Nutritional Wellness Blog from BeautifulandWell.com

Recent studies conclude that increased intakes of omega-3 fatty acids may prevent age-related vision loss, otherwise known as age-related macular degeneration (AMD), the leading cause of blindness in people aged 55 and older.

What is age-related macular degeneration (AMD)?

According to AMD Alliance International, a global coalition of vision and seniors’ organizations dedicated to raising awareness of AMD and the options available for prevention, early detection, treatment, rehabilitation and support services to individuals and families around the world affected by AMD, AMD  is a degenerative retinal disease that causes central vision loss and leaves only peripheral vision which qualifies as “legal blindness” in the Western world.  Although approximately 30 million people are affected by AMD globally, awareness of the condition is low.  Moreover, due to the aging population of Baby Boomers, the incidence and prevalence of AMD is expected to be on the rise and may triple by 2025.

Two types of AMD exist- dry and wet.  Dry AMD, on the other hand, occurs when normal tissue in the macula disappears slowly resulting in a pale area of the macular called central geographic atrophy (a medical term for dryness).  Wet AMD occurs when blood vessels grow abnormally beneath the macular and eventually leak causing scarring to the macular, thereby obscuring sight.

Studies support increase intake of omgea-3 to prevent AMD

According to the US National Eye Institute, increased consumption of omega-3 fatty-acids contribute to the prevention of age-related vision loss by up to 30%.  In another major study, the Age-Related Eye Disease Study (AREDS), omega-3 intake supports the prevention of AMD by 30%.  Moreover, according to findings published online in the American Journal of Clinical Nutrition, the risk of both dry AMD and wet AMD are reduced through the intake of omega-3 fatty acids by 32% and 35% respectively.

Omega-3’ eye health benefits

Omega-3 fatty acids, and in particular DHA, play an important role in the layer of nerve cells in the retina, and studies have already reported that omega-3 may protect from developing AMD.

Indeed, a meta-analysis published in the June 2008 issue of the Archives of Ophthalmology found that a high intake of omega-3 fatty acids may reduce the risk of AMD by up to 38 per cent.

The new study supports these earlier findings. SanGiovanni and his co-workers looked at  1,837 people participating in an Age-Related Eye Disease Study. All the participants were considered to be at a moderate-to-high risk of advanced AMD.

Based on 12 years of research, the scientist found out that the participants with the highest omega-3 intakes had a 30 percent lower risk of developing AMD than people with the lowest intakes.

“The 12-year incidence of central geographic atrophy and neovascular AMD in participants at moderate-to-high-risk of these outcomes was lowest for those reporting the highest consumption of omega-3 fatty acids,” concluded the researchers.

Educating ourselves about how to protect our eye sight and decrease the risk of vision loss should be a priority.  Taking a good nutritional supplement, especially one that can help to slow macular degeneration, is a good insurance policy.  One such high quality nutritional supplement specifically formulated to protect eyes and lower the risk for AMD is TOZAL Eye Health Formula make by AmeriSciences.  TOZAL contains a high percentage of Omega 3, as well as Lutein & Zeaxanthin, which all promote vision health. To learn more about TOZAL or to purchase TOZAL from a reputable AmeriSciences distributor, click here.

by Edward L. Paul, Jr., O.D., Ph.D.

Since 2001 the accepted standard of care in treating dry Age-Related Macular Degeneration (AMD) has consisted of recommending an AREDS based nutritional supplement. Clinicians may change that recommendation with the publication of the landmark TOZAL Study which was published in the February issue of the British journal BMC Ophthalmology. The TOZAL Study incorporated taurine, omega-3 fatty acids, zinc, antioxidants and lutein. With the exception of taurine, this formulation is very similar to the AREDS II formulation that is in the first year of a six-year trial. The TOZAL Study design had as a primary objective the measurement of change of Visual Acuity (VA) as measured with the ETDRS charts in subjects with intermediate dry AMD who were treated with this novel nutritional supplement. The range of best-corrected VA at baseline was 20/32-20/125, the same range of VA used in the MIRA-1 study (the MIRA-1 study was used as a “distant” control group). The study contrasted VA at baseline to VA measured under the same conditions at 6 months. Based upon other studies, it is well acknowledged that VA in a group of subjects with intermediate AMD decreases over a 6-month period and the decrease has been demonstrated to be about 1.5 lines.

