Original Internist, June, 2001 by Allen M. Kratz

Introduction

Homeopathic nutraceuticals may seem like an oxymoron, since historically, homeopathic products have been regulated as drugs, whereas dietary supplements are considered to be foods. However, recent events seem to have blurred the distinction between the two and created a new and exciting class of products, homeopathically prepared nutraceuticals, often termed homeovitics. [1,2,3]

Homeopathy is a 200-plus-year-old approach to healing that utilizes products that are prepared in accordance with standards as set forth in the Homeopathic Pharmacopoeia of the United States (HPUS) and its current Revision Service (HPRS). The Food and Drug Administration (FDA) regulates these products as over the counter (OTC) drugs and requires that homeopathic producers be registered as pharmaceutical manufacturers.

Nutraceuticals are defined by the American Nutraceutical Association (ANA) as functional foods that have potentially disease preventing and health promoting properties. They are also naturally occurring dietary substances in pharmaceutical dosage forms, thus including "dietary supplements" as defined by the Dietary Supplement Health and Education Act of 1994 (DSHEA) as well as comparable substances unintended for oral ingestion. [4]

At first glance, these two types of products may seem quite different as far as their definitions are concerned. They are, however, similar in many ways. Homeopathics and nutraceuticals are usually grouped together on retailers' shelves. They both offer an alternative to conventional OTC drugs. They have similar pharmaceutical dosage forms and similar uses, albeit with different mechanisms of action. They may, in fact, be used together to treat self-limiting, self-diagnosed conditions. Their sources are sometimes the same, particularly in herbal or botanical origin. One can often find the same herbal component of a nutraceutical available in a homeopathic form. The basic difference is in the method of production -- the homeopathic is in an energetic form while the herbal or nutraceutical is molecular in substance.

Legal Issues

From a regulatory standpoint, the FDA permits products to be labelled as homeopathic only if all active ingredients are prepared according to the HPRS. For example, if a formulation contained a homeopathically prepared herbal as well as an amount of the same herbal in pure form, the product would be considered a nutraceutical rather than a homeopathic.

Combinations of homeopathically prepared substances are very popular in the self care marketplace. Their use is sanctioned in a "Statement Regarding Combinations of Homeopathic Drugs" which appears in the current HPRS. However, combinations are unmonographed in the HPRS and are considered to be unofficial homeopathic products. Homeopathically prepared nutraceuticals are therefore unofficial homeopathic products in combination whose labelling is regulated by the DSHEA.

In Europe, where homeopathy originated and has flourished, combinations are very popular in both self care and in clinical treatment of diagnosed illnesses. The term "homeotherapy" is used to describe the various contemporary approaches used in European countries. A recent publication from the European American Coalition of Homeopathy (EACH) states the following:

"For a legitimate classification of a pharmaceutical (or nutraceutical) as a 'homeopathic medication,' it is not the manner of use, but solely the aspect of manufacture which is decisive. These medications are produced in accordance with pharmaceutical-galenical (nutraceutical) criteria, which are stipulated within the official homeopathic pharmacopoeias and the valid, authorized guidelines of the European union." [5] (italics added for clarification)

This progressive European approach to homeopathy is being adopted in the USA. It recognizes that homeopathically produced substances can be used in many ways ... as self care in acute situations, in chronic illness, for specific indications, i.e., stress, insomnia, and for support of organs and systems as homeopathic nutraceuticals.

In May of 1998, the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), recognizing the potential usefulness of homeopathic nutraceuticals, stated the following:

"All substances, including vitamins, when prepared according to HPRS Guidelines and meeting the Criteria for Eligibility are eligible for consideration for inclusion in the HPRS (HPUS). [6]

At the same time, the HPCUS provisionally accepted for inclusion in the HPRS a number of new nutraceuticals that joined a growing list of such substances that are currently monographed. Examples of types of nutraceuticals officially recognized in the HPRS are as follows: [7]

1) Vitamins (e.g., ascorbic acid, pyridoxine, riboflavin)
2) Minerals (e.g., calcium salts, zinc salts, potassium salts)
3) Hormones (e.g., cortisone, pancreatin, epinephrine)
4) Biochemicals (e.g., adenosine triphosphate, coenzyme A, cysteine)
5) Glandulars (e.g., thyroid, pancreas, adrenal cortex)
6) Herbals (e.g., ginkgo, garlic, goldenseal, echinacea

Clinical Indications

Interestingly enough, some of the earliest and still important homeopathics, the cell salts and Bach flower remedies, can be considered to be nutraceuticals in their clinical uses. This is the common thread that weaves homeopathics and nutraceuticals together - their use.

Most newer homeopathic combination products that one sees on pharmacy and health food store shelves usually contain well recognized herbals that are also available as nutraceuticals. To illustrate this point, consider a homeovitic formulation for stress. It might contain ginseng or several ginsengs for their adaptogenic effect. Add some gotu kola, which also has an anti-stress effect, plus royal jelly, a natural source of the valuable B vitamin, pantothenic acid. Ginsengs and gotu kola, besides being nutraceuticals, are also official homeopathic substances, while royal jelly is a very popular nutraceutical. This formulation is an example of combining the best of both worlds - homeopathic nutraceuticals.

Cellular Detoxification

Cellular detoxification is a bodily function that may also be supported by homeopathic nutraceuticals. This concept is discussed in the aforementioned book, Homeotherapy, under the therapeutic school known as Antihomotoxic Therapy and Homotoxicology. [5] This approach targets xenobiotics such as environmental chemicals and heavy metals. These cellular toxins are thought to be a significant contributing factor in all chronic illness.

