cbd and essential oils for hearing loss, tinnitus and vertigo sh assn... · traditional chinese...

CBD and Essential Oils for

Hearing Loss, Tinnitus and Vertigo

Robert M. DiSogra, AuD

Audiology Consultant

Millstone, NJ

www.drbobdisogra.com

Disclosure I

There are no non-financial

relationships to disclose for this

presentation

Disclosure II

Robert M. DiSogra and

Louisiana Speech-Language-

Hearing Association

do not endorse any of the products

mentioned in today’s program

The content of this program is

for educational purposes

Disclosure III

Disclosure IV

Robert M. DiSogra is receiving an

honorarium for

today’s program

Millstone

2 3

1

4

#1

Recognize the Role that the

Food and Drug Administration

has in regulating CBD and

Essential Oils (EO)

Learning Outcomes

#2

Recognize the potential risks

of using CBD oil or an EO

when there is no evidence-based

research to support the

manufacturer’s claims

Learning Outcomes

#3

Use effective counseling techniques

for patients interested in using

CBD oil or an EO

for their auditory/vestibular

complaint(s)

Learning Outcomes

Outline

1. Essential oil (EO) history and overview

2. What’s makes an oil “essential?

3. How safe are EOs?

4. EO internet health claims

5. Marketing EOs

Outline

6. Cannabidiol oil (CBD) history, the law,

public interest and safety

7. CBD oil internet health claims

8. Marketing CBD oil

9. Ethics for Audiologists (EO and CBD)

10. Counseling your patient

Plant Oils

Used in

Traditional

Chinese

Medicine

(TCM)

>3000 years

Extracting the Oil by

Steam Distillation

Necessary? Vital? Critical?

Imperative? Integral? Needed?

Must-Have? Required?

All Important?

What is an Oil?

Paracelsus von

Hohenheim

1493-1541

Swiss Alchemist

Proposed

alternative

treatments for

sickness

Definition of “Essential Oil”

The “essence” of

an oil is its

flammability

(volatility)

“Essential Oil”



Complex mixture

of volatile

compounds

Abundant in

aromatic plants

and vegetables

Volatility

“A rapidly evaporating

oil of plant derivation”

Volatile oils are also

referred to as

“aromatic oils”

www.activationproducts.com/blog/what-are-volatile-oils

No FDA Definition for

“Essential Oil”

Introduced into

any natural

opening of the body

Alcohol – Ethanol

- aromatic

- product of

fermentation

Major Components of Essential Oils

Amines – Derived from ammonia

- pungent smell

- found in both pharmaceutical

and cleaning products


Aldehydes – Latin: alcohol dehydrogenatus

Aromatic

- Cinnamaldehyde

- Cilantro

- Vanillin


Esters – Organic compounds

Fatty acids


Ketones - Produced naturally in the liver

- Alternative fuels for the body

- Used in industrial solvents


Oxides - Binary compounds of oxygen

with another element

example: CO2 or H2O


Phenols (Phenolics) – Vapors can be

irritating/edematous to lung

tissue

- Antiseptic use (Jos. Lister)

- Can be used as an anesthetic

(Propofol)



Terpenes – Class of organic compounds

Produced in cone-bearing

seed plants such as trees

Strong odor

How Safe Are Essential Oils?

FDA is not

required to

approve EOs or

cosmetics before

they go on the

market…


However…

EOs must be safe

when used

according to the

label’s directions

which means….


Mfgrs. have legal

responsibility for

safety & proper

labeling but it is

not required

by federal law!


www.fda.gov/Cosmetics/ProductsIngredients/Ingredients/ucm388821.htm#how

Do EOs ‘Go Bad?’

YES!

EOs will degrade

overtime and lose

potency if not stored

properly (according to label

directions and

in a dark location)

(77 F)

No national or

international

organization oversees

or certifies

the quality, purity

of EOs

Some EO Facts

Therapeutic or Clinical Grade?

It’s a marketing term!

