(5) Complimentary Therapies Part 1

Dietary supplement - BIG PICTURE

• Dietary supplement = something taken to supplement/increase dietary intake.

  • Can include:

    • vitamins/minerals

    • herbs/botanicals

    • amino acids

    • extracts/concentrates/metabolites

  • Dietary supplements ARE regulated — but much less strictly than drugs before they reach the market.

Dietary Supplements

topics

• Regulation & Labeling

• Quality, Safety & Interactions

• Patient Counseling / Product Selection

• Homeopathy

Regulation & Labeling - topics?

• Drugs vs Dietary Supplements/New Dietary Ingredients

• cGMPs

• Supplement Labels

• Proprietary Blends

• Supplement Claims

Regulation

• Dietary supplements can enter the market without the same premarket proof of safety/efficacy required for drugs → FDA mainly monitors for harm after marketing.

• New dietary ingredients have MORE safety requirements than older/grandfathered ingredients.

cGMPs

• Dietary supplements must follow current Good Manufacturing Practices (cGMPs).

  • cGMP → product should be made properly + accurately labeled + free of adulterants/impurities.

• BUT: Supplement cGMP requirements are more poorly enforced / lower standard than drugs.

SUPPLEMENT LABELS

1. Basic label information (JUST LOOK)

   • Know the label provides things such as:

     • product name

     • says it is a dietary supplement

     • directions

     • manufacturer information

     • Supplement Facts

     • serving size

     • ingredients

     • amount per serving

2. Herbal products

   • Label must identify:

     Scientific/Latin name + plant part used

     • Example idea:

       • Same plant
         → root vs leaf vs berry
         → may give different constituents/effects.

PROPRIETARY BLENDS

• A proprietary blend must tell you:

  • total weight of the blend

  • ingredients in order of predominance

• BUT it does not have to tell you:

  • the exact amount of every individual ingredient

• Why do we care? Problem: Unknown individual doses → harder to judge efficacy + safety.

SUPPLEMENT CLAIMS

types

• Structure/Function Claims

• Treatment/Medical Claims

• Health Claims

• FDA vs FTC

SUPPLEMENT CLAIMS

Structure/Function Claims

• "supports healthy ___"

• It talks about supporting normal structure/function, NOT treating disease

• Rigorous clinical evidence is NOT required for these claims.

SUPPLEMENT CLAIMS

Treatment/medical claim

• "Treats high blood pressure."

• That is claiming to treat a disease.

• Not allowed for an ordinary dietary supplement.

SUPPLEMENT CLAIMS

Health claim

• Connects something with a specific health/disease outcome.

• These require a higher level of supporting evidence/FDA review than a basic structure-function statement.

SUPPLEMENT CLAIMS

FDA vs FTC

FDA = LABEL

FTC = ADVERTISING

 Quality, Safety & Interactions - topics

• Plant Product Variability

• Standardization

• Adulteration

• Third-Party Quality Testing

• Drug–Supplement Interactions

• Special Populations

Plant Product Variability

• Plant composition can change because of: (JUST UNDERSTAND)

  • growing conditions

  • harvest time

  • species

  • plant part

  • preparation/extraction method

• Therefore: One company's herbal supplement is NOT automatically equivalent to another company's.

Standardization

• Standardization = product is made to contain a defined amount /% of a particular constituent or marker.

• you can’t assume all products with the same herb are the same.

ADULTERATION

• commonly associated with intentional adulteration - B-W-S

  • bodybuilding → steroid-like substances

  • weight loss → unapproved drug ingredients

  • sexual enhancement → drug-like ingredients

Why? To make the supplement work better.

Third-Party Quality Testing

• Examples:

  • USP

  • NSF

  • ConsumerLab

• Third-party seal ≠ safe or effective

  • - It does not prove that the supplement works.

• It mainly tells you things like:

  • Checks whether the supplement contains what the label says it contains

  • It may also check for contaminants/unlisted ingredients.

DRUG–SUPPLEMENT INTERACTIONS

• PK interactions

  • Absorption + metabolism

    • Supplement changes absorption/CYP metabolism → drug concentration can change.

• PD Interactions

  • Drug and supplement can have:

    • Additive effects

    • opposing effects.

Special Populations

• Older Adults

• Children / Pregnancy / Lactation

• Kidney / Liver Disease

• Surgery

Special Populations

Pregnancy / lactation / children

• Evidence is limited → be cautious.

• Generally:
  → discuss/refer to provider
  → don't casually recommend supplements.

Special Populations

Older adults

More:

• medications/supplements

• chronic diseases

→ more opportunity for interactions

Special Populations

Kidney/liver disease

• Some supplements can cause:

  • hepatotoxicity

  • nephrotoxicity

• Kidney impairment may also reduce supplement elimination.

Special Populations

SURGERY

• Stop supplements at least 2 WEEKS before elective surgery.

• Especially worry about supplements that affect: S-B-G-P

  • Sedation
    Bleeding
    Glucose
    blood Pressure

• These can cause problems during surgery/anesthesia.

HOW TO COUNSEL A PATIENT

• Step 1: What is actually in the product?

  • Safety

  • Effectiveness

  • Product Quality

  • Recommend / Tolerate / Discourage / Refer

• SAFETY TRUMPS EFFICACY.

  • If it is unsafe → don't care how well it might work.

• Don't automatically tell patients: "Supplements are useless."

  • Ask what they're taking and why, because you want patients to tell you about their supplement use.

Homeopathy - topics

• 2 principles

• Potentiation / Succussion

• Dilution Notation

• Key Takeaways

HOMEOPATHY

• This is different from a dietary supplement.

HOMEOPATHY

2 principles

• Principle #1 — Like cures like

  • Something that causes symptoms → in a tiny amount supposedly treats similar symptoms.

• Principle #2 — Minimum dose

  • MORE dilute = considered MORE potent

HOMEOPATHY

preparation process

• Potentiation

  • Dilute → vigorously shake → dilute again → shake again → repeat

  • Vigorous shaking = succussion.

HOMEOPATHY

Dilution notation

• X/D → 10-fold dilution steps

• C → 100-fold dilution steps

• Highly diluted products can theoretically contain essentially none of the original substance.

HOMEOPATHY

Key Takeaways

• not regulated the same as dietary supplements/drugs

• no definitive evidence of efficacy

• no validated mechanism of action

• usually low toxicity

• highly dilute products → low interaction risk