CHAPTER 56 Use of Herbs and Herbal Dietary Supplements in Dentistry
Alternative (integrative, complementary, natural, holistic) medicine is composed of a broad range of treatments that are often preventive in nature and commonly directed at treating the whole person rather than a specific disease. Substances used in alternative therapies are most often derived from natural sources. Many of these—particularly herbal medicines—have been used for more than 2000 years and are relied on by approximately 80% of the world’s population in developing countries. Most people who use alternative care modalities do so because they are following traditions handed down from one generation to the next. What Western culture calls alternative treatments are in most cultures often the only available options for health care. Most such treatments have lacked rigorous scientific evidence of efficacy; however, there is a growing body of clinical research documenting the activity and utility of some of these regimens. The National Institutes of Health have designated such therapies as complementary and alternative medicine (CAM). In contrast, Western medicine (sometimes referred to as allopathic) includes a diverse array of scientific, mostly evidence-based pharmacologic and surgical technologies, which, although described as “mainstream,” “conventional,” “orthodox,” or “traditional,” have been practiced for little more than a century. These treatments focus almost exclusively on eliminating disease.
The term alternative medicine is used in this chapter to indicate “interventions neither taught widely in medical schools nor generally available in hospitals.”10 This selection is not meant to exclude other terms. The increasingly popular term integrative medicine may be preferable because it stresses that these treatment protocols often can be effectively integrated with conventional medicine to optimize the health of the patient.
For decades in the United States and in some European countries, alternative medicine—and alternative (or holistic) dentistry—has implied care at the “fringe” of accepted medical (or dental) practice. There is an increasing trend now to incorporate many of these forms of care into the mainstream and include them as covered benefits in health insurance plans. Alternative medical therapies, depending on how they are defined (e.g., whether prayer is included as a CAM therapy) are used by an estimated 25% to 42% of the U.S. population.4,10,18 About 20% use natural products, including vitamins, minerals, herbs, and other dietary supplements. Table 56-1 lists the reasons why patients pursue CAM therapies. Visits to alternative care practitioners exceed visits to allopathic primary care physicians by more than 200 million annually, and Americans spend an estimated $30 billion a year on these services plus $18.8 billion on dietary supplements; most of these expenses are not reimbursed.10 In response to these trends, most medical and some dental schools in the United States now provide at least introductory coursework in CAM.
|Thought CAM combined with conventional medicine would help||54.9%|
|Thought CAM would be interesting to try||50.1%|
|Thought conventional medicine would not help||27.7%|
|Conventional medicine professional suggested CAM||25.8%|
|Conventional medicine too expensive||13.2%|
CAM, Complementary and alternative medicine.
From Reference 4.
A survey of 46,000 subscribers to Consumer Reports magazine found that 60% of individuals who used alternative therapies told their physicians they were doing so, and most physicians approved of (55%) or were neutral to (40%) their actions.16 One in four patients tried alternative therapies at the recommendation of a physician or nurse. Another national survey concluded that individuals who use alternative therapies are better educated but often less healthy than individuals who do not use them.3 These individuals are not dissatisfied with conventional medicine, but they find alternative therapies “more congruent with their own values, beliefs, and philosophical orientations toward health and life.”3 Although most people using herbal medicines do so in a manner consistent with evidence-based medicine, there is concern that “evidence-based information is not reaching the consumer” and that “health care professionals should proactively educate consumers.”5 This conclusion presumes that health care professionals themselves are first educated on the scientifically established benefits of botanicals. The health benefits of an increasing number of CAM treatments are being supported by published peer-reviewed research. One such study documented that healthy individuals who regularly consume one or more dietary supplements (e.g., vitamin C) may have superior health, increased longevity, or both compared with their peers.20 Chiropractic and acupuncture for certain chronic and acute conditions have been accepted by the American Medical Association (AMA), which often is reserved in accepting new or unconventional treatment modalities. Most CAM therapies are not so endorsed because the AMA considers scientific evidence regarding their efficacy lacking or insufficient. The AMA does not endorse the sale of dietary supplements from physicians’ offices based on concerns that the inventorying and sale of such products may inappropriately affect physicians’ clinical judgments.
Although some authors claim that alternative medicine differs from allopathic medicine by virtue of treating the patient as a whole person rather than for the specific disease or collection of diseases, alternative therapies do offer disease-specific methods of care. CAM treatment modalities also constitute a more self-determined form of health care, especially because they are frequently integrated with nutritional and lifestyle modifications. This chapter focuses on natural pharmacologic and therapeutic agents—principally botanical (herbal) remedies—that constitute one of the alternative or integrative means of health maintenance and disease treatment.
The growth of alternative therapies in the United States was spurred by the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994. This act greatly boosted the market for dietary supplements, including vitamins, minerals, and botanical remedies. Under DSHEA (Box 56-1), manufacturers could promote herbal products for the maintenance of health by using “structure/function” claims, such as the product “enhances the immune system” and “improves memory.” It also permits, but does not require, manufacturers to list product safety precautions. Clarification of DSHEA in 1998 allowed herbal product manufacturers and distributors to make some additional claims, primarily to suggest their use for modifying natural life events, including menopause, pregnancy, and aging.
