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The Pros and Cons of Herbal Use:

A Discussion for the Healthcare Professional

Presentedby-

Yvette P. Ladd, RPh, ACE-CPT, RYT-200

Staff pharmacist-Outpatient Pharmacy

August Health, Fishersville, VA

Objectives:

  • Explore the prevalence of herbal supplement use
  • List and discuss the pros and cons of herbalsupplement use
  • List commonly used herbal supplements and potential drug interactions
  • Identify the healthcare professional’s role in gathering information and making decisions about herbalsupplement use among patients
  • Provide resources for learning about herbalsupplements and their regulation

Herbal History

Herbal or Botanical:

A plant or part of a plant used for its flavor, scent, or potential therapeutic properties. Includes flowers, leaves, bark, fruit, seeds, stems, and roots.

  • Herbal medicines reflect some of the first attempts to improve thehuman condition. The personal effects of the mummified prehistoric“ice man” found in the Italian Alps in 1991 included medicinal herbs. By the Middle Ages, thousands of botanical products had beeninventoried for their medicinal effects.

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  • In some Asian and African countries, 80% of the population depends on traditional medicine for primary health care.
  • Herbal medicines are the most lucrative form of traditional medicine, generating billions of dollars in revenue.
  • More than 100 countries have regulations for herbal medicines.

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The Prevalence of Herbal Use:

  • Herbs fall under the category of dietary supplements.
  • The most commonly used dietary supplement is a multivitamin/mineral complex
  • Approximately 30 to 40% of US adults have used anherbal supplement. Roughly, 72% of those are usingherbals in conjunction with prescription medications.

FACTORS ASSOCIATED WITH HERBAL THERAPY USE BY ADULTS IN THE UNITED STATES • Paula Gardiner, MD; Robert Graham MD, MPH; Anna T.R. Legedza, ScD; Andrew C. Ahn, MD, MPH; David M. Eisenberg,MD; Russell S. Phillips, MD

  • Herbal supplement sales in the U.S. increased 3.3% in 2010, reaching a total estimated figure of 5.2 billion dollars.

HerbalGram. 2011; American Botanical Council; Herb Sales Continue Growth – Up 3.3% in 2010; byMark Blumenthal;Ashley Lindstrom;Mary Ellen Lynch;Patrick Rea

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According to the market report the top 10 best selling herbs in 2011 were, in rank order:

  1. Cranberry
  2. Saw palmetto
  3. Soy
  4. Garlic
  5. Gingko
  6. Echinacea
  7. Milk thistle
  8. Black cohosh
  9. St. John's Wort
  10. Ginseng

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The Cons:

  • Herbs are assumed safe because they are ‘natural’- ‘a plant or a food’

-potential drug interactions exist

-patient age health can compromise metabolism

  • Use and adverse events are under-reported

-Forty-one percent (41%) of patients do not disclose herbal supplementation to their health providers

-uncertainty exists as to what causes and adverse event due to polypharmacy and/or polyherbacy

  • Dosing of herbs can be difficult

-standardization vs. whole plant

-different dosage forms

  • Lack of knowledge of health care professionals

-they don’t know where to look for information

-patients expect their doctors to be informed

  • Lack of Regulation
  • Lack of science-based research
  • Lack of Quality Control (QC)–contamination and adulteration

The Pros:

  • Herbs are affordable and accessible

-lack of health insurance, limited income

-there is a trend of mistrust of the medical establishment

-patients want to be in control of health and medical needs. Herbal supplementation is consistent with the current paradigm shift in making lifestyle modifications to improve health and a desire to take a more ‘natural’ approach toward medical care. Lifestyle makes a difference in how a patient will respond to treatment.

  • Herbs aid bodily functions and help to normalize imbalances, thus enhancing the body’s ability to heal itself

-herbs have a long history of use

-herbs typically have few side effects

-very few drug interactions have been documented

  • DSHEA(1994) gives the FDA authority to regulate herbs

-cGMP instituted in 2010-requiring phytoequivalence within a dosage form and also addressing cultivation methods

-the SIDI protocol

-in 2006 adverse event reporting by manufacturers and distributors became mandatory

  • Research is growing

-Natural Medicines Comprehensive Database: the number of scientific publications on this subject has increased over 140 times from the 1980’s-2007.

