Sadly, most of the diseases we struggle with here in America are preventable.  Diabetes, heart disease, stroke and many cancers
and even Macular Degeneration (AMD) are preventable with improved diet, exercise, lifestyle change and weight loss.  Click on Jamie's picture below to hear a great 20 minute
lecture on the problem and his ideas for the cure.

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TOZAL®: SETTING A NEW STANDARD OF CARE

 FOR PATIENTS WITH AMD

                                                    By Dr. Edward Paul & Carlos Montesinos

AmeriSciences has always been known for its science-based approach to supplementation as well as its unsurpassed manufacturing and quality standards.  The introduction of TOZAL Eye Health Formula as the latest addition to the product lineup marks yet another milestone in the evolution of nutrition as the new standard of care and wellness.  This column has always been dedicated to communicating our pursuit of quality through ethical manufacturing and evidence-based formulation, and in doing so we always attempt to present such information in an objective manner. Yet this product embodies something that is greater than just the sum of its parts or the science behind it: hope, and the gift of eyesight.  That very fact makes the editing of this edition something particularly unique because methodical objectivity can quickly turn into subjective excitement when one understands not just the overwhelmingly positive results, but most importantly, what they mean in terms of the potential to positively affect so many people’s lives.  Nevertheless, our scientific roots and our commitment to education force us to, at times, play devil’s advocate, and always present the evidence without bias.  In a nutshell, the remarkable results of the TOZAL study revealed that more than half (57%) of the subjects in the treated group improved an average of one-half a line of visual acuity at 6 months.  In contrast to the well-known natural course of age-related visual decay that results in deterioration, nearly 77% of patients supplemented with TOZAL® Eye Health Formula improved or stayed the same, and only about 23% deteriorated (but no worse than placebo).  In fact, compared to the placebo group, there was an overall two line improvement of visual acuity.  Yet as remarkable as these results are on their own, what really catches the attention of most eye care professionals is that the “placebo” used in this TOZAL study was not an inert or sugar pill, but rather a product until then considered the “standard of care”: the AREDS-based formulation, also known as Bausch & Lomb’s PreserVision®.  Hence, TOZAL® Eye Health Formula was shown effective at not only improving visual acuity, but in doing so, it was also shown far superior to the conventional standard of care.  Yet as overwhelmingly positive as the evidence is, we are scientists too, and we understand the due diligence that other physicians and scientists engage in while evaluating new alternatives for their patients.  Likewise, we also encourage patients to become educated, conduct their own research, and of course, get their queries answered.  To that end, we have compiled a list of questions which, frequent or not, will help address some of the most important aspects of the TOZAL study and formulation.

TOZAL FACTS

STUDY SIZE AND RELEVANCE OF FINDINGS

The TOZAL clinical trial was conducted at five highly regarded, nationally known prestigious retinal clinics - four centers based at academic institutions. Institutional Review Boards, governed by the Code of Federal Regulations and policed by the Food and Drug Administration, have ultimate scientific, ethical, and regulatory authority over research conducted in humans. Five separate IRBs evaluated and approved the formulation for safety, the protocol for compliance, and the methodology for relevance. There were no adverse effects reported during the trial nor have there been any since the product has been commercially available. Of noteworthy relevance is the fact that this study's results proved statistically significant, with a P value of 0.045.  Contrary to popular belief, size of effect is a consideration in developing size of sample.  In other words, large N values (i.e. sample size) do not necessarily increase the validity of the investigation.  An N of over 30 is valid and open to most statistical techniques, however the smaller the N value the more difficult it is to reach statistical significance.  The results of the TOZAL Study have been deemed statistically and, most importantly, clinically significant by academia in both optometry and ophthalmology.

THE VITAMIN A DEBATE

Much has been said about vitamin A toxicity, also known as hypervitaminosis A.  It is caused by overconsumption of preformed vitamin A, not carotenoids, and it is associated with long-term ingestion of amounts greater than ten times the current Reference Daily Intake (or 25,000 to 33,000 IU/day).  The TOZAL® Eye Health Formula contains 10,000 IU of preformed vitamin A; well below the established level of toxicity.

Contrary to previous studies which questioned vitamin A’s role in hip fractures, the latest research clearly indicates that vitamin A intake is not associated with detrimental effects on bone mineral density (BMD) or fracture risk (1-3).

