quote:

Originally posted by Patriot:

quote:

Originally posted by rduckwor:
Sadly, after the comments above regarding the powdered fruits and veggies, no SIG Forum member would likely admit to taking this supplement. It would have been helpful to hear some personal testimonies regarding the product. Unlikely now.

RMD

They got smacked hard by the FDA back in 2019.

Here is the warning letter. I’d love to see the response which is a requirement. Any company that is issued a warning letter MUST provide a response to each and every statement and if found insufficient, the process continues.

https://www.fda.gov/inspection...ture-580888-08202019

Wow, just read the warning letter. It explains why there are no claims of health benefits on the product now.

quote:

Originally posted by frayedends:
Clinical studies are not clinical trials. Here is an example of clinical trial for this stuff and the conclusions and trial criteria show that the trial was less than successful. If it’s helping you that is great. But buyer beware. There is a reason supplements put the statement about the not meant to treat disease.

https://www.pbm.va.gov/PBM/cli...iteDrugMonograph.pdf

Less than successful? I guess you didn't read the whole paper at your link. I'll paste the relevant parts here:

• Patients at high risk for developing advanced AMD (Categories 3 and 4) reduced their
risk of developing advanced stages of AMD by about 25% when treated with the
combination of antioxidants and zinc (odds ratio = 0.66; 99% CI: 0.47-0.91; p=0.01).
• Patients at high risk for developing advanced AMD who were treated with zinc alone or
antioxidants alone reduced their risk of developing advanced AMD by 21% (significant) and 17% (not significant), respectively.
• The combination of antioxidants and zinc statistically significantly reduced the risk of
visual acuity loss in Categories 3 and 4 AMD (odds ratio = 0.73; 99% CI: 0.54-0.99;
p=0.008) as compared to placebo. Zinc alone and antioxidants alone showed favorable
trends on this measure, but the differences were not statistically significant.
• No statistically significant evidence of a benefit in delaying progression from Category
2 to Categories 3 and 4 was shown in any treatment group

quote:

Originally posted by Flash-LB:

quote:

Originally posted by frayedends:
Clinical studies are not clinical trials. Here is an example of clinical trial for this stuff and the conclusions and trial criteria show that the trial was less than successful. If it’s helping you that is great. But buyer beware. There is a reason supplements put the statement about the not meant to treat disease.

https://www.pbm.va.gov/PBM/cli...iteDrugMonograph.pdf

Less than successful? I guess you didn't read the whole paper at your link. I'll paste the relevant parts here:

• Patients at high risk for developing advanced AMD (Categories 3 and 4) reduced their
risk of developing advanced stages of AMD by about 25% when treated with the
combination of antioxidants and zinc (odds ratio = 0.66; 99% CI: 0.47-0.91; p=0.01).
• Patients at high risk for developing advanced AMD who were treated with zinc alone or
antioxidants alone reduced their risk of developing advanced AMD by 21% (significant) and 17% (not significant), respectively.
• The combination of antioxidants and zinc statistically significantly reduced the risk of
visual acuity loss in Categories 3 and 4 AMD (odds ratio = 0.73; 99% CI: 0.54-0.99;
p=0.008) as compared to placebo. Zinc alone and antioxidants alone showed favorable
trends on this measure, but the differences were not statistically significant.
• No statistically significant evidence of a benefit in delaying progression from Category
2 to Categories 3 and 4 was shown in any treatment group

I do have to correct myself. This clinical trial was not for the supplement you referred to. They only point to this trial as a way to say..."Hey, we have a supplement that has similar ingredients to the stuff studied in this trial."

Add to that a few things. The trial showed tiny improvement in 1 category of AMD. The improvement wasn't much and could not necessarily be tied to the supplement since some trial participants took other supplements during the trial. Some of them didn't take everything they were supposed to take. They did not compare this supplement to other supplements.

At most this trial showed a 25% improvement for Cat 3 and 4. This was only slightly better than zinc alone (21%).

Again, this may actually be helpful. But you have to understand that these companies use a lot of lingo to say thing but ultimately have a legal requirement to admit they have not done the work to get it approved. I would not be surprised if they get dinged by FDA for saying it improves AMD and claiming it is only a supplement. But when I say buyer beware it's because these companies use a lot of word smithing to cover their asses. For instance, PreserVision doesn't say it reduces progression of AMD. It say it contains the stuff that NEI researchers recommended to help reduce the risk of progression.

Apart from that my concerns are, if you read the clinical trial of the antioxcidant and zinc, you see there are a lot of concerns with drug interactions and when and how you take some supplements. These are things people taking "vitamins" may not realize or pay attention to.

Balance of Nature has only an 88% approval rating as a seller on amazon to make it even worse.

I don't buy anything from any seller on amazon unless they have a mid 90s or above rating.