1. Five things to share with your patients about herbal medicine
Cynthia McGrath, DNP, FNP-BC
Prepared for: Pharmacology Update
Saint Anthony College of Nursing
2 November 2018

2. Objectives
Define the terms “complementary”, “alternative” and “integrative” medicine for this presentation.
Discuss the current ‘landscape’ of the use of herbal medicines and patient’s values: who, what, when & why.
Highlight the effectiveness and safety concerns of herbals for common conditions.
Increase your knowledge & confidence in discussing herbal use with your patients.

3. EBM 1996, David Sackett, MD
Duke University. (2018).

4. Johns Hopkins Nursing EBP Model, 2003
(Newhouse, Dearholt, Poe, Pugh, & White, 2005).
Evidence-based Practice: A Practical Approach to Implementation.
Newhouse, Robin; PhD, RN; Dearholt, Sandra; MS, RN; Poe, Stephanie; MScN, RN; Pugh, Linda; PhD, RNC; White, Kathleen; PhD, RN; CNAA, CMAC. Journal of Nursing Administration. 35(1):35-40, January 2005. 2
© 2005 Lippincott Williams & Wilkins, Inc. Published by Lippincott Williams & Wilkins, Inc.

5. Evidence-Based Practice
Includes the patient’s values
Patient-centered care
Increases adherence
Better outcomes
Systematic Research: RCT
Clinician’s Expertise

6. The terms “complementary medicine” “integrative medicine” and
True or False
The terms “complementary medicine”
“integrative medicine”
and
“alternative medicine”
mean the same thing.
–are interchangeable.

7. Background: Definitions & history
Complementary & Integrative Medicine
The use of non-mainstream approaches
together with
Conventional medical approaches
Alternative medicine/ health approaches
The use of products or practices
in place of
Conventional medicine.
Complementary Health Approaches

8. My source: NIH CAM – Complementary- Alternative Medicine
National Center for Complementary and Integrative Health [NCCIH]
Formerly National Center for Complementary & Alternative Medicine [NCCAM]
CAM – Complementary Alternative Medicine

9. Definitions - NCCIH Complementary and Alternative Medicine [CAM]
Diverse approaches that are not part of conventional medicine
Complementary: with conventional
Integrative: uses CAM treatments that have evidence
Health & Well-being: Wellness

10. Mission of NCCIH:
To define, through rigorous scientific investigation,
The usefulness and safety of complementary and integrative health interventions -
And their roles in improving health and health care.

11. Terms & Definitions
Non-vitamin, Nonmineral Dietary Supplements [NVNM].
Dietary & Herbal supplements
Botanicals
Nutraceuticals / Phytonutrients
Polyherbacy

12. Who uses herbals – and why?
College students – friend, family, magazine
Prevent colds, give them energy, make up for inadequate diet [DUNDAS]
Echinacea, ginseng, and Ginkgo biloba = most frequently consumed herbal supplements
Vitamin C & calcium = most frequently consumed vitamin / mineral supplement.
Pain is a common reason why people turn to complementary health approaches.
Fibromyalgia, Musculoskeletal disorders

13. Who uses herbals – and why?
92% of Women >60 y/o
Up to 16 /day
94% of Nursing home residents
Vitamin D is the most frequent [Hekel, B, 2017]
Treat & Prevent a Variety of Ills
Women’s ERA = Updated definition:
Expectations Regarding Aging
Cancer patients
Education and Income
Hekel, B.E. (2017).

14. Reasons for herbal use Want ‘holistic approaches’
Dissatisfaction with attitudes of their HCP
Needs unmet by Conventional medicine
Unhappy with prescription drugs/ Side effects
Chronic disease
Perceived safety, effectiveness
Rejection of established medical practices
High cost of medical care
Desire for control over their health/ healthcare
Advertising/ marketing
Arcangelo, V.P. (2017).

15. Use of Herbals is increasing
data: CDC
Multivitamin, Multi-mineral products
Women more commonly reported use of products than men

17. Americans over 60 yrs
70% of Americans > 60 years use 1 dietary supplement daily
29% use 4 or more supplements daily
8% take 3 medications/day and at least 1 supplement
Kiger, P.J. (2017).

