Transcript Chapter 26 outline

Chapter 26:
Natural/Herbal Products
and Dietary Supplements
Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
Chapter 26 Outline

Natural/Herbal Products and Dietary
Supplements

Limited regulation
 Safety of herbal and nutritional products
 Drug interactions
 Standardization of herbal products
 Good manufacturing practice
 Herbal supplements used in oral health care
Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
2
Natural/Herbal Products and
Dietary Supplements


Haveles (pp. 320-321) (Fig. 26-1)
Herbal medicine refers to the use of a plant’s
seeds, berries, roots, leaves, bark, or flowers
for medicinal purposes

Herbalism is becoming much more commonplace
in Western medicine
 Herbal supplements are available without a
prescription
cont’d…
Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
3
Natural/Herbal Products and
Dietary Supplements


Haveles (p. 320)
Because herbals are considered to be natural
products or dietary supplements, manufacturers
do not have to prove efficacy in treating or
preventing a specific disease nor can they
make that claim


They can state that the herbal or natural product can
be used for general health and well-being
Most patients do not consider them to be medicine
because a prescription is not necessary for their use
Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
4
Limited Regulation


Haveles (p. 321)
Dietary Supplement Health and Education Act
(DSHEA)


More than 20,000 herbal and other natural
products are available in the United States
Herbal products are marketed as dietary
supplements in the United States and are not
required to comply with safety and efficacy
regulations imposed on drug products
cont’d…
Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
5
Limited Regulation


Haveles (p. 321)
DSHEA

Herbal products are regulated by the DSHEA,
which exempts vitamins, minerals, and botanical
products from meaningful U.S. Food and Drug
Administration (FDA) regulation
• Before this act, manufacturers had to prove that the
herbal product was safe and effective
• Today the FDA must prove that the product is unsafe
cont’d…
Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
6
Limited Regulation



Package labeling
Other aspects of the DSHEA prevent the use of
therapeutic claims on the label


Haveles (p. 321)
All herbal products must be labeled as a dietary
supplement
The DSHEA requires that the following phrase
must be included on each natural product’s
label: “This product is not intended to
diagnose, treat, cure, or prevent any disease”
Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
7
Safety of Herbal and Nutritional
Products


Haveles (pp. 321-322) (Table 26-1)
Most of the herbal products available contain
ingredients that produce profound
pharmacologic effects


Some products may have potential therapeutic
effects, and the vast majority cause adverse
effects and drug interactions
Because some of these products have
pharmacologically active ingredients, the dental
health professional should acknowledge this and
treat the herbal product as a drug
Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
8
Drug Interactions


Haveles (p. 322) (Table 26-2)
Herbal products can interact with conventional
drugs and cause disastrous results



Garlic, gingko biloba, and feverfew can increase the
risk for bleeding when taken in conjunction with
antiplatelet drugs or anticoagulants
Ma huang contains ephedrine and can increase
heart rate when given with sympathomimetic drugs
St. John’s wort can induce the 3A3/4 isoenzyme of
the cytochrome P-450 system
cont’d…
Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
9
Drug Interactions


Haveles (pp. 322, 324) (Box 26-1)
Information is available regarding drug
interactions with herbal supplements is limited

Until herbal supplements are standardized and
labeling is accurate and comprehensive, obtaining
accurate information on possible interactions will be
difficult
Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
10
Standardization of Herbal
Products


Haveles (pp. 322-323)
Standardization is the process by which one
or more active ingredients of an herb are
identified and all batches of the herbs
produced by a single manufacturer contain
the same amount of active ingredient
specified on the label

A major consequence of a lack of standardization
is the variability of the quantity of the known or
supposed active ingredient
Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.
11
Good Manufacturing Practice


Haveles (pp. 323-324)
Good Manufacturing Practice (GMP) standards
were introduced by the FDA in 2003 to ensure
that dietary supplements be devoid of
adulterants, contaminants, and impurities and
that package labels accurately reflect the
identity, purity, quality, and strength of what is
actually inside the package
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12
Herbal Supplements Used in Oral
Health Care


Haveles (p. 324)
Herbal supplements are used in several
different oral health care products

They include essential oils that are used in mouth
rinses, xylitol, acemannan, oil of cloves, and triclosan
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Acemannan

Acemannan hydrogel is an extract of the aloe
vera plant leaf that has immunomodulating
properties


Available as an over-the-counter topical patch to
reduce the healing time of aphthous ulcerations
Thought to cause the ulceration to heal at a faster
pace
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Essential Oil Mouth Rinse

Over 20 mouth rinses that contain the
essential oils (EOs) thymol, eucalyptol, and
menthol have been approved by the
American Dental Association (ADA)

EOs are proposed to have a bacteriostatic effect
on oral pathogens known to cause plaque and
gingivitis
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15
Oil of Cloves
(Eugenol)

Oil of cloves have been used for many years
as a topical analgesic for dental pain

No published clinical trials that confirm its efficacy
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Triclosan

Triclosan is an herbal-based product that has
been shown to significantly reduce plaque
and gingivitis when compared with placebo
dentifrice

One triclosan-containing product has received the
ADA’s Seal of Acceptance for its antigingivitis
effect
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Xylitol

Xylitol is a naturally occurring sweetener
derived from plants that can be extracted
from birch bark, raspberries, plums, and corn
fiber

Xylitol cannot be metabolized by Streptococcus
mutans to form acids
 Xylitol’s antibacterial effects inhibit the ability of
microbes to adhere and grow in plaque
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