Complementary and Alternative Medicine 1

Complementary and Alternative therapies tend to focus on the whole person, taking into consideration an individual’s physical, emotional, mental and spiritual health – consumer-health/in-depth/alternative- medicine/art

Terminology r/t Complementary and Alternative Medicine (CAM) Complementary and alternative medicine (CAM) is the popular term for health and wellness therapies that have traditionally not been part of conventional Western medicine. “Complementary” refers to using a non-mainstream approach together with conventional medicine (eg using acupuncture to help with side effects of cancer treatment “Alternative” refers to using a non-mainstream approach in place of conventional medicine (eg using certain diets to cure cancer instead of surgery, chemo, radiation, or biological modifiers) “Traditional” generally refers to knowledge, skills, and practices based on the theories, beliefs, and experiences indigenous to different cultures used for health (WHO). “Integrative care” results when health care providers and facilities offer both types of care. “Natural” treatments are not necessarily natural… and they’re not necessarily safe! 3

What is considered an “alternative” therapy? – Types of therapies that are broadly identified as “alternative” change over time – See the National Center for Complementary and Alternative Medicine (NCCAM) – depth/alternative-medicine/art

Examples of alternative therapies -per NCCAM Whole medical systems- philosophy-based practices, such as: ancient healing systems (eg ayurveda from India, or traditional Chinese medicine); homeopathy (minute doses of a substance that cause symptoms to stimulate the body's self-healing response); naturopathy (focuses on noninvasive treatments to promote innate healing, incorporates variety of practices, eg massage, acupuncture, herbal remedies, exercise and lifestyle counseling) Mind-body medicine- meditation, prayer, relaxation, yoga, art therapies Biologically based practices - treatments use ingredients found in nature, eg herbs (ginseng, ginkgo, echinacea, etc.); dietary supplements (selenium, glucosamine sulfate, etc) Manipulation and body-based practices- chiropractic or osteopathic manipulation, massage Energy medicine- work with a person’s chi, prana or life force. Energy therapies include qi gong, therapeutic touch, reiki and magnet therapy. Distinctions between therapies aren't always clear-cut. Some systems use techniques from more than one category. health/in-depth/alternative-medicine/art ?pg=2 Also see National Center for Complementary and Alternative Medicine (NCCAM) health/in-depth/alternative-medicine/art ?pg=2 5

CAM Use Most CAM studies in the U.S. show that few people forego conventional medicine. However, the percentage of the US population that reports using some form of CAM is: – approximately 38 percent of adults (about 4 in 10) – approximately 12 percent of children (about 1 in 9) Usually used for symptoms, not cure Nonvitamin/ nonmineral natural products and deep- breathing exercises are the most common forms of CAM used Use has increased for several therapies, including deep breathing exercises, meditation, massage therapy, and yoga. 6

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Top 10 Selling Herbal Supplements in 2010 Cranberry Saw Palmetto Soy Garlic Ginkgo Echinacea Milk Thistle Black Cohosh St. John’s Wort Ginseng 8

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What health conditions are people using herbs or supplements to treat? Female hormonal imbalance/menopause – soy, black cohosh Urinary problems - cranberry, saw palmetto CV risk/cholesterol – garlic, milk thistle Arthritis – omega 3, glucosamine, chondroitin, co-enzyme Q-10 Overall wellness & vitality – combination herbs, omega-3, co-E Q10, ginseng Colds/immune support - echinacea Cognitive problems – ginkgo Depression – St, John’s Wort 10

Dietary supplements… 11 … are defined by FDA as “vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites” intended to supplement the diet and to promote health and relieve symptoms of disease. … are regulated under: 1)Dietary Supplement & Health Education Act of 1994 (DSHEA) 2)Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006) 3)Current Good Manufacturing Practices of 2007 (CGMPs) Nonetheless, as of 2016, these products can STILL be marketed WITHOUT ANY PROOF OF SAFETY OR EFFICACY Label: must identify product as a dietary supplement  must state: This product is not intended to diagnose, treat, cure or prevent any disease.  may insinuate specific benefits to body structure or function but may not overtly claim

Dietary supplements, cont’d 12 Current Good Manufacturing Practices of 2007 (CGMPs) is a set of standards issued by the FDA in response to serious concerns listed below. These practices were designed to ensure that:  Dietary supplements be devoid of impurities, adulterants (such as heavy metals, toxins, pharmaceuticals)  Labels accurately reflect the identity, purity, quality or strength of what’s inside  Label lists active and inactive ingredients Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006)  Mandates reporting of serious adverse events for nonprescription drugs and dietary supplements such as deaths; hospitalizations; life-threatening experiences; persistent or significant disabilities; or birth defects.  Manufacturers and distributors must report these to the FDA within 15 days.

