Omega-3, Antioxidants Ruled Out in Treating AMD,
Leading Cause of Blindness in Elderly
Study clarifies role of supplements, including lutein,
zeaxanthin, in preventing advanced AMD: incurable disease that is
leading cause of blindness in senior citizens
May 6, 2013 - Adding omega-3 fatty acids did not
improve a combination of nutritional supplements commonly recommended
for treating age-related macular degeneration (AMD), a major cause of
vision loss among older Americans, according to a study from the
National Institutes of Health (NIH).
The plant-derived antioxidants lutein and
zeaxanthin also had no overall effect on AMD when added to the
combination; however, they were safer than the related antioxidant
beta-carotene, according to the study published online yesterday in the
Journal of the American Medical Association.
“Millions of older Americans take nutritional
supplements to protect their sight without clear guidance regarding
benefit and risk,” said NEI director Paul A. Sieving, M.D., Ph.D.
“This study clarifies the role of supplements in
helping prevent advanced AMD, an incurable, common, and devastating
disease that robs older people of their sight and independence.”
The AREDS formulation to slow AMD
The Age-Related Eye Disease Study (AREDS), which
was led by NIH’s National Eye Institute and concluded in 2001,
established that daily high doses of vitamins C and E, beta-carotene,
and the minerals zinc and copper — called the AREDS formulation — can
help slow the progression to advanced AMD.
The American Academy of Ophthalmology now
recommends use of the AREDS formulation to reduce the risk of advanced
AMD. However, beta-carotene use has been linked to a heightened risk of
lung cancer in smokers. And there have been concerns that the high zinc
dose in AREDS could cause minor side effects, such as stomach upset, in
In 2006 the NEI launched AREDS2, a five-year study
designed to test whether the original AREDS formulation could be
improved by adding omega-3 fatty acids; adding lutein and zeaxanthin;
removing beta-carotene; or reducing zinc. The study also examined how
different combinations of the supplements performed.
Omega-3 fatty acids are produced by plants,
including algae, and are present in oily fish such as salmon. Lutein and
zeaxanthin are carotenoids, a class of plant-derived vitamins that
includes beta-carotene; both are present in leafy green vegetables and,
when consumed, they accumulate in the retina.
Prior studies had suggested that diets high in
lutein, zeaxanthin, and omega-3 fatty acids protect vision. Before the
AREDS2 study finished, manufacturers began marketing supplements based
on the study design.
In AREDS2, participants took one of four AREDS
formulations daily for five years. The original AREDS included 500
milligrams vitamin C, 400 international units of vitamin E, 15
milligrams beta carotene, 80 milligrams zinc, and two milligrams copper.
Other groups took AREDS with no beta-carotene, AREDS with low zinc (25
milligrams), or AREDS with no beta-carotene and low zinc.
Participants in each AREDS group also took one of
four additional supplements or combinations: These included
lutein/zeaxanthin (10 milligrams/ 2 milligrams), omega-3 fatty acids
(1,000 milligrams), lutein/zeaxanthin and omega-3 fatty acids, or
placebo. Progression to advanced AMD was established by examination of
retina photographs or treatment for advanced AMD.
AMD breaks down cells in the layer of tissue called
the retina in the back of the eye that provide sharp central vision,
which is necessary for tasks such as reading, driving, and recognizing
faces. Advanced AMD can lead to significant vision loss and, in the
United States, is the leading cause of blindness. About 2 million
Americans have advanced AMD; another 8 million are at risk.
In the first AREDS trial, participants with AMD who
took the AREDS formulation were 25 percent less likely to progress to
advanced AMD over the five-year study period, compared with participants
who took a placebo.
In AREDS2, there was no overall additional benefit
from adding omega-3 fatty acids or a 5-to-1 mixture of lutein and
zeaxanthin to the formulation. However, the investigators did find some
benefits when they analyzed two subgroups of participants: those not
given beta-carotene, and those who had very little lutein and zeaxanthin
in their diets.
“When we looked at just those participants in the
study who took an AREDS formulation with lutein and zeaxanthin but no
beta-carotene, their risk of developing advanced AMD over the five years
of the study was reduced by about 18 percent, compared with participants
who took an AREDS formulation with beta-carotene but no lutein or
zeaxanthin,” said Emily Chew, M.D., deputy director of the NEI Division
of Epidemiology and Clinical Applications and the NEI deputy clinical
“Further analysis showed that participants with low
dietary intake of lutein and zeaxanthin at the start of the study, but
who took an AREDS formulation with lutein and zeaxanthin during the
study, were about 25 percent less likely to develop advanced AMD
compared with participants with similar dietary intake who did not take
lutein and zeaxanthin.”
Because carotenoids can compete with each other for
absorption in the body, beta-carotene may have masked the effect of the
lutein and zeaxanthin in the overall analysis, Chew said. Indeed,
participants who took all three nutrients had lower levels of lutein and
zeaxanthin in their blood compared to participants who took lutein and
zeaxanthin without beta-carotene
Removing beta-carotene from the AREDS formulation
did not curb the formulation’s protective effect against developing
advanced AMD, an important finding because several studies have linked
taking high doses of beta-carotene with a higher risk of lung cancer in
smokers. Although smokers were not given a formulation with
beta-carotene in AREDS2, the study showed an association between
beta-carotene and risk of lung cancer among former smokers. About half
of AREDS2 participants were former smokers.
