Multidisciplinary Approaches to Herbal Usage Sara L. Warber

1
Multidisciplinary Approaches to Herbal Usage

• Sara L. Warber, MD
• Linda Diane Feldt, RPP, NCTMB
• Sara Al-rawi, ND, MPH
• Leslie Shimp, PharmD

Special thanks to Suzanna Zick, ND, MPH
2
Objectives

• Describe patterns of herb use in America
• Discuss various philosophies of herbal use
• Discuss the herbal regulatory issues
• Describe the use, effects, and toxicity of
  several common herbs
• Evaluate the type of evidence for each herb
• Appreciate contributions of multidisciplinary
  partners in care

3
Historical Context of Herb Usage

• Physical evidence dates back 60,000 years
• All cultures have traditions of herb use for
  healing
• 2000 BC - First known materia medica in Sumeria
• 1st Century AD - Chinese Materia Medica
• 25 of prescription drugs derived from plants
• 80 of world population uses herbal medicine for
  primary care

4
(No Transcript)
5
(No Transcript)
6
The state of herbal research
7
Herbalism

• Traditional Healers
• Native American, Ayurvedic, Tibb, Unani, Tibetan,
  etc
• Traditional Chinese
• Western Folkloric
• Western Scientific
• Earth-centered
• Ethno-botanical

example categories from the American Herbalist
Guild
8
Herbalism Training and Education

• College and University courses
• Electives within schools that teach wellness,
  holistic health, bodywork or somatic practices
• Apprenticeship programs both formal and informal
• Correspondence courses

9
Herbalism Training and Education (cont)

• Traditional initiation and training often
  combined with religious/spiritual practices
• Self taught
• Promotional material and workshops provided by
  manufacturers
• Multi level marketing materials

10
Western Folkloric Tradition

• promotes ethical harvesting of plants
• uses the whole parts of the plant, in season
• encourages consumer involvement
• emphasis is on nutritive aspects of herbs
• primarily uses plants that grow locally, and
  encourages direct involvement with the plants by
  growing and wildcrafting

11
Western Folkloric Tradition (cont)

• uses a holistic approach to support body systems
  the individual
• encourages sharing of information, stories and
  experience with others
• can work in a supportive role with conventional
  Western Medicine

12
Concerns and Challenges

• Herbalism is a very broad term that describes a
  profession many thousands of years old.
• Herbalists and the scientific community have only
  recently begun to forge mutual respect, goals,
  and to determine ways of working together.
• Herbalists must proactively respond to
  unprecedented consumer interest.

13
Concerns and Challenges

• Protecting consumers, supporting scientific
  research, and preserving herbal traditions are
  intriguing challenges for this profession.
• Consumers and health care providers may have
  difficulty determining who is qualified as an
  herbalist.
• Herbal use is now being driven primarily by
  advertising and manufacturers, not by health care
  providers and traditional sources of information.

14
Naturopathy

• Naturopathic Medicine is a distinctively natural
  approach to health and healing that recognizes
  the integrity of the whole person- recognizing
  that the patient's mental, emotional, and
  physical states must all be treated for a lasting
  effect.
• The practice of Naturopathic Medicine emerges
  from six underlying principles of healing
• First do no harm. Primum no nocere
• Identify and treat the cause. Tolle causam
• The healing power of nature. Vis medicatrix
  naturae
• Doctor as teacher. Docere
• Prevention. Prevention is the best "cure
• Treat the whole person. Multifactorial nature of
  health, disease and healing.

15
Naturopathy

• Primary Health Care Provider
• Four-Year Graduate Level naturopathic medical
  college
• Includes basic and clinical sciences
• Graduates must pass a board licensing examination
• Over 1500 Clinic Hours

16
Naturopathic Therapeutic Modalities

• Clinical Nutrition
• Homeopathic Medicine
• Physical Medicine
• Counseling and Lifestyle modifications
• Traditional Chinese Medicine
• Botanical Medicine
• Based in Native American and European traditions
• Customize treatments to individual needs
• Draws on scientific literature, folk traditions
  and empirical evidence

17
Herbal Modes of Delivery

• Teas
• Water based infusion for flowers and leaves
• Decoction
• A strong tea used for bark, roots and seeds
• Tincture
• Alcohol, vinegar, water or glycerin based extract
• Capsules
• Ground and dried herbs in a gelatin or vegetable
• capsule
• Salve
• An oil and beeswax/lanolin mixture used topically
  on the body

18
High Quality Companies

• Dried Herbs
• Pacific Botanicals
• Trout Lake Botanicals
• Frontiers

• Encapsulated Herbs
• Scientific Botanicals
• Phytopharmica
• Naturopathic Formulary (NF)
• Wise Women Herbals
• Thorne Research

19
High Quality Herbs (cont)

• Tinctures
• Herb Pharm
• Eclectic Institute
• MediHerb
• Wise Women Herbal
• Naturopathic Formulary (NF)