Remarkably, the 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 (0.0541 logMAR). In contrast to the well known natural course of AMD that demonstrates deterioration, nearly 77% treated with the nutritional supplement improved or stayed the same and only about 23% worsened (but no worse than placebo). Hence, the TOZAL supplement formula alone in this study has altered the natural course of the progression of intermediate AMD. It is well known that the original AREDS study demonstrated that nutritional supplements reduced the progression in the treated group when compared to the placebo group by about 25% but the subjects still demonstrated progression of the disease process and lost visual acuity. The AREDS II is now underway but the results will not be available for approximately 5 years. Since the TOZAL formulation is very similar (but not identical) to the AREDS II formulation, the TOZAL results predict the eventual positive AREDS II results. Conservative clinicians may choose to wait another 5 or so years for the AREDS II results to be announced before recommending TOZAL or similar nutritional supplements. Alternatively, many less conservative clinicians may choose to treat their patients with intermediate AMD with the TOZAL formula at the present time in order to provide the additional 5 or so years of protection and perhaps even result in VA improvement in as little as 6 months.

Recent literature has also indicated that higher intake of omega-3 fatty acids is associated with decreased likelihood of having wet AMD. Omega-3 fatty acids appear to influence processes involved in the development of neovascularization – specifically DHA may protect the retina by influencing which genes turn on and off, while fatty acids overall may eventually form compounds that promote cell survival and proper blood vessel function, reduce inflammation and maintain energy balance. Considering the cost of the recommended two-year course of monthly injections of Lucentis reaches nearly $50,000, TOZAL vitamin therapy for AMD not only makes sense, but improves quality of life at a reasonable cost. While the TOZAL Study specifically looked at the supplement’s influence on AMD, a growing body of evidence suggests that supplements containing antioxidants, lutein, and omega-3 fatty acids may reduce the risk and positively impact other eye diseases such as dry eye syndrome, cataracts, and glaucoma.

In summary, the TOZAL Study has demonstrated statistical and clinical significance of VA improvement and/or stability for subjects with intermediate AMD who were treated with the TOZAL formulation. Furthermore, omega-3 fatty acids appear to reduce the likelihood of a patient advancing to wet AMD. These findings predict that the results of the much larger AREDS II study, to be available in approximately 5 years, will yield similar positive effects.

Source: AmeriSciences.com

Press Release

HOUSTON, Sept. 18 /PRNewswire/ — AmeriSciences, a leading developer of science-based nutritional supplements, is poised to revolutionize the way eye-care practitioners treat age-related visual deterioration with the launch of its clinically-proven TOZAL Eye Health Formula. Research indicates that by 2030, as many as 68 million Americans will be over the age of 65, and a significant number of these older Americans will suffer from low vision or blindness.

Since 2001, the eye-care industry’s standard of care for patients suffering from age-related vision loss has been nutritional supplements based on the Age-Related Eye Disease Study (AREDS). While AREDS provided clinical proof that nutritional supplements can positively affect a degenerative health issue, scientific discoveries over the last seven years have revealed other micronutrients that are more effective in maintaining and supporting good health and vision. Among these beneficial compounds are taurine, omega-3 fatty acids, zinc, antioxidants and lutein, which are the main ingredients in the TOZAL Eye Health Formula.

“TOZAL exemplifies AmeriSciences’ commitment to providing the safest, most effective science-based nutritional products on the market today,” said Carlos Montesinos, Product Development & Quality Assurance Director, AmeriSciences. “We believe that TOZAL will set a new standard of care for nutrition-based eye care. Like all of our products, TOZAL also meets or exceeds pharmaceutical industry quality benchmarks for over-the-counter products.”

Two years ago, TOZAL became the focus of a multicenter study that ultimately demonstrated through clinical testing how the proper combination of these compounds was effective at reducing the onset of age-related visual impairment after six months of consistent supplementation. The results of this study, which were published in the February 2007 issue of BMC Ophthalmology, a peer-reviewed, open-access journal, affirmed that regular use of the TOZAL formula impeded the natural course of visual degeneration in 77 percent of the treated test subjects. Evidence from the TOZAL study also indicated that visual acuity actually improved by as much as one-half line (eye chart) among 57 percent of those tested. All patients receiving the AREDS-type nutritional supplement lost some vision.

A large new study, published in August in The American Journal of Clinical Nutrition, also supports the use of TOZAL in preventing vision loss. The study, which took place across seven European nations, found that seniors given omega-3 fatty acids reduced their risk of developing macular degeneration by up to 70 percent. TOZAL is the only eye-health supplement that includes omega-3 acids.

