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Alternative and Complementary Therapies Thomas L. Davis, MD. Department of Neurology Vanderbilt University Western Medicine • • • • • Pathologically based - “We have no cure” Limited practioners “Expensive” May be painful Negative testimonials despite positive studies Alternative Medicine • Symptomatically based- Treatment for everything • Unlimited practioners - Do it yourself • “Inexpensive” • Nonpainful • Positive testimonials Other Terms • Evidence based medicine • Good medicine / Bad medicine The majority of health care delivered is “alternative”? 1. True 2. False The Adkins diet is alternative medicine? 1. True 2. False Alternative Medicine • WHO reports 65-80% of the world population relies on traditional medicine • 30 billion dollar industry in USA • > 1000 homeopathic meds sold OTC Legislation - Alternative Medicine • Dietary Supplement Health and Education Act of 1994 ingested products that are intended to supplement the diet are considered foods and are exempt from federal drug laws. • Labeling Addendum 1997 - “ This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease” • Acupuncture - not recognized in Tennessee. Several states allow licenser of nonphysician practioners. What is CAM? Complementary and alternative medicine, as defined by the National Center for Complementary and Alternative Medicine (NCCAM), is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine. The list of practices that are considered CAM changes continually, as those therapies that are proven to be safe and effective become adopted into conventional health care and as new approaches to health care emerge. Complimentary v. Alternative • Complementary medicine is used together with conventional medicine. • Alternative medicine is used in place of conventional medicine. • Integrative medicine combines mainstream medical therapies and CAM therapies for which there is some high-quality scientific evidence of safety and effectiveness. Dietary Supplement Health and Education Act of 1994 • Product (other than tobacco) intended to supplement the diet, which contains one or more of the following: vitamins; minerals; herbs or other botanicals; amino acids; or any combination of the above ingredients. • Intended to be taken in tablet, capsule, powder, softgel, gelcap, or liquid form. • Not represented for use as a conventional food or as a sole item of a meal or the diet. • It is labeled as being a dietary supplement. Herbal Products • A US survey of adults who regularly take prescription medication, 18% reported the concurrent use of at least one herbal product or high-dose vitamin. • 61.5% of those who used unconventional therapies did not disclose such use to their physicians. Fugh-Berman A, Lancet, 355:134, 2000 Most patients volunteer the use of alternative therapies with their physicians? 1. True 2. False Herbal Therapies • 40% prescription drugs sold in US contain ingredients derived from nature • 25% of drugs contain at least 1 component derived directly, or from chemical modeling of flowering plants Herbal Treatments of PD Mucuna puriens Vitex agnis castors Banisteria caapi Vicia faba Atropa belladonna Cannibus sativa L-DOPA (Indian Legume) Dopamine agonist MAO inhibitor L-DOPA Anticholinergic Anticholinergic (Indian hemp) Ginkgo Ginkgo biloba • Memory loss, claudication, stroke, tinnitus • Ginkgolides, Bilbobalides • Free radical scavenger, anticoagulant • AE’s: hemorrhage Valerian Valeriana officinalis • • • • Anxiety, insomnia ? Valerenic acid Sedative AE’s: oversedation, no evidence of dependence St. John’s-Wort Hypericum perforatum • Depression • Hypericin, psuedohypericin • MAO inhibitor • AE’s: light sensitivity, tyramine effect Indinavir and St John’s Wort Before St John’s wort After St John’s wort 300 mg TID x 14 days Piscitelli, SC et al, Lancet, 355:547, 2000 Herbal Products: St John’s Wort • Patients on serotonin-reuptake inhibitors, cyclosporin, digoxin, warfarin, HIV protease inhibitors, oral contraceptives and other drug substrates of CYP3A/P-gp are advised to avoid St John's wort. Herbal Products Fugh-Berman A, Lancet, 355:134, 2000 Metabolife has pointed to several animal studies and two human studies to support its claims of safety and effectiveness: one at Vanderbilt University and the other at Columbia University. When contacted by Newsweek in August of 1999, "researchers from both studies said that neither was comprehensive enough to support any conclusions about long-term usage of the product . . . Vanderbilt insisted that its name be removed from Metabolife's promotional materials." Herbal Medications • Potentially potent • Polypharmacy - may contain other ingredients • Unregulated • Not standardized • “Natural” not necessarily good • Can’t have it both ways What Should You Do ? • • • • Learn about it Talk about it Use it Encourage patients to think of them as medicines • Encourage patients to grow their own • Encourage well designed trials