Article Date: 10/1/2010

Food for Thought
nutrition

Food for Thought

Follow these four tips to incorporate nutrition into your practice.

Jeffrey Anshel, O.D., F.A.A.O., Carlsbad, Calif.

Nutritional support for visual disorders is a rapidly growing area of eye care that offers you, the private practitioner, another avenue for practice specialization. In addition, both clinical and marketing research reveals a need for this specialty.

Specifically, less than 5% of the U.S. population actually eats the nine to 13 servings of fruits and vegetables recommended by the Food and Drug Administration (FDA).1 Also, in 2009, more than $29 billion was spent on nutritional supplements and herbal products in the United States, according to the Nutrition Business Journal's 2010 Healthy Foods Report. (Eyecare supplements are included in the category of "specialty" supplements in this report.)

Further, many patients are choosing healthcare practitioners who advertise the use of both conventional and natural interventions. The reason: Patients place value on less invasive treatments.

Enter "Integrative Optometry," a model of practice specialization, in which the practitioner neither rejects conventional medicine nor accepts alternative therapies, such as nutritional supplements, uncritically.

If you're interested in adapting the "Integrative Optometry" model, follow these four tips.

1. Acquaint yourself with the basics

Learn the basics of nutrition. To do this, visit www.optometric.com/article.aspx?article=101828 and www.optometric.com/article.aspx?article=101915. Also, consider joining the Ocular Nutrition Society (www.ocularnutritionsociety.org), which offers information on nutrition and the eye. (See "The Regulation of Dietary Supplements vs. Drugs," below.)

2. Identify "real" science

Confusing data exist on the effects of nutritional ingredients and products. Therefore, to determine a study's validity (e.g. sort the real science from the marketing hype), read the entire study (not just the headline or abstract), and be aware of the limitations of these study types:

The randomized controlled trial (RCT). While this is the gold standard for establishing the efficacy of pharmacologic agents, this is poorly suited to the evaluation of nutritional effects. The reasons: First, chronic diseases have long latency and multi-factorial causation, so it's difficult to determine exactly when a disease process begins and how long it has been developing. Without knowing a disease's starting point, it's difficult to say when nutritional treatment (which is preventative) can be effective. Second, all foods contain a variety of nutritional ingredients designed to work synergistically, whereas drugs are designed to work alone. In other words, nutrients act in modest beneficial ways in virtually every body system (we don't eat spinach just because it contains lutein, for example). Drugs act potentially on single targets. The RCT is designed for single outcomes.

"Observational" studies. These studies don't include a "no exposure" group. Researchers can't, for example, ask one group of participants to stop taking vitamin C for several years and see how they fare. So, only different levels of intake exist.

Food-intake questionnaires. Uncertainty in quantitative measures of food intake due to inaccurate reporting and recall bias is often the case with these studies. Also, some of these studies have subjects record food intake at the beginning and end of the study period. This method assumes subjects eat similarly throughout the study's entire duration — not necessarily the case. Further, how the food reported by subjects is translated into nutritional intake may be questionable. The reason: It depends on where the food was grown, how it ripened, whether it was organic and the weather conditions under which it was grown. (Food grown in drought conditions, for example, is smaller and less nutrient dense than food grown in more optimal conditions.)

The bottom line: Scrutinize these studies. You don't want to prescribe a dietary supplement that lacks legitimate science behind its formulation.

3. Play detective

In addition to ensuring the product(s) has legitimate science behind its formulation, make sure the company behind a specific product is valid prior to deciding which dietary supplement( s) to offer your patients. For instance, if the company's advisory board is comprised of marketing background but no medical background, this is a red flag that the company may not be the best one from which to purchase dietary supplements.

Through my own research, I've found that dependable companies offer:

► Current valid scientific rationale for anyone to review.

► Third-party good manufacturing practices (GMP) certification. (This is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact a product's quality, and reviews are conducted and certified by an outside authority. GMPs are enforced in the United States by the US FDA, under Section 501(B) of the 1938 Food, Drug, and Cosmetic Act [21USC351]).

► Training for you and your staff on how the product is designed to work, ideal candidates, typical patient questions and how to dispense the product.

► A money-back guarantee (this shows that the company is confident in its product).

► A website that emphasizes science vs. price and marketing.

A myriad of multi-level marketing (MLM) programs exist to market many products, including nutritional products. While some good products are marketed this way, I've found that MLM tends to promote the advantages of "profits vs. patients." So, any time a company suggests you can earn "six-figures a month" or some such ridiculous number, I suggest you walk away. In my opinion, MLM does not fit into the professional image of the eyecare practitioner.

Something else to investigate: cost. Strive to keep costs down, but also be aware of the best value. If a particular product sells for a lower price than a seemingly similar product, compare the ingredients of each to see what, specifically, the less expensive formula contains. Several patients take an array of pills to try to "target" specific issues, such as dry eye. Many times, a multiple vitamin supplement covers the same ingredients and can take the place of several individual pills. This will save patients money in the long run — something they'll greatly appreciate, and can therefore, lead to patient loyalty and referrals. (See "Dispensing Tips," below.)

4. Learn the misconceptions

Obtain education on the misconceptions regarding dietary supplements, so you can pass this education to your patients and be prepared to answer their questions. The four general misconceptions:

1. Since dietary supplements are natural, they are safe. While this statement is mostly true, these products can be abused and cause dangerous effects if not taken appropriately. Excessive amounts of beta-carotene, for instance, can actually cause agerelated macular degeneration (AMD).2 This is espenutrition cially critical for herbal products, such as ephedra, which more closely mimic the action of drugs.

