Herbal Facts and Fallacies

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1 Herbal Facts and Fallacies Geneva Briggs, Pharm.D., BCPS MedOutcomes, Inc. This program has been brought to you by PharmCon PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education

Herbal Facts and Fallacies Accreditation: Pharmacists: 798-000-09-020-L01-P Pharmacy Technicians: 798-000-09-020-L01-T CE Credits: 1.

2 Herbal Facts and Fallacies Accreditation: Pharmacists: L01-P Pharmacy Technicians: L01-T CE Credits: 1.0 contact hour Target Audience: Pharmacists & Technicians Program Overview: Many people don't realize that conventional medicine is rooted in herbalism, and are unaware that medical science still depends strongly on plants to provide the blueprint for much of modern medicine. There are hundreds of plants and trees which produce herbal medicines and therefore it is difficult to have any specialist with knowledge of all the available herbs. Join your friends and peers online to listen and discuss herbal remedies. Find out how herbal drug interactions with prescription drugs could be potentially fatal! Objectives: Increase awareness of the use of herbs. Describe the alternative medications that are most dangerous. Identify the most common drug interactions with alternative medications. Identify five sources of unbiased information on alternative medications and supplements. This program has been brought to you by PharmCon

of Virginia. Dr. Briggs is a clinical associate with MedOutcomes, Inc. where she develops and presents educational programs for pharmacists. Speaker Disclosure: Dr.

3 Herbal Facts and Fallacies Speaker: Dr. Geneva Clark Briggs, a board-certified Pharmacotherapy Specialist, received her Doctor of Pharmacy and Bachelor of Science in Pharmacy degrees from Virginia Commonwealth University, Medical College of Virginia. Dr. Briggs is a clinical associate with MedOutcomes, Inc. where she develops and presents educational programs for pharmacists. Speaker Disclosure: Dr. Briggs has no actual or potential conflicts of interest in relation to this program This program has been brought to you by PharmCon PharmCon is accredited by the accreditation counsel for Pharmacy Education as a provider of continuing pharmacy education Legal Disclaimer: The material presented here does not necessarily reflect the views of Pharmaceutical Education Consultants (PharmCon) or the companies that support educational programming. A qualified healthcare professional should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity.

4 Objectives Increase awareness of the use of herbs. Describe the alternative medications that are most dangerous. Identify the most common drug interactions with alternative medications. Identify five sources for unbiased information on alternative medications and supplements.

5 Poisons and medicines are oftentimes the same substances given with different intents Peter Mere Latham ( )

6 Herbal Remedies in the US The herbal and pharmaceutical industries in the United States share a common heritage. Most pharmaceutical manufacturers of today were originally herbal extract producers. Many modern herbal manufacturers are becoming pharmaceutical manufacturers

7 Why learn about Herbal Medicine? Your patients are using herbs. Many drugs came from plants. So, why shouldn t there be potential for efficacy of herbs? Herbs have pharmacological properties including side effects, interactions. Suggestive evidence exists on efficacy

8 Your Patients are Using Herbs! 14% percent of the population takes at least 1 herbal/supplement each week (JAMA Jan 16, 2002) 16% of prescription drug users also use 1+ herbal/supplement $17.8 BILLION on dietary supplements $4.2 Billion for Herbal products (NEJM Dec 19, 2002) YET only 38% told their doctor

12 Concerns with Phytomedicine REGULATORY: Unmonitored, uncontrolled, non uniform products No standards of bioequivalence between brands, or between lots Ingredients not required to be completely listed Producers do not need to prove safety or efficacy Adulteration has commonly been described

13 More Concerns with Phytomedicine Many touted for prevention hard to evaluate. Placebo effect is strong. Quality of science varies. Much of the research is not in English.

14 Herbal Quality Proper identification and plant taxonomy Different lots, genetic variation Time of harvesting, proper part of plant Environmental and soil conditions

15 Asian or Chinese patent medicines Of 251 purchased in CA, 24 contained lead, 36 arsenic, 35 mercury 24% of 2,609 samples of Chinese patent medicines contained pharmaceutical adulterants J Clin Pharmacol 1997; 37: BMJ 1994; 308: N Engl J Med 1998; 339: 847

16 Herbal Standardization Determining active constituents is a biochemical challenge Echinacea caffeic acids, alkylamides, marker compounds, interspecies variation Ginseng ginsenosides, 30 different types St. John s Wort hypericin or hyperforin as active ingredient. To which do you standardize?

