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Nutrition, Vitamins & Supplements for Seniors

Vitamin claims for treating age-related macular degeneration challenged

Research shows that of 11 popular supplements analyzed all have misleading claims

photos showing before and after effects of age-related macular degenerationDec. 9, 2014 - Americans spend billions of dollars each year on nutritional supplements. And, for senior citizens with aging eyes, purchasing eye vitamins that claim to help protect vision is an attractive proposition. Unfortunately, a new study finds these claims for most products from the top-selling brands don't match the scientific evidence, especially for treating the leading cause of blindness among older adults, age-related macular degeneration (AMD).

The study published online in Ophthalmology, the journal of the American Academy of Ophthalmology, looked at 11 of the top-selling ocular nutritional supplement products and analyzed their content. They found that only four of the 11 had equivalent ingredients and dosages of the formulas proven effective in slowing the progression of a common eye disease in clinical trials.

In addition, while all 11 products studied claimed to “support,” “protect,” “help” or “promote” vision and eye health on their packaging, none of them specified that there is scientific proof that vitamins can be used in the primary prevention of eye disease.

Age-related macular degeneration (AMD) is the deterioration of the eye's macula, which is the central part of the retina that enables the eye to see fine details clearly. Recommended treatment for AMD at certain stages of the disease includes nutritional supplements.

The landmark Age-Related Eye Disease Study (AREDS) found in 2001 that a specific formula of nutritional supplements containing high doses of antioxidants and zinc could slow the worsening of AMD in those who have intermediate AMD and those with advanced AMD in only one eye.

A follow-up study that concluded in 2011, AREDS2, determined that the formula was still effective if one ingredient, beta-carotene (a form of vitamin A), was replaced with related nutrients, lutein and zeaxanthin. Beta-carotene was substituted in AREDS2 due to its link to increased risk of lung cancer in smokers.

 The two studies prompted a surge in sales of eye supplements which are marketed as containing the AREDS or AREDS2 formulas.

In reality, only a specific formula of nutritional supplements (the AREDS  and AREDS2 formulas) has been proven effective in slowing the progression of age-related macular degeneration (AMD) and only in those who had already been diagnosed with intermediate or advanced AMD.

To test whether the products are consistent with the studies’ findings, researchers compared the ingredients in top-selling brands to the exact formulas proven effective by AREDS and AREDS2. The researchers – based at Yale-New Haven Hospital-Waterbury Hospital, Penn State College of Medicine, Providence VA Medical Center and Warren Alpert Medical School of Brown University – identified the five top-selling brands based on market research collected from June 2011 to June 2012, and analyzed the brands’ 11 products.

They found that, while all of the products studied contained the ingredients from the AREDS or AREDS2 formulas:

  ● Only four of the products had equivalent doses of AREDS or AREDS2 ingredients

  ● Another four of the products contained lower doses of all the AREDS or AREDS2 ingredients

  ● Four of the products also included additional vitamins, minerals and herbal extracts that are not part of the AREDS or AREDS2 formulas

 

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In addition, while all 11 of the products’ promotional materials contained claims that the supplements “support,” “protect,” “help” or “promote” vision and eye health, none had statements specifying that nutritional supplements have only been proven effective in people with specific stages of AMD.

There were also no statements clarifying that currently there is not sufficient evidence to support the routine use of nutritional supplements for primary prevention of eye diseases such as AMD and cataracts.

“With so many vitamins out there claiming to support eye health, it’s very easy for patients to be misled into buying supplements that may not bring about the desired results,” said first author Jennifer J. Yong, M.D.

“Our findings underscore the importance of ophthalmologists educating patients that they should only take the proven combination of nutrients and doses for AMD according to guidelines established by AREDS and AREDS2.

It’s also crucial that physicians remind patients that, at this time, vitamins have yet to be proven clinically effective in  preventing the onset of eye diseases such as cataracts and AMD.”

>> The results table in pdf format of the analyzed

>> More information about AMD and AREDS supplements  

Recommendations from American Academy of Ophthalmology

The American Academy of Ophthalmology recommends ophthalmologists consider antioxidant vitamin and mineral supplementation, per the AREDS and AREDS2 trials, for patients with intermediate or advanced AMD. It also maintains that, based on the six-year timeframe of the AREDS trial, there is no evidence to support the use of these supplements for patients who have less than intermediate AMD. Ophthalmologists can read the Academy’s AMD Preferred Practice Pattern guidelines at http://bit.ly/aaoamdppp.

Dietary supplements are neither evaluated nor regulated for efficacy or safety under the Dietary Supplement Health and Education Act (DSHEA) of 1994.

In addition, FDA approval is not required for dietary supplements to be marketed.

Notable in-press studies recently published online in Ophthalmology include:

  ● Genetic Testing in Persons with Age-Related Macular Degeneration and the Use of the AREDS Supplements: To Test Or Not to Test?: The controversy surrounding the use of genetic testing to guide the treatment of persons with AMD continues. This report provides the context of genetic testing for patients with AMD and reasons why it is not recommended.

  ● Long-term Effects of Therapy with Ranibizumab on Diabetic Retinopathy Severity and Baseline Risk Factors for Worsening Retinopathy: This exploratory analysis found that when intravitreal ranibizumab is administered for up to three years, it can both improve severity of diabetic retinopathy and prevent its worsening.

It also found that prolonged delays in initiation may limit the therapeutic effect and that, although uncommon, development of proliferative diabetic retinopathy still occurs in some eyes undergoing anti-VEGF therapy. This effect may be related to the presence of macular nonprofusion. 


About the American Academy of Ophthalmology
The American Academy of Ophthalmology, headquartered in San Francisco, is the world's largest association of eye physicians and surgeons, serving more than 32,000 members worldwide. The Academy's mission is to advance the lifelong learning and professional interests of ophthalmologists to ensure that the public can obtain the best possible eye care. For more information, visit www.aao.org. 

The Academy is also a leading provider of eye care information to the public. The Academy's EyeSmart program educates the public about the importance of eye health and empowers them to preserve healthy vision. EyeSmart provides the most trusted and medically accurate information about eye diseases, conditions and injuries. OjosSanos™ is the Spanish-language version of the program. Visit www.geteyesmart.org or www.ojossanos.org to learn more.

About Ophthalmology
Ophthalmology, the official journal of the American Academy of Ophthalmology, publishes original, peer-reviewed, clinically-applicable research. Topics include the results of clinical trials, new diagnostic and surgical techniques, treatment methods, technology assessments, translational science reviews and editorials. For more information, visit www.aaojournal.org.

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