• Misc.
• Bezweken
• Women's Transition

20
Herbal Products -- Herbal MarketRegulated -- or
-- Unregulated

• Herbal regulations are significantly different
  from pharmaceutical regulations.
• Both FDA and FTC (Federal Trade Commission) have
  a role in regulating herbal products.
• Major Federal Laws governing herb products
• FDC Act (1938)
• Nutrition Labeling and Education Act (1990)
• DSHEA
• Food and Drug Administration Modernization Act

21
Herbal Regulation - Role of FDA

• FDA can stop the marketing of a toxic or
  unsanitary product.
• FDA can stop the marketing of a product with
  false or unsubstantiated claims.
• FDA can take action against a product which poses
  a significant unreasonable risk of illness or
  injury.
• FDA can prohibit claims that a product cures or
  treats a disease.
• FDA can stop the marketing of a new (post 1994)
  dietary ingredient if safety data is lacking.

22
Herbal Regulation - Role of FTC

• FTC governs the advertising and promotion of
  herbs and dietary supplements. It can
• Outlaw unfair or deceptive practices
• Stop unsubstantiated advertising
• Investigate complaints and seek civil penalties
  for violations of trade regulations

23
Current Status - and - Implications

• Adulteration, Purity, Identification
• Safety
• Effectiveness
• Potency
• Quality Control

24
Current Status - and - Implications
Adulteration, Purity, Identification

• Drugs -
• pure chemical constituents - proof required
• drugs must meet USP standards long experience
  with standards
• Herbs -
• misidentification of herb possible (use of common
  names)
• greater potential for contamination (source and
  form of product)
• adulteration - prescription drugs

25
Current Status - and - ImplicationsSafety

• Drugs -
• Must be studied prior to marketing and via
  post-marketing surveillance
• Information required on label or package insert
• Herbs -
• Evidence of safety is not required for marketing
• Data on safety often unavailable
• FDA is required to show herb unsafe to remove it
  from the market

26
Detecting an Adverse Reaction Number of Persons
who need to be exposed to a drug to have a 95
chance of detection
27
Current Status - and - ImplicationsEffectiveness

• Drug
• Effectiveness data from controlled trials
  generally required
• Herb
• Proof not required

28
Current Status - and - ImplicationsPotency

• Drug -
• standardized
• Herb
• Varies with genetics, growing conditions, harvest
  time, product preparation

29
Current Status - and - ImplicationsQuality
Control - Standardization

• Drug -
• required
• Herb -
• Not required
• Some Herbal Industry Standards
• USP monographs (21 herbs)
• Consumer Laboratory (consumerlab.com)

30
Health Professionals Actions

• Do ask about herb use
• Avoid products with multiple herbs
• Consider following LFTs, BUN, Cr
• Consider herbs in differential
• Obtain samples when problems suspected
• Report to MedWatch 1-800-332-1088

31
The Herbs

• Echinacea
• Ginseng
• Ginkgo biloba
• Garlic
• Saw palmetto

32
Echinacea spp.

• E. pallida, purpurea, or angustifolia
• Use prevention and treatment of colds, flu
• One of most popular herbs in US
• German Commission E
• supportive for colds, chronic URI, UTI
• UK - GSL

33
Echinacea Systematic Review

• 16 randomized or quasi randomized trials
• Echinacea preparation vs. no treatment or placebo
• 8 trials on prevention, 8 trials on treatment
• 3396 patients involved
• Majority with positive results
• Cannot say which preparation is best

Melchart, D. et al. Cochrane Database Syst Rev
20002.
34
Echinacea - Toxicology

• No known side effects
• Contraindications
• progressive systemic diseases eg TB, MS
• pregnancy
• Drug interactions
• Theoretical - Corticosteroids, cyclosporine
• Immunostimulating effect

35
Echinacea Case Study

• 46 yo female with CHF
• Heart cath age 53, followed by Staph infection
• Broad spec. antibiotics ? no effect
• Echinacea ang. 30-40 drops every 3 hours ?
  Symptom improvement within 2 hours
• Two days both, stopped Ech. ? symptoms returned
  within 4 hours
• Ech and Antibiotic together ? no symptoms

36
Case Study Follow-up

• MD stopped antibiotics, pt. stopped Ech. ?
  Symptoms returned
• Ech. as before ? symptoms gone
• One day without Ech ? some symptoms
• Ech 10 drops/day ? no symptoms
• For next 7 years, until death, if skipped two
  days of Ech ? symptoms returned - proven at least
  five times

37
Significant points

• Echinacea fought an antibiotic resistant
  infection
• Low dose (nourishing) as effective as high dose
  (stimulating)
• Low dose safe to use long term
• Long term use was necessary
• Mechanism of action for effect of low dose
  unknown

38
(No Transcript)
39
Ginseng Whats in a Name?

