A Standard of Care for Preventive and Integrated Medicine

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General Guidelines: A Standard of Care for Preventive and Integrated Medicine Joel Kahn, MD, FACC, FACP, FSCAI Kerrie Saunders, MS, LLP, PhD Robert Rakowski, DC, CCN, DACBN, DIBAK Samantha Eagle, ND, MS

This document is intended for the discussion among medical and scientific peers interested in the practice and scope of Integrated/Integrative and Preventive Medicine. It is not intended to replace the advice to a patient from his/her practitioner.

“Modern and scientific healthcare should be firmly set in evidence-based medicine, defined as the conscientious, explicit, and judicious use of the current best evidence in making decisions about the care of individual patients.”1 Sackett, et al. Evidence-based medicine: What it is and what it isn't. BMJ (1996) 312: 71–72.

”We can now start to see the future of healthcare and medicine more clearly. We are moving from a medicine for the average to a medicine for the individual.” Dr. Jeffrey Bland, PhD, FACN, FACB, CNS

PROBLEM

According to the Centers for Disease Control, the five leading causes of death in the United States (heart disease, cancer, chronic lower respiratory diseases, stroke, and unintentional injuries), account for a whopping 63 percent of all U.S. deaths.2 It is for this reason that preventive healthcare is now the primary focus of intervention in an effort to stop the now global rise in the prevalence of chronic disease morbidity and mortality.

The practice of Integrated (aka Integrative) Healthcare includes preventive lifestyle strategies now termed Therapeutic Lifestyle Change (TLC) behaviors, by the National Institutes of Health.3 For example, the food and fitness habits, sunlight conversion, fresh air intake, and water intake of each individual patient. Since the dynamic processes associated with disease begin before the diagnosis is made, preventive medicine encourages anticipatory actions that can be categorized as primary, secondary, and tertiary prevention.4,5,6

The American Medical Association, the Physicians Committee for Responsible Medicine, the Harvard Medical School, the Cleveland Clinic, the Johns Hopkins School of Medicine, and the American College of Lifestyle Medicine are among the establishments now promoting preventive therapeutic lifestyle change behaviors. Today’s patients now expect their practitioners to address therapeutic lifestyle changes as part of the medical treatment planning process.

This document is intended to provide general guidance for a discussion between practitioners and medical and scientific peers interested in the practice and scope of Integrated/Integrative and Preventive Medicine, and is not meant to replace the advice of a physician to his/her patient.

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BACKGROUND

Members of the medical community generally accept that a Standard of Care refers to how a sufficiently trained, evidence-based practitioner would evaluate and manage a patient care treatment protocol. Legally defined, a Standard of Care “…corresponds to a level of competence in performing medical tasks accepted as reasonable, and reflective of a skilled and diligent health care provider.”7

Therefore, a medical malpractice determination can be found if it is demonstrated that a Standard of Care has been breached - through either insufficient accurate data collection, or through the promotion of a treatment strategy which is either ineffective or even harmful. A practitioner must exercise the degree of care expected of a minimally competent physician under the same circumstances.

It was as far back as 1860, when the Illinois Supreme Court issued its first decision on what would constitute a Standard of Care. It was a case involving a physician represented by then-practicing attorney, Abraham Lincoln, claiming that the physician was negligent for improperly applying a plaster cast.8 The Illinois Supreme Court declared that a physician or surgeon must be held to employ a reasonable amount of skill and care. This standard is established through the testimony of experts in the field relating to specifics of each case.

In Daubert v. Merrell Dow Pharmaceuticals, the US Supreme Court held that expert testimony must meet two requirements. Firstly, the evidence presented must be shown to constitute scientific knowledge, and secondly, the evidence must be relevant to the case in question. The Supreme Court further identified a number of factors that may be used to determine whether evidence submitted as scientific knowledge is valid, including whether the theory or technique has been tested as scientifically valid, whether the idea has been subjected to scientific peer review or published in scientific journals, whether the theory or technique is generally accepted as valid by the relevant scientific community, and whether standards have been circulated to govern the operation of the technique and the known or potential rate of error involved in the technique.9

SCOPE OF CONDITIONS including, but not limited to:

