Mount Sinai research on omega-3 fatty acid supplementation for dry eye

Bottom Line: A clinical trial supported by the National Eye Institute shows that oral omega-3 is no better than placebo in relieving signs and symptoms of dry eye disease.

Results: The mean change in symptom score was similar in the active and placebo supplement groups. There were no significant differences between groups for changes in signs of dry eye disease: conjunctival staining, corneal staining, tear break-up time, and Schirmer test.

Why the Research Is Interesting: Dry eye disease (DED) is a common, chronic condition affecting approximately 14 percent of adults in the United States. It causes ocular discomfort, fatigue, visual disturbances, pain, and irritation, which affect quality of life. When medical care costs are combined with productivity loss, the annual cost of dry eye disease to the United States economy is over $55 billion. Most available treatments do not sufficiently relieve symptoms for the majority of patients, and that's why many clinicians and patients turn to dietary supplements of omega-3 fatty acids (ω3) because of their anti-inflammatory actions and lack of significant side effects. Although there is no definitive evidence for the efficacy of ω3 supplements in relieving signs and symptoms of dry eye disease, the American Academy of Ophthalmology's Preferred Practice Pattern states that ω3 products may be beneficial "though the evidence is insufficient to establish effectiveness." This Dry Eye and Assessment Management Study (DREAM) is the first large-scale real-world, double-masked, randomized clinical trial that studies the long-term efficacy and safety of omega-3 supplementation for symptomatic DED. Results show there are no safety issues linked to this supplement when taken for DED and no serious adverse effects.

Who: 535 patients from 27 ophthalmology and optometry, academic and private practices, throughout the United States

When: October 2014 through September 2017

What: The study measured omega-3 fatty acid supplementation for the treatment of symptoms and signs of dry eye disease.

How: Researchers conducted a multi-center, double-masked, placebo-controlled, randomized clinical trial. The active supplement group received a daily dose of 3,000mg of marine-derived omega-3 fatty acid, 2,000mg eicosapentaenoic acid (EPA), and 1,000mg docosahexaenoic acid (DHA). The placebo group received 5,000mg of olive oil (approximately 1 teaspoon).

Study Conclusions: Despite use of other treatments, patients with moderate to severe dry eye disease randomly assigned to take ω3 or placebo supplements for one year both experienced improvement in mean values for symptoms and signs. However, researchers found no evidence of a beneficial effect of ω3 supplements on the symptoms and signs of dry eye disease relative to placebo supplements.

"DREAM results do not support w3 supplementation for dry eye disease. There is a cost, and the money may be better spent on other treatments for dry eye disease," explains Dr. Asbell.

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Author: Penny Asbell, MD, Study Chair of the NIH-funded Dry Eye Assessment and Management (DREAM) Study; Professor of Ophthalmology at the Icahn School of Medicine at Mount Sinai; Director of the Cornea and Refractive Surgery Service at The Mount Sinai Hospital

About the Mount Sinai Health System

The Mount Sinai Health System is New York City's largest integrated delivery system encompassing seven hospital campuses, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai's vision is to produce the safest care, the highest quality, the highest satisfaction, the best access and the best value of any health system in the nation. The System includes approximately 7,100 primary and specialty care physicians; 10 joint-venture ambulatory surgery centers; more than 140 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. The Icahn School of Medicine is one of 3 medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report's "Best Medical Schools", aligned with a U.S. News & World Report's "Honor Roll" Hospital, No. 13 in the nation for National Institutes of Health funding, and among the top 10 most innovative research institutions as ranked by the journal Nature in its Nature Innovation Index. This reflects a special level of excellence in education, clinical practice, and research. The Mount Sinai Hospital is ranked No. 18 on U.S. News & World Report's "Honor Roll" of top U.S. hospitals; it is one of the nation's top 20 hospitals in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Geriatrics, Nephrology, and Neurology/Neurosurgery, and in the top 50 in four other specialties in the 2017-2018 "Best Hospitals" issue. Mount Sinai's Kravis Children's Hospital also is ranked in six out of ten pediatric specialties by U.S. News & World Report. The New York Eye and Ear Infirmary of Mount Sinai is ranked 12th nationally for Ophthalmology and 50th for Ear, Nose, and Throat, while Mount Sinai Beth Israel, Mount Sinai St. Luke's and Mount Sinai West are ranked regionally. For more information, visit http://www.mountsinai.org/, or find Mount Sinai on Facebook, Twitter and YouTube.

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