People typically don’t tell their providers about CAM – Health professionals need to non-judgmentally address CAM in the medication history. Concern for medication interactions, disease intx or organ effects – ?pro-active education? Safety – Adverse effects of the herb/supplement – Drug-herb Interactions – direct or indirect effects – Contaminants – toxins or pharmaceuticals Efficacy – Will it treat the problem? – Is the patient foregoing potentially effective treatment? – Placebo effect can be strong! Concerns about CAM Therapies 13

Drug-Herb Interactions  Principal concerns are for 1.increased toxicity 2.decreased therapeutic effects  Major Types of interactions: Pharmacokinetic or pharmacodynamic mechanisms  Induction of Cytochrome P450 enzymes  St. John’s Wort  Inhibition of Cytochrome P450 enzymes  Resulting in:  Additive, Synergistic, or Potentiating effects- Increasing/ magnifying the same effects  Inhibition, Antagonism- Exerting opposite effects  Or something entirely new and different 14

Most Common Drug-Herb Interactions “The popularity of herbal medicinal products (HMPs) makes it important to understand potential interactions between herbs and prescribed drugs. The likelihood of herb-drug interactions could be higher than drug-drug interactions, if only because drugs usually contain single chemical entities, while almost all HMPs (even single-herb products) contain mixtures of pharmacologically active constituents.” Fugh-Berman, A., and Ernst, E., (2001) 15

Most Common Drug-Herb Interactions St John’s Wort – of herbs, most intx Warfarin- of drugs, most intx; – 8 of the 10 most widely used supplements have the potential to interact with the blood-thinning medication warfarin – mayoclinic,org “Patients taking drugs with a narrow therapeutic index (cyclosporine, digoxin, hypoglycemic agents, lithium, phenytoin, procainamide, theophylline, tricyclic antidepressants, and warfarin) should be discouraged from using herbal products. All drugs with a narrow therapeutic index may either have increased adverse effects or be less effective when used in conjunction with herbal products.“ Crit Care Nurse Apr;22(2):22-8, 30, 32; quiz Herbal remedies: drug-herb interactions. Kuhn MA 1. Crit Care Nurse.Kuhn MA 16

Clinical herbal interactions with conventional drugs: from molecules to maladies. Curr Med Chem. 2011;18(31): Curr Med Chem. Limited clinical studies and case reports have identified a number of herb-drug interactions potentiated by the concurrent use of herbal medicines with prescription drug. Drugs that have a high potential to interact with herbal medicines usually have a narrow therapeutic index, including warfarin, digoxin, cyclosporine, tacrolimus, amitriptyline, midazolam, indinavir, and irinotecan. Many of them are substrates of cytochrome P450s (CYPs) and/or P-glycoprotein (P-gp). Herbal medicines that are reported to interact with drugs include garlic (Allium sativum), ginger (Zingiber officinale), ginkgo (Ginkgo biloba), ginseng (Panax ginseng), and St. John's wort (Hypericum perforatum). Well-designed studies are warranted to address the mechanisms and clinical significance of important herb-drug interactions. 17

The clinical consequence of herb-drug interactions varies from being well-tolerated to moderate or serious and even life-threatening events. garlic has been shown to increase the clotting time and international normalized ratio (INR) of warfarin, cause hypoglycaemia when taken with chlorpropamide, and reduce the area under the plasma concentration-time curve (AUC) and maximum concentration of saquinavir in humans ginkgo may potentiate bleeding when combined with warfarin or aspirin, increases blood pressure when combined with thiazide diuretics, and has even led to a coma when combined with trazodone, a serotonin antagonist and reuptake inhibitor used to treat depression ginseng reduced the blood levels of warfarin and alcohol as well as induced mania if taken concomitantly with phenelzine, a non-selective and irreversible monoamine oxidase inhibitor used as an antidepressant and anxiolytic agent. Multiple herb-drug interactions have been identified with St. John's wort that involve significantly reduced AUC and blood concentrations of warfarin, digoxin, indinavir, theophylline, cyclosporine, tacrolimus, amitriptyline, midazolam, and phenprocoumon. Curr Med Chem. 2011;18(31): Curr Med Chem. 18

19 Resources for learning more about CAM and herbs

Resources for learning more about CAM and herbs

 You can’t know everything, so know your resources  and its vetted, reviewed resources, such as …  Where to get info on CAM:  NIH: The “National Center for Complementary and Integrative Health” and the “National Center for Complementary and Alternative Medicine (NCCAM) may be the same resource (?)   Where to get info on herbs:  National Institutes of Health- many webpages  Food and Drug Administration has many downloadable monographs on herbal medicines, herbal supplements, CAM, etc     Longwood Herbal Task Force – has clinician education sheets and patient education handouts 21

22 Make time to relax!