 Obese, Overweight  Underweight, wasting  Heart disease  Stroke  Cancer  Diabetes  Psychiatric issues (particularly substance abuse/dependence, body dysmorphic disorder, anorexia, bulimia, anxiety, depression)

Page 2 of 8 PRACTICE SPECIALTIES including, but not limited to:

 Cardiology  Endocrinology  Family Practice  Internal Medicine  Physical Therapy  Nephrology  Dietetics and Nutrition  Oncology  Preventive Medicine  Psychiatry  Psychology  Functional Medicine  Chiropractic  Hospitals  Nurses  Physician Assistants

APPROACH

The generally accepted etiology of disease progression is as follows: molecule, membrane, organelle, cell, tissue, organ, system, and then total body involvement. Therefore, effective primary, secondary, and tertiary prevention methods, as well as optimal treatment planning depends upon the knowledge - not mere supposition - of each patient’s actual chemical and structural composition. In fact, many medications are safer and more effective when dosed based upon actual fat mass, or lean mass, rather than just total body weight.

Since it is the goal of integrated interventions prescribed or suggested to be evidence-based, the best available and accurate assessment of the patient will include traditional laboratory studies (such as cell counts, serum chemistry, and imaging techniques) for the assessment of cells, tissues, and the function of organ systems and body composition assessment.

Many of today’s integrated practitioners prefer supine position Bioelectrical Impedance Analysis (BIA) to gather data on the composition of the body. Supine BIA is a quick, safe and painless technology utilizing a low electrical current passed through the body, utilizing four adhesive electrode pads. Since the current moves differently through the fluids and lean tissue of the body, passing more easily through the fluids and lean tissue, but encountering resistance (impedance) through fat tissue, it is possible to get a detailed summary report of body composition on each individual patient. Accurate body composition assessment can also help prevent judgment errors, which can sometimes result in significant ethical and legal risk, in terms of pharmaceutical and nutraceutical dosing, and lifestyle, fitness, and nutritional recommendations.

Along with whole body composition and hydration at the cellular level, supine BIA can also offer Phase Angle, a glimpse at membrane function for practitioners, significantly earlier in the etiology of disease progression.

Page 3 of 8 Consider the case of 3 patients, each with same height, weight, age and gender, each needing to lose 20 pounds to achieve ideal body weight range. One patient has 20 pounds of extra water retention, the second patient as 20 pounds of extra body fat, and the third patient has to lose a combination of 20 pounds of extra water retention and fat. These patients require different treatment approaches based upon the evidence the practitioner would only have if s/he knew the body composition of each patient. By tracking subtle changes in the patient’s body composition (testing varies at the practitioner’s discretion typically from weekly to annually), the practitioner can assess preventive measures and interventions and change strategies at intervals unique to the patient’s unique needs and goals.

EVALUATION

1. Accurate biometric collection  Height, weight, blood pressure, pulse, respiration, temperature  Age, gender  Genetics, genomics, ethnicity, race  Kinetic Activity Monitoring, objectively measured and monitored for duration, intensity and frequency of movement  Supine Bioelectrical Impedance Analysis 1. Hydration Status: Total Body Water, Intracellular Water %, Extracellular Water % 2. Composition data 1. Bone Mineral Content, Lean Soft Tissue, Fat, Lean Mass, Total Body Water, Skeletal Muscle Mass 3. Phase Angle 4. Metabolic (Basal Metabolic Rate, Daily Energy Expenditure)  X-ray and/or DEXA scan  Nutrition 1. Status 2. History 3. Serum Immunoglobulin assessments (IgG, IgE, IgA, IgM) 4. Stool food sensitivity testing for wheat

 Blood chemistry and/or saliva and/or urine analysis 1. CBC, ferritin, Iron, CMP, HgBA1c, hsCRP, homocysteine, 25-OH serum vitamin D 2. Lipid profile (TC, HDL, LDL, Triglycerides, apoE) 3. MTHF(r) mutation assessment. This methylenetetrahydrofolate reductase (NAD(P)H) reaction is required to convert homocysteine to methionine, to make proteins and other important compounds 4. Occult stool assessment 5. Pulse Oximetry 6. Urine Dipstick for glucose, bilirubin, ketones, protein, urobilinogen, blood, nitrite, leukocytes, pH and specific gravity 7. Urine MMA (Methyl Malonic Acid) for the assessment of Vitamin B12 status (inverse relationship – if MMA is high, B12 status is low)

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8. Reproductive hormone profile (E1, E2, E3, Progesterone, Testosterone, LH, FSH, SHBC) 9. Thyroid profile (TSH, T3, T4, reverse T3, Thyroid Antibodies, PTH) 10. Hypothalamic-Pituitary-Adrenal assessment (above assays and DHEA, Cortisol, ACTH, CRH) 11. Neurotransmitter assessment (Dopamine, Serotonin, Adrenaline, Norepinephrine, Epinephrine, etc.)

