Natural/Herbal Products and Dietary Supplements

evolve.elsevier.com/Haveles/pharmacology

Herbal medicine, also called botanical medicine and phytomedicine, refers to the use of a plant’s seeds, berries, roots, leaves, bark, or flowers for medicinal purposes. Long practiced outside conventional medicine, herbalism is becoming much more commonplace in Western medicine. More aggressive marketing of the purported health benefits of herbal and dietary supplements has dramatically increased their use during the last decade. Some people use herbal supplements because they are available without a prescription, eliminating the cost and time of visiting a health care professional whose prescription is needed for conventional agents (Figure 27-1). Others have turned to herbal supplements because of cultural influences, a sense of taking control of one’s health, distrust of physicians, and a lack of health insurance. Also, improvements in analysis and quality control, as well as advances in clinical research, show the value of these supplements in the treatment and prevention of disease.

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Figure 27-1 Herbal supplements are widely available without a prescription—in grocery stores, drug stores, and health food stores. Copyright 2009 JupiterImages Corporation.

 

Patients do not always report supplement use.

The recent trend in the use of natural or herbal substances has seen an exponential rise in the use of these products and the number of people using them. As a result, dental hygienists need to inquire about the use of these products as part of the health history/medication review.

During this growth period, concerns have been raised about adequate safety and efficacy research and about a lack of uniform product standardization. Because they 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. However, they can state that herbal or natural products can be used for general health and well-being. Because they are considered natural products or dietary supplements, most patients do not consider them medicine, especially since a prescription is not necessary for their use. Dental hygienists should make it a point to ask about herbal or dietary supplement use because many patients fail to mention them.

Much of what is known about herbal products or supplements has been compiled by the German Commission E, an expert panel composed of physicians, pharmacists, pharmacologists, and biostatisticians. This commission was originally established by the German Federal Health Agency (equivalent to the U.S. Food and Drug Administration [FDA]) to review and analyze the world literature on plant-based products. Commission E Monographs contain information regarding the chemistry, pharmacology, toxicology, traditional uses, and if available, data on clinical trials, epidemiologic studies, and patient case records on herbal products. These monographs are regarded as the most authoritative guide to herbal therapy available today. An English translation is available and is titled The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines.

Limited regulation

Dietary Supplement Health and Education Act

More than 20,000 herbal (botanical) and other natural products are available in the United States. The term natural has been associated with herbal products because they are primarily derived from plant sources. 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. Manufacturers cannot make claims of curing conditions, but they can make claims of improving structure or function. The FDA can allow a qualified health claim if there is scientific evidence to support it. Before 1994, the FDA attempted to propose stricter regulations for the herbal supplement industry. However, aggressive lobbying by the dietary supplement industry and thousands of letters from the general public to Congress blocked the proposed regulations.

 

FDA must prove a product is unsafe.

Today, herbal products are regulated by the Dietary Supplement Health and Education Act (DSHEA), which exempts vitamins, minerals, and botanical products from meaningful FDA regulation. Before this act, the manufacturer had to prove that a herbal product was safe and effective. Today, the FDA must prove that the product is unsafe. The manufacturer needs only to notify the FDA of any efficacy claims. Changes in the Federal Food, Drug and Cosmetic Act in 2006 now require the supplement industry to report all serious dietary supplement-related adverse drug effects to the FDA. In 2007, the FDA drafted regulations that would require supplement manufacturers to test for purity and to ensure that their products do not contain contaminants and to verify that the contents within the package matched the labeling information. These regulations were approved in August of 2007, and were to be phased in over the next 3 years, and and completely in place by the end of 2010. However, when the final bill, Dietary Supplement Full Implementation and Enforcement Act of 2010, was introduced it was referred back to committee twice. Many in Congress felt that the Bill was over regulating the dietary supplement industry. However, the proposed legislation is needed to regulate this growing industry.

