By Mike Montemarano, Associate Editor03.09.20
The Global Organization for EPA and DHA (GOED), a trade group comprised of leaders in the omega-3 industry, believes the way in which two simultaneously-released studies were publicized downplayed recent clincal affirmations supporting cardiovascular health benefits provided by fish oil supplementation.
Cochrane, an England-based non-profit research institute, recently backtracked on a prior study which challenged cardiovascular benefit claims of EPA and DHA, two long-chain omega-3 fatty acids (LCn3s) found in fish oil supplements.
The original study, published in July 2018, analyzed a combined 79 randomized trials involving 112,059 people. It concluded that omega-3 consumption via popular supplement delivery methods “probably makes little or no difference to risk of cardiovascular events.”
“They [researchers] found high certainty evidence that long-chain omega 3 fats had little or no meaningful effect on the risk of death from any cause,” the study authors wrote at the time. “The risk of death from any cause was 8.8% in people who had increased their intake of omega 3 fats, compared with 9% in people in the control groups.”
“They also found that taking more long-chain omega 3 fats (including EPA and DHA), primarily through supplements probably makes little or no difference to risk of cardiovascular events, coronary heart deaths, coronary heart disease events, stroke or heart irregularities,” the researchers continued.
At the time, Cochrane lead author Dr. Lee Hooper, who is a member of the World Health Organization Nutrition Guidance Expert Advisory group (NUGAG), said: “We can be confident in the findings of this review which go against the popular belief that long-chain omega 3 supplements protect the heart. This large systematic review included information from many thousands of people over long periods. Despite all this information, we don’t see any protective effects.”
Quest for an NRV
GOED noted this study took place shortly before the Food and Agricultural Organization (FAO) of the United Nations’ Codex Committee on Nutrition and Foods for Special Dietary Uses discontinued its work on the nutrient reference values (NRVs) of EPA and DHA.
Nutrient reference values are international guidelines for recommended daily nutrient values, which are utilized for food and supplement labeling purposes. Many countries that do not currently have an NRV for EPA or DHA would likely adopt the NRV established by FAO. The WHO NUGAG’s gathering of research was a part of this process, however, GOED contended that research conducted was not a joint FAO/WHO process, and the FAO was not in a position to comment on the outcomes of the reviews.
GOED said it hopes it can eventually pursue an NRV-NCD for EPA and DHA in the future, however, it would require a Codex member country to submit a proposal for new work at a future meeting pending the availability of new scientific evidence.
Backtrack
Changes in Cochrane’s conclusion on omega-3s came on Feb. 29 this year, when Cochrane added seven new trials to its analysis, bringing the number to 162,796 participants.
Three of the seven new studies which yielded statistically significant evidence suggesting that fish oil offers cardiovascular health benefits were published shortly after the WHO-commissioned Cochrane meta-analysis. These three studies were also published just before the WHO Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) discontinued evaluating whether or not to establish a nutrient reference value (NRV) for EPA or DHA.
“A Study of Cardiovascular Events in Diabetes (ASCEND) reported an 18% statistically significant reduction in risk of vascular death and a 21% risk reduction for coronary death in response to 840 mg EPA+DHA daily in patients with diabetes who are not known to have arterial disease,” GOED included in a list. “Vitamin D and Omega 3 Trial (VITAL) reports statistically significant risk reductions in total myocardial infarction (MI) (28%); total coronary heart disease (CHD) (17%); and fatal MI (50%) in response to 840 mg EPA+DHA daily. REDUCE-IT reports statistically significant risk reductions in the primary endpoint of major adverse cardiovascular events (MACE) (25%); cardiovascular death or nonfatal MI (25%); fatal or nonfatal MI (31%); and cardiovascular death (20%) in response to 3,840 mg EPA daily.”
In the update, Cochrane reported that increasing long-chain omega-3s “slightly reduces the risk of coronary heart disease mortality and events,” citing positive findings that the risk reductions for cardiovascular mortality and coronary heart disease events were 8% and 9%, respectively.
“The updated evidence suggests that increasing LCn3 slightly reduces CHD mortality and CHD events (previously the evidence suggested little to no effect),” the study authors wrote. “Our understanding of effects of LCn3 on other outcomes, and of ALA on all outcomes, has not altered.”