PREVENTION/MANAGEMENT

1) Shared treatment planning and decision-making to engage the patient through education 2) Individualized dosing of any prescription or nutraceutical a) Ensure safety by educating patient and cross-referencing any existing intake of prescriptions, nutraceuticals, homeopathy, herbs, Ayurvedic or Traditional Chinese Medicine protocols 3) Education and counseling for sub-optimal test results a) Activity level (strength, endurance, range of motion, variety, frequency) b) Nutritional intake (foods to avoid, foods to maintain, foods to increase) c) Hydration status (water intake, electrolyte balance, omega 3:6 ratio) d) Healthy sleep and waking patterns e) Fresh air f) Sufficient sun exposure/ Vitamin D conversion g) Harmful lifestyle choices (alcohol and other drug misuse, risk-taking behaviors, etc.) h) Positive thinking and purposeful activities i) Adequate social network

4) Practitioners may consider an increase in methionine-rich foods, as part of a treatment plan regarding documented MTHF(r) mutation (i.e. beans, peas, brazil nuts, sesame seeds, wheat bran, fennel seed, chia seed, caraway seed, carob, etc.)

5) Strategies that may be employed to affect change on body composition, as measured by the bioelectrical impedance analysis

a) To help DECREASE FAT and INCREASE LEAN MASS:

 Fitness: Strength (i.e.: weights, weight machines, calisthenics)  Fitness: Endurance (i.e.: cardio, spinning, walking, running, swimming)  Fitness: Range of Motion (i.e.: yoga, tai chi, dance, stretching)  Increase intake of Beans, Peas, Lentils, Sprouts, or Quinoa (General daily goal = 2 cups for men; 1.5 cups for women; 1 cup for children)  Eliminate trans fats (hydrogenated and partially hydrogenated oils and fats  Decrease or eliminate dairy, beef, chicken, turkey, fish, pork and added oils  Increase green vegetables (Discuss appropriate cautions if patient is taking blood thinning medications)  Increase red, orange and yellow vegetables

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b) To help DECREASE EXTRACELLULAR WATER and INCREASE INTRACELLULAR WATER: (Note: recent exercise, sauna, pre-menstrual, alcohol, caffeine, diuretics & some medications also affect cell water balance)

 Increase omega-3s (walnuts, purslane, chia seeds, ground flaxseeds, hempseeds, pumpkin seeds)  Decrease omega-6s (i.e.: many vegetable oils, boxed & processed foods, fried foods, fast foods)  Dramatically decrease or eliminate caffeine  Dramatically decrease or eliminate alcohol  Eliminate artificial sweeteners  Increase hydration by drinking enough water. The general formula is to divide total weight in pounds by 2, and then drink that number of ounces of water each day. For example, if the patient weighs 160 pounds, their baseline goal is to drink about 80 ounces of water daily (with an additional 5 ounces for every 15 minutes of exercise). Note that fresh plant foods like fruits and vegetables are naturally high in water, also.  Increase electrolyte-rich foods (i.e.: bananas, oranges, celery, grapes, berries, cucumbers, chives, basil, berries), and consider whole food plant-derived electrolyte supplementation. Note: Consider kidney function prior to a targeted focus on specific electrolyte(s).  Increase B vitamins (fruits, berries, vegetables), and consider appropriate whole food plant-derived multiple B vitamin supplementation.  Superfood Supplements (i.e. containing whole food organic phytonutrients and antioxidants)  Consider creatine supplementation if appropriate

6. There are plant-based, functional/medical food meal replacement shakes, available at practitioner discretion, for issues related to body composition support, detoxification, excessive hormone clearance, and insulin function, for example. This type of targeted nutrition is utilized by some Integrated Practitioners, generally suggesting 2 small healthy meals and 2 functional/medical meal replacement shakes (mixed with water, ice, greens, frozen berries, as appropriate to the individual patient) per day, for a short period of time as the patient acclimates to a healthier whole food intake.