Any company can say

their oils are

“therapeutic grade”

Usually it’s an

“in-house”

certification

www.planttherapy.com

Essential Oil Is ‘Graded’

(by whom?)

Grade A – Therapeutic Grade

Grade B – Natural/Food Grade

Grade C – Perfume Grade

Floral Waters (Low Quality)

The correct term should be

“Aromatherapy Grade”

doTerra is a private company that

trademarked this term and seal!

Designed it to resemble the seals that

are from independent bodies

®

"CPTG“

Certified Pure Therapeutic Grade

What to Look for from an EO Mfgr.

Common name

Latin name

(exact genus and species)

Country of origin

What to Look for from an EO Mfgr.

What part of plant was processed?

Type of Extraction

(distillation or expression)

How it was grown?

(organic, wild-crafted, traditional)

Essential Oils Are Classified as FOOD

Because They Are PLANT-BASED!

American College of Healthcare Sciences

Portland, OR

On-line degree

Aroma Therapists Use

the Term

“Essential Oil”

Is an Essential Oil a Drug?

YES!

If it is intended for a therapeutic use (i.e., relieves tinnitus, eases pain,

relaxes muscles,

treats depression or anxiety,

or helps you sleep)

The fact that a

fragrance material or

other ingredient comes

from a plant doesn’t

keep it from being

regulated as a drug


DRUG

intended to treat

a disease or

prevent illness


Biological Activities of EOs

Nychas G.J.E. Natural antimicrobials from

plants. In: Gould G.W., editor. New Methods

of Food Preservation. 1st ed. Blackie

Academic & Professional; London, UK: 1995


Koh K.J., Pearce A.L., Marshman G., Finlay-Jones J.J., Hart

P.H. Tea tree oil reduces histamine-induced skin inflammation.

Br. J. Dermatol. 2002;147:1212–1217


Aruoma OI. Free radicals, oxidative

stress, and antioxidants in human

health and disease. J Am Oil Chem Soc.

1998;75:199–212


Maruyama N., Sekimoto N., Ishibashi H. Suppression of

neutrophil accumulation in mice by cutaneous application

of geranium essential oil. J. Inflamm. 2005;2:1–11


Dhifi W, Bellili S, Jazi S, Bahloul S, Mnif W. Essential oils’

chemical characterization and investigation of some biological

activities: a critical review. Medicines (Basel). 2016 Dec; 3(4): 25

Essential oils “represent a new option in

the treatment of inflammatory diseases”

EO Disclaimer

The information is not intended or implied

to be a substitute for professional

medical advice, diagnosis or treatment…

EO Disclaimer

All content, including text, graphics, images

and information, contained on or available

through this web site is for general

information purposes only…

EO Disclaimer

For any health queries,

please consult your doctor or

qualified health care provider…

EO Disclaimer

The MiracleofEssentialOils.com

is not responsible nor liable for

any advice, course of treatment,

diagnosis or any other information,

services or products that you

obtain through this site.

www.themiracleofessentialoils.com/essential-oils-for-vertigo/

“The Publisher

cannot accept

responsibility for

any injury or

mishap to persons or

property from the

use of any methods,

products,

instructions or ideas

referred to within

this publication.”

Yes, It’s

MOLD!

Yes, It’s

MOLD!

The Role of the FDA

“These statements have not been

Evaluated by the FDA…

…this product is not intended to treat,

cure or prevent any disease”

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat or cure any disease.

Are EOs FDA approved?

Center for Drug

Evaluation and Research

(CDER)

[email protected]

Australia

(EOs) are classified and regulated under the

same policies as conventional medicines

Dunning T. Applying a quality use of medicines framework to using essential

oils in nursing practice. Compliment Ther Clin Pract, 2005 Aug;11(3):172-81.

So Who Regulates EO

Advertising Claims?

