According to JAMA, the meta-analysis did not show that omega-3s had any significant connection to fatal or non-fatal cardiovascular events. The study concluded there was no support for the use of Omega-3 supplements for people with a history of heart disease.
Shortly after JAMA’s meta-analysis was issued, the Natural Products Association (NPA) responded, saying that the U.S. Food and Drug Administration (FDA) does not agree with the conclusion of the study.
The FDA has approved a qualified health claim on Omega-3s for cardiovascular disease and has already approved prescription medication for fish oil, noted Dr. Daniel Fabricant, president and CEO of the NPA. "We continue to believe in the strong body of evidence that Omega-3 fatty acids provide a positive nutritional supplement for millions of Americans" who do not consume enough seafood, he added.
“Meta-analyses can provide some insight but it is highly desirable for a meta-analysis to include a sensitivity analysis to determine the 'robustness' of the results. Two common ways to perform sensitivity analysis are to analyze the data using various methods and to present the results when some studies are removed from the analysis. If these actions cause serious changes in the overall results, the credibility of the results is compromised. That was absent from this analysis,” said Fabricant.
The Global Organization for EPA and DHA issued a member alert predicting media coverage of the study. GOED offered these points:
- The data in the paper is actually in line with a GOED-funded meta analysis published by Maki et al last August showing a statistically significant 8% reduction in cardiac death risk
- The Maki meta-analysis also demonstrated that at-risk populations, like those with elevated triglycerides or LDL cholesterol, had a larger — 17%— risk reduction in cardiac death. This new JAMA meta-analysis did not explore the effects on these populations for CHD mortality risk.
- The authors mention that there are four large trials that will be published in 2018 and 2019 that will add to the body of research and GOED agrees that we are waiting for these other studies to clarify the results. These four studies will nearly double the number of subjects that have been studied to date.
- The paper also included a comparison between subgroups for major cardiovascular events, such as those with diabetes or participants taking statins, which will be useful for informing future research.
- It’s important to point out that the study did not say there is NO risk reduction, just that there were no statistically significant associations and that it does not support current guidelines. There was no call from the authors to change guidelines as a result of their analysis. Additionally, the discussion section of the paper states, "The 95% CI in the present meta-analysis of 10 trials...cannot exclude a 7% lower risk of major vascular events and a 10% lower risk of CHD associated with omega-3 FA supplements."
