Complementary and Alternative Medicine (CAM)/Nutrition in Integrative and Functional Medicine (NIFM)

What are two major types of studies?

1. Observational & Epidemiologic Human Studies

2. Randomized Control Trials (RCTs) aka Human Clinical Trials

What are some characteristics associated with observational and epidemiologic human studies?

• help provide associations and theories about the importance of certain food compounds (ex: phytochemical) after long term exposure

• cannot provide causality

• risk of confounding variables

What re some characteristics associated with RCTs/Human clinical studies?

• help to identify potential mechanistic functions (closer to demonstrating causality and thus is the golden standard)

• tend to examine biomarkers throughout time, not usually just clinical endpoints

• aimed at demonstrating physiological phenomenon in response to foods or to isolated phytochemical components

Describe the hierarchy of research study designs.

• secondary research tend to be the strongest study design bc its a summary of multiple studies

Rank primary research types in terms of their strength (4).

STRONGER

1. RCT (golden standard)

2. Interventional

3. Observation Trials w/ Control Group

4. Case reports (single, or very small observations)

WEAKER

What are the different categories of research evidence? (4)

1. “A” Very Strong Evidence

2. “B” Strong Evidence

3. “C” Moderate Evidence

4. “D” Weak Evidence

What are three examples of study deigns that fall under the “A” category?

1. RCT

2. meta-analyses of RCTs

3. Epidemiologic Studies (cross sectional or prospective)

What are two examples of study deigns that fall under the “B” category?

1. cohort

2. case-controlled studies

What are two examples of study deigns that fall under the “C” category?

1. individual case studies

2. limited case control study evidence

What is one example of a study design that falls under the “D” category?

1. anecdotal evidence

How is CAM and NIFM relevant to people with diabetes?

• a review shows that about ½ of individuals with diabetes reported using some complementary and alternative medicine approaches

  • its common but use is inconsistent

  • mostly self administered without professional guidance

What is one issue with taking dietary supplements if you have T2D?

many supplements can interact with their medicine resulting in

What are three potential supplement-drug interactions for those who have T2D and take supplements?

1. reduced effectiveness of glucose lowering medication

2. hypotension/low BP

3. increased risk of hepatic liver disease development

What is the definition of Complementary and Alternative Medicine (CAM)?

a group of diverse medical and healthcare systems, practices, and products that are not generally considered to be a part of conventional medicine

What is complementary medicine?

therapy used along with conventional medicine

What is alternative medicine?

therapy used in place of conventional medicine

What is functional medicine?

• philosophy that is individualized, patient-centered, and science-based that empowers patients and practitioners to work together to address the root cause (not just the symptoms) of disease and promote wellness

• focus on the whole person, lifestyle, and willingness to use a wide range of therapeutic approaches such as natural and less invasive interventions when possible

What are two core concepts under functional medicine?

1. dynamic balance

2. recognition of internal and external factors

Explain the concept of dynamic balance under functional medicine.

idea that complex interactions exist among an individual’s genetic predisposition, environmental inputs, and lifestyle

• want to seek balance between mind, body, and spirit

• even minor imbalance can produce a cascade of biological triggers

Explain the concept of internal and external factors under functional medicine.

internal and external factors give rise to core physiological imbalances and dysfunction in physiological systems

• ex: nutrition insufficiencies influence develop of chronic diseases due to their role in cellular metabolism

Using the philosophy of functional medicine, what are 8 clinical imbalances that can arise as a result of internal and external factors?

1. cellular integrity

2. digestion

3. detoxification

4. energy metabolism

5. inflammation

6. oxidative stress

7. neuro-endocrine-immune

8. nutritional status

What is functional nutrition?

component of functional medicine, but takes the holistic person approach and emphasizes the idea of “food as medicine” and “food as healing”

What does the term “functional” mean in functional nutrition and functional medicine?

refers to chronic illnesses and sub-clincal imbalances that often don’t receive complete attention or support from the conventional healthcare system

What is Integrative and Functional MNT?

person centered nutrition interventions in health and chronic diseases that recognize the person as a holistic whole.

What are the five different components of integrative and functional MNT that surround nutrition care?

1. systems

2. food lifestyle environment

3. nutrition physical signs and symptoms

4. biomarkers

5. metabolic pathways and networks

all components are connected

What are different components that would be examined under food, lifestyle, and environment of integrative and functional MNT?