18. Americans over 60 yrs past use of supplements
Supplement use associated with:
increased age
already taking Rx drug
past use of supplements
Kiger, P.J. (2017).

19. Qualities of Supplement Users
Overall health & wellness
Gaps in nutrients – to fill them in
Regular use
Seasonal use
More likely to exercise, healthy diet
MVI
Fish Oil
Calcium
Vitamin D
Vitamin C
Dickinson, A., Blatman, J., El-Dash, N. & Franco, J.C. (2014).

20. Our conundrum Side effects of traditional prescriptions
NSAIDS – risk of heart disease, renal SE
Not a “drug/medicine” since they don’t need Rx
Fibromyalgia: Lack of efficacy w/ opioids
Relief of suffering
Intolerance of Rx drugs
Expanding direct-to-consumer marketing
Economics, Regulation

21. Become an Influence on our patient’s Decisions to use herbals
Considerations:
Efficacy: Does it work?
Safety: Does it harm the body’s organs? Is it used ‘in place of’?
Risk: Does it interfere with other Rx or OTC drugs?

22. And So.…..
The Five Things to Share with your patients

23. First Thing
1. Herbal preparations have pharmacologic properties, even though they’re “Natural”.
Risk for Drug - Herb Interactions
It is important to share information w/ you [& all HCPs] about taking Herbals.

24. Drug-Herbal interactions: How
If taken together, they may
Compete with other drugs for:
Transport proteins- P-glycoproteins (Pgp)
Key Enzyme systems
Glucuronosyltransferases (UGT)
CYP enzymes needed for metabolization
MEANING THAT……
Herbals can affect therapeutic levels
Inhibition or induction

25. Drug-Herbal interactions: How
Effects of Drug + Herbal can be the same [exaggerated effect]
Or opposed [lowering] each other
Zolpidem + Valerian  excess sedation
Herbal: Herbal interactions
Many studies done an animals
Difficult to predict effect in humans

26. Second Thing 2. Become a consumer who is well informed.
Importance of reliable information about the herbal being used or considered

27. Oversight of Rx drugs and Herbals
“Dietary Supplements”
Prescription Drugs
Considered a food
No testing required for new ingredients
No FDA oversight
Must meet some FDA standards
Don’t have to prove safety, efficacy or quality
Disclaimer required
Rigorous testing/ efficacy
FDA approval & ongoing safety oversight
PK and PD known
Metabolism/ MOA understood
SE published
Labelling requirements
Arcangelo, V.P. (2017).

28. DSHEA Disclaimer: Required by law
"This statement has not been evaluated by the FDA.
This product is not intended to diagnose, treat, cure, or prevent disease.”

29. Laws, Acts, regulation: A brief overview
Herbals were 1st healing modality >5,000 years
1906 – Food and Drugs Act
1912 – Sherley Amendment
Federal Food, Drug, and Cosmetic (FDC) Act
1962 – Thalidomide, Sleeping pill linked w/ defects
1994
Dietary Supplement Health and Education Act (DSHEA)
Defined & classified dietary supplement as FOOD
Authorized FDA to promote good manufacturing processes
May regulate nicotine as a drug
Food and Drug Administration. (2018b).

30. Resources for Consumers [patients]
Consumer Reports
NCCIH: What Consumers need to know about supplements
Herbs at a glance
FDA: Consider before buying

32. NCCIH: Herbs at a Glance
Cinnamon
“Studies done in people don’t support using cinnamon for any health condition.
A 2012 systematic review of 10 randomized controlled clinical trials in people with T1 or T2 DM suggests that:
Cinnamon doesn’t help to reduce levels of glucose or HbA1c.
Cinnamon supplements appear to be safe for most people for short-term use if not taken in large amounts.
Some may have allergic reactions to cinnamon
Should not be used in place of conventional medical care or to delay seeking care if you have health problems.
This is particularly true if you have diabetes.”