• A variety of ginseng species exist including
• American Panax quinquefolius
• Korean Panax ginseng
• Japanese Panax japonicus
• Sanchi Panax notoginseng
• Vietnamese Panax vietnamensis
• Siberian Eleutherococcus senticosus

40
genus Panax

• These plants all have somewhat different
  properties.
• Even within the single species Panax ginseng,
  different traditional preparation methods result
  in different actions.
• Red Asian ginseng, is steamed and cured,
  resulting in a product that is considered more
  stimulating than white ginseng.

41
American or Oriental Ginseng (Panax spp)

• Dose 1-2 g root (20-30 mg ginsenosides).

42
Panax ginseng

• Used for thousands of years for weakness/fatigue
• Animal studies
• Acts as calcium antagonist and ? nitric oxide
  from endothelial cells ? vasodilation
• Stimulates immune system (phagocytosis, NK cell
  activity, interferon)
• Hypoglycemic effects

43
Panax ginseng

• Improves mental function, including
• Faster reactions, abstract thinking, better
  attention and accuracy, cognitive performance
• RCT, 384 older women
• 16 wk ginseng vs placebo
• Improved Psychological Well-Being index
• No evidence for effect on physical performance
• 227 volunteers ? efficacy of influenza vaccine
• Modest effect on diabetes, including ? Hgb A1C

44
Panax ginseng - Toxicology

• Side effects nausea, diarrhea, excitement,
  insomnia, headaches, estrogenic effects, and
  blood pressure abnormalities
• Potential interactions Phenelzine, warfarin,
  oral hypoglycemics, insulin, caffeine

45
(No Transcript)
46
Case

• 76 y.o. man
• History
• Myocardial infarction
• Hypertension
• Hypercholesterolemia
• Now with new onset multi-infarct dementia
• His daughter wants to know if a natural
  supplement with ginkgo biloba and garlic will
  help him?

47
Ginkgo biloba

• Powdered leaves
• Tincture or infusion

• Most ancient tree known
• Uses cerebral insufficiency, Alzheimers Ds,
  intermittent claudication, tinnitis

48
Gingko biloba Dementia

• Dose 120 mg/d of EGb 761
• Safety side effects equal
• Problems high dropout rate (50 tx, 62 placebo)

• 52 week RCT, double blind, multi-center
• Outcomes in 309 pts (ITT)
• Pt cognition tx no change, placebo worse
  (p0.04)
• Caregiver assess tx slight improve, placebo
  worse (p.004)

49
Ginkgo - Toxicology

• Adverse events
• GI complaints
• bruising spontaneous bleeding
• Avoid or monitor carefully if taking warfarin,
  heparin, or NSAIDs
• Can increase insulin levels
• May increase sedation with trazodone

50
(No Transcript)
51
Garlic (Allium sativum)

• Uses
• lower cholesterol
• anti-thrombotic
• lower blood pressure
• anti-microbial agent
• Contains alliin in intact garlic bulb
• Alliin ? allicin
• 600 900 mg of dried powder (1.3 allicin)

52
Garlic - Evidence

• German Commission E
• elevated blood lipids
• prevention of age-related vascular changes
• 25 studies between 1979-1998 with 2,920 people
• Mixed results highly dependent on type of garlic
  preparation

53
Garlic - Evidence

• 2 Meta-analyses
• garlic lowered total cholesterol between 9-12
• Meta-analysis
• anti-hypertensive - 10 reduction
• Double blind RCT - 152 subjects for 4 years
• garlic reduced development of atherosclerosis

54
Garlic - Toxicology

• Side effect - body odor
• Theoretical interaction - Warfarin
• Potential decreased platelet aggregation

55
(No Transcript)
56
Saw Palmetto (Serenoa repens)

• Hexane extract of dried berries
• Spasmolytic activity
• Inhibition of androgen
• Anti-inflammatory
• Not an inhibitor of 5?-reductase

• Used for benign prostatic hypertrophy

57
Saw Palmetto - Evidence

• 18 RCTs, 16/18 double-blinded
• 2939 men, duration 4-48 weeks
• Decreased nocturia, improved symptom scores vs.
  placebo
• Improved symptom score, improved peak urine flow
  vs. finasteride
• Dose 400 mg dry extract BID

Wilt TJ, et al. JAMA 1998 2801604-1609.
58
Saw Palmetto - Toxicology

• Rats 80x human dose for 6 months
• No negative influences
• Human trials, German Commission E
• GI disturbances, headache
• No significant adverse effects
• Drug interactions
• Theoretical - Estrogens, oral contraceptives,
  iron
• German Commission E reports none

59
(No Transcript)
60
Implications for Practice

• Obtain accurate and complete history of herbal
  use by patients
• Continuously expand herb knowledge
• Consult persons with herbal expertise
• Share knowledge with your patients
• Document, document, document

61

• What wonders await beyond the known?