Additionally, the authors wrote that high-certainty evidence suggested “increasing LCn3 reduced triglycerides by ˜15% in a dose-dependent way.”
While three positive studies on fish oil’s cardiovascular benefits that were later incorporated into the meta-analysis were published shortly after Cochrane’s meta-analysis, and preceded the Codex Committee’s decision to discontinue work toward establishing an NRV for fish oils, the Codex Committee hadn’t taken the three studies into consideration, in spite of discussions with GOED.
“As we’ve learned over the last four years, this is not an easy endeavor and one that is not as grounded in science as we once thought,” GOED said in response to the outcome. “Regardless of GOED’s future decision to pursue an NRV-NCD for EPA+DHA, it’s clear that GOED needs to make a concerted effort to educate global government bodies about the benefits of omega-3s.”
On the same day that Hooper updated the Cochrane meta-analysis, she also co-authored a study which found that, among 47 randomized controlled trials, increasing LCn3 has little or no effect on the rates of cancer diagnoses, cancer deaths, and that increasing total omega-3s and omega-6s may slightly increase risk of cancer diagnosis, and cancer death. However, the doses in some trials were very high, according to Cochrane.
The risk increase, according to the authors, is that if 1,000 males increased their omega-3 intake, it would result in an extra three cases of prostate cancer per year. Separate from this study, approximately one in nine men is diagnosed with prostate cancer during his lifetime, according to American Cancer society estimates.
On the concurrent research updates provided on Feb. 29, and some of the media coverage of the studies on heart benefits and cancer risk, GOED provided some thoughts about recent headlines, which appeared to have focused on the cancer risk claims despite the positive news of statistically significant findings related to fish oil and heart health.
Essentially, the organization finds that comparing substantiated heart disease claims to statistically insignificant impact on cancer outcomes doesn’t follow logically.
Chris Gearheart, director of GOED member communications and engagement, said that describing one health effect as “offsetting” another in the realm of nutritional supplements was unprecedented.
“GOED found this highly questionable,” Gearheart said. “We hope consumers will hear about what her meta-analysis actually found—statistically significant 8% and 9% risk reductions for cardiovascular mortality and coronary heart disease events. It’s never been claimed that omega-3 consumption prevents cancer, so this meta-analysis does not really share anything new or surprising.”
Cochrane, an England-based non-profit research institute, recently backtracked on a prior study which challenged cardiovascular benefit claims of EPA and DHA, two long-chain omega-3 fatty acids (LCn3s) found in fish oil supplements.
The original study, published in July 2018, analyzed a combined 79 randomized trials involving 112,059 people. It concluded that omega-3 consumption via popular supplement delivery methods “probably makes little or no difference to risk of cardiovascular events.”
“They [researchers] found high certainty evidence that long-chain omega 3 fats had little or no meaningful effect on the risk of death from any cause,” the study authors wrote at the time. “The risk of death from any cause was 8.8% in people who had increased their intake of omega 3 fats, compared with 9% in people in the control groups.”
“They also found that taking more long-chain omega 3 fats (including EPA and DHA), primarily through supplements probably makes little or no difference to risk of cardiovascular events, coronary heart deaths, coronary heart disease events, stroke or heart irregularities,” the researchers continued.
At the time, Cochrane lead author Dr. Lee Hooper, who is a member of the World Health Organization Nutrition Guidance Expert Advisory group (NUGAG), said: “We can be confident in the findings of this review which go against the popular belief that long-chain omega 3 supplements protect the heart. This large systematic review included information from many thousands of people over long periods. Despite all this information, we don’t see any protective effects.”
Quest for an NRV
GOED noted this study took place shortly before the Food and Agricultural Organization (FAO) of the United Nations’ Codex Committee on Nutrition and Foods for Special Dietary Uses discontinued its work on the nutrient reference values (NRVs) of EPA and DHA.
Nutrient reference values are international guidelines for recommended daily nutrient values, which are utilized for food and supplement labeling purposes. Many countries that do not currently have an NRV for EPA or DHA would likely adopt the NRV established by FAO. The WHO NUGAG’s gathering of research was a part of this process, however, GOED contended that research conducted was not a joint FAO/WHO process, and the FAO was not in a position to comment on the outcomes of the reviews.