“The TOZAL study demonstrates that treatment with this supplement can help patients with age-related vision loss,” said Francis E. Cangemi, M.D., a macular degeneration specialist affiliated with Vitreo-Retinal Associates of New Jersey who led the TOZAL study.

As a result of the landmark TOZAL study, AmeriSciences collaborated with TOZAL developer and prominent optometrist Dr. Edward Paul to create the only nutritional supplement on the market based on his patented formula. TOZAL Eye Health Formula was released in February exclusively through independent distributors of AmeriSciences nutritional products with incredible response from consumers and vision-care specialists alike.

“I grew tired of telling my patients with age-related vision loss that there was nothing I could do for them,” said Dr. Paul about developing his breakthrough TOZAL formula. As a highly-respected optometrist and nutritionist, Dr. Paul has been in private practice in Wilmington, North Carolina, for more than 20 years helping people to see better and live healthier lives through a combination of traditional and complementary medicine.

“I think that because of AREDS, the eye-care industry was the first in the health field to really embrace nutritional supplementation as a way of helping patients with age-related health issues,” Dr. Paul said. “But now we have something better and more effective with TOZAL. We would be remiss if we did not give our patients the option of using these supplements given the statistical and clinical proof that TOZAL can help them.”

In addition to his research and eye-care practice, Dr. Paul is the author of several books, including “Conquering Macular Degeneration” and “101 Great Ways to Improve Your Health.” An authority on the subject of age-related vision impairments, Dr. Paul also serves as a contributing writer for several national medical magazines and is a frequent guest on national television and radio programs. Dr. Paul is a member of the AmeriSciences Scientific Advisory Board.

A specially-packaged combination of two premium nutritional products- AmeriSciences Antioxidant Plus and AmeriSciences Omega Max-TOZAL Eye Health Formula has been hailed by health-care professionals from across the United States as a product that is destined to revolutionize the eye-care industry.

AmeriSciences is headquartered in Houston, Texas.

For more information on AmeriSciences’ new TOZAL Eye Health Formula, visit www.tozalformula.com or www.amerisciences.com.

Source: http://biz.yahoo.com/prnews/080918/neth047.html?.v=70

Multicenter study finds unique combination of micronutrients superior to current ‘AREDS’ standard of care; Results supported by new omega-3 study

HOUSTON, Texas– A landmark study at five university-based research centers found that TOZAL(R), a patented combination of antioxidants and micronutrients, enabled patients with “dry” maculardegeneration to improve their vision. Patients in the study’s placebo arm, who received the “AREDS-type” nutritional formulation (the current standard of care), continued to lose their eyesight. Results of the TOZAL study are supported by a major new study, which shows that omega-3 acids cut the risk of developing “wet” macular degeneration.

“The TOZAL study demonstrates that treatment with this supplement can help patients with age-related vision loss,” said lead investigator Francis E. Cangemi, M.D., a macular degeneration specialist affiliated with Vitreo-Retinal Associates of New Jersey.

At six months, 57 percent of those in the TOZAL treatment group improved an average of one-half eye-chart line of visual acuity, and 20 percent stayed the same. All patients in the placebo (AREDS-type nutritional supplement) arm lost visual acuity, with an average loss of 1.49 lines at the end of six months. The treatment group continued to show improvement over time, while most in the placebo group continued to lose visual acuity over time. The study was published in the February 2007 issue of BMC Ophthalmology, a peer-reviewed open-access medical journal.

Age-related macular degeneration is a progressive disorder associated with central vision loss and is the leading cause of visual impairment and blindness in people over age 60. More than 15 million Americans have macular degeneration, and an additional 50 million are at risk. Ninety percent of those with macular degeneration have the atrophic or “dry” form of the disease.

Although there is no cure for macular degeneration, the accepted standard of care since 2001 has been the use of nutritional supplements based on the federally funded Age-Related Eye Disease Study (AREDS). Further studies have suggested that the AREDS formulation is not optimal and clinical trials of a new formulation — dubbed “AREDS II” — are now underway. TOZAL’s ingredients are similar to those in AREDS II, with some additional components. TOZAL is made from taurine, omega-3 fatty acids, zinc, antioxidants and lutein.