33. Third Thing
3. Be skeptical and evaluate manufacture’s Claims & Statements about the benefits of an herbal.
Direct-to-consumer marketing
Their precious $$
May be expen$ive and ineffective
You care about their wallet
Medicare supplement doesn’t cover weight loss med

34. Herbals are BIG Business!!
Grand View Research. (2018).

35. “Buzz” on herbal supplements
Misleading marketing claims of nonprescription drugs
57% of claims potentially misleading
10% were false
33 % objectively true
Website Claims about boosting Male Fertility
Faerber, A. E. & Kreling, D. H. (2014).
Samplaski,M.K. & Clemesha C.G. (2018).

36. Herbals for 3 common conditions
Weight loss
Pain
Two Unpleasant Symptoms

37. Herbals for 3 common conditions
Weight loss – Garcinia Cambogia
Pain – Turmeric, Glucosamine/Chondroitin
Two unpleasant symptoms
Anxiety – Kava
Memory Loss – Ginkgo Beloba
Red Flag Ingredients
USES = Purported

38. Garcinia Cambogia: Cambogia gemmi-guta
Garcinia tree – India, SE Asia
Active Ingredient: Hydroxycitric acid (HCA)
USES – Weight loss
Insufficient Evidence to rate effectiveness
Often contains potassium
There are safety concerns: avoid in pregnancy, lactation; liver toxicity
Potential interactions with drugs:
Escitalopram, Sertraline
Dextromethorphan
ACE-I, ARB [Potassium]
Most common SE - mild:
GI – mild diarrhea, hepatotoxicity
CV - hyperkalemia
Natural Medicines Database. (2018a).

39. Turmeric: Curcumin Spice in Asian food – member of the Ginger family
Curcumin = yellow, active ingredient
USES: OA, dyspepsia, abdominal pain, IBS, UC, PUD, Depression, AD, RA
Oral, topical, enema [UC]
Clinical trials – up to 8 months = safe, when used appropriately
Dose – 2.2 grams/ day – Turmeric extract
Curcumin – 4 G/day up to 30 days
Natural Medicines Database. (2018e).

40. Turmeric: Mechanism of action
Depends on the use
Inflammation: seems to inhibit CRP, inflammatory cytokines [RA, Rhinitis]
Cancer – seems to increase apoptosis of cancer cells
Animal research – antidiabetic effects
May have antithrombotic effects
Natural Medicines Database. (2018e).

41. Turmeric: Effectiveness
4,769 Products!!!
Mixed
OA – 500 mg BID of a specific product
Knee Joint pain  Functionality – 2 months
Comparable to ibuprofen 400 mg BID-TID
SAFETY: Cautious w/ CYP 3A4 substrates
SE – death if IV; yellow stool; GI
Natural Medicines Database. (2018e).

42. Glucosamine/Chondroitin - Glucosamine
USES – OA, RA, TMJ, Glaucoma
Glucosamine = natural human macromolecule
3 forms: Glucosamine HCL; Glucosamine Sulfate; N-acetyl glucosamine
Glucosamine – insufficient reliable evidence – depends on formulation
SE – rare
DI – warfarin; acetaminophen may levels of gluocsamine
Natural Medicines Database. (2018c).

43. Glucosamine/Chondroitin - chondroitin
Found in the body: glycosaminoglycan
Some products: chondroitin pig or cow trachea
Supplements derived from animals
Bovine spongiform encephalopathy (BSE)
Manufacturing methods
Chondroitin – Improvement in Knee OA: 800 – 2,000 mg/day - several studies
SE – rare – well tolerated up to 3 years
DI – warfarin
Natural Medicines Database. (2018c).

44. Kava: Piper methysticum
Plant grown in the Pacific Islands
USES – anxiety, ADHD, Insomnia, BZD withdrawal
Safety – possible – hepatotoxicity  liver transplant
Pregnancy – loss of uterine tone [some reports] – AVOID
Evidence – Mixed / contradictory
May help w/ menopausal symptoms, anxiety in menopausal women
SE – long term use: ECG abnormalities, puffy face
DI – CYP 3A4 [amlodipine, simvastatin]
Natural Medicines Database. (2018d).