ABSORPTION OF BETA-CAROTENE

Lutein and other carotenoids have been shown to reduce the rate of absorption of beta-carotene, possibly due to a competitive process.  It is for this very reason that, compared to the AREDS formula, TOZAL® contains some preformed vitamin A (beta-carotene is a precursor to vitamin A).  Lutein has not been found to reduce the absorption of preformed vitamin A.

WHAT ABOUT BETA-CAROTENE IN SMOKERS?

Two studies in the mid-1990’s raised questions about the safety of beta-carotene, when it was observed that the chronic ingestion of very large quantities (50,000 IU) of synthetic beta-carotene increased lung cancer risk in smokers and asbestos workers.  Several other studies since, both of a trial and cohort nature, most notably the Physician’s Health Study, which included more than 2,000 smokers and lasted approximately 12 years (twice as long), and the Heart Protection Study, have failed to find any similar safety issues related to beta-carotene, and in fact have found a reduction in some forms of cancer.

Furthermore, these concerns have only been raised with the synthetic form of beta-carotene, and only in smokers.  They have never involved food-derived, natural beta-carotene, which is actually heavily promoted for smokers via supplementation of the diet with carotene-rich fruits and vegetables.

TOZAL Eye Health Formula contains 18,640 IU of natural, food-derived beta-carotene, providing a safe and effective formulation that is well below even the most conservative of daily dosage concerns.  Moreover, smoking is the number one risk associated with age-related visual decay, and any patient concerned about their long-term eye health should consider quitting as a first step in the preservation of their sight.

ANY GENITOURINARY CONCERNS WITH ZINC?

The University of Wisconsin - Madison found that hospital admissions due to genitourinary causes in patients on zinc were 11.1% vs. 7.6% for the non-zinc formulations.  That being said, in the original AREDS trial, zinc proved to be the most effective single nutrient - with the zinc arm performing statistically as well and the zinc + antioxidants.

TOZAL Eye Health Formula, as well as all AREDS-based formulations, contain 69 mg of Zinc. Considering the overwhelmingly positive evidence in terms of eye health, not to mention other structures and functions of the body, it is clear to many in the scientific community that the risk/benefit ratio merits supplementation with these 69 mg of zinc. On the subject of prostate health, the UW/Madison study (referenced earlier) clearly states that "there was NO increase in prostate cancer or other cancers with zinc supplementation." Furthermore, the AREDS study showed that there was a significant decrease in cancer diagnosis seen in patients receiving antioxidants or antioxidants + zinc vs. placebo.

Zinc is one the most researched nutrients with respect to its positive effect on eye health issues such as AMD (some published studies have used as much as 200 mg of zinc without significant adverse effects). The only negative effect that zinc has had on a any population base is a slight (3.5%) increase in genitourinary complications at dosages of 80+ mg daily.

To keep things in perspective, six (6) oysters contain an average of 78 mg of zinc (TOZAL and AREDS formulas contain 69 mg).

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Dr. Schneider's Amazing Curcumin and Cinnamon Bars.

1/2 cup ground turmeric

1/2 cup ground cinnamon

1/4 cup dark cocoa powder (unsweetened)

1 1/2 cup organic almond butter

1/2 cup peanut butter

1/2 tsp salt

1 tsp vanilla

1/2 cup honey

Mix all together in a large mixing bowl

Press mixture into a tupperware 6 X 6 inch flat container (with cover)

refrigerate

cut into <1 inch cubes,  (about 50)

eat one cube daily

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Astronauts Test Use of Nutritional Supplements in Space

