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  1. Integrative Medicine Nutritional Implications

  2. Complementary and alternative medicine (CAM): • Complementary and alternative medicine (CAM): alternative, adjunctive health care practices: not presently an integral part of conventional medicine; includes botanical use, mind-body approaches, musculoskeletal manipulation, energy medicine, nutrition-diet interventions Thomson in Krause, p. 470

  3. CAM Therapies Include • Alternative medical systems, such as naturopathy, traditional Chinese medicine, ayurveda, and homeopathy • Mind-body therapies, such as meditation, prayer, art or music therapy • Biologically based therapies such as herbs, whole foods diets, and supplementation • Manipulative therapies such as massage, chiropractic medicine, osteopathy, yoga • Whole medical systems based on energy therapies such as qi gong, magnetic therapy, and reiki

  4. Integrative medicine • Integration of these approaches into conventional medicine; nutritional care is a primary therapy in this model • Focused on combined use of conventional and CAM approaches • Evidence-based • Includes wellness and prevention Thomson in Krause, p. 471

  5. National Center for Complementary and Alternative Medicine (NCCAM) Part of the National Institutes of Health —Investigates and evaluates alternative therapies and their effectiveness

  6. Theoretical Basis of Holistic Therapies • Health as a vital, dynamic state; more than the absence of disease • The healing force of nature • Self-healing power of living things; organisms have inherent self-defense mechanisms against illness • Includes naturopathy, chiropractic, homeopathy, traditional Oriental medicine, acupuncture, phytotherapy

  7. Integrative Therapies • Naturopathy • Homeopathy • Traditional Chinese medicine • Acupuncture • Phytotherapy Health is more than the absence of disease. The body can heal itself.

  8. Naturopathy • Practitioners diagnose and treat at the primary care level • Train in 4-year postgraduate institutions • Most states require licensure • Uses natural methods of healing (light, heat, air, water, and massage) • Training includes pathology, microbiology, physical and clinical diagnosis, pharmacognosy, hydrotherapy, physical therapy, nutrition, • Treatments include phytomedicines, electrotherapy, physiotherapy, minor surgery, mechanotherapy, nutrition, nutritional supplements, and natural forces

  9. Chiropractic Concepts • Body has the ability to heal itself; Practitioner’s role is to assist • The structure and condition of the body influences how well it functions • The mind-body relationship is important in maintaining health and promoting healing • Locate and eliminate subluxations, musculoskeletal problems that interfere with the body’s ability to maintain health • Primary therapy is manual manipulations, along with lifestyle

  10. Chiropractic Practitioners • Do not prescribe drugs or perform surgery • Licensed and regulated in all 50 states and 30+ countries • Practitioners must graduate from 4-year accredited college of chiropractic and pass a nationally-administered exam

  11. Chiropractic • The most widely-used of the complementary and alternative treatments, particularly for low back pain, neck pain, and headache • Effectiveness is being studied by the Consortial Center for Chiropractic Research, a consortium of chiropractic schools and universities, established by NCCAM

  12. Homeopathy • Law of similars: Substances in large doses that produce symptoms of a disease in healthy people will cure the same symptoms when administered in very dilute amounts • Remedies become potentized through repeated dilution and succussion (shaking)

  13. Homeopathy • Results of research on the effectiveness of homeopathy have been contradictory • Appears to have more than a placebo effect, but scientific basis unclear • Generally regarded as safe (many homeopathic remedies are so dilute that the healing substance is nondetectable by chemical means

  14. Traditional Chinese Medicine • Based on the concept of body life force chi (Qi) • Forces that must be balanced —Yin and yang and blood • Invisible energy circuits called meridians carry chi and blood throughout the body

  15. Nutrition in Traditional Chinese Medicine • Components: Food as a means of obtaining nutrition, food as a tonic or medicine, fasting • Foods classified by taste (sour, bitter, sweet, spicy, salty) and property (cool, cold, warm, hot and plain) • Regulate yin, yang, chi, blood

  16. Acupuncture and Moxibustion • Acupuncture: Use of thin needles, inserted into points on the meridians, stimulating the body’s energy or chi • Moxibustion: application of heat along meridian acupuncture points, affecting chi and blood, balancing substances and organs • Treat disharmony in the body

  17. Acupuncture as Anesthesia • Has been used to produce regional anesthesia • Appears to act through needle stimulation, triggering the release of opioids • Research has been mixed • Has been shown to be efficacious in adult postop management, chemotherapy-induced nausea, postoperative dental pain