MEASURABLE OUTCOME GOALS

Preventive and Integrated Medicine practitioners seek optimal wellness goals, not placement within average ranges. By ‘personalizing’ medicine, the practitioner can better identify patients at risk11 , as we seek to move from a treatment designed for an average person, to a treatment designed and optimized for the individual.

Optimized treatment goals may include:

 Movement toward, or maintenance of Optimal BIA-measured Phase Angle values10: NOTE: Elite and Professional athletes generally have phase angles of 1.0 points higher than the general population.

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Age Men Women (years) 20-29 7.9 7.3 30-39 7.6 7.0 40-49 7.3 6.7 50-59 6.9 6.3 60-69 6.4 5.8 70-79 5.8 5.2 80-89 5.1 4.5

 Adequate frequency and variety of physical activity

Sedentary Range Inactive Range Healthy Heart Range Weight Loss Range Endurance Range

 Sufficient (not excessive) nutritional macronutrient and micronutrient intake.  The elimination or very significant reduction of trans fats and refined food products  Optimal BIA hydration status measurements10:

ICW % Goal for ICW% Goal for Age (years) Men Women (TBW % Goal = 60) (TBW% Goal = 55) 20-29 66 61 30-39 65 60 40-49 64 59 50-59 62 57 60-69 60 55 70-79 58 53 80-89 56 51

 The cessation of tobacco use  Significant decrease in alcohol intake  If diagnosis of addiction present, abstinence from all mood-altering substances

This document is intended to provide general guidance for a discussion between practitioners and medical and scientific peers interested in the practice and scope of Integrated/Integ rative and Preventive Medicine, and is not meant to replace the advice of a physician to his/her patient.

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 Optimal blood pressure range  Optimal HgBA1C range  Optimal lipid profile range  Reduction in risk-taking behaviors (i.e. unprotected sexual activity, distracted driving, etc.)  Reduction in days lost from work due to illness or disability  Ensure on-going support services (resources, media, groups, hotlines, etc.)  Monitoring and evaluation of abnormal results until resolution

SUMMARY

Integrated practitioners can optimize treatment planning by gathering the most complete picture possible of both the chemistry and the structure of the body. In this way, evidence-based medicine offers both the patient and practitioner a stronger sense of commitment to safe and effective treatment plans to prevent and reverse disease, and to promote optimal health.

REFERENCES

1. Sackett DL, Rosenberg WM, Gray JA, et al. Evidence-based medicine: What it is and what it isn't. BMJ (1996). 312:71–72 2. Potentially Preventable Deaths from the Five Leading Causes of Death in the United States, 2008–2010, Centers for Disease Control and Prevention, May (2014). 3. Your GUIDE TO Lowering Your Cholesterol With TLC, U.S. Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute, NIH Publication No. 06–5235, December (2005). 4. The Top 10 Causes of Death. (n.d.). Retrieved March 16, 2014, from World Health Organization website: http://www.who.int/mediacentre/factsheets/fs310/en/index2.html 5. Katz, D., & Ather, A. (2009). Preventive Medicine, Integrative Medicine & The Health of The Public. Commissioned for the IOM Summit on Integrative Medicine and the Health of the Public. 6. Leavell, H. R., & Clark, E. G. (1979). Preventive Medicine for the Doctor in his Community (3rd Ed.). Huntington, NY: Robert E. Krieger Publishing Company. 7. McGraw-Hill Concise Dictionary of Modern Medicine, The McGraw-Hill Companies, Inc. (2002), as cited at http://medical- dictionary.thefreedictionary.com/Medicolegal+SOC 8. Richie v West, 23 III. 329 (1860) 9. Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, 589 (1993) 10. Rakowski, Robert, The BIA Doctor’s Interpretation Guide – Revised (2014). 11. Widmer, RJ, & Lerman, A. The Importance of Functional Tests in Personalized Medicine. Rambam Maimonides Medical Journal, April 2013, Vol. 4, Issue 2, e0014.

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