This is a new article that was posted on February 7th, 2017 . We published a press release called Eye Vitamins: Helpful or Harmful in March 2016- A simple test can remove the risk- You can find the test here: http://macularisk.com/– we are working diligently to get Medicare to cover this test.- MDA
Re-thinking Antioxidant Supplementation for Macular Degeneration
After the AREDS trial, people with moderate to severe age-related macular degeneration were advised to take dietary supplements to slow the progression of the disease. But some experts say the trial actually showed supplements don’t work, and might even make some patients worse.
by: Harriet Hall
Age-related macular degeneration (AMD) is a leading cause of blindness. Known risk factors include smoking, obesity, hypertension, high intake of vegetable fat, and low dietary intake of antioxidants and zinc. The AREDS (Age-Related Eye Disease Study) trial was designed to test whether supplementation with an antioxidant formula could slow the progression of the disease. In 2001 the results of the trial were published in the Archives of Ophthalmology. They found that a mixture of vitamin C, vitamin E, beta-carotene, zinc, and copper significantly slowed the progression of disease in patients with moderate to severe age-related macular degeneration. It was a large multicenter double-blind study.
There was concern about possible harm from certain ingredients in the original formulation (beta-carotene was associated with lung cancer in smokers, and zinc in high doses was known to cause adverse effects), so a subsequent study, AREDS2, was done. It tested the effects of various changes in the formulation: removing beta-carotene, reducing the amount of zinc, and adding lutein/zeaxanthin or omega-3 fatty acids. The results, published in 2013, found that there was no additional benefit from the changes.
I wrote about AREDS in 2010, with an update on AREDS2 in 2014. I was skeptical then, and I am even more skeptical now that more information has come to light about the trials.
Most clinicians accepted the results of AREDS and recommended that patients with moderate to advanced AMD take a supplement mixture. There was no evidence that patients with mild AMD would benefit, and there was no suggestion that supplements could prevent the disease from developing in the first place. Not everyone followed the actual evidence. Eye vitamin preparations were taken by people who had no evidence-based justification for taking them. And many of the eye vitamins on the market were different from the AREDS mixtures.
A Cochrane review considered the strength of the evidence to be “moderate,” concluding:
People with AMD may experience delay in progression of the disease with antioxidant vitamin and mineral supplementation. This finding is drawn from one large trial conducted in a relatively well-nourished American population. The generalisability of these findings to other populations is not known. Although generally regarded as safe, vitamin supplements may have harmful effects.
Was the AREDS trial actually negative?
Dr. Daniel Seigel accused the AREDS investigators of distorting their findings. He said they promoted a nonsignificant result into a conclusive recommendation. The original study design called for 4 tests, none of which was statistically significant. “One, testing the effect of zinc on progression to advanced AMD, achieved a level of significance defined by the investigators as suggestive.” Essentially, the results were negative. They then restricted their analysis to a sub-group and “featured a combined treatment group which in secondary analysis broke the boundary of statistical significance, thereby disregarding the primary analysis in which neither treatment was significant.” They then made a conclusive recommendation based on these inconclusive findings. Dr. Seigel points out that a negative result would have been more in line with the majority of other studies in which antioxidant supplements have failed to prevent diseases.
In a letter to the editor in the Archives of Ophthalmology, Ambati and Ambati cautioned against “misplaced enthusiasm.” They said the benefit of these supplements is questionable, some of the ingredients may be harmful, and the study’s methodology is flawed. The researchers failed to correct for post hoc analysis. When the proper corrections are made, “The effect of the combination treatment on loss of visual acuity, the only endpoint that truly matters to patients…is even less compelling at a similarly corrected P=.24.”
Another professor of ophthalmology, Cynthia J. Mackay, published a devastating critique on her website She claims that the study results were actually negative, that the researchers went back and changed the research design after the study was completed, that they arbitrarily threw out all patients with mild AMD from the study, and the definition of “success” was changed from “preventing vision loss and progression” to “preventing AMD events.” She said:
The only people who supposedly “benefitted” from this drug are people who have intermediate AMD in one eye, and advanced AMD in the other. No other type of patients had any benefit. Even if a doctor accepts the results of this study, he should only recommend this drug to this small subgroup of patients.
She also pointed out that there were conflicts of interest, that there was no rationale for choosing the particular ingredients in AREDS, that all the ingredients were known to cause serious problems, and that the doses are far above recommended amounts.
The manipulation of the data amounts to what Norbert Kerr, writing in Personality and Social Psychology Review, called “HARKing: Hypothesizing After the Results are Known.”
Conflicts of interest
The AREDS study was funded in part by Bausch + Lomb, and many of the investigators had ties to the company. One of the AREDS study authors, Dr. Ferris, holds a patent for the AREDS formulation with Bausch + Lomb and earns royalties, and he did disclose this conflict of interest in a few published papers; yet in many of the papers he co-authored reporting AREDS data, he neglected to report it….
Read more: https://sciencebasedmedicine.org/re-thinking-antioxidant-supplementation-for-macular-degeneration/
Source: Science-Based Medicine