Chapter 26: Natural/Herbal Products and Dietary Supplements Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.

2 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

3Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. Natural/Herbal Products and Dietary Supplements  Haveles (pp ) (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…

4Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 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

5Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 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…

6Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 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 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 Today the FDA must prove that the product is unsafecont’d…

7Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. Limited Regulation  Haveles (p. 321)  Package labeling  Other aspects of the DSHEA prevent the use of therapeutic claims on the label  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”

8Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. Safety of Herbal and Nutritional Products  Haveles (pp ) (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

9Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 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…

10Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 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

11Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. Standardization of Herbal Products  Haveles (pp )  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

12Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. Good Manufacturing Practice  Haveles (pp )  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

13Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 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

14Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 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

15Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 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

16Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 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

17Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 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

18Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 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