• food

• supplements

• culture and traditions

• environment

• relationships

• sleep

• stress

• spirituality

What are different components that would be examined under nutrition signs and symptoms of integrative and functional MNT?

nutrition focused physical exam

What are different components that would be examined under biomarkers of integrative and functional MNT?

• anthropometrics

• genomics/SNPs

• immune/inflammatory

• organic acids

• toxins

What are different components that would be examined under metabolic pathways and networks of integrative and functional MNT?

• anabolic/catabolic

• nutrient cofactors

• cellular respiration

• eicosanoid series

• biotransformation

• steroidogenic pathway

• urea cycle

What are different components that would be examined under systems of integrative and functional MNT?

• cellular integrity

• digestion

• detoxification

• energy/metabolism

• inflammation/oxidative stress

• neuro-endocrine-immune

• nutritional status

What two things does integrative and functional MNT recognize about people?

1. each client has a unique genetic make-up

2. each client functions in an environment with internal and external factors that influence interactions between the mind, body, and spirit

What four things are typically assessed in integrative and functional medical nutrition therapy?

1. biochemical biomarkers

2. genomic assessments

3. environmental toxicology

4. therapeutic approaches (conventional and complementary)

What is “optimal health” under integrative and functional medical nutrition therapy?

conceived as an integrated function of biology, environment, and behavior; and measured as a product of physical, mental, social, and spiritual variables

• not just the absence of disease

Are functional test covered by insurance?

many functional test are NOT covered by insurance

Are functional test always validated?

NOT always validated - most are NOT

What are four issues with IFM and NIFM?

1. lack of standardization of training in IFM and NIFM

2. complexity of info

3. risk of misinformation

4. communication and education gaps

need to develop an effective and comprehensive literacy framework

Why should we study CAM?

many people in the US use CAM therapies

• there can be misinformation so it’s important we understand it so that we can help them make informed choices and limit the negative impact it has on them if any

What are four reasons for the use of CAM?

1. historical/cultural importance

2. availability and relative affordability

3. belief that TCAM products are composed of natural, safe ingredients, are holistic and without risk of harm

4. dissatisfaction with conventional medicine (2/3 of CAM users don’t disclose CAM use)

Describe the mainstream use of CAM approaches in physician office visits.

data suggest growing popularity and mainstream use

• 2% → 8% in complementary health approaches

• 87% involve herbal/botanical/other dietary supplements other than vitamin and minerals

What kind of person is more likely to use CAM?

• adults

• more women than men (40% of women reported recent CAM use)

What are four challenges associated with CAM?

1. not many well-designed clinical trials (lack of scientific rigor leads to inconsistent and inconclusive findings)

2. no standardized credentialing of CAM practitioners

3. not covered by health insurance

4. much CAM use is unreported

What are the three different categories of CAM?

1. whole body systems of medicine (traditional approach to integrative medicine)

2. mind and body practices

3. natural products

What are four different types of whole body/systems of medicine that fall under CAM?

1. ayurvedic medicine

2. traditional chinese medicine (TCM)

3. homeopathic medicine

4. naturopathic medicine

What is ayurvedic medicine?

traditional medicine form India

• strives for balance of 3 humors or “doshas” through lifestyle actions

• ex: yoga, meditation, diet, herbal supplements

What is traditional chinese medicine?

wide range of methods that seek balance of body forces

• ex: herbal supplements, acupunture, qigong, tai chi

What is homeopathic medicine?

expresses that illness is a normal response of the body as it attempts to heal itself

• “like heals like”

• meds contain small amounts of active substances that promote the body to heal itself

What is naturopathic medicine?

disease prevention and healing through natural holistic means including diet, herbal therapies, and other whole body and mind/body practices

Under CAM, what are mind and body practices?

• focuses on the interactions among the brain, mind, body, and behavior

• uses the mind to affect physical functioning and promote health

What are 8 specific therapies that address interactions of mind and body?

1. acupuncture

2. meditation

3. movement therapy

4. relaxation techniques

5. spinal manipulation

6. tai chi, yoga

7. healing touch

8. hypnotherapy

can have physiologic benefits

What are the benefits of meditation?

meditation promotes specific posture, focused attention ,adn an open attitude

• benefits: to increase calmness and physical relaxation, improve physiological balance, cope with illness, and enhance overall health and well-being

What are the benefits of yoga?

yoga is a combination of physical postures, breathing techniques, meditation, and a distinct philosophy

• benefits: to improve quality of life, reduce stress, lower heart rate and BP, help relieve anxiety, depression, and insomnia, and improve overall physical fitness, strength, and flexibility

Describe the effect of yoga on T2DM?

