CAM increased in popularity in the United States for the past few decades, and continues to be used [1–3, 8]. A survey conducted in 1990 by Eisenberg and colleagues is widely considered to have served as a wake-up call for healthcare professionals concerning the growing popularity of CAM in the U.S. [1]. In this landmark survey of 1,539 respondents, the researchers disclosed that one in three Americans who participated in the survey had used at least one CAM therapy during the past year and that visits to CAM providers totaled 425 million, which exceeded the number of visits to all U.S. primary care physicians that year. The majority of those who used CAM therapies for serious medical conditions also sought care from their conventional physicians, but approximately 72% did not disclose their CAM activities to these physicians. Further, most (estimated at 75%) of the expenditures associated with the use of CAM therapy were paid out-of-pocket.

When consumers were surveyed in 1997, an even greater number of participants had used a CAM modality (42% vs. 34% in 1990), out-of-pocket expenditures were similar, and the same percentage of users did not share their CAM activities with their conventional physicians [2]. A 2001 survey examined lifetime use and age at onset and found 67.6% of 2,055 respondents had used at least one CAM therapy in their lifetimes [3]. For the population as a whole, lifetime use increased with age. This study concluded that the trend for CAM therapies was strong and that there would be a continuing demand for CAM therapies for the foreseeable future. National survey results report similar findings with 38% of adults disclosing CAM use [4, 9], and 49% specifying use of a dietary supplement product [8] for reasons that include boosting energy and a general sense of well-being.

Given the prevalence of CAM use, OHCPs should be prepared to communicate with patients on their patterns of use and whether or not the CAM is intended for a systemic effect or to treat an oral health condition. In rural communities and low income or minority populations, access to dental care may be challenging and patients may turn to alternative remedies for oral conditions such as pain, bleeding gums, and xerostomia [10, 11].

Among the key issues regarding CAM use that concern healthcare providers is the uncertainty over efficacy and safety of CAM practices. Many of these modalities have been used in other cultures for centuries. In the U.S., however, consumers are quick to adapt therapies that have not been validated through research. Concerns regarding natural products that may differ from those of other countries due to species, soil, water, growing conditions, or the circumstances regarding product manufacturing further complicate assurance of consistent health outcomes associated with CAM practices. The creation of NCCAM in 1998 was a major step forward in establishing the groundwork for investigating efficacy and safety of various CAM modalities in the US. The mission of NCCAM is to subject CAM practices to rigorous scientific scrutiny to identify usefulness, safety, and efficacy of CAM in health care [12]. NCCAM’s research approach includes basic and translational research as well as observational and clinical trials. Areas of interest include chronic pain, inflammation, and modalities to support health and wellness [13]. For those CAM modalities that are found to be health-promoting, the expectation is that they can be safely integrated into mainstream medicine. However, given the paucity of clinical trials of CAM on dental and oral health outcomes, clinicians should individually evaluate the risk/benefit profile and make a determination to use or not to use the CAM approach within patient care modalities. Rakel [14] describes a system of evaluating the benefit in light of the potential harm. In weighing the evidence with the harm to make an informed choice, the clinician can assess if there is evidence with no or minimal harm, then there is potential for use; conversely if there is little evidence and potential harm, the indication for use would be unfavorable. However to weigh the evidence against possible harm, the OHCP must be well versed in the CAM modality or should consult with or refer to a CAM practitioner.

Dietary supplements are considered natural products [5]. The large number of dietary supplement products available and the use of supplements by consumers may be attributed to the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA, pronounced “De-shay”). Congress passed DSHEA as an amendment to the Federal Food, Drug, and Cosmetic Act [15]. DSHEA included several provisions that set dietary supplements and dietary supplement ingredients apart from the usual regulations that apply to food and drugs. It defined “dietary supplement,” established a new framework for assuring safety, provided guidelines for the use of claims that could be made about dietary supplements and for the literature that was displayed where supplements were sold, established labeling requirements for dietary supplements, and granted the Food and Drug Administration (FDA) the authority to establish Good Manufacturing Practices (GMPs) for the production of dietary supplements.

