THERAPEUTICS WITH NATURAL REMEDIES

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1 THERAPEUTICS WITH NATURAL REMEDIES Stephen Holt MD, LLD (Hon.) ChB., ND, FRCP (C), MRCP (UK), FACP, FACG, FACN, FACAM Distinguished Professor of Medicine, NYCPM

2 HISTORIC PERSPECTIVES Pharmacognosy: the study of natural products used in medicine Ancient discipline of medical science Pharmakon = drug, Gnosis = knowledge

3 CONCEPTS Natural medicine cannot integrate into general medical practice without a scientific base Botanicals or herbs are drugs and many drugs are botanicals or herbs, or synthetic copies Dietary supplement manufacturers exhibit widespread ignorance about pharmaceutical science Hiding behind mythical and magical thinking is no longer acceptable in integrative medicine

4 CONCEPTS Some natural clinicians baulk at attempts to explain the bioactivity of natural therapies within the framework of current scientific knowledge While sympathy exists for this position, our understanding of pharmacodynamic effects of herbs, botanicals or nutrients must be based on scientific principles Conversations about clinical pharmacology among dietary supplement manufacturers are rare and practically non-existent with their customer base

5 DRUG OR NUTRACEUTICAL DISPOSITION If dietary supplements are to be used as therapeutic agents, there must be some respect for basic pharmacologic concepts. The concepts are A, D, M and E One may look critically at some dietary supplements by simply considering factors that influence absorption, distribution, metabolism and excretion of chemical compounds [drugs or nutraceuticals]

6 ABSORPTION Absorption is a complex function of route of delivery, chemical characteristics, processes of movement across absorption barriers and physiological events such as gastric emptying, or modified by presence of disease, age etc Some nutraceuticals claim that they have absorption and bioavailability that cannot be present, based on simple scientific principles

7 ABSORPTION [examples] FISH OIL: Unstable in regular formulations, denatured by gastric acid, power is with EPA. Dosage requirements high, compliance issues, triple bioavailability with enteric coat. Standard fish oil products passe SHARK CARTILAGE: solid or extract, enzymatic degradation of antiangiogenic proteins, buccal absorption a fairy tale, interesting facilitated absorption by a leaky gut

8 DISTRIBUTION Drug distribution is often uneven: different tissue binding, different PH or permeability of tissues Example: Antioxidant Therapy: Ideal antioxidant has lipophilic and hydrophilic profiles and acts in a wide REDOX range Single high dosage antioxidants have dangerous pro-oxidant effects eg vit.c, E Most antioxidant supplements do not use the correct principles of formulation

9 METABOLISM The process of chemical alteration of drugs in the body A primary but not exclusive function of the liver Inactive and active metabolites are produced, by synthetic or non-synthetic reactions Example: Isoflavones: genistein/genistin, conjugation eg daidzein sulfate. A complicated story

10 EXCRETION Elimination from the body, primarily by the kidneys A real concern exists with age related reduction in renal function and nutraceutical dosage adjustment Some complex mechanisms exist eg reabsorption transport mechanisms, tubular secretion and biliary excretion with enterohepatic cycling

11 GENERAL ISSUES Dietary Supplements are the main stay of alternative and complementary medicine Growth overall in OTC sales Contemporary switch to natural remedies The natural remedy first line option as well as the last line option

12 DSHEA- BASED MODEL WEAK SUPPORTING DATA DIETARY SUPPLEMENT STRONG R & D PRODUCT AS A DIETARY SUPPLEMENT? CREATE PLATFORM BODY STRUCTURE FUNCTION CLAIM SELL WITH CLAIM PEER ACCEPTANCE PEER ACCEPTANCE SELL (PHASE IV AND V) SUCCESS FAILURE SUSTAINED

13 A PEEK INTO THE INDUSTRY The product of the month The evidence based formula Condition specific formulations CEO survey reveals scientificbased, new formulations are of major importance Who formulated the supplements you use in your practice?

14 KEY PUBLIC HEALTH INITIATIVES Lifestyle medicine combined with nutritional interventions have overshadowed allopathic approaches for many public health problems First line options for disease prevention are not rooted generally in drugs or surgery Many factors have moved consumers of health care to the new paradigm of simple, gentle and more natural interventions

15 KEY PUBLIC HEALTH Adult obesity INITIATIVES Childhood obesity (A Dead-Loss Disorder) Cardiovascular health Cancer Arthritis Osteoporosis THERE MUST BE A CONDITION SPECIFIC APPROACH

16 THE KEY PUBLIC HEALTH INITIATIVE The metabolic syndrome (SYNDROME X) A complex disorder rooted in genetics, adverse lifestyle with primary nutritional precipitation Defining Syndrome X

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18 THE PUBLIC HEALTH RISK Syndrome X increases risk for : Maturity Onset Diabetes Mellitus Cardiovascular Disease Cardiovascular Deaths Deaths from ALL CAUSES Am.J.Epidemiol, 148, 958, 1998.

19 SYNDROME X : THERAPEUTICS Soluble fiber eg oat beta glucan hydrocolloid Soy Protein 25 g/day Omega 3 fatty acids (EPA) Chromium Alpha lipoic acid Vanadium Antioxidants eg ellagic acid, bioflavonoids Starch blockers Cinnamon Maitake Green coffee bean extract Hoodia gordonii

20 LOWERING CHOLESTEROL When the treatment is worse than the disease Diet Exercise Aggregate benefits of Soluble Fiber, Soy Protein, Omega 3 fatty acids, Garlic, and others [synergy]

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23 WEIGHT MANAGEMENT A holistic management approach that is best undertaken by a practitioner of integrative medicine Multifactorial causes requiring multipronged approaches Weight loss must not be the sole target for management. HOODIACY? The real issue is obesity related disease, disability and death

24 DIETARY SUPPLEMENTS AS A PROFIT CENTER Declining revenue for cognitive activity in clinical practice Dietary supplement dispensaries are a major profit center Supplement sales promote return visits and precipitate spontaneous demands from patients for disease prevention Margins on sales are high Supporting literature saves consultation time Avoid any unethical relationships with supplement purveyors

25 ETHICS Physicians must not engage in self referral Private labels with physician identity are problematic [legal liabilities] State licensing authorities have mixed beliefs about supplement sales At law, dietary supplements are not to be used to prevent or treat any disease Medical practice should not be legislated

26 CONCLUSION The interface between alternative medicine and allopathic medicine is increasingly indistinct At least three quarters of all patients in an out-patient, hospital, clinic are taking supplements, some of which are worthless A doctor who sells a dietary supplement that is available in retail will ruin their practice [A HUGE ISSUE] Supplement dispensation by healthcare professionals will lead to the responsible use of dietary supplements

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