“Consumers should be suspicious

of products that claim to treat a

wide range of diseases…”

FDA Office of

Regulatory Affairs

“Scientific research

indicates that essential

oils cannot treat or cure

any chronic disease or

other illnesses”

Lee MS, Choi J. Aromatherapy for health care: an

overview of systematic reviews. Maturitas. 2012, 3 (71):

257–260

“Personal testimonials

are no substitute for

scientific evidence”

FDA Office of Regulatory Affairs

Searching the

Internet for EO

Information

Deceiving Internet Ads

Deceiving Advertising

SPRAY VIBRATING DEVICE

Approved for Tinnitus Relief?

FDA Registered?

All businesses

wanting to sell

any healthcare

product must

REGISTER

with the FDA


Once

REGISTERED

with the FDA,

the FDA now

allows or

“approves” the

company to sell

their product(s)


The company is

“FDA approved”

for selling the

product but the

product is not

approved for

tinnitus relief!

Marketing

Essential Oil

Amazon.com - Page 1 of 7

75 items/page = 500+ products!

Herbs, supplements

and oils

are exempt from

rigorous federal

regulations and

testing (required for products

classified as

prescription drugs)

REMINDER!

Essential Oil Research

As of 6/3/2020

National Library of Medicine

21,117 Studies

Essential Oil Research Specifically

for HL, Tinnitus and Vertigo

As of 6/3/2020

National Library of Medicine

No Published Research

Abu Ali al-Ḥusain Ebn Abdullah Ebn Sina

(980 –1037 AD)

Known as Avicenna

Medical Writer

“Canon of

Medicine”

Lily oil and Spotted Orchid oil are

mentioned as remedies for tinnitus

Outline

1. CBD Oil Overview and History

2. Why is CBD Oil Such a Hot Topic?

3. Research

4. Health Claims

5. Marketing CBD Products

6. CBD Products

7. Counseling

Cannabidiol (CBD) Oil

A low Tetra-Hydro-Cannabinol

(THC)

Derived from

cannabis sativa

Extracted from flowers, leaves

and buds of Cannabis plants

(marijuana or hemp)

Hemp plants are

similar

to marijuana

plants, but contain

much lower levels

of THC

THC causes a

psychoactive high

in marijuana users

CBD users do not

experience a high

Cannabidiol (CBD) Oil

Why So Much Interest in CBD Oil?

Congress passed the

Agriculture Improvement Act (aka The Farm Bill of 2018)

June 2018

Hemp removed from the

Controlled Substances Act

of 1970

Opened the door

for marketing the

non-narcotic aspects

of hemp

June 2018

Hemp is no longer listed as a

Schedule I Controlled Substance

Chapter and Verse

The first and only CBD-based drug,

Epidiolex,

was approved by the FDA

June 2018

Oral solution

Tx of seizures

associated with two

rare types of

epilepsy:

Lennox-Gastaut Synd.

and

Dravet Synd. GW Research Ltd.

June 2018

Put the spotlight on CBD and hemp oils

CBD and

hemp oils

June 2018

“Although studies examining the specific

therapeutic effects of CBD are increasing,

clinical data do not support the popular

uses of CBD for…

CBD Oil Research

As of 6/3/2020

1 Study (PTSD)

CBD Oil Research for

HL, Tinnitus and Vertigo

As of 6/3/2020

None!

Plant-based herbal products are

not classified as drugs

by the FDA

Classification: FOOD!

They are from the

rigorous regulations and testing

required for prescription drugs

Marketing

CBD Oil

Estimated CBD Oil Sales

$16.32 billion

by 2026

Rose B. CBD marketing 101: strategies for sellers to stand out in a

Sea of green. https://www.bigcommerce.com/blog/cbd-marketing.

Accessed 1/10/2020

Marketing

CBD Oil

What Mfgrs.

Cannot Say

Manufacturers and “Cannapreneurs’’

Cannot Make Health or

Medical Claims

OR

Untested Assumptions (advising pts about

treating HL, tinnitus,

vertigo, etc. with CBD)

WARNING!

Cannot Have

User Testimonials

Cannot Sell CBD

as a

Dietary Supplement

WARNING!