17 Which herbals are most likely to cause significant adverse effects?

18 Top 10 Offenders Kava [Piper methysticum] Comfrey Chaparral [Larrea tridentata] Germander [Teucrium genus] Aristolochic acid Germanium dioxide or lactate citrate Lobelia [Indian tobacco] Stephania L tryptophan Ephedra (ma huang)

19 Beyond the Top 10 Pennyroyal oil Sassafras Borage Calamus Coltsfoot Life root

20 Significant Interactions with Alternative Supplements

St John s Wort [Hypericum perforatum] Digoxin Warfarin Theophylline Nefazodone Oral contraceptives Antiretrovirals Cyclosporine Imatinib

21 St John s Wort [Hypericum perforatum] Digoxin Warfarin Theophylline Nefazodone Oral contraceptives Antiretrovirals Cyclosporine Imatinib (Gleevec) Irinotecan [Camptosar] Simvastatin Amitriptyline SSRI (fluoxetine, sertraline, etc.) Lancet 2000;355: Pharmacotherapy 2004;24:

22 Herbal and Supplement Products That Interact with Warfarin Increased INR Ginkgo Biloba Dong Quai (Angelica sinesis) Danshen (Salvia miltiorrhiza) Vitamin E Decreased INR St. John s Wort Coenzyme Q10 American ginseng Altered Platelets Garlic [Allium sativum] Feverfew Ginseng Turmeric Meadowsweet Willow bark Contain Coumarins* Horse chestnut Red clover Lancet 2000;355:13438 J Clin Pharm Ther 2002;27:

23 Significant Interactions with Alternative Meds and Supplements Siberian Ginseng (Eleutherococcus senticocous) Digoxin Valerian [Valeriana officinalis] alcohol, benzodiazepines, anticonvulsants, TCA Licorice ACE I, ARB, diuretics, digoxin Lancet 2000;355:13438

24 Significant Interactions with Alternative Meds and Supplements Kava and valerian alcohol, barbiturates, antispychotic drugs, sedatives, benzodiazepines Garlic saquinavir Red rice yeast [Chinese red rice] statins, gemfibrozil, fenofibrate

25 Patient Groups Most Likely to Have Problems Multiple medications HIV/AIDS Cancer Transplant Treated with warfarin, digoxin, or other agents prone to drug interactions Undergoing surgery Am J Health-Syst Pharm 2004;61:

26 Avoid Recommending Herbals Pregnant and lactating women Children

27 Problem Products in Surgery Ginkgo biloba Saw Palmetto American Ginseng [Panex quinquefolias] Kava St John s wort Feverfew

28 Problem Products in Cancer Treatment Garlic Ginkgo Echinacea Panax ginseng St John s wort Kava J Clin Oncol 2004;22:

29 Reasonably Effective Herbals Aloe Vera (topical) Arnica (topical) Black Cohosh Chamomile tea Echinacea Evening primrose oil Feverfew Garlic Ginger Ginkgo Biloba Hawthorn Peppermint tea Saw Palmetto Siberian Ginseng St John s wort Valerian

30 Reliable Printed Resources Herbal medicine: Expanded Commission E monographs Review of Natural Products Tyler s Herbs of Choice. The Therapeutic Use of Phytomedicinals Tyler s Honest Herbal: A Sensible Guide to the Use of Herbs and Related Products. Facts and Comparisons: The Review of Natural Products

31 Reliable Online Resources consumerlab.com herbalgram.com American Botanical Council nccam.nih.gov NIH s National Center for Complementary and Alternative Medicine vm.cfsan.fda.gov Center for Food Safety and Applied Nutrition

32 Reliable Online Resources /scont_about_evaluations.htm University of Illinois s.pdf Healthcare Professional s Guide to Evaluating Dietary Supplements

33 To Buy Anything and Everything Blood Circulator Made of medicinal rhubarb, prepared rehmannia root, common peony root, peach seed, bitter apricot seed, licorice root, scute, dun fly, gadfly, leech, June beetle grub, dried lacquer and ground beetle.

34 Patient Counseling Ask every pt about herbs and supplements Address natural must mean safe If it sounds too good to be true, it probably is Avoid preparations with >1 herb Avoid switching brands frequently Buy packaged products with name/address of manufacturer, batch/lot number common and scientific name, standardization when possible dosing guidelines, side effects

35 Patient Counseling Encourage disclosure of ALL medicinal substances Discuss available information about alternative medicines Discuss health risk and self monitoring Set objective goals to follow progress Steer patients seeking to self treat serious disorders such as depression to a physician

36 How to Report an Adverse Effect Complete the Medwatch form online at Report by telephone (1 800 FDA 1088) Download a copy of the form and either fax it to FDA 0178 or mail it back using the postage paid addressed form.

37 Evaluating Products for Quality USP standardization (feverfew, ginger, chamomile, cranberry, ginkgo biloba, St John s wort, saw palmetto, milk thistle, valerian, siberian ginseng, and echinacea) Reputable manufacturer Consumerlab.com evaluations

38 Points to Remember FDA neither establishes nor regularly enforces any standards of quality for herbs Herbs are technically unapproved drugs, in an OTC limbo Best advice: obtain a standardized extract marketed by a reputable firm

39 Conclusion Current regulation of dietary supplements fails to address substantial risk to public health Educate patients to give Full Disclosure Know the problem herbs and most common interacting herbs Report adverse events

Geneva Briggs, Pharm.D., BCPS MedOutcomes, Inc.

Geneva Briggs, Pharm.D., BCPS MedOutcomes, Inc. Objectives Discuss the alternative medications that are most dangerous. Identify the most common drug interactions with alternative medications. List five