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Table 3

Illustrative example to show differences between three statistical approaches comparing the effect of treatments on functional outcomes “truncated due to death.” We consider the population of patients eligible for the ABC trial and for each patient, generate the potential outcome under control by mimicking characteristics of the control group from the ABC trial such that 62% of the patients receiving the control would experience death by 12 months, the mean cognition among survivors is 42, and based on the composite outcome, as described in the manuscript, 50% of the patients will survive past 72 days (25% of patients will survive to 12 months with cognition score >39). Assuming the monotonicity assumption holds, potential outcomes under intervention were derived based on the effect of the intervention on mortality and the functional outcome among always survivors (for a total of six scenarios). For each scenario, the true population value of the treatment effect defined by the survivors analysis, the SACE and composite endpoint approach are displayed

View this table:

When the intervention has no effect on mortality (scenarios 1 and 2), there are no mortality benefiters, only always survivors (38%) and always diers (62%) ( table 3 ). In this case, the SACE approach and survivors analysis produce the same results regardless of whether there is no effect (scenario 1) or a positive effect of the intervention on cognition (scenario 2). Further, when the intervention has no effect on mortality, the SACE can be estimated directly from trial data without making any additional assumptions. The composite endpoint approach identifies that there is no difference in the distribution of the potential composite outcomes in scenario 1 (rank statistic=0) and the shift in the distribution of cognition scores among always survivors in scenario 2 (rank statistic >0).

In scenarios 3 through 6, the intervention has a positive effect on mortality, which results in no change to the proportion of always survivors (38%) but creates a stratum of mortality benefiters (21%, table 3 ). When the intervention has a positive effect on mortality, the SACE approach and survivors analysis will not necessarily provide the same results; whether or not these approaches are equivalent depends on characteristics of the mortality benefiters. In scenarios 3 and 4, the effect of the intervention is to promote survival in more robust patients with high cognition such that the 12 month cognition scores among the always survivors and mortality benefiters under intervention have the same distribution. In these scenarios, the survivors analysis and the SACE provide the same results ( table 3 ). Alternatively, in scenarios 5 and 6, the effect of the intervention is to sustain less healthy individuals, creating a heterogeneous group of survivors (hearty always survivors and frail mortality benefiters). In these scenarios, the survivors analysis underestimates the SACE regardless of whether or not the intervention improves cognition among always survivors (eg, scenario 5: survivors analysis −7 v SACE 0) and use of the survivors analysis could lead to erroneous conclusions about the efficacy of the intervention on cognition. In scenarios 3 through 6, the composite endpoint approach identifies the shift in the distribution driven by the effect of the intervention on mortality and, in scenarios 4 and 6, on cognition.

In the newest study, published in the New England Journal of Medicine in May, more than 6,000 Italians at high risk for cardiovascular disease took 1,000 milligrams of omega-3 supplements a day. After five years, they did no better than a placebo group in terms of cardiovascular death rates or hospital admissions. This was true even of people with low baseline dietary intakes of omega-3s and those not taking statins.

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Critics have raised questions about some of the newer studies, saying they were not large enough to detect benefits, didn’t last long enough or used omega-3 doses that were too low. Others have criticized how the studies included in the meta-analyses were selected. Had certain other studies been included, the critics say, the overall results would have been more positive. Still, benefits that are so hard to spot are likely to be quite small.

The most salient point may be that in the studies from recent years, far more participants at elevated cardiovascular risk were taking “state-of-the-art” medication, such as statins and blood pressure drugs, compared to early studies. That helps explain the apparent lack of effect of the supplements. Even if omega-3s provide benefits, these would be hard to detect against the backdrop of the much larger benefits of these drugs. That could also make the supplements all the more unnecessary. (The same thing is seen in studies of low-dose aspirin, the benefits of which appear much smaller than previously estimated, now that so many high-risk people are taking statins.)

Sardines: A Good Source of Omega-3s

All seafood has something good to offer. But sardines (a name given to many small fishes in the herring family) are a top choice across the board.

Bottom line: The proposed cardiovascular benefits of fish oil supplements now seem uncertain. Some major studies are underway and may help clarify matters. In any case, your best bet is to get your omega-3s from two or three servings of fatty fish a week. The AHA continues to advise people with heart disease or high triglycerides to consider taking the supplements, after consulting their doctors. That’s still good advice if you don’t eat fish, especially since some of the other proposed benefits of omega-3s may still pan out. The supplements have few, if any, serious adverse effects—unless, that is, they lead you to think you can eat an unhealthy diet or can avoid taking the statins or other drugs you may need.

Bottom line:

Originally published May 2013. Updated March 2014.

Published March 09, 2014

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