While the TOZAL study shows how a combination of nutritional components can arrest macular degeneration, a study published in an August 8 issue of The American Journal of Clinical Nutrition demonstrates that one critical ingredient in the TOZAL formulation — omega-3 fatty acids — can significantly reduce the risk of developing the disease. In a large population-based study in seven European countries, researchers found that seniors who had higher intakes of omega-3 docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) had far lower risks of developing wet macular degeneration. Those in the top 25 percent of DHA and EPA levels — 300 milligrams a day and above — reduced their risk by 70 percent. TOZAL is the only currently available eye-health formulation that contains these acids.

“While the AREDS II study will not be completed for five years, both of these studies demonstrate the value of trying this new nutritional approach right now to stave off five years of age-related vision loss,” said Dr. Cangemi.

Dr. Cangemi enrolled 75 elderly patients in the TOZAL study who had at least one of their eyes diagnosed with dry macular degeneration. Study sites included New York Eye and Ear Infirmary, Ohio State University, University of California, Irvine and University of Texas, Austin. All patients were treated with the TOZAL formulation for six months.

Study participants saw the researchers during five visits over the six months, during which they repeatedly received a battery of eye tests. Participants were instructed to take TOZAL three times a day and to maintain a log, which was checked by researchers on each visit. The primary objective of the study was to measure change in visual acuity, while a secondary objective was to find improved macular function as measured by these tests.

“We saw significant improvements in visual acuity, but did not see demonstrated improvements in function,” said Dr. Cangemi. “This is likely due to the short duration of the study.”

The study’s Institutional Review Board determined that all patients must receive the standard of care, so no true placebo arm was permitted. Instead, Dr. Cangemi used a widely accepted placebo protocol and constructed comparisons with placebo data from the “MIRA-1″ study, which followed the same inclusion and exclusion criteria as TOZAL. All patients in the MIRA study — including those in the placebo arm — received AREDS supplements.

Patients in the TOZAL study were initially divided into two groups: those receiving TOZAL plus electrical microcurrent stimulation (MCS) and those receiving TOZAL and sham MCS. MCS was abandoned early in the study. Reported results are based on the arm of the study in which 37 patients received TOZAL and sham MCS.

TOZAL was developed by Edward L. Paul, O.D., Ph.D., an optometrist and nutritionist who is an authority on nutrition and vision loss. Dr. Paul has licensed the TOZAL formulation to AmeriSciences, a leading developer of science-based nutritional supplements that is based in Houston. He serves on the AmeriSciences Scientific Advisory Board.

Dr. Cangemi received funding for the study and manuscript preparation from Atlantic Medical, Inc., a company that holds patent rights to TOZAL.

Source: PRNewswire / Atlantic Medical, Inc.

PR Contact: Rexy Legaspi of Widmeyer Communications, +1-646-213-7245, rexy.legaspi@widmeyer.com

Francis E Cangemi

Vitreo-Retinal Associates of New Jersey, 119 Prospect Street, Ridgewood, New Jersey 07450 USA

BMC Ophthalmology 2007, 7:3doi:10.1186/1471-2415-7-3

Received: 6 November 2006
Accepted: 26 February 2007
Published: 26 February 2007

Abstract

Background

The primary objective of this prospective study was to measure the change from baseline in visual function – Best-Corrected Visual Acuity (BCVA) via the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, contrast sensitivity, central 10 degree visual fields and retinal imaging (angiograms and photographs) at 6 months in subjects with atrophic (dry) age-related macular degeneration treated with a targeted nutritional supplement.

Methods

37 mixed gender patients with a mean age of 76.3 +/- 7.8 years were enrolled at 5 independent study sites and received standard of care with a novel formulation of a nutritional supplement. Results were compared to a placebo cohort constructed from the literature that was matched for inclusion and exclusion criteria. A paired t-test was used to test a null hypothesis and a two-sided alpha level of 0.05 was used to determine statistical significance.

Results

76.7% of 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 of a line of visual acuity (VA) over the 6-month period. There was a statistically significant improvement in VA from baseline with P = .045. The results provide strong evidence that the treatment being studied produces an improvement in VA.

Conclusion

Treatment with this unique nutritional supplement increased VA above the expected baseline decrease in the majority of patients in this population with dry macular degeneration. The results of the TOZAL study agree with the LAST and CARMIS studies and are predictive for positive visual acuity outcomes in the AREDS II trial. However, patients will likely require supplementation for longer than 6 months to effect changes in additional visual parameters.

The full-text electronic version of this article can be found online at: http://www.biomedcentral.com/content/pdf/1471-2415-7-3.pdf

© 2007 Cangemi; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.