  18. Traditional Chinese Herbs • Includes herbs and minerals as well as animal products • Pharmacopoeias published as early as the third century BC • Most medicinals include multiple substances

  19. Phytotherapy • Science of using plant-derived substances to treat and prevent illness • Botanicals: come as bulk herbs, tinctures, capsules and tablets; includes herbs and other plant materials • Sometimes the active ingredient has been identified; sometimes not • Have a long history of research and use in Europe

  20. Botanical Formulations • Teas: weak concentration prepared by steeping fresh/dried herbs for a few minutes in water • Infusions: more concentrated than teas; steeped for 15 minutes • Decoction: Most concentrated of beverages; botanical is boiled for 30-60 minutes

  21. Botanical Formulations • Extracts: herbs are extracted with an organic solvent to dissolve the active components; concentrated form • Tincture: extract in which solvent is alcohol • Glycerite: extract in which the solvent is glycerol or mixture of glycerol, propylene glycol, and water; more suitable for children

  22. Botanical Formulations • Capsules: Herbal material enclosed in a hard shell made from gelatin or cellulose • Tablets: herbal material is mixed with filler to form the hard tablet; may be coated or uncoated • Lozenges (troches): active components are released in the mouth when chewed or sucked • Soft gels: used to encase liquid extracts, such as omega-3 fatty acids or vitamin E • Essential oils: fragrant, volatile plant oils used for aromatherapy, bathing; not to be used internally unless specifically directed

  23. American Herbal Products Assoc Botanical Safety Rating System • Class 1: herbs that can be safely consumed when used appropriately • Class 2: herbs for which restrictions apply, e.g. for external use only, not to be used during pregnancy, nursing, etc • Class 3: herbs labeled “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” • Class 4: insufficient data for classification

  24. Dietary Supplement Health and Education Act of 1994 (DSHEA) • Defined dietary supplements as “a product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these incredients • Reclassified botanicals as dietary supplements, distinct from food or drugs

  25. Dietary Supplement Health and Education Act of 1994 (DSHEA) • Plant extracts, enzymes, vitamins, minerals, hormonal products available without prescription may carry “structure-function” claims • Cannot claim to prevent or cure specific conditions • Must display disclaimer, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”

  26. Required Labeling of Dietary Supplements under DSHEA • Name (echinacea, for example) • Ingredient information • Disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease." • Supplement Facts panel, which includes serving size, amount and active ingredient. • Name and address of manufacturer, packer or distributor.

  27. Supplement Facts Panel

  28. Dietary Supplement Claims • Health claim: describes the relationship between a substance and a disease condition; FDA does not approve, but must be notified • Qualified health claim: based on emerging scientific evidence; must be approved by FDA • Structure-function claim: most common; does not claim to prevent disease, but a physiological effect is noted, e.g. “increases blood flow to the heart.”

  29. Allowed This product helps to increase blood flow to the heart. This product promotes urinary tract health This product improves absent-mindedness. This product reduces stress and frustration Not Allowed This product prevents heart disease This product prevents urinary tract infections. This product reduces risk of Alzheimer’s Disease. This product improves depression. Labeling Under DSHEA

  30. Regulation of Dietary Supplements • Dietary supplements are not subject to the same standards as prescription or over-the-counter drugs • Manufacturers do not have to prove their products are safe or effective before they put them on the market • FDA can pull supplements proven to be dangerous, but only after the fact; it is up to the FDA to make its case

  31. Regulation of Dietary Supplements: Medwatch • The FDA’s Medwatch system can be used to report possible adverse reactions to dietary supplements http://www.fda.gov/medwatch/report/hcp.htm

  32. Examples of FDA Warnings • January, 2004: FDA warns consumers not to feed their babies “Better than Formula Ultra Infant Immune Booster 117" being sold over the internet as a dietary supplement • February, 2002: Consumers warned to stop using the products PC SPES and SPES capsules because they contain undeclared prescription drug ingredients that could cause serious health effects

  33. Examples of FDA Warnings • November, 2001: consumers warned to immediately stop use of LipoKinetix, a weight loss product; implicated in a number of serious liver injuries. • March, 2002: consumers advised of risk of severe liver injury associated with the use of kava-containing dietary supplements to ease stress and anxiety. • February, 2004: issues final rule forbidding sale of ephedra-containing weight loss products; associated with significant adverse health effects including heart attack and stroke

  34. Dietary Supplement and Nonprescription Drug Consumer Protection Act 12/06 • Requires manufacturers and distributors of dietary supplements and OTC drugs to report all serious adverse events to FDA • Requires manufacturers to keep all adverse event records, serious and non-serious, for six years; allows FDA to inspect these records. • Sets a 15-day time limit for manufacturers to give FDA the serious reports they receive.