Package Labeling

Other aspects of the DSHEA prevent the use of therapeutic claims on the label. All herbal products must be labeled as dietary supplements. These products cannot have labels such as “for treatment of hypertension.” However, the labels can contain claims of effects on the structure or function of the body. Thus a natural product could be said to “increase immunity” without a comment about what that might mean to a person’s health. Another rule is that information may be provided that may not be necessarily scientific, but it cannot be false or misleading. Again, the responsibility for proof of misleading labeling is in the hands of the FDA.

The DSHEA required 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.” This phrase is also required in the advertising of such herbal products. (It is said really quickly in television and radio ads.) Another requirement is that “information” must be physically separate from the natural product. The product would be on one shelf and the information would be placed in another aisle. It is unclear what benefit separating the information from the product would serve other than having gotten the Act passed. Health food store employees help customers obtain the literature and associate it with the products to determine their purchase choices.

Safety of herbal and nutritional products

Many consumers consider herbal products to be nontoxic or free of side effects because they are often called “natural” remedies. Most of the herbal products available contain ingredients that have profound pharmacologic effects. Some products may have potential therapeutic effects, and the vast majority have adverse effects and drug interactions. Since 1994, the FDA has investigated more than 800 reports of adverse reactions with more than 100 different ephedra alkaloid-containing products. Adverse effects included insomnia, nervousness, tremor, headaches, hypertension, seizures, arrhythmias, heart attack, stroke, and death. More than 50% of the adverse effects were reported in people younger than 40 years, and another 25% occurred in people 40-49 years of age. In 2004, following reports of cardiovascular events with ephedra (ma huang), the FDA issued a regulation prohibiting the sale of all dietary supplements containing ephedrine alkaloids and warned consumers to stop taking the product. A Utah supplement company challenged the ban, stating that the FDA was trying to regulate a food supplement as a drug. Unfortunately, a federal judge ruled in favor of the supplement company.

 

Treat herbal products as drugs.

Because some herbal products have pharmacologically active ingredients, the dental health professional should acknowledge this fact and treat any herbal product as a drug. Any use of herbal products by the patient should be noted in the patient’s chart. Table 27-1 lists examples of selected herbal products, their adverse effects, and implications for the dental hygienist.

Table 27-1

Selected Natural Herbs: Adverse Effects and Dental Hygiene Implications

Herbal Supplement(s) Adverse Effect(s) Dental Hygiene Implications
Feverfew Oral mucosal irritation, ulcerations Potential to cause ulcerations.
Check oral cavity for ulcerations.
Ephedra (ma-huang) Tachycardia, hypertension Monitor blood pressure and pulse rate.
Niacin, yohimbe Postural hypotension Raise the chair to the sitting position slowly.
Have the patient dangle the legs over the side of the treatment chair for a few minutes and then slowly get out of the treatment chair.
Chaparral, comfrey, kava (oral dose forms) Hepatotoxicity, bleeding Reduce the metabolism of many drugs.
Patient may require lower doses of those drugs because of potential for increased bleeding during procedures.
Monitor the patient for clotting.
Angelica, clove, feverfew, garlic, ginkgo, ginseng, red clover, high doses of vitamin E Bleeding Potential for increased bleeding during procedures.
Monitor the patient for clotting.
Coenzyme Q10, echinacea, milk thistle, pomegranate, wormwood Allergic reactions Watch for and alert the patient to the possibility of skin rash, stomatitis, angioedema, shortness of breath.

Oral Adverse Effects

The most common adverse oral and dental effects of herbal medications are many and include dysgeusia, gingival hyperplasia, intraoral hemorrhage, necrosis, oral candidiasis, oral ulceration, stomatitis, tooth discoloration, and xerostomia, according to research conducted at the Case Western Reserve University School of Medicine. St. John’s wort, an herbal supplement used to treat mild depression, causes xerostomia, just as prescribed antidepressants do. Oral ulcers, lip irritation, swelling, and gingival bleeding have been reported with the use of feverfew. There have been reports of increased gingival bleeding with ginkgo; and oral and lingual dyskinesia with the use of kava. Other reports include tongue numbness and taste changes with the use of echinacea.

Drug interactions

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Apr 12, 2015 | Posted by in Dental Hygiene | Comments Off on Natural/Herbal Products and Dietary Supplements
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