Just as with AREDS, I believe AREDS 2 has a multitude of problems. Instead of studying just one or two variables the study has as many as six. Then it is stated over and over again within the abstract, methods and results that there is no true placebo group. Why not simplify the project so it includes an absolute placebo or control group?
Science at one time would not accept any one study as definitive proof. Proof became part of the landscape as knowledge evolved over a period of time and effort. Yet, for example, the federal government adopted policy around the results of the original AREDS a study with fragile results at best, and it was only one study concerning the matter.
Let’s take a look at AREDS 2. This is an extension of the original Age Related Eye Disease Study or AREDS. It’s objective is stated as, “To determine whether adding lutein & zeaxanthin , omega-3s or both to the AREDS formulation decreases the risk of developing advanced AMD and to evaluate the effect of eliminating beta carotene, lowering zinc doses or both in the AREDS formulation.”
Comparisons with the placebo demonstrated no statistically significant reductions in progression to advanced AMD with the lutein and zeaxanthin, the omega-3, or both the L/Z and omega-3 groups. Further the study shows that lowering zinc and eliminating beta carotene provided no statistical effect on progression of advanced AMD. If there is no statistical increase in the rate of progression of AMD by eliminating beta carotene, substituting L/Z for beta carotene, or reducing zinc isn’t that saying the original AREDS may not be valid at all? Or, is the study made so confusing by the lack of a true placebo group that the average academic reader is confused about the true outcome?