Formulations of official (HPRS) homeopathic substances, e.g., mercury, lead, aluminum, combined with homeopathically prepared nutraceuticals can be employed as detoxifiers as an adjunct to nutritional programs. Homeovitic cellular detoxification is being recognized as an important first step in nutritional protocols. Its efficacy has been validated by a meta-analysis of 105 published studies on cellular detoxification which concluded that 80% of the outcomes meeting the criteria for meta-analysis were positive. [8]

A clinical study completed in the summer of 2000 reported in the International Journal of Integrative Medicine (IJIM) measured the effect of homeovitic cellular detoxification on DNA repair in a 48-day protocol focusing on xenobiotic chemicals, heavy metals and latent viruses. These researchers also evaluated the immune-enhancing activity of cellular detox by measuring glutathione (GSH) levels, natural killer cell (NK) activity, and antioxidant capacity. All three of these outcome parameters were significantly increased (p[less than].05), indicating beneficial effects on immune function and DNA repair. [9]

Another example of this concept is the homeovitic blending of enzymes and other biochemicals to support the body's cellular functions. A number of Kreb's cycle intermediates are official homeopathic substances (e.g., acetic and citric acids), as are other important cellular chemicals such as coenzyme A, adenosine triphosphate (ATP), nicotinamide adenine dinucleotide (NAD), and alpha lipoic acid. A homeovitic formulation containing these and other homeopathically prepared nutraceuticals including coenzyme Q10 (CoQ 10), cytochrome C, Sadenosylmethionine (SAM) and tetrahydrofolic acid had a positive effect on the immune system in a preliminary study that was published in the Journal of Applied Nutrition in 1996. [10]

In conclusion, homeopathic nutraceuticals are a contemporary blending of both homeopathy and nutrition. This is a new concept whose time has come. Homeopathics and nutraceuticals are currently regulated by the FDA through both drug regulations and the DSHEA. These products have unquestioned safety. Their clinical uses and validation are expanding the borders of a new frontier.

About the Author

Allen Morgan Kratz received his BSc and MSc degrees in Pharmacy from the Philadelphia College of Pharmacy and Science. After receiving a MSc in Radiological Health from Temple University, he returned to PCP&S to serve on its faculty. His Doctor of Pharmacy degree was conferred in 1968. Academically, Dr. Kratz is affiliated with two universities. He is a Clinical Assistant Professor of Pharmacy Practice at the Medical University of South Carolina, College of Pharmacy and also a Clinical Assistant Professor in the Department of Medicine at the College of Osteopathic Medicine, Nova Southeastern University in Ft. Lauderdale, Florida. Dr. Kratz was a contributor, editor or author of several professional reference texts including Remington's Practice of Pharmacy (14th and 15th editions) and the United States Dispensatory (27th edition). He was appointed to the Editorial Board of The Merck Manual (12th edition) as the first pharmacist to serve in that capacity. He was a board member for the 13th edition as well. Cur rently, Dr. Kratz serves as co-editor of the "Journal of the American Nutraceutical Association" (JANA) and was recently appointed editor of a new book titled Nutraceuticals and Pharmaceuticals: An Integrative Approach to be published by CRC Press LLC. He is a member of Advisory Boards to the International Academy of Nutrition and Preventive Medicine, The Society of Natural Pharmacy and the American Nutraceutical Association. He is also the co-author of a chapter on Complementary Health Care in the 19th and new 20th editions of Remington: The Science and Practice of Pharmacy and is a frequent contributor to professional publications and peer-reviewed journals. Dr. Kratz is a member of the Homeopathic Pharmacopoeia Convention of the US (HPCUS) and is the founder and CEO of HVS Laboratories in Naples, FL. He may be contacted by phone at (800)801-9494 or by email at amkratz@aol. com.

REFERENCES

(1.) Gennaro AR. Remington: The Science and Practice of Pharmacy. 19th Edition. Chapter 50: "Alternative Healthcare". Mack Publishing, 1995; 834.
(2.) Pizzorno JE, Murray MT. A Textbook of Natural Medicine. Section 3: "Contemporary Homeopathy". Churchill Livingstone, 1993.
(3.) Clark CC. Encyclopedia of Complementary Health Practice. Springer Publishing, 1999; 391.
(4.) Kratz AM. "Nutraceuticals: New opportunities for pharmacists." Journal of the American Nutraceutical Association, 1998; 1:27.
(5.) European American Coalition on Homeopathy: Editing committee Homeotherapy 1997; Baden-Baden Germany.
(6.) Homeopathic Pharmacopoeial Convention of the United States (HPCUS), Board of Director's meeting minutes. 16 May, 1998.(7.) Homeopathic Pharmacopeia of the United States Revision Service (HPRS) published by the Homeopathic Pharmacopoeial Convention of the United States. Semi-annual updates.
(8.) Linde K, Jonas W, et al. "Critical review and meta-analysis of serial agitated dilutions in experimental toxicology." Human & Experimental Toxicology, 1994; 13:481-492.
(9.) Corsello 5, Ghen MJ, Kamhi FJ, et al. "Cellular detoxification: An integrative aproach to anti-aging." International Journal of Integrative Medicine, 2000; 2(6):19-26.
(10.) Kratz AM. "Homeovitics ... contemporary, innovative homeopathy." Journal of Applied Nutrition, 1996; 48:7-9.

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