2. Dietary supplements are ineffective. The effectiveness of nutrients is much more subtle and longterm than it is with drugs, but they are effective nevertheless. Their effectiveness is more apparent in the area of prevention, rather than in disease remediation. For instance, many clinicians think that since B-vitamins are excreted in the urine, they are useless. What these clinicians don't realize, however, is that the normal process of using the vitamin happens inside the body, and then it is excreted after use. A large study showed that B-vitamins could actually be preventive for AMD.3

3. They're all the same. This is especially untrue when considering a multiple vitamin. The type, form and amount of each nutrient can make a major difference in how it works. For example, Vitamin D3 is 70% more absorbable than Vitamin D2.

4. More is better. Just because a certain amount is effective, that doesn't mean ten times that amount is ten times more effective.

The eyes are not only a window to the soul but a mirror of the body. By adapting the "Integrative Optometry" model, you gain an enhanced understanding of the patient's overall health and its link to eye conditions — something that can greatly benefit patients, in terms of management protocol, and your practice, in terms of referrals, which leads to financial growth. OM

1. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics, Accessed 2010. http://www.cdc.gov/nchs/hus/healthy_people/hp2010.htm
2. Tan Js, Wang JJ, Flood V, et al. Dietary antioxidants and the long-term incidence of age-related macular degeneration: the Blue Mountains Eye Study. Ophthalmology. 2008 Feb;115(2):334-41.
3. Christen WG, Glynn RJ, Chew EY, et al. Folic acid, pyridoxine, and cyanocobalamin combination treatment and age-related macular degeneration in women: the Women's Antioxidant and Folic Acid Cardiovascular Study. Arch Intern Med. 2009 Feb 23;169(4):335-41.

The Regulation of Dietary Supplements vs. Drugs
The Dietary Supplement Health and Education Act (DSHEA) was enacted in 1994 and defines a dietary supplement as a product taken by mouth that contains "vitamins, minerals, herbs or other botanicals, amino acids and substances such as enzymes, organ tissues, glandulars and metabolites." In addition, the DSHEA states dietary supplements can be extracts or concentrates and may be come in forms, such as tablets, capsules, soft gels, gel caps, liquids, powders or bars. (When in a bar form, however, information on their label must not represent the product as a conventional food or a sole item of a meal or diet, the DSHEA states.) And, regardless of form, the DSHEA places dietary supplements under the general umbrella of "foods," not drugs, and requires every supplement be labeled a dietary supplement. (For more information, visit www.fda.gov/food/dietarysupplements/default.htm.)
Further, under the DSHEA, the dietary supplement manufacturer is responsible for ensuring that the product is safe before the manufacturer markets it. This is where premarket notification (510k) enters the picture. A premarket submission is made to the Food and Drug Administration (FDA) to demonstrate that the device (or nutrient, in this case) is safe and effective. That is, the manufacturer of the dietary supplement must show the FDA that the nutrient is at least as safe and effective, that is, substantially equivalent, to a legally marketed supplement that is not subject to premarket approval (PMA) (defined below). In other words, submitters must compare their dietary supplement to one or more similar legally marketed supplements and make and support their substantial equivalency claims. This means that neither the specific product's safety nor its effectiveness must be proven prior to its release to the public. As a result, these products must have the following disclaimer: "These statements (i.e. claims about a product's efficacy on a certain condition) have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease." (For more information, visit www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/Premarket-Notification510k/default.htm.)
That said, the FDA is responsible for taking action against any unsafe dietary supplement product post-market. The government agency's post-marketing responsibilities include monitoring safety (e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts and accompanying literature.) Meanwhile, the Federal Trade Commission regulates dietary supplement advertising.
New drugs, however, require a PMA, the most strict device marketing application the FDA requires. Specifically, the applicant (e.g. individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or other legal entity) must receive FDA approval of its PMA application prior to marketing their product. Such approval is based on FDA determination that the PMA contains sufficient valid scientific evidence to assure the product is both safe and effective for its intended use(s). So, an approved PMA is, in effect, a private license granting the applicant permission to market the product. (For more information, visit www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm.)
Other than these differences, dietary supplements and drugs maintain the same requirements in the areas of labeling, good manufacturing practices (GMP) (e.g. the manufacturing, packing, labeling, etc. to ensure quality), facility registration and advertising.

Dispensing Tips
Consider a small display, either in your dispensary or near your front desk, of the nutritional products you've chosen to dispense. This immediately shows patients that you not only have the expertise to offer spectacles and contact lenses to better their vision, but dietary supplements as well.
Place a brochure about why nutrition is important for eye health in your reception area. The Ocular Nutrition Society offers an "Eye on Nutrition" brochure (www.ocularnutritionsociety.org/brochure-order/ons_brochure.jpg) that introduces patients to the concepts of why nutrition is important for eye health. This, or similar brochures, will likely peak a patient's interest and prompt him to ask you questions about how dietary supplements can help his eye health.
Carefully explain to the patient how a dietary supplement, if any, can benefit him. After diagnosing a condition, provide patient education on the specific benefits of the supplement you feel may benefit him. This will make the patient more likely to subscribe to this treatment.
Hand the patient a brochure that fully explains the product you are recommending. This compliments your personal patient education and works to answer any further questions the patient may have.
Have the product you're recommending on hand. If the patient decides to purchase the dietary supplement right away, you should have it available to dispense as a convenience to the patient. If he wants to consider it later, simply alert your office staff (via a routing slip) that you have discussed this product with the patient. Your staff can ask the patient whether he wishes to make the purchase again at a later time. Either way, the patient knows that it is available and something that can assist in his treatment.

Dr. Anshel has written numerous articles and books regarding nutritional influences on vision and computer vision concerns. He is the founder of Corporate Vision Consulting and is president of the non-profit Ocular Nutrition Society. E-mail him at eyexam@cox.net, or send comments to optometricmanagement@gmail.com.


Optometric Management, Issue: October 2010