 HOUSTON, TEXAS - After nearly four years of joint research between Houston-based AmeriSciences and NASA / Johnson Space Center (JSC), a senior NASA medical officer has confirmed that two of the resulting nutritional supplement formulas were used and tested in space by the astronauts of mission STS-125 of May 11, 2009 and the mission STS-127 of July 15, 2009 and are now in use and testing aboard the International Space Station. This marks a milestone in the advancement of a project between AmeriSciences and NASA/JSC to develop nutritional supplements for the astronauts to meet the needs of long-duration spaceflight as well as conditioning here on Earth. Commenced through a Space Act Agreement between AmeriSciences and NASA/JSC back in the fall of 2005, this joint research effort has now progressed to in-flight testing as well as clinical ground studies to determine safety and effectiveness of the resulting formulations. "NASA/JSC has always had to push forward with new technologies to meet the extreme conditions of outer space . . . nutritional supplementation is another one of those areas of technology in which NASA can make a significant contribution to society as a whole while promoting the health of the participants in their space program," comments Lou Gallardo, Chairman of AmeriSciences. "We are proud to be working closely with NASA/JSC on this project and combining all of our expertise to create the best products possible for the astronauts." The years of preparation and research by experts from both AmeriSciences and NASA has led to the use and testing of antioxidant and multivitamin formulations aboard the Space Shuttle and International Space Station. The commencement of use and testing of these formulas on Space Shuttle mission STS-125 was important to said research as this mission to repair the Hubble Space Telescope presented extra physiological challenges. Prolonged Extra-Vehicular Activities (EVAs or "spacewalks") and the high-orbit location of the telescope exposed the astronauts to an increased risk of higher levels of radiation and other medical concerns. "This is just the first step towards preparing for the rigors of long-duration space flight on the human body," explains Gallardo, "the goods news is that the results from this research can impact everyone's health here on Earth." AmeriSciences currently markets versions of the two formulas used on these missions. They are marketed as AmeriSciences Omega Max (an Omega 3 fatty acid supplement) and AmeriSciences Premium Multivitamin.

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Whenever there are interesting articles published which could affect the vision of my patients, I like to let you know.  The following abstract is from The Journal of the American Medical Association.  The article describes increased risks for complications during cataract surgery if you, or your loved one, is taking  tamsulosin (Flomax)for the treatment of benign prostatic hypertrophy(BPH).  If you have taken Flomax in the past, or are taking it now, please make sure to tell your eye surgeon before cataract surgery so that special measures can be taken to minimize the risks of vision loss.  Cataract surgery is safe, but letting your cataract surgeon know beforehand will make it even safer.

Association Between Tamsulosin (Flomax) and Serious Ophthalmic Adverse Events in Older Men Following Cataract Surgery.

 Chaim M. Bell, MD, PhD; Wendy V. Hatch, OD, MSc; Hadas D. Fischer, MD; Geta Cernat, MD, MSc; J. Michael Paterson, MSc; Andrea Gruneir, PhD; Sudeep S. Gill, MD, MSc; Susan E. Bronskill, PhD; Geoffrey M. Anderson, MD, PhD; Paula A. Rochon, MD, MPH

JAMA. 2009;301(19):1991-1996.

Context    Both benign prostatic hyperplasia (BPH) and cataract formation are common in older men. The  -adrenergic receptor blocker tamsulosin is frequently prescribed to treat BPH, and research suggests this drug may increase the intraoperative difficulty of cataract surgery. No studies have documented whether use of tamsulosin or other  -blocker drug therapies affect the risk of serious postoperative adverse events.

Objective    To assess the risk of adverse events following cataract surgery in older men prescribed tamsulosin or other  -blocking drugs used to treat BPH.

Design    Setting, and Patients  Nested case-control analysis of a population-based retrospective cohort study using linked health care databases from Ontario, Canada. We included all men aged 66 years or older who had cataract surgery between 2002 and 2007 (N = 96 128).

Main Outcome Measures     A composite of procedures signifying retinal detachment, lost lens or lens fragment, or endophthalmitis occurring within 14 days after cataract surgery. The risk of these adverse events was compared between men treated with tamsulosin or other  -blockers and men with no exposure to these medications in the year prior to cataract surgery. We separately examined the association of drug exposure that was either recent (within the 14 days before surgery) or previous (15-365 days before surgery).

Results    Overall, 3550 patients (3.7%) in the cohort had recent exposure to tamsulosin and 7426 patients (7.7%) had recent exposure to other  -blockers. Two hundred eighty-four patients (0.3%) had an adverse event. We randomly matched 280 of the cases to 1102 controls according to their age, surgeon, and year of surgery. Adverse events were significantly more common among patients with recent tamsulosin exposure (7.5% vs 2.7%; adjusted odds ratio [OR], 2.33; 95% confidence interval [CI], 1.22-4.43) but were not associated with recent exposure to other  -blockers (7.5% vs 8.0%; adjusted OR, 0.91; 95% CI, 0.54-1.54) or to previous exposure to either tamsulosin ( 1.8% vs 1%; adjusted OR, 0.94; 95% CI, 0.27-3.34) or other  -blockers (2.9% vs 2.1%; adjusted OR, 1.08; 95% CI, 0.47-2.48). This corresponds to an estimated number needed to harm (NNH) of 255 (95% CI, 99-1666).