  35. Cautions Regarding Dietary Supplements • There may be a discrepancy between the ingredients on the label and what’s inside • This is especially true of herb mixtures, such as Chinese herbs • The dosage of the “active ingredient” in herbals can vary widely depending on the variety of plant, where it’s grown, climate, etc.

  36. Read the Dietary Supplement Label and Verify…. • Complete botanical name of the product (make sure it is the right botanical) • The part of the plant used to make the product; it should be the part that contains the active components • The concentration of the botanical and if it is appropriate, neither too weak or two strong Debusk, RM. A practical guide to herbal supplements for nutrition practitioners. Top Clin Nutr 16:53, 2001

  37. Read the Dietary Supplement Label and Verify…. • The daily dosage needed to obtain the desired effect • The list of ingredients used to identify fillers, potential allergens • Lot number • Expiration date • Recognized seal of approval (Good Housekeeping, USP, Consumerlab) • Compare prices: prices vary widely Debusk, RM. A practical guide to herbal supplements for nutrition practitioners. Top Clin Nutr 16:53, 2001

  38. Evaluating Dietary Supplements • Obtain unbiased evaluative information from resources like Supplement Watch and Consumer Lab www.consumerlab.com • Encourage patients to purchase supplements from well-known manufacturers

  39. ConsumerLab Study of 20 Multivitamins Vitamins that failed: • The Vitamin Shoppe Multivitamins Especially for women: Contaminated with lead • — Hero Nutritionals Yummi Bears: Had twice the labeled amount of vitamin A • — Nature's Plus Especially Yours for Women: Took twice as long as allowed to disintegrate • — AARP Maturity Formula: Took nearly twice as long as allowed to disintegrate • — Eniva VIBE: Only 54 percent of claimed vitamin A • — Pet-Tabs Complete Daily Vitamin-Mineral Supplement for Dogs: Contained lead • Accessed at MSNBC http://www.msnbc.msn.com/id/16655168/ • Released 1/2007

  40. ConsumerLab Study of 20 Multivitamins Vitamins that passed: • Centrum Silver • Member's Mark Complete Multi • One A Day Women's • Flintstones Complete • http://www.msnbc.msn.com/id/16655168/ January, 2007

  41. Tips for Picking a Multivitamin from CSPI • Choose well-known mainstream brands by companies that have a lot at stake. • Buy from large, trusted retailers, not unknown sellers on the Internet. • Look on the bottle for a stamp from USP, NSF or ConsumerLab.com. While the stamp doesn't guarantee the product is safe and effective, it does indicate that the manufacturer has submitted the product for testing to show that it contains what is stated on the label. • Don’t spend a fortune on vitamins. Pricey products toting all sorts of "extras" aren't necessary and may be trouble. • Center for Science in the Public Interest accessed at http://www.msnbc.msn.com/id/16655168/ 1/07

  42. Evaluating Dietary Supplements United States Pharmacopeial Convention (USP) Dietary Supplement Verification Program (DSVP) • Certification mark (USP®) indicates that the product contains the dietary supplement listed on the label in the stated amount and that the product is manufactured properly • Does not speak to the safety or efficacy of the ingredients, only to good manufacturing practices

  43. CAM Providers: MDs/DOs • Over 1/3 of medical schools offer instruction in alternative medicine • More than half of family physicians in the US regularly prescribe alternative treatments or have used themselves

  44. CAM Providers: RDs • Nutrition in Complementary Care DPG, a subunit of the American Dietetic Association http://www.complementarynutrition.org/ • Some RDs are incorporating counseling about CAM into their practices

  45. CAM Providers: Other • RNs • RPh • ND: naturopath provider • DC: chiropractor • OMD: oriental medical doctor • Accupuncturist • Massage Therapist • Hypnotherapist • Herbalist

  46. Tips for Patients: Evaluating CAM Providers • Check for licensing, education, accreditation of provider • Check for complaints (BBB, Board of Health, Attorney General’s office, patient support groups) • Speak with the practitioner in person, evaluate facilities and neighbors