DSHEA defined a dietary supplement as a product intended to supplement the diet that contains a vitamin, a mineral, a herb or other botanical, an amino acid, or a combination of these. Additionally, a dietary supplement is intended for ingestion in pill, capsule, tablet, or liquid form; is not represented for use as a conventional food or as the sole item of a meal or diet; and is labeled as a “dietary supplement” [15]. All dietary supplements must be labeled as such and must carry the following disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease” [15]. This disclaimer is mandatory for all supplements, whether or not they are effective in improving health. It conveys no judgment on the part of the FDA as to whether or not the supplement is effective for its intended purpose.

To help consumers decipher how much is known about the intended purpose of a dietary supplement, DSHEA further established regulations for product claims. There are two types of claims that are of particular help to supplement users: health claims and structure/function claims. Health claims are the “gold standard,” must make a direct linkage between a dietary ingredient and a health benefit, and have significant scientific agreement to support the claim [16]. Dietary supplements cannot claim to decrease risk of a disease unless the claim has been cleared by the FDA as a health claim [16]. An example of an approved health claim may be applied to dietary carbohydrates and dental caries; noncariogenic carbohydrate sweeteners such as sugar alcohols may claim “sucralose, the sweetener in this food, does not promote tooth decay.”

The second type of claim, the structure/function claim, and is more general, stating that a particular supplement may promote a healthier condition but the claim cannot make a direct link between the supplement and a disease [17]. These may be more commonly used as they do not require preapproval from the FDA for a manufacturer to make the claim. Structure/function claims cannot state that a supplement will prevent, treat, or cure a disease. An example of an allowable structure/function claim would be: “Soy isoflavones promote bone health” since it makes no reference to a disease state.

In contrast to drugs, dietary supplements are not subjected to premarket approval for safety and efficacy. However, DSHEA did establish current Good Manufacturing Practices (GMPs), which were phased in by 2010, and manufacturers of dietary supplements in the U.S. are required to abide by these stated practices [18]. GMPs apply to manufacturers of dietary supplements and stipulate conditions under which supplements are manufactured, packaged, and tested. Manufacturers are required to follow the regulations for clean and safe manufacturing, quality control, and accuracy in labeling. The GMPs are welcome to healthcare practitioners and consumers to add confidence in buying dietary supplements.

The main difference between how dietary supplements and drugs (both prescription and over-the-counter) are brought to market is associated with the degree of scrutiny that products are subjected to prior to being released to the market. Drugs undergo extensive safety and efficacy testing that involves numerous stages of review that eventually involves human clinical trials. This forms the basis for FDA approval of a drug’s entry into the marketplace, whereas dietary supplements do not have to undergo this level of premarket testing and approval, and hence some impure or ineffective products have been documented [19, 20].

Information on dietary supplements with adverse effects can be found on the FDA website at www.​fda.​gov. Adverse events such as increased blood pressure, heart rate, and dizziness have been associated with supplements that stimulate the central nervous system such as sources of caffeine (guarana) or ma huang (ephedra). In fact, ephedra is banned for sale in the US due to associated adverse effects of dietary supplements containing the substance [21]. In addition to safety concerns, there is often limited evidence that a particular supplement is effective for its intended purpose. However, high quality manufacturers can elect to have their products evaluated by independent testing labs. Among the more rigorous certification programs are those offered by the U.S. Pharmacopeia (www.​usp.​org) and NSF International (www.​nsf.​org).

Good oral health is an essential foundation for optimal overall health. The recognition that oral health is integral to general health is reinforced in a position of the Academy of Nutrition and Dietetics and in Healthy People 2020 [22, 23]. Additionally, the Surgeon General’s Report on Oral Health [24] underscores the fact that diseases and limitations of the oral cavity may impact general health and wellness. OHCPs are concerned with preventing disorders that affect the health of the oral cavity and preventing and alleviating symptomatic manifestations of systemic diseases. This chapter will review CAM modalities that patients may use for systemic or oral health so that the OHCP may be able to openly communicate on CAM therapies and evaluate the impact the CAM therapy may or may not have on the oral health or procedure provided to the patient.