Conclusions  Exposure to tamsulosin within 14 days of cataract surgery was significantly associated with serious postoperative ophthalmic adverse events. There were no significant associations with exposure to other  -blocker medications used to treat BPH.

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Ocular Surgery News (OSN) has 82,000 readers worldwide with 6 international editions, 210 editorial board members representing 40 countries.  OSN covers over 40 meetings each year worldwide.

Click Here to see Dr. Schneider's most recent article in the April 2009 issue of Ocular Surgery News.

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Role of Nutraceuticals in Managing Ophthalmic Patients

Timothy L. Schneider, M.D.

    The practice of advising patients to use nutritional supplementation in eye care has met with some scrutiny within the medical community. Ample research demonstrates the positive benefits of nutritional supplements, particularly Omega-3 fatty acids, as an adjunct to standard pharmacotherapy in the care and treatment of our patients, particularly those with age-related macular degeneration (AMD) and dry eye syndrome (DES).

     Dietary Omega-3 fatty acids can reduce age-related macular degeneration (AMD) according to a study published in the American Journal of Clinical Nutrition (August 8, 2008). A team of European researchers coordinated by the London School of Hygiene and Tropical Medicine, studied patients with AMD and evaluated dietary intake of fish and Omega-3 fatty acids compared with a control group.  Participants’ intake of the main Omega-3 fatty acids, docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), was obtained by linking collected dietary data with food composition tables.  Findings in this study revealed that individuals who habitually consume oily fish (or who consume 300mg of DHA and EPA daily), were 70% less likely to have wet AMD. A strong inverse association between levels of DHA and EPA was demonstrated. There was no protective effect found from consumption of non-oily white fish. (1) 

       In a study published in the Archives of Ophthalmology (2001), it was concluded that, “higher intake of vegetable, monounsaturated, polyunsaturated fats and linoleic acid (Omega-6 fatty acids)—rather than total fat intake, may be associated with a greater risk for advanced AMD”. Conversely, diets high in Omega-3 fatty acids and fish were inversely associated with risk for AMD when intake of linoleic acid, was low. (2)  The U.S Twin Study of Age-Related Macular Degeneration found that while fish consumption and Omega-3 fatty acid intake reduce the risk of AMD, cigarette smoking increases the risk. (3)

 “A Systematic Review and Meta-Analysis of Dietary Omega-3 Fatty Acid and Fish Intake in the Primary Prevention of Age-Related Macular Degeneration”, (Archives of Ophthalmology,  June, 2008), reviewed nine studies involving 88,974 subjects. It was found that high dietary intake of Omega-3 fatty acids was associated with an overall 38% reduction in the risk of late AMD.  Further, consuming Omega-3’s at least twice weekly was associated with reduced risk of both early and late AMD. (4)

     The Age-Related Eye Disease Study,(AREDS Report #20) found that higher intake of total long chain Omega-3’s and fish were positively linked to decreased likelihood of having neovascular AMD.  Arachidonic Acid (AA) was the only dietary lipid directly associated with neovascular AMD prevalence. Participants getting the most dietary AA through meat, dairy and Omega-6 fatty acids were 56% more likely to have late AMD. (5)  AREDS Report No. 23 recently suggested that Omega-3 fatty acid intake was associated with a decreased risk of the progression from bilateral drusen to central geographic atrophy. (6)

Additional studies suggest that other nutritional factors may play a role in slowing the onset, or limiting the effects of AMD, including AREDS Report #22. This study revealed that high dietary intake of lutein and zeaxanthin were independently associated with a reduced likelihood of having neovascular AMD. Subjects consuming the highest amount of lutein and zeaxanthin were 35% less likely to have neovascular AMD and 55% less likely to have geographic atrophy. (7)

     In 2004, the Lutein Antioxidant Supplementation Trial (LAST Study) found that visual function improved with lutein alone or together with antioxidants, vitamins and minerals in male patients with atrophic AMD. (8)  In another such study, the Carotenoids and Antioxidants in Age-Related Maculopathy Italian Study (CARMIS Study), the influence of short-term carotenoid and antioxidant supplementation on retinal function in non-advanced AMD was studied. Using multi-focal electroretinograms in response to 61 M-stimuli to the central 20 degrees of the visual field, pre-treatment (baseline) conditions were assessed after six and twelve months of supplementation. In non-advanced AMD eyes, a selective dysfunction in the central retina (0-5 degrees) can be improved  by  supplementation with carotenois and antioxidants. (9)

