Regenerative medicine refers to the use of cells, cytokines, scaffolds, and growth factors to improve the repair of damaged or poorly functioning tissues or organs (Fitzwater, 2013). This therapy involves collecting tissue (generally fat, bone marrow, or blood) from the patient, isolating the desired cells or products, and administering the products back to the patient. These autologous products function to replace damaged tissue or stimulate the body’s own repair mechanisms to bring about healing. Much of the focus of regenerative medicine is on the use of stem cells but also includes the use of interleukin antagonists, platelet-rich plasma (PRP), and other products. Regenerative medicine is used most often in the treatment of orthopedic disorders in horses and dogs. Other potential uses include chronic kidney disease and asthma in cats as well as immune-mediated disorders like inflammatory bowel disease and autoimmune hemolytic anemia in companion animals. The efficacy of regenerative medicine is somewhat controversial at this time because of questions related to the lack of extensive data from controlled studies. Some uncertainty remains whether positive results are due to tissue repair, an antiinflammatory effect, or postprocedure rest and restrictions.

The American Veterinary Medical Association (AVMA) defines nutraceutical medicine as “the use of micronutrients, macronutrients, and other nutritional supplements as therapeutic agents.” In veterinary medicine, the term is generally used to refer to endogenous substances (not botanicals) that have been prepared or synthesized to support bodily functions. The popularity of these products, which may have characteristics of nutrients and pharmaceuticals, has seen tremendous growth in use by people in recent years. The medical community has acknowledged that some of them may have treatment or preventive effects (Boothe, 1997).

As people have become more aware of alternative medical options for themselves, they have come to expect similar options for their pets. Veterinarians and their clients can be expected to use nutraceuticals as treatment options to complement traditional medicine or when traditional treatment options have been exhausted.

The former North American Veterinary Nutraceutical Council proposed that a veterinary nutraceutical be defined as “a nondrug substance that is produced in a purified or extracted form and administered orally to provide agents required for normal body structure and function with the intent of improving the health and well-being of animals.” Even though the definitions listed for nutraceutical and veterinary nutraceutical seem straightforward, a great deal of confusion exists over what is actually a nutraceutical. It has been stated that the term nutraceutical was developed to refer to a product marketed under the premise of being a dietary supplement but with the real intent of preventing or treating a disease (Warren, 2007).

The question often asked about these products is “Is it a food (nutrient) or a drug?” If it is a food, then it is not subject to U.S. Food and Drug Administration (FDA) approval; if it is a drug, it must go through the FDA approval process at a great deal of expense to the manufacturer. A product is usually determined to be a drug if its label has a claim that indicates a therapeutic or preventive intent. If the product has a label claim of a medical use and does not carry a new animal drug application (NADA) (indicating FDA approval), the product then becomes an unapproved drug and is subject to FDA regulation. Because the FDA has limited resources and higher priority issues, regulatory action may not be taken against these unapproved products. If a product is determined to be a food, it is usually determined to be “generally regarded as safe (GRAS)” by the FDA. Any product that is given by injection is considered a drug.

The Dietary Supplement Health and Education Act (DSHEA) of 1994 listed dietary supplements as vitamins, minerals, amino acids, herbal products, and substances that supplement the diet by increasing total dietary intake. This action made these products “food” and excluded them from FDA regulation. The Act does require, however, that the manufacturer show a disclaimer on the label after the product claim that says, “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.” Because of concerns about potential residues and the potential differences in response across species, the Center for Veterinary Medicine (CVM) of the FDA has stated that the DSHEA does not apply to animals or animal feeds.

Because nutraceuticals have not been through an extensive evaluation process to validate their purity, safety, and efficacy, it is up to the veterinarian to evaluate the suitability of particular products for use in companion animals and to promote their use in the context of a valid veterinarian–client–patient relationship. Veterinary technicians should consult with their veterinarians to formulate sound advice to give to clients regarding use of these products. Some questions that should be answered when a nutraceutical product is evaluated include the following:

• What controlled studies have been done to determine whether the product does what it claims to do, and who performed the studies? Are these studies published in reputable veterinary journals?

• Does the product contain what it says it does, and is that product bioavailable? Bioavailability may be influenced by the source and form of the product (e.g., glucosamine HCl vs. glucosamine sulfate).

• Is the label easily understandable and are all ingredients listed in the same units? Ingredients should be listed by the order of magnitude by weight.

• Is the dosage listed on the label, along with clear instructions for use?

• Is the product free of contaminants? Were good manufacturing practices (GPAs) followed?

• Does the label carry a United States Pharmacopeia (USP)–verified label for the product or ingredient/s?

• Is the manufacturer a member of the National Animal Supplement Council (NASC)?

• Does the product have a lot number and expiration date on the label?

• Does the product rely on testimonials rather than scientific evidence for validation?

Clients should be urged to make use of information regarding nutraceutical quality by making use of the ConsumerLab (www.consumerlab.com) and USP (www.usp.org) websites.

The following is a partial list of the substances marketed as nutraceuticals. Some of these products may not be “endogenous substances” as defined earlier.

Modern herbal medicine makes use of the fact that plants or plant material contains chemicals (drugs) that may be used in a manner similar to drugs supplied by the pharmaceutical industry. Proponents of herbal medicine argue that whole plants (as opposed to a purified product) provide the advantages of synergy and safety. Synergy, they state, occurs when the primary therapeutic chemical in a plant/plants interacts with other chemicals in the plant/plants to provide a magnified or more efficacious effect. Safety, they believe, occurs because multiple chemicals in a plant may dilute any singly toxic ingredient. Some herbal practitioners report that plants “may contain antimicrobial, anticancer, and immune modulating factors” (Wynn, 2002) not presently known in currently used drugs. Herbal medicine, when used in conjunction with conventional medicine, can provide another dimension of service to the veterinary client and patient.

Very few controlled studies have been performed to document the safety and efficacy of herbal products. Veterinarians must rely on empiric data, anecdotal information, and personal experience to guide their use of botanicals. The Cochrane Collaboration provides a library of papers from studies conducted with the use of botanical medicine. Botanicals are classified as supplements by the FDA according to the DSHEA and fall into a regulatory gray zone where few monitoring programs are in place to ensure the potency and purity of these products. Plants may vary in their makeup according to climate conditions, soil type, fertilizer used, and other factors. Manufacturing practices, packaging procedures, and storage conditions also may influence the quality of the product. Quality control practices regarding the actual content of the product as well as its strength and purity may vary widely from manufacturer to manufacturer and from country to country. A coalition of animal supplement manufacturers formed the NASC, a voluntary membership group, to address issues of quality control in the industry in the United States. Some veterinarians have advised against using herbal products manufactured in China because of reported contamination with heavy metals, herbs found in the product not listed on the label, or the presence of “spiked” (added) substances like anabolic steroids, glucocorticoids, thyroxine, and other substances (Rishniw, 2006). A useful resource for checking the quality of herbal products is the ConsumerLab website.

When choosing a product, veterinarians also must consider potential interactions of botanicals with conventional drugs that are being simultaneously administered and possible breed or species differences in drug responses. Certain herbs like ginkgo biloba, red clover, and feverfew may decrease platelet aggregation and should not be given before surgery or with conventional drugs that inhibit clotting. St. John’s Wort should not be given with some drugs that modify behavior (monoamine oxidase inhibitors [MAOIs]). Potential herb–drug interactions are listed in Table 18-1. Other potential interactions can be found at the PubMed and ConsumerLab websites.

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