THERAPEUTICS WITHNATURAL REMEDIES

Stephen Holt MD, LLD (Hon.) ChB., ND, FRCP (C), MRCP (UK), FACP, FACG, FACN, FACAM

Distinguished Professor of Medicine, NYCPM

HISTORIC PERSPECTIVES

• Pharmacognosy: the study ofnatural products used in medicine

• Ancient discipline of medicalscience

• Pharmakon = drug, Gnosis =knowledge

CONCEPTS• Natural medicine cannot integrate into

general medical practice without ascientific base

• Botanicals or herbs are “drugs” andmany drugs are botanicals or herbs, orsynthetic copies

• Dietary supplement manufacturersexhibit widespread ignorance aboutpharmaceutical science

• Hiding behind mythical and magicalthinking is no longer acceptable inintegrative medicine

CONCEPTS• Some natural clinicians baulk at attempts

to explain the bioactivity of naturaltherapies within the framework of currentscientific knowledge

• While sympathy exists for this position,our understanding of pharmacodynamiceffects of herbs, botanicals or nutrientsmust be based on scientific principles

• Conversations about clinicalpharmacology among dietary supplementmanufacturers are rare and practicallynon-existent with their customer base

DRUG OR NUTRACEUTICALDISPOSITION

• If dietary supplements are to be used astherapeutic agents, there must be somerespect for basic pharmacologic concepts.

• The concepts are A, D, M and E• One may look critically at some dietary

supplements by simply consideringfactors that influence absorption,distribution, metabolism and excretion ofchemical compounds [drugs ornutraceuticals]

ABSORPTION• Absorption is a complex function of route

of delivery, chemical characteristics,processes of movement acrossabsorption barriers and physiologicalevents such as gastric emptying, ormodified by presence of disease, age etc

• Some nutraceuticals claim that they haveabsorption and bioavailability that cannotbe present, based on simple scientificprinciples

ABSORPTION [examples]• FISH OIL: Unstable in regular

formulations, denatured by gastric acid,power is with EPA. Dosage requirementshigh, compliance issues, triplebioavailability with enteric coat.Standard fish oil products passe

• SHARK CARTILAGE: solid or extract,enzymatic degradation of antiangiogenicproteins, buccal absorption a “fairy tale”,interesting facilitated absorption by aleaky gut

DISTRIBUTION• Drug distribution is often uneven:

different tissue binding, different PH orpermeability of tissues

• Example: Antioxidant Therapy: Idealantioxidant has lipophilic and hydrophilicprofiles and acts in a wide REDOX range

• Single high dosage antioxidants havedangerous pro-oxidant effects eg vit.C, E

• Most antioxidant supplements do not usethe correct principles of formulation

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-syntheticreactions

• Example: Isoflavones: genistein/genistin,conjugation eg daidzein sulfate. Acomplicated story

EXCRETION• Elimination from the body, primarily by

the kidneys• A real concern exists with age related

reduction in renal function andnutraceutical dosage adjustment

• Some complex mechanisms exist egreabsorption transport mechanisms,tubular secretion and biliary excretionwith enterohepatic cycling

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” aswell as the “last line option”

DSHEA- BASED MODEL• WEAK SUPPORTING

DATA

DIETARY SUPPLEMENT

? CREATE PLATFORM

SELL WITH “CLAIM”

PEER ACCEPTANCE

SUCCESS FAILURE

• STRONG R & D

“PRODUCT” AS A DIETARYSUPPLEMENT

BODY STRUCTURE FUNCTIONCLAIM

PEER ACCEPTANCE

SELL (PHASE IV AND V)

SUSTAINED

A PEEK INTO THE “INDUSTRY”• The product of the month• The evidence based formula• Condition specific formulations• CEO survey reveals scientific-

based, new formulations are ofmajor importance

• Who formulated the supplementsyou use in your practice?

KEY PUBLIC HEALTHINITIATIVES

• Lifestyle medicine combined withnutritional interventions haveovershadowed allopathic approachesfor many public health problems

• First line options for diseaseprevention are not rooted generally indrugs or surgery

• Many factors have moved consumersof health care to the new paradigm ofsimple, gentle and more “natural”interventions

KEY PUBLIC HEALTHINITIATIVES

• Adult obesity• Childhood obesity (A Dead-Loss

Disorder)• Cardiovascular health• Cancer• Arthritis• Osteoporosis

THERE MUST BE A CONDITION SPECIFIC APPROACH

THE KEY PUBLIC HEALTHINITIATIVE

• The metabolic syndrome(SYNDROME X)

• A complex disorder rooted ingenetics, adverse lifestyle withprimary nutritional precipitation

• Defining Syndrome X

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.

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

LOWERING CHOLESTEROL

• When the treatment is worsethan the disease

• Diet• Exercise• Aggregate benefits of Soluble

Fiber, Soy Protein, Omega 3fatty acids, Garlic, and others[synergy]

WEIGHT MANAGEMENT

• A holistic management approach that isbest undertaken by a practitioner ofintegrative medicine

• Multifactorial causes requiringmultipronged approaches

• Weight loss must not be the sole target formanagement. HOODIACY?

• The real issue is obesity related disease,disability and death

DIETARY SUPPLEMENTS AS APROFIT CENTER

• Declining revenue for cognitive activity inclinical practice

• Dietary supplement dispensaries are a majorprofit center

• Supplement sales promote return visits andprecipitate spontaneous demands frompatients for disease prevention

• Margins on sales are high• Supporting literature saves consultation time• Avoid any unethical relationships with

supplement purveyors

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

CONCLUSION• The interface between alternative medicine

and allopathic medicine is increasinglyindistinct

• At least three quarters of all patients in anout-patient, hospital, clinic are takingsupplements, some of which are worthless

• A doctor who sells a dietary supplementthat is available in retail will ruin theirpractice [A HUGE ISSUE]

• Supplement dispensation by healthcareprofessionals will lead to the responsibleuse of dietary supplements