     The Taurine, Omega-3 Fatty Acids, Zinc, Antioxidant, Lutein Study (TOZAL Study) investigated the impact of the listed nutritional supplements on visual function in patients with atrophic AMD. Seventy–six percent of the subjects receiving the nutritional supplement demonstrated stabilization or improvement of BCVA at 6 months. Subjects gained an average of 0.0541 logMAR or one-half line of visual acuity over the 6-month period, with statistically significant improvement in VA from baseline (p=0.045). (10) Although the study period was relatively short, these results align with both the LAST and CARMIS studies, and may predict a positive outcome for the AREDS 2 Trial.  AREDS 2 Trial is currently underway to evaluate in a case-controlled manner, the effects of Omega-3 fatty acids, lutein, and zeaxanthin.

Dry Eye Syndrome

     AMD is not the only ophthalmic disease that may benefit from nutritional supplements.  The Women’s Health Study found a 68% reduction of dry eye syndrome (DES) in women who consumed five to six servings of tuna per week, one of the largest contributors of Omega-3’s in American diets. A high ratio of Omega-6/Omega-3 (n-6/n-3) greater than 15:1 was associated with a greater than two-fold prevalence of DES, suggesting that the ratio of inflammatory Omega-6 fatty acids (n-6) to anti-inflammatory Omega-3 fatty acids (n-3) is important. It appears that the anti-inflammatory effects of Omega-3 fatty acids may play a role in preventing DES. (11)

     Cataract development appears to be altered by nutritional supplementation as well. High dietary levels of lutein and zeaxanthin resulted in a 32% lower prevalence of nuclear cataract compared to lower levels of dietary intake in women studied in the CAREDS study (12) These findings were mirrored in another study assessing dietary intake of 39,876 female health professionals looking at dietary carotenoids, and Vitamins C and E. (13)

How Does It Work?

The etiology of AMD and dry-eye syndrome (DES) appears to be multi-factorial, but inflammation likely plays a major role. Prevention and treatment appear to involve the inflammatory cascade. One of the most potent inhibitors of inflammation is Omega-3 fatty acids. Essential fatty acids are natural modulators of inflammatory activity via their metabolism to eicosanoids, locally acting hormone-like lipids involved in the control of inflammatory and immune responses. Eicosanoids are derived from three fatty-acid precursors: dihomogammalinoleic acid (20:3, n-6 DGLA), arachidonic acid (20:4, n-6 AA), and eicosapentaenoic acid (n-3 EPA).  The modulation of inflammatory activity is based on the balance of these precursors. Omega-3 fatty acids suppress the biosynthesis of arachidonic acid (AA)-derived eicosanoids. Dietary intake determines the balance of Omega-3 fatty acids to Omega-6 fatty acids in cellular membranes (14) High intake of Omega-3 fatty acids results in displacement of the usually more abundant AA, with EPA and DHA. Eicosanoids derived from AA, (prostaglandins E2 and leukotriene B4) are vigorously pro-inflammatory. (11) Arachidonic acid was the only dietary lipid directly associated with neovascular AMD prevalence. (5)  Prostaglandins derived from 3-series and 5-series leukotrienes from EPA are 10 to 100-fold less biologically active. (15). Omega-3 fatty acids also suppress COX-2 and have greater affinity resulting in higher formations of EPA-derived, as compared to AA-derived eicosanoids. When the ratio of n-6/n-3 is 4:1 or lower, there is a competitive inhibition of the conversion of DGLA to AA; resulting in enhanced metabolism of  DGLA to the 1-series prostaglandins including PGE1 which has a number of anti-inflammatory actions. This is also thought to be one of the etiologies of DES (dry eye syndrome). (16)  Similarly, it is also thought that Omega-3 long-chain polyunsaturated fatty acids (LCPUFAs) may exhibit cytoprotective and cytotherapeutic actions contributing to a number of anti-angiogenic and neuroprotective mechanisms within the retina. (17)

          Lutein and Zeaxanthin were found to reduce the likelihood of neovascular AMD, geographic atrophy, and large or extensive drusen in the AREDS Report # 22. Their potent antioxidant properties are concentrated in the ocular tissues of the retina and protect the retina from oxidative stress by absorbing blue light which can cause photochemical damage. It appears that nNOS and COX-2 expression are inhibited by lutein. (18)

What Does This Mean for the Medical Community?

