inflammatory herb.
• Depending on the dose can cause side effects like
  headache, lethargy, sodium and water retention.
  Several references of poisoning from over
  consumption.

43
Cranberry

• One of the most useful herbs for the prevention
  and treatment of urinary tract infections.
• The effectiveness of cranberry juice in treating
  UTI results not from its acidifying properties
  but as a result of its ability to prevent the
  microorganisms from adhering to the epithelial
  cells that line the urinary tract.

44
Horehound

• Cough remedy for over 400 years.
• Stimulatory effect on the secretions of the

bronchial mucosa.
45
Black Cohash Cimicifuga racemosa

• Numerous clinical trials in Germany and US for
  the treatment of menopausal hot flashes.
• The studies indicate that it is superior to
  placebo and similar to HRT.
• It does not bind estrogen receptors in the
  breast.
• Unclear of effects on uterine endometrium.
• Side effects primarily GI and headache.
• Dose is 20-40 mg BID
• DO NOT CONFUSE WITH BLUE COHASH which is toxic to
  the cardiac muscle.

46
Red Clover

• Claims are made that it contains 10x the
  isoflavones as soy.
• One of the few plants that contain 4 isoflavones
  genistein, daidzein, formononetin, and biochanin.

47
Red Clover Continued

• More than 300 women in Australia double-blind
  placebo-controlled trial. One of these at Baker
  Medical Research Institute in Melbourne tested
  the effect of 80 mg of red clover isoflavones.
  Researchers reported that arterial compliance an
  index of elasticity of large arteries was
  significantly improved.

48
Don Quai (Angelica sinensis)

• Chinese have used in treatment of gynecological
  disorders. Claim it reduces menstrual cramping,
  irregular menses and menopausal symptoms.
• Western science finds little support for the use
  of dong quai. A double blind placebo controlled
  trial with 71 postmenopausal women who
  experienced hot flashes with either dong quai or
  placebo for 24 weeks.
• The herb also contains natural coumarin
  derivatives and creates a 2 fold elevation in
  prothrombin time after 4 weeks.

49
Milk Thistle (Silybum marianum)

• The proteins found within the fruit of milk
  thistle have been shown to stabilize the
  hepatocyte membrane and increase the synthesis of
  ribosomal RNA resulting in a protective effect on
  the liver.
• The dose used in clinical trials in Germany for
  the treatment of liver disease was 420 mg/day of
  an extract standardized to contain 70 silymarin.
  
• No known drug interactions.
• Side effects are mild GI disturbances, diarrhea.
• Many studies with Milk Thistle have flawed design
  but useful in hepatitis (Am J Gastroenterology
  93(2)139-43)

50
Summary of the Herbal Myths

• Myth Herbs are natural, so they must be safe
  and effective.
• Myth Herbs must be safe and effective because
  theyve been used for thousands of years.
• Myth You dont need to tell your doctor youre
  taking herbs.
• Myth If the label says an herb works, there
  must be some evidence that it does.
• Myth All products that say they contain a
  particular herb are essentially the same.
• Myth There is not much you need to know about
  how to take herbs.

51
Future

• Herbal medicine may have possibilities in our
  attempt to achieve optimum health.
• Chronic medical conditions
• Mild, acute complaints
• Reduce side effects of pharmaceuticals
• Prevention

52
Future

• Professionals must educate themselves about the
  most commonly used herbs so that they may make
  informed choices based on scientifically sound
  information.
• Be open
• Be skeptical
• Be willing to learn

53
GARLIC
1. Over 1,000 papers on health benefits
of garlic in the past 20 years.
2. Allicin in garlic is a potent antibiotic.
3. Sulfides provide antithromobitic properties.
4. Dutch investigators report garlic reduces
cholesterol and inhibits platelet aggregation.
5. It is important to be careful of the form of
garlic and the potential side effects.