Manufacturers and “Cannapreneurs”

How Is CBD Supplied?

Does CBD Oil Go Bad?

YES

Will degrade

overtime

Will lose potency if

not stored properly

(77 F)

Price Range: $20 - $300+

“…expert in Alternative

and Herbal Medicine”

“…has carried out

expensive [italics added]

research on alternative

medicine” [extensive?]

NOTE

No publications by

Karl Burmer

in PubMEd data base

6/3/2020

CBD OIL FOR

MENIERE'S DISEASE:

Effective Remedy for Vertigo,

Tinnitus and Progressive Deafness

Title Same Topic on PubMed

CBD Oil for…

Alzheimer’s 0

Asthma 0

Back Pain 0

Bipolar Disorder 1 (case report)

Cancer treatment 4 (pain reduction)

Costochondritis 0

Crohn’s Disease 1

Cystic Fibrosis 0

Endometriosis 1 (pain reduction)

Hemorrhoids 0

Hepatitis 0

Neurogen. Disease 1 (Huntington’s

Disease)

Pancreatitis 1

Pneumonia 0

Stroke 0

NOTE

No publications

in the

PubMed data base

for

Vertigo, Tinnitus and

Progressive Deafness

6/3/2020 CBD OIL FOR

MENIERE'S DISEASE:

Effective Remedy for

Vertigo, Tinnitus and

Progressive Deafness 150

User testimonials are not a substitute

for evidence-based research

IT WORKED FOR ME…IT CAN WORK FOR YOU!

1993

MedWatch Program

A voluntary reporting system for adverse

drug and dietary supplements reactions

Can be filed by health

professionals and consumers

EO/CBD Oil Side Effects

www.fda.gov/medwatch

1.800.FDA.1088

Can Audiologists Sell

EOs or CBD Oil To Their Patients

With HL, Tinnitus or Vertigo?

“Can I offer essential oils or CBD

products to my patients for HL,

tinnitus or vertigo?”

“If my patients can buy these

products online why not

let me sell them?”

Code of Ethics

Oils and Ethics

Principle of Ethics I

Rules of Ethics

K. Individuals shall dispense

products only when benefit

can reasonably be expected.

Principle of Ethics III

Rules of Ethics

F. …statements to the public shall

not contain misrepresentations

when advertising, announcing,

and promoting products.

Oils and Ethics

Oils and Ethics

PRINCIPLE 4

Members shall provide only

services and products that are in

the best interest of those served.

Oils and Ethics

PRINCIPLE 5

Members shall provide accurate

information…about the services and

products offered.

Oils and Ethics

Oils and Ethics

PRINCIPLE I

Members shall fully inform

patients of the nature and possible

results of … products sold

Oils and Ethics

PRINCIPLE III

Rules

Members shall provide only those

procedures, products and services that,

according to the member’s best

professional judgment, [italics added]

are in the best interests of the patient.

Oils and Ethics

SUMMARY

How Do EOs Help

HL, Tinnitus or Vertigo?

They Don’t!

Counseling Your Patients

FDA has not

approved any

Essential Oil

or

CBD Oil

for HL, tinnitus

or vertigo


User testimonials

and

non-scientifically

proven statements

may be very

convincing

however…


…there is no published

evidence-based research

that shows

EOs and CBD products

are effective for HL, tinnitus,

or vertigo

PubMed – 4/28/2020

“Care must be taken when directing

patients toward CBD products…

…there is little regulation, and studies

have found inaccurate labeling…”

VanDolah HJ, Bauer BA, Mauck KF. Clinicians’ guide to

cannabidiol and hemp oils. Mayo Clin Proc. September

2019;94(9):1840-1851

Grinspoon, P. Cannabidiol (CBD - what we know and

what we don’t). Harvard Health Blog. August 27, 2019

Further Reading

THANK YOU!

www.drbobdisogra.com

cbd and essential oils for hearing loss, tinnitus and vertigo sh assn... · traditional chinese...

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