     Nutritional supplements have been the subject of much controversy in the established medical community. An estimated 38 million adults in the United States used dietary supplements or herbal products in 2002. (19) Dietary supplements are big business in the US. Consumer sales in 2006 were estimated at $22.5 billion, with some 60% of Americans taking at least a daily vitamin. (14) Only one-third of these patients told their healthcare providers about their use of vitamins. Many people use vitamins or other nutritional supplements in order to feel better, perform better or look better. This is the foundation of the Wellness Industry.  For many years the AMA deemed the use of vitamins unnecessary, assuming that most Americans received adequate nutrition in their daily food intake. However, in 2002 the AMA reversed its stance, claiming that scientific understanding of vitamins had advanced, and that clearly, nutritional supplements may play a key role in preventing many common illnesses, including cancer, depression, heart disease, osteoporosis, dementia and macular degeneration.

      Despite growing acceptance of the use of nutritional supplementation, some members of the medical community still consider these supplements to be simply a modern form of “snake oil”. Ironically, the Chinese have used snake oil for centuries to treat a multitude of ailments, primarily arthritis. Snake oil was brought to this country in the 1800’s by Chinese laborers who came to build the transcontinental railroad. Richard Kunin, M.D., in his 1989 analysis published in the Western Journal of Medicine, found the Chinese Water Snake oil to contain 20% eicosapentaenoic acid (EPA), one of the two of Omega-3 fatty acids used by our bodies.  The Chinese water snake was found to have the highest concentration of Omega-3 fatty acids of any natural source. (20,26) Thus it appears that the Chinese knew more about health and wellness than was originally believed, and snake oil actually did treat disease, as research is confirming.

    It is estimated that 15% of white women 80 years of age and older, will develop neovascular AMD or geographic atrophy. The number of persons stricken with AMD will increase by nearly 2.95 million by 2020. In 2004, it was estimated that 7.3 million people had early stages of AMD. (21)

Estimated cost of a single Lucentis® (ranibizumab) injection for the treatment of neovascular AMD is in the neighborhood of $1,950.00. Trials showed twelve injections per year to be most effective in improving vision, which totals $23,500.00 per eye per year.(22)  AMD has a profound impact not only on one’s economic position, but also on quality of life. One-third of all patients with AMD were found to have clinical depression secondary to severe reduction in quality of life. (23)   If only a small percentage of the ophthalmic community embraces the findings of the AREDS, CARMIS, TOZAL and LAST studies, and present nutritional supplementation as an adjunct to patient care, hundreds of thousands of patients’ lives may be positively affected. When measuring the risks of taking a product such as TOZAL™ , (AmeriSciences®, Houston, TX) versus developing neovascular AMD, the risk/benefit ratio strongly favors use of such nutritional supplementation. Patients will find a way to use these products, and we as physicians need to direct them to only the highest quality pharmaceutical-grade products with high bioavailability and highest likelihood of success.  It is not enough that we recommend our patients eat fish with their AREDS-formula vitamin. Research from the American Journal of Clinical Nutrition (Aug. 2008), showed that 26 servings of cod were required to equal the EPA and DHA content of twice weekly servings of farm-raised salmon. (500mg EPA + DHA/d) 

Should We Wait Until 2012 For the Results of the AREDS 2 Study?

    Omega-3’s have been suggested to decrease the risk for AMD, dementia, depression, coronary artery disease, arthritis, hyperlipidemia, and even cancer. Unpublished data from the Framingham Heart Study suggest that > 180 mg/d of dietary DHA is associated with a 50% reduction in dementia risk.(24)   Greg M. Cole, a researcher at the University of California, Los Angeles, who sees great promise in using Omega-3 fatty acids to prevent Alzheimer’s disease and other forms of age-related dementia, expresses concern that current clinical trials lack funding to target the most promising patient population—people who have not yet started to show signs of those problems. “The risk of Alzheimer’s doubles with every five years after age 65,” he says, “and we’ve got a generation of 75 million people heading into that. We can’t afford to miss something that might help with prevention just because we couldn’t find the money to study it.” (15,25) 