GOED said it hopes it can eventually pursue an NRV-NCD for EPA and DHA in the future, however, it would require a Codex member country to submit a proposal for new work at a future meeting pending the availability of new scientific evidence.
Backtrack
Changes in Cochrane’s conclusion on omega-3s came on Feb. 29 this year, when Cochrane added seven new trials to its analysis, bringing the number to 162,796 participants.
Three of the seven new studies which yielded statistically significant evidence suggesting that fish oil offers cardiovascular health benefits were published shortly after the WHO-commissioned Cochrane meta-analysis. These three studies were also published just before the WHO Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) discontinued evaluating whether or not to establish a nutrient reference value (NRV) for EPA or DHA.
“A Study of Cardiovascular Events in Diabetes (ASCEND) reported an 18% statistically significant reduction in risk of vascular death and a 21% risk reduction for coronary death in response to 840 mg EPA+DHA daily in patients with diabetes who are not known to have arterial disease,” GOED included in a list. “Vitamin D and Omega 3 Trial (VITAL) reports statistically significant risk reductions in total myocardial infarction (MI) (28%); total coronary heart disease (CHD) (17%); and fatal MI (50%) in response to 840 mg EPA+DHA daily. REDUCE-IT reports statistically significant risk reductions in the primary endpoint of major adverse cardiovascular events (MACE) (25%); cardiovascular death or nonfatal MI (25%); fatal or nonfatal MI (31%); and cardiovascular death (20%) in response to 3,840 mg EPA daily.”
In the update, Cochrane reported that increasing long-chain omega-3s “slightly reduces the risk of coronary heart disease mortality and events,” citing positive findings that the risk reductions for cardiovascular mortality and coronary heart disease events were 8% and 9%, respectively.
“The updated evidence suggests that increasing LCn3 slightly reduces CHD mortality and CHD events (previously the evidence suggested little to no effect),” the study authors wrote. “Our understanding of effects of LCn3 on other outcomes, and of ALA on all outcomes, has not altered.”
Additionally, the authors wrote that high-certainty evidence suggested “increasing LCn3 reduced triglycerides by ˜15% in a dose-dependent way.”
While three positive studies on fish oil’s cardiovascular benefits that were later incorporated into the meta-analysis were published shortly after Cochrane’s meta-analysis, and preceded the Codex Committee’s decision to discontinue work toward establishing an NRV for fish oils, the Codex Committee hadn’t taken the three studies into consideration, in spite of discussions with GOED.
“As we’ve learned over the last four years, this is not an easy endeavor and one that is not as grounded in science as we once thought,” GOED said in response to the outcome. “Regardless of GOED’s future decision to pursue an NRV-NCD for EPA+DHA, it’s clear that GOED needs to make a concerted effort to educate global government bodies about the benefits of omega-3s.”
On the same day that Hooper updated the Cochrane meta-analysis, she also co-authored a study which found that, among 47 randomized controlled trials, increasing LCn3 has little or no effect on the rates of cancer diagnoses, cancer deaths, and that increasing total omega-3s and omega-6s may slightly increase risk of cancer diagnosis, and cancer death. However, the doses in some trials were very high, according to Cochrane.
The risk increase, according to the authors, is that if 1,000 males increased their omega-3 intake, it would result in an extra three cases of prostate cancer per year. Separate from this study, approximately one in nine men is diagnosed with prostate cancer during his lifetime, according to American Cancer society estimates.
On the concurrent research updates provided on Feb. 29, and some of the media coverage of the studies on heart benefits and cancer risk, GOED provided some thoughts about recent headlines, which appeared to have focused on the cancer risk claims despite the positive news of statistically significant findings related to fish oil and heart health.
Essentially, the organization finds that comparing substantiated heart disease claims to statistically insignificant impact on cancer outcomes doesn’t follow logically.
Chris Gearheart, director of GOED member communications and engagement, said that describing one health effect as “offsetting” another in the realm of nutritional supplements was unprecedented.
“GOED found this highly questionable,” Gearheart said. “We hope consumers will hear about what her meta-analysis actually found—statistically significant 8% and 9% risk reductions for cardiovascular mortality and coronary heart disease events. It’s never been claimed that omega-3 consumption prevents cancer, so this meta-analysis does not really share anything new or surprising.”