Adapted from Israelsen LD: Summary of the Dietary Supplement Health and Education Act of 1994. Quarterly review of natural medicine, Seattle, WA, Spring 1995, Natural Product Research Consultants.
Under DSHEA, dietary supplements, including herbal products, are legally classified as foods. They are exempted from the normal review process the U.S. Food and Drug Administration (FDA) requires for drugs. New drugs require extensive documentation of purity, safety, and efficacy before FDA approval is given. Dietary supplements require no prior approval, however, of the manufacturer’s claims. Nevertheless, the FDA can rely on third-party research to remove products from the market deemed to be unsafe. The FDA’s 2004 ban on the sale of ephedra (Ephedra sinica, ma-huang) was the first successful action taken by the FDA since DSHEA to remove a potentially dangerous herbal product from the marketplace.
DSHEA also requires that manufacturers must be able to substantiate, when challenged, all claims made either on the container or in the literature that accompanies the dietary supplement product. Such challenges can come from the FDA or from self-regulatory mechanisms, such as the industry-funded program of the National Advertising Division of the Better Business Bureau, wherein ad claims are being reviewed for accuracy, resulting in the revision of such claims where evidence may be lacking or, if the manufacturer does not comply, referral to the Federal Trade Commission for possible action. DSHEA also authorized the FDA to establish Good Manufacturing Practices (GMP) for dietary supplements. The final rule by the FDA regarding current good manufacturing practice for dietary supplements was published in June 2007, and companies are required to comply with all provisions in 1, 2, or 3 years, depending on whether the companies are large-sized, medium-sized, or small-sized. Standard testing remains an ongoing major challenge, however, in the herb and dietary supplement industries and in the analytic laboratory industry.
Because credibility is an increasingly important factor with consumers, some manufacturing companies of natural products, eager to gain and retain the public’s trust, voluntarily established relatively stringent GMP in advance of the final GMP rule published by the FDA for dietary supplements. The botanical product industry is represented by the American Herbal Products Association, the leading organization that works exclusively with herbal product manufacturers to enhance their quality and credibility. Several other trade associations also work with herbal manufacturers (e.g., Council for Responsible Nutrition, Natural Products Association, and United Natural Products Alliance). These organizations work with their respective industry members and with the FDA to help promote quality manufacturing standards for herbal and other dietary supplements in cases in which such quality has been shown to be lacking.
For professionals and the lay public, ConsumerLab publishes results of random tests of CAM products on its website (www.consumerlab.com). Products approved by ConsumerLab are eligible to receive its “CL” seal of approval if the manufacturer wishes to pay for the privilege. Currently, approximately 7% of these approved products carry this seal, and the number of such products is expected to increase. The United States Pharmacopeia is also conducting GMP and product quality audits and is offering a seal in its Dietary Supplement Verification Program. Another nonprofit group, NSF International (the world’s largest certifier of the purity of drinking water and water filters), also has a program to monitor supplement manufacturers’ GMP adherence and product identity and quality.
In addition to a growing trend within the industry to improve quality control, efforts are being made to document the efficacy of natural products for disease prevention and therapy. U.S. investigators face special challenges regarding herbal and other natural products. Much of the existing scientific evidence is reported in languages other than English. The problems of product purity, standardization, and quality control that have plagued this sector are potential research confounders in the United States.
Herbal supplement claims allowed under DSHEA are sometimes based on limited scientific data and may contain no detailed information concerning the types and concentrations of known active ingredients in the preparations.31 Nevertheless, credible information is accumulating for certain herbal remedies. Ginkgo biloba does have antiplatelet effects and may have antioxidant properties; however, its suggested benefit in treating dementia and depression has yet to be reliably shown.6 Saw palmetto (Serenoa repens) has been documented to decrease symptoms associated with benign prostatic hyperplasia.7,12,30
In industrialized nations, the German Commission E has been generally acknowledged as the leading regulatory model regarding the therapeutic actions of herbs. The German Commission E published 380 monographs in 1983-1995 based on extensive research. Its work has promoted product standardization, high manufacturing quality, and the acceptance and prescribing of herbal medicines (phytomedicines) by physicians in Germany, although the work of the Commission is now largely that of an advisory role to the German government,7 as the role of evaluating and approving herbal medicines is now being conducted on a pan-European basis by the European Medicines Evaluation Agency. In the United States, the National Center for Complementary and Alternative Medicine (NCCAM, a division of the National Institutes of Health) is charged with developing evidence-based research information on the full range of alternative therapies, including the use of herbal supplements, by funding a large battery of randomized controlled trials and basic research at more than a dozen research centers documenting the mechanisms of actions of these complex natural substances.
Natural products of plants are marketed in unmodified forms, such as the whole leaf, bark, berry, or root; as powders in capsules and tablets; as herbal teas; and in various extracts and other derivatives. The recorded use of natural preparations for their pharmacologic effects dates from at least 2735 bc, when a Chinese emperor recommended the use of ephedra (Ephedra sinica, which contains ephedrine and at least five other sympathomimetic agents) for a respiratory condition. Approximately 25% to 30% of pres/>