45. Ginkgo Beloba - Ginkgoaceae
Uses – memory loss, dementia, headache, tinnitus, vertigo, sexual dysfunction – SSRI
Active Ingredients – flavonoids, terpenoids
Safety – possibly, when oral; toxic & carcinogenic high doses
MOA – May have neuroprotective properties – anti-inflammatory cytokines [IL-6, TNF-alpha]
Evidence – conflicting & inconsistent; doesn’t seem to prevent dementia;
specific extract: EGb 761 may be comparable to donepezil
SE – GI, cardiac [PAF]; dizzy
DI - inhibits platelets; atorvastatin levels 
Anastasi, J.K., Lac, M.C., & Capili, B. (2011); Natural Medicines Database. (2018b).

46. Fourth Thing
4. Avoid combining certain prescription medications and herbals.
Herb-drug Interactions

47. Red Flag Drugs / Herbals
Warfarin
AED’s [phenytoin, valproate]
Aspirin
St. John’s Wort
Kava
Ginkgo biloba

48. Drug-Herbal interactions: Mixed
Echinacea [oral] – CYP, Pgp
Garlic - CYP
Black Cohosh
Green Tea
Vitamin E >1,000 U/Day warfarin’s effect

49. Adrenal preparations Ashwaganda Potential interactions with:
Antidiabetic drugs: additive effects
Antihypertensive drugs: Lowers systolic & diastolic BP – risk of hypotension
Benzodiazepines – increases effects
Immunosuppressants – may decrease effectiveness [Prednisone, Imuran]
Thyroid meds – may boost synthesis of thyroid hormone
Antiplatelet drugs – may boost effect [Magnolia] – risk of bleeding

50.  Fifth Thing 5. Please talk to us! Include us in decision-making
If stopping something
You are studying Herbal Medicines and Supplements 

51. Resources for Prescribers
Natural Medicine Comprehensive Database
TRC
Nurse Practitioner Journal
Journal for Nurse Practitioners
esearch.com/home.aspx?cs=&s=ND

52. Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.
Published by Lippincott Williams & Wilkins, Inc.
Pruitt, Rosanne; PhD, APRN-BC; Lemanski, Ashley; Carroll, Adam. Herbal supplements: Research findings and safety.
Nurse Practitioner. 43(5):32-37, May 17, DOI: /01.NPR

53. Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.
Published by Lippincott Williams & Wilkins, Inc.
Pruitt, Rosanne; PhD, APRN-BC; Lemanski, Ashley; Carroll, Adam. Herbal supplements: Research findings and safety.
Nurse Practitioner. 43(5):32-37, May 17, DOI: /01.NPR

54. Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.
Published by Lippincott Williams & Wilkins, Inc.
Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.
Published by Lippincott Williams & Wilkins, Inc.
Pruitt, Rosanne; PhD, APRN-BC; Lemanski, Ashley; Carroll, Adam. Herbal supplements: Research findings and safety.
Nurse Practitioner. 43(5):32-37, May 17, DOI: /01.NPR

55. References
Anastasi, J.K., Lac, M.C., & Capili, B. (2011). Supplements: Talking with your Patients. Journal for Nurse Practitioners, 7(1), Arcangelo, V.P. (2017). Complementary and Alternative Medicine. In V.P.Arcangelo, A.M. Peterson, V. Wilbur, V., & J.A. Reinhold (Eds.), Pharmacotherapeutics for Advanced Practice: A Practical Approach, 4th ed. (pp ). Philadelphia: Wolters Kluwer. Centers for Disease Control. (2017). Percentage of Adults aged 20 Years and Over Who consumed dietary supplements. National Center for Health Statistics. SOURCE: NCHS, National Health and Nutrition Examination Survey, 2011–2012 and 2013–2014. Retrieved from Derjung, M., Paterniti, D.A., Good, J.S., & Coulter, I. D. (2013). Physician-Patient Communication about Dietary Supplements. Retrieved from Dickinson, A., Blatman, J., El-Dash, N. & Franco, J.C. (2014). Consumer usage and reasons for using dietary supplements: report of a series of surveys. J Am Coll Nutr. 33(2): doi: / Duke University. (2018). Introduction to Evidence-Based Practice Tutorial. Retrieved from Faerber, A. E. & Kreling, D. H. (2014). Content Analysis of False and Misleading Claims in Television Advertising for Prescription and Nonprescription Drugs. Journal of General Internal Medicine. 29: 110. doi: Feinberg, T., Lilly, C., & Innes, K. (2017). Nonvitamin, Nonmineral Dietary Supplement Use among Adults with Fibromyalgia: US, Evidence-Based Complementary and Alternative Medicine. Article ID doi: Food and Drug Administration (FDA). (2018a). Five things to consider before taking a supplement. Retrieved from Food and Drug Administration (FDA). (2018b). Milestones in U.S. Food and Drug Law History. Retrieved from Grand View Research. (2018). Dietary Supplements Market Size, Share & Trend Analysis Report By Ingredient (Botanicals, Vitamins, Minerals, Amino Acids, Enzymes), By Product, By Application, By End-use, And Segment Forecasts, 2018 – Retrieved from analysis/dietary-supplements-market

