Surprise, surprise!
The AREDs committee just published a report in the Archives of Ophthalmology that suggested the ARED study participants who reported the highest intake of lutein/zeaxanthin were statistically less likely to have advanced AMD or large extensive intermediate drusen than those reporting lowest dietary intake.
Does anyone else wonder why the same committee fought so hard to prevent lutein and zeaxanthin from being included in the AREDs2 study?
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51 comments:
I like how you question these studies. You make us aware of things we would never have known about. Thanks for keeping us updated. Also thanks for the wonderful product. My doctor has noticed a difference in my eyes. Keep up the great work!
Two more questions:
1) Given this information, how must the AMD patient feel who has repeatedly been told by his or her retina specialist that science does not support supplementing with lutein and zeaxanthin - even those a large number of small studies have clearly shown the benefits of xanthophyll supplemention for anyone at risk of, or diagnosed with, AMD.
2) And given this information: How does a doctor justify asking his or her advanced AMD patients to participate in a masked nutrient study that will have over 2000 AMD patients taking a daily supplement for four or five years that does not include lutein and zeaxanthin?
I thought the AREDs2 study was going to include lutein and Zeaxanthin?
Here are the AREDs2 study formulations:
1) - Placebo
2) - 10 mg lutein/2mg zeaxanthin
3) - 1 gm EPA/DHA from Salmon Oil
4 - 10 mg lutein, 2 mg zeaxanthin, 1 gm EPA/DHA
The study participants are all being offered the original AREDS formulation.
Those who agree to take the AREDS formulation and consent to yet a third randomization will be randomized to receive one of the four alternatives:
1) 500 mg vitamin C, 400 IU vitamin E, 25,000 IU beta-carotene, 80 mg zinc oxide and 2 mg of copper (original ARED formulation now called the "Standard of Care" by some.
2) 500 mg vitamin C, 400 IU vitamin E, no beta-carotene, 80 mg zinc oxide, 2 mg copper.
3) 500 mg vitamin C 400 IU vitamin E, no beta-carotene, 25 mg of zinc, and 2 mg of copper,
4) 500 mg vitamin C, 400 IU vitamin E, 25,000 IU beta-carotene, 25 mg zinc oxide, 2 mg copper.
The study committee also elected to provide Centrum Silver to all study participants who WANT to take a multiple in addition to 8 masked study formulations.
Is it any wonder that no one is taking this totally confusing study seriously?
Addendum: Any way you look at it, half or more of the diagnosed AMD study participants will not be receiving lutein and zeaxanthin in the formulation they are agreeing to take for five years.
Would you want your Mother involved in this study?
There is a lack of morality in government sponsored clinical studies designed to protect industry and investigator reputation over actual loss of vision from AMD.
Based on the amount of peer-reviewed published information on the AMD link to inflammation, mitochrondia health and genome science, a large number of nutrients vital to the prevention or management of AMD were obviously left out of the study formulations, and the amount of xanthophyll carotenoids included cannot possibly be considered therapeutic.
I don't know who the objector is, but I must point out that the AREDS research group members have brilliant credentials that I do not question.
Did anyone bother to point out to the ARED research group that the cute new Centrum Silver includes hydrogenated palm oil (trans fats) medium chain triglycerides, and red, blue and yellow dye?
And no I would not want my Mother taking Centrum Silver because the hard pressed pills rarely disolve in older stomachs, and the new Centrum Silver chewables include Sorbitos, Aspartame (increased risk of cancer at very low levels), the red, blue and yellow dyes, and hydrogenated soybean oil (again trans fats).
The government sponsored AREDs2 study is disturbing on many levels; one being the results are likely to be considered category one evidence-based medicine.
Those of us who attended many of the AREDs2 research committee meetings understand this study is more about politics than nutrition science, but it's what we have to work with so let's be supportive.
This is very much needed information. I sure wonuldn't want anyone in my family period involved in such a study.
After reading the list of possible randomized formulations the AREDs2 study participants will be given, one would hope for #4 in the top group and #3 in the bottom.
What a shame it would be to find out you wasted five years of precious sight on #1 in the top group (placebo) and #1 in the bottom group (excessive beta carotene and zinc).
How will the government (NEI)compensate study participants who experience vision loss because they were randomized to the placebo group?
Troubling Friday Pearl, but how dare this blog question the integrity of the NEI and the AREDs2 research committee!
"Learn from yesterday, live for today, hope for tomorrow. The important thing is not to stop questioning." Albert Einstein
As risky as it is to be involved in these studies, we need them. We need people to take these risks to prove what we may know is true to the rest of the public.
At least that's what I believe.
Many consumers of nutritional supplements do not realize that there is an impending danger to their Right to take nutritional supplements, including lutein and zeaxanthin. Codex Alimentarius, or 'Codex' for short, a part of the Central American Free Trade Agreement, CAFTA, could result in an international body, the World Trade Center (WTC), restricting or banning the personal use of nutritional supplements in order to ‘harmonize’ U.S. law to international standards. Supplement use is severely restricted in many European countries. To prevent this from happening here, consider supporting Dr. Ron Paul for the presidency of the US. Ron Paul understands that individuals have rights and, as a Congressman, has introduced legislation to protect people's right to take nutritional supplements. Check it out at http://www.ronpaul2008.com/
Ashley,
Do we really need a placebo arm for the AREDs2 study, and would you want your Mother to take that risk, knowing the disease progression can be slowed with full-spectrum nutrition, as suggested in the LAST and Phototrop study results.
The pharmaceutical gold standard for nutraceutical clinical research is rarely appropriate for nutrition research since nutrients are not presented as stand-alone substances in food.
Karen, you asked a good question. The original ARED study had a placebo arm, which proved that those folks who take no supplements have more disease progression than those who don't.
Why would we want to put that many AMD patients at that kind of risk?
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