     An ophthalmology practice with three retina-specialists was recently asked about their treatment of patients with AMD and offered three very different views: The first retina specialist stated that until the results of the AREDS 2 clinical trial are known, he could not recommend additional nutritional supplements besides an AREDS-formula vitamin. His partner stated that he simply advises his AMD patients to take a daily multiple vitamin. The third partner stated that he recommends AREDS-formula vitamins with Omega-3 fatty acids. This retina group runs the gamut of practice patterns with regard to nutritional supplementation, from an AREDS ‘denier’ to Omega-3 ‘embracer’.

     With so much new evidence suggesting that nutritional supplements may play a major role in the prevention and treatment of several ophthalmic diseases, we as physicians must ask ourselves, “What is our role in this industry?  Ophthalmology must become active in the wellness of our patients. The data supporting Omega-3’s for its myriad potential benefit on the eyes, heart, lipid levels, and brain is reason enough to recommend them to our patients. As U.S. healthcare continues to struggle with regard to health-care-delivery systems and reimbursement, the biggest missing piece is that M.D.’s are not playing an active role in wellness and the prevention of disease. Physicians must facilitate patient education and provide them with wise choices regarding products which are safe and highly bio-available. Many physicians have a ‘comfort threshold’ which needs to be reached before prescribing a new medication, therapy or supplement to our patients. That threshold is reached through familiarizing ourselves with current research, discussion with colleagues and personal experience. Risk of treatment must be weighed versus the possible benefit to our patients. Nutritional supplements pose very little risk. Of course, communication with our patients about taking any new medication or supplement is critical to its proper use and adherence. The possible benefit in terms of maintaining independence, preserving vision, health care and personal cost savings, and lightening the burden on family care-givers are positive beyond measure. There will always be skeptics who are wary as to whether it is the physician’s place to suggest or recommend nutritional supplements. As more and more research support nutritional supplementation, NOT recommending them may pose the biggest risk. Omission of this treatment option may not play well into the premise of the Hippocratic oath:  “Do No Harm”.

REFERENCES

(1) Oily fish consumption, dietary docosahexaenoic acid and eicosapentaenoic acid intakes, and associations with neovascular age-related macular degeneration

C Augood, U Chakravarthy, I Young, J Vioque, PTVM ,  Am J Clin Nutr.      August, 2008;88:398-406.

(2) Dietary Fat and Risk for Advanced Age-Related Macular Degeneration,  JM Seddon, B Rosner, RD Sperduto, L Yannuzzi, JA     Arch Ophthalmol. 2001;119:1191-1199.

(3) Cigarette Smoking, Fish Consumption, Omega-3 Fatty Acid Intake, and Associations With Age-Related Macular Degeneration: The US Twin Study of Age-Related Macular Degeneration,   Johanna M. Seddon, MD, ScM; Sarah George, MPH; Bernard Rosner, PhD,   Arch Ophthalmol. 2006; 124:995-1001.

(4) Dietary  OMEGA-3 Fatty Acid and Fish Intake in the Primary Prevention of Age-Related Macular Degeneration,  A Systematic Review and Meta-analysis    Elaine W-T. Chong, MBBS; Andreas J. Kreis, MD; Tien Y. Wong, MBBS, PhD, FRANZCO; Julie A. Simpson, PhD; Robyn H. Guymer, MBBS, PhD, FRANZCO    Arch Ophthalmol. 2008;126(6):826-833.

(5) The relationship of dietary lipid intake and age-related macular degeneration in a case-control study: AREDS Report No. 20.

SanGiovanni JP, Chew EY, Clemons TE, Davis MD, Ferris FL 3rd, Gensler GR, Kurinij N, Lindblad AS, Milton RC, Seddon JM, Sperduto RD; Age-Related Eye Disease Study Research Group. Arch Ophthalmol. 2007 May;125(5):671-9.

(6) The Relationship of Dietary Omega-3 Long-Chain Polyunsaturated Fatty Acid Intake With Incident Age-Related Macular Degeneration, AREDS Report No. 23. Age-Related Eye Disease Study Research Group,  Arch Ophthalmol. Sept. 2008. Vol. 126 (no.9) 1274-1279.