  • Consumer Demand will result in an increase in Quality Control measures

-manufacturers who want to stay in business will create and follow QC standards

-USP, NSF, NPA

-Certificate of Analysis

-3rd party certification programs

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Commonly use Herbs and Potential Drug Interactions:(this is not a comprehensive list)

  • Gingko and Garlic - increased risk of bleeding when used with antiplatelet, anticoagulant or antithrombotic agents (Coumadin, Plavix, Lovenox, nsaids)
  • St. John’s Wort – induces cytochrome P450- an enzyme involved in the metabolism of more than 50% of all prescription medications; may also have a synergistic effect with SSRI’s and other drugs that influence serotonin levels
  • Saw Palmetto – inhibits cyclo-oxygenase (COX) and increases the antiplatelet effects of warfarin; may have anti-estrogenic effects
  • Green Tea - caffeine content can pose problems with various drugs – i.e. with amphetamines or decongestants may increase risk of CNS side effects
  • Echinacea–inhibits certain CYP enzymes- increased potential for hepatotoxic effects of other medications due to elevated serum drug levels; also a potential to interfere with immunosuppressant drugs (cyclosporine, Cellcept, Prograf, corticosteroids)

The Medical Assistant's role in herbal use among patients:

  • Take a thorough history from the patient
  • update EMR (software may have capability of being customized for this purpose)
  • have receptionist ask for updates to medications and supplements as they as for other information
  • Encourage patients:
  • to communicate all supplement use and why
  • to purchase products with a solid reputation for quality
  • to report suspected adverse events or drug interactions to the manufacturer
  • Educate yourself
  • Continuing education
  • Self-education
  • Herbal workshops
  • Resources (final pages of this presentation)
  • Reach out to local Naturopathic doctors,Master Herbalists, local health food stores (verify education of staff) - (invite them in for in-services- great way to support one another)
  • Talk to specific manufacturers
  • Understand the basics of DSHEA (Herbalgram February 2012 and CRNUSA website noted in resources section)
  • ingredients in existence prior to DSHEA to not have to be prove safety or effectiveness, new ingredients DO!

The Medical Assistant's role in herbal use among patients: (continued)

  • Educate yourself(continued)
  • Self-education (continued)
  • be aware of health claims- allowed: addresses a specific nutritional deficiency; supports health; is linked to a particular function (digestive, immunity)- claims must be followed by disclaimer:
  • once on market FDA monitors safety and associated product information (in conjunction w/FTC)
  • Serious adverse reactions MUST be reported to FDA via MEDWATCH
  • Stay abreast of current research and quality control standards(resources)
  • the more research available the more sales and use of herbal products. This industry isn't going away!
  • Educate yourpatients-Provide evidence-based educational material and a list of other resources.

Communicate & Educate!

Web resources for herbal research:

Research:

  • National Institutes of Health: NationalCenter for Complimentary and Alternative Medicine
  • Integrative Medicine Research- science based research
  • The Cochrane Collaboration- science based research
  • US Pharmacopeial- standardization/certification of botanicals, science based research, the ‘white paper’
  • Natural Medicines Comprehensive Database- complete herb information; science based research; drug interaction checker;rating for significance of potential drug interactions; patient handouts

Product Integrity:

  • Consumer Lab.com- Independent Testing/Reporting; current news
  • Emerson Ecologics- an example of quality control

General Herbal information:

  • Herb Research Foundation- comprehensive information about botanicals
  • American Botanical Council- the HerbalGram; monographs (patient handouts); research; international regulatory status
  • Herb Pharm- brand of tinctures; but also offer educational material
  • Herb Society of America- herbal history, use and more!
  • American Herbal Products Association- representing the companies behind the products; current news, research, resource for NDIs.

Regulation:

  • Center for Responsible Nutrition- Representing manufacturers and suppliers

A great place to learn about DSHEA.

Other Resources:

Books/Journals:

  • The ABC Clinical Guide to Herbs (free with membership to American Botanical Society)
  • A-Z Guide to Drug-Herb-Vitamin Interactions
  • Nutritional Healing (Balch)- great overall reference
  • Women’s Encyclopedia of Natural Medicine (Hudson)
  • Rosemary Gladstar's Medicinal Herbs: A Beginner's Guide: 33 Healing Herbs to Know, Grow, and Use
  • Complimentary Therapies in Medicine (journal)
  • German Commision E Monographs (also availablefrom American Botanical Society)
  • 2012 USP Dietary Supplements Compendium (DSC)

Manufacturers of Products:

Review if available or ask about Quality Control policies and procedures. Companies that care about quality should not be afraid to share information with you. Many of them also conduct their own research.

Examples-

Emerson Ecologics

Pure Encapsulations

Metagenics

NOW

Gaia