The DREAM study disappointment
If only it could be as simple as a pill.
Alas, I think that the DREAM study results may have put that dream to bed. And while I'm personally deeply disappointed, at the same time, in my opinion, it's about time we learned something conclusive about whether Omega 3 supplements do, or do not, predictably tend to help people with dry eye. That is, before every last huckster in the industry has one privately labeled.
THE NEWS: The long-awaited results of a very large, extensive, carefully planned and executed, NEI-funded study of Omega 3 supplements and dry eye, called the DREAM study, were finally published today in the New England Journal of Medicine. Drumroll... the benefits were no better than placebo.
THE BACKGROUND: Ever since the Women's Health Study results were published in 2005 drawing a correlation between DIETARY intake of Omega 3/6 and lower dry eye risk, everyone has been promoting, or, even more commonly, formulating or private-labeling and hawking Omega 3 dry eye supplements of every possible description. And why not? After all, they're supposed to be good for health generally and if they can help our dry eye to boot, good. And after all (forgive the cynicism, but...) dry eye patients take a lot of chair time and produce little revenue, the least they can do is shell out for some supplements. The only thing really going against the logic has been the lack of scientific support for the concept. It's not that there haven't been dozens, or maybe hundreds, of studies done on Omega 3 supplements since 2005. In fact, it's quite the opposite. But studies are one thing. Good studies are another. REPEATABLE studies yet another. TFOS DEWS II's Management and Therapy report, which reviewed >10 years worth of such studies, cited a long list of issues preventing the kind of meta-analysis that we would need in order to draw actual conclusions from those studies.
THE STUDY: Multi-center, double-blind clinical trial. A whopping 923 patients were screened. Eligibility was based on a combination of symptoms and clinical signs of dry eye (with the clinical signs tested at two separate visits). These were patients with moderate to severe dry eye despite other treatments. The final analysis included results from 499 patients. They took a daily dose of 3,000 mg of fish oil (2,000 mg EPA, 1,000 mg DHA) or an olive oil placebo for ONE YEAR. Their OSDI (symptom score), conjunctival staining, corneal staining and Schirmer scores and other clinical signs were assessed before, at 6 months, and at 12 months. And in the end? Everybody got better, a bit, in some ways. Including... those taking the placebo.
MY THOUGHTS: I only recently read the TFOS DEWS II conclusions about Omega 3 supplements, and honestly, while it didn't give any good news about the efficacy of supplements, I was so RELIEVED at the inconclusive-cum-politely-disparaging nature of their conclusions. I've watched study after study after study get published over the years, and felt vaguely inadequate to understand any of them in context. When everyone conducts their studies so differently, you can't aggregate and you can't generalize. Who do you believe, especially when they all have pretty small patient cohorts a host of exclusions, a relatively short treatment period and other issues? So it was at least comforting to see a large group of experts come to that conclusion.
But I was still holding out hope that the DREAM study would give us some good news. Heaven knows we could use some.
Alas, it was not to be. The consolation prize is the high confidence level. If something doesn't work, we need to know. To be clear, I don't think this means no Omega 3 supplements help anyone. Rather, I think it proves that the broad-brush conventional wisdom that ALL dry eye patients should take Omega 3 supplements is not necessarily supported by scientific evidence.
SO: Where do the DREAM study results leave us as regards the relationship between Omega 3 and dry eye?
Perhaps exactly where the Women's Health Study left us 13 years ago: DIET.
Though, trust me, you're not going to be seeing ANY randomized double blind studies on THAT in the next 13 years.