(7) The Relationship of Dietary Carotenoid and Vitamin A, E, and C Intake With Age-Related Macular Degeneration in a Case-Control Study AREDS Report No. 22 Age-Related Eye Disease Study Research Group^*       Arch Ophthalmol. 2007;125(9):1225-1232.

(8) Double-masked, placebo-controlled, randomized trial of lutein and antioxidant supplementation in the intervention of atrophic age-related macular degeneration: the Veterans LAST study (Lutein Antioxidant Supplementation Trial).  Richer S, Stiles W, Statkute L, Pulido J, Frankowski J, Rudy D, Pei K, Tsipursky M, Nyland J.  Optometry
Volume 75, Issue 4, April 2004, Pages 216-229.

(9) Carotenoids and Antioxidants in Age-Related Maculopathy Italian Study, CARMIS study,  V . Parisi , M . Tedeschi , G . Gallinaro , M . Varano , S . Saviano , S . Piermarocchi

Ophthalmology, Feb. 2008 Volume 115 , Issue 2 , Pages 324 - 333.

(10) TOZAL Study: An open case control study of an oral antioxidant and omega-3 supplement for dry AMD,  Francis E Cangemi, BMC Ophthalmology 2007, 7:3.

(11) The relationship between dietary n-3 and n-6 fatty acids and clinically diagnosed dry eye syndrome in women

Biljana Miljanović, Komal A. Trivedi, M. Reza Dana, Jeffery P. Gilbard, Julie E. Buring, and Debra A. Schaumberg

Am J Clin Nutr. 2005 October; 82(4): 887–893.

(12) Associations Between Intermediate Age-Related Macular Degeneration and Lutein and Zeaxanthin in the Carotenoids in Age-Related Eye Disease Study (CAREDS) Ancillary Study of the Women's Health Initiative  Suzen M. Moeller, PhD; Niyati Parekh, PhD; Lesley Tinker, PhD; Cheryl Ritenbaugh, PhD, MPH; Barbara Blodi, MD; Robert B. Wallace, MD; Julie A. Mares, PhD; for the CAREDS Research Study Group . Arch Ophthalmol. 2006;124:1151-1162.

(13) Dietary Carotenoids, Vitamins C and E, and Risk of Cataract in Women   A Prospective Study    William G. Christen, ScD; Simin Liu, MD; Robert J. Glynn, ScD; J. Michael Gaziano, MD; Julie E. Buring, ScD    Arch Ophthalmol. 2008;126(1):102-109.

(14) Getting to Know Nutraceuticals, Thomas Hayden, Scientific American,

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 (15) Immunonutrition: the Role of Omega-3 Fatty Acids.  Alexamnder, JW Nutrition. 1998; 14:627-33.

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(17) The Role of Omega-3 long-chain polyunsaturated fatty acids in health and disease of the retina.  SanGiovanniJP and Chew EY. Prog in Retinal Eye Res 2005. 24:87-138.

(18) Inhibiiton of nNOS and COX-2 Expression by Lutein in Acute Retinal Ischemia.  Choi JS et al.  Nutrition 2006 22:608-71.

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(21) Prevalence of Age-Related Macular Degeneratioin in the United States,  The Eye Disease Prevalence Research Group.  Arch Ophthalmol. 2004 122: 564-573.

(22) Lucentis (ranibizumab) FDA approved new drug for wet macular degeneration,  The Eye Digest, web publication,  University of Illinois Eye and Ear Infirmary,  6/17/2007.

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(24) Potential role of dietary n–3 fatty acids in the prevention of dementia and macular degeneration^: Supplement: n–3 Fatty Acids: Recommendations for Therapeutics and Prevention, Elizabeth J Johnson and Ernst J Schaefer,  American Journal of Clinical Nutrition, Vol. 83, No. 6, S1494-1498S, June 2006

(25) Prevention of Alzheimer's disease: Omega-3 fatty acid and phenolic anti-oxidant interventions .  G . Cole , G . Lim , F . Yang , B . Teter , A . Begum , Q . Ma , M . Harris-White , S . Frautschy  Neurobiology of Aging , Volume 26, Dec. 2005 Issue 1 , Pages 133 - 136

(26) Snake Oil Salesmen Were on to Something:  Snake oil really is a cure for what ails you, if that happens to be arthritis, heart disease or maybe even depression.  Cynthia Graber, Scientific American,  November 1, 2007

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