• one study found improvements in BMI, measures of glycemia, measure of oxidation

• one study found decrease weight, waist circ., improved BP, lipids, depression, but no difference in glycemic control

• one study found yoga as effective for lowering HbA1C

• decrease in HbA1C was greater in studies with greater frequency of yoga sessions

Under CAM, what are natural products?

herbs, botanicals, vitamins, minerals

• most widely used CAM therapy in US

• often marketed as dietary supplements

According to the FDA, what are the three criteria of dietary supplements?

to be a product other than tobacco that

1. is intended to supplement the diet

2. is intended to be taken by mouth (pill, capsule, tablet, or liquid)

3. contains one or more dietary ingredients (macronutrients, vitamins, minerals, aa, herbs)

What is the definition of botanicals?

a plant or any plant part valued for its medicinal or therapeutic properties, flavors, and or scent

• can be fresh or as supplement

What are herbs?

subset of botanicals

• generally refers to the above ground parts

What are nutraceuticals?

product isolated or purified from foods and generally sold in medicinal forms not usually associated with food

Who tends to take dietary supplements?

• older adults

• females

• non-hispanic white

• higher education level

• tend to have higher nutrient intakes from food sources (therefore showing that they are not simply making up nutrients from inadequate food sources)

What are two different dietary supplement label claims?

1. health claims

2. structure/function claims

What are health claims?

describes a relationship between substance and disease, and this relationship can only determine disease risk reduction only, cannot claim cure or prevention

• requires prior authorization by FDA

What are two different types of health claims?

1. health claim

2. qualified health claim

What is the difference between health claim and qualified health claim?

• health claim: based on high quality data and scientific evidence

  • ex: “0.8 mg folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects…”

• qualified health claim: based on emerging but not conclusive evidence

  • “evidence suggest but does not prove…”

  • supportive but not convulsive research shows that…”

What are structure function claims?

describe the role of a nutrient or dietary ingredient intended to affect normal structure or function; but cannot claim to prevent, treat or manage a disease condition

• ex: Ca builds strong bones

What is a nutrient content claim?

describes level of a nutrient in a product using terms such as free, high, and low, or more, reduced, and lite

• FDA must approve before use

What are two federal agencies that have oversight over dietary supplements?

1. FDA

2. Federal Trade Commission

What is the role of the FDA in terms of dietary supplements?

in charge of labeling dietary supplements

• packaging, inserts, and promotional materials at point of sale

What is the role of the Federal Trade Commission in terms of dietary supplements?

in charge of advertising of dietary supplements

• print and broadcast ads, infomercials, catalogs, and direct marketing materials

Describe the marketing difference between drugs and DS/food?

DRUGS

• products assumed to have toxic potential

• benefits > risk under conditions of use

• pre-market approval (need to be approved before put out)

DS/FOOD

• products assumed to be safe

• in absence of benefits, any risk is unacceptable

• post-market approval (put out, don’t need approval until something happens)

Dietary supplements are regulated as food, not drugs

Due to marketing, what are the consumer expectations of dietary supplements?

• products are natural and safe

• products are tested and approved

• substance causes no harm when used as directed

• total product is safely manufactured and marketed

• if harm occurs, monitoring is in place and problem can be responded in a timely manner

these expectations are not always accurate; evidence for effectiveness, safety, and quality of many supplements are often lacking

What is the Dietary Supplement Health Education Act (DSHEA)?

ensures access to supplements but does not guarantee product quality or accuracy of labeling

• research has documented cases where actual supplement contents differed from label calims

How do you identify quality of supplements?

several organizations certify manufacturers for good manufacturing practices (GMP)

• different certifications are USP, GMP, NSF, and UL

• logos may not always appear on product label

What is the difference between NSF and USP certification?

• NSF: evaluates chemical composition only

• USP: assess both chemical composition and bioavailability

Why is dietary supplement (non vitamin/mineral supplement) research difficult?

whole plant or parts of plants used rather than individual components

• active components usually consist of mixture of different chemical compounds found in the plant

What are six critical issues that need to be addressed in dietary supplement research?

1. source identification (similar looking plants)

2. composition, stability, contaminants, adulterants

3. mechanisms of action not always known

4. dose response

5. masking/blinding not always done

6. interactions with other stuff

food first approach remains the preferred strategy

What is St. John’s Wort?

supplement that interferes with 70% of medications