56. References
Grassi D, Desideri G, Necozione S, Lippi C, Casale R, Properzi G, Blumberg JB, & Ferri C.J. (2008). Blood pressure is reduced and insulin sensitivity increased in glucose-intolerant, hypertensive subjects after 15 days of consuming high-polyphenol dark chocolate. Nutr.138(9): Hekel, B.E. (2017). Influence of Expectations of Aging on Older Women's Use of Dietary Supplements Using the Health Promotion Theory. (Doctoral dissertation, University of Wisconsin, Milwaukee). [Abstract]. Retrieved from Kiger, P.J. (2017). Older Americans Report High Use of Dietary Supplements. AARP Health. Retrieved from fd.html Loya A.M., González-Stuart A., & Rivera J.O. (2009). Prevalence of Polypharmacy, Polyherbacy, Nutritional Supplement use and Potential product interactions among Older adults living on the United States- Mexico border: A Descriptive, Questionnaire-based study. Drugs Aging, 26(5), doi / Lynch, T. & Price, A. (2007). The Effect of Cytochrome P450 Metabolism on Drug Response, Interactions, and Adverse Effects. AmFamPhysician, 76(3), Natural Medicines Database. (2018a).Garcinia cambogia. Retrieved from product.aspx?cpid= Natural Medicines Database. (2018b). Ginkgo. Retrieved from supplements/professional.aspx?productid=333 Natural Medicines Database. (2018c). Glucosamine Chondroitin. Retrieved from product.aspx?cpid= Natural Medicines Database. (2018d). Kava. Retrieved from supplements/professional.aspx?productid=872#adverseEvents Natural Medicines Database. (2018e).Turmeric. Retrieved from supplements/professional.aspx?productid=662 Newhouse, R., Dearholt, S., Poe, S., Pugh, L.C., & White, K.M. (2005). Evidence-based Practice: A Practical Approach to Implementation. The Journal of Nursing Administration, 35(1),

57. References
National Center for Complementary and Integrative Health. (2018a). Complementary, Alternative, or Integrative Health: What’s In a Name? Retrieved from National Center for Complementary and Integrative Health. (2018b). NCCIH Facts-at-a-Glance and Mission. Retrieved from P.J. (2017). Older Americans Report High Use of Dietary Supplements. AARP Health. Retrieved from americans-fd.html National Center for Complementary and Integrative Health. (2017). Cinnamon. Retrieved from T. & Price, A. (2007). Robinson JH, Callister LC, Berry JA, Dearing KA: Patient-centered care and adherence: definitions and applications to improve outcomes. (2008). J Am Acad Nurse Pract., 20, doi /j x. Sackett, D. L., Rosenberg, W. M. C., Gray, J. A. M., et al (1996). Evidence based medicine: What it is and what it isn't - It's about integrating individual clinical expertise and the best external evidence. British Medical Journal, 312(7023), Samplaski, M.K. & Clemesha, C.G. (2018). Discrepancies between the Internet and academic literature regarding vitamin use for male infertility. Transl Androl Urol. doi: /tau Siminoff, L. A. (2013). Incorporating patient and family preferences into evidence-based medicine. BMC Medical Informatics and Decision Making, 13(Suppl 3), S6. DOI: / S3-S6 Simon, N. (2010). Most Patients Don't Tell Their Doctors They Take Supplements. AARP Health Drugs and Supplements. Retrieved from supplements/info /most_patients_dont_tell_their_doctors_they_take_supplements.html