“Removing beta-carotene simplifies things,” said
Wai T. Wong, M.D., Ph.D., chief of the NEI Neuron-Glia Interactions in
Retinal Disease Unit and a co-author of the report. “We have identified
a formulation that should be good for everyone regardless of smoking
status,” he said. Adding omega-3 fatty acids or lowering zinc to the
AREDS formulation also had no effect on AMD progression.
More than 4,000 people, ages 50 to 85 years, who
were at risk for advanced AMD participated in AREDS2 at 82 clinical
sites across the country.
Eye care professionals assess risk of developing
advanced AMD in part by looking for yellow deposits called drusen in the
retina. The appearance of small drusen is a normal part of aging, but
the presence of larger drusen indicates AMD and a risk of associated
Over time, the retina begins to break down in areas
where large drusen are present during a process called geographic
atrophy. AMD can also spur the growth of new blood vessels beneath the
retina, which can leak blood and fluid, resulting in sudden vision loss.
These two forms of AMD are often referred to as dry AMD and wet AMD
Second study looks at AREDS formulas on cataract
In a separate study, published online yesterday in
JAMA Ophthalmology, the AREDS2 Research Group evaluated the
effect of the various AREDS formulas on cataract, a common condition
caused by clouding of the eye’s lens.
Globally, cataract is the most common cause of
blindness and is a major health problem in areas where cataract surgery
is unavailable or unaffordable. About 24.4 million Americans are
directly affected by cataract.
As reported in 2001, the original AREDS formulation
does not protect against cataract. In AREDS2, none of the modified
formulations helped reduce the risk of progression to cataract surgery,
although a subgroup of participants with low dietary lutein and
zeaxanthin gained some protection.
“While a healthy diet promotes good eye health and
general well-being, based on overall AREDS2 data, regular high doses of
antioxidant supplements do not prevent cataract,” Chew said.
Many factors contribute to the development of AMD
and cataract, including genetics, diet, and smoking.
Scientists are unsure how supplements in the AREDS
formulation exert their protective effects. However, an
April 2013 report in the journal
Ophthalmology by the AREDS Research Group shows the
beneficial effects of taking the AREDS vitamins are long-lasting.
The report describes a follow-up study of AREDS
participants. Those who took the AREDS formulation during the initial
five-year trial were 25 to 30 percent less likely to develop advanced
AMD - mostly due to a reduction in the number of neovascular, or wet,
AMD cases - over the next five years, compared with participants who
took placebo during AREDS. Seventy percent of all participants were
taking the original AREDS formula by the end of the follow-up period.
“Long-term use of AREDS supplements appears safe
and protective against advanced AMD,” said Chew. “While zinc is an
important component of the AREDS formulation, based on evidence from
AREDS2 it is unclear how much zinc is necessary. Omega-3 fatty acids and
beta-carotene clearly do not do not reduce the risk of progression to
advanced AMD; however, adding lutein and zeaxanthin in place of
beta-carotene may further improve the formulation.”
The AREDS2 study results provide physicians and
patients with new information about preventing vision loss from AMD.
People over 60 years old should get a dilated eye exam at least once a
year and should discuss with their eye care professional whether taking
AREDS supplements is appropriate.
The research described in this report was supported
by the NEI Intramural Research Program and contracts N01-EY-5-0007,
NOI-EY-0-2127, HHS-N-260-2005-00007-C. Additional research funds were
provided by the National Institute of Neurological Disorders and Stroke;
the National Institute on Aging; the National Heart, Lung, and Blood
Institute; the National Center for Complementary and Alternative
Medicine; and the NIH Office of Dietary Supplements.
The National Eye Institute, part of the National
Institutes of Health, leads the federal government's research on the
visual system and eye diseases. NEI supports basic and clinical science
programs that result in the development of sight-saving treatments. For
more information, visit
About the National Institutes of Health (NIH): NIH,
the nation's medical research agency, includes 27 Institutes and Centers
and is a component of the U.S. Department of Health and Human Services.
NIH is the primary federal agency conducting and supporting basic,
clinical, and translational medical research, and is investigating the
causes, treatments, and cures for both common and rare diseases. For
more information about NIH and its programs, visit
AREDS2 Research Group. “Lutein/Zeaxanthin and
Omega-3 Fatty Acids for Age-Related Macular Degeneration. The
Age-Related Eye Disease Study 2 (AREDS2) Controlled Randomized Clinical
Trial.” JAMA, published online May 5, 2013.
AREDS2 Research Group. “Lutein/Zeaxanthin for the
Treatment of Age-Related Cataract.” JAMA Ophthalmology, published online
May 5, 2013.
Chew et al. “Long-Term Effects of Vitamins C, E, Beta-Carotene and Zinc
on Age-Related Macular Degeneration.” Ophthalmology, published online
April 11, 2013.
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