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【medical-news】【NEJM】鱼油 (Omega-3) - 是吃, 还是不吃?

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这个帖子发布于7年零260天前，其中的信息可能已发生改变或有所发展。

意大利的一帮学者报告了他们一项耗时 5 年的研究结果 - 鱼油 (Omega-3 fatty acid) 对于那些有心血管病风险, 但没有发病的人来说, 没有任何"防心血管疾患" 的作用. 这个结果报告与先前的一些相关研究结果是大相径庭.

不过, 这研究结果里有一项还是值得信赖滴, 那就是 -"By the end of the trial, the overall cardiovascular risk
profile had improved in both groups. The plasma triglyceride level fell significantly more in patients given n?3 fatty acids than in those who received placebo.

米国有一种高纯度, 需 Rx 才可买到的鱼油 - 商品名 "Lovaza" (http://en.wikipedia.org/wiki/Lovaza/ - GSK), 就是专门用来降甘油三酯滴.

Study questions fish oil benefit before heart attack

By Gene Emery

NEW YORK | Wed May 8, 2013 5:03pm EDT

The study - a gold-standard randomized, controlled trial - tested the effect of omega-3 fatty acids, which are found in oily fish such as tuna or sardines. Patients in the study had risk factors for heart disease, such as high blood pressure, high cholesterol, a history of smoking or narrowed arteries. But patients who had a heart attack in the past weren't allowed to enroll.

Five years after the study began, 11.7 percent of the 6,244 patients taking a capsule containing one gram of fish oil daily had died or been hospitalized for heart problems, compared to 11.9 percent for the 6,269 volunteers who instead received one gram of olive oil every day as a placebo.

The result, reported in the New England Journal of Medicine on Wednesday, is in sharp contrast to other research suggesting that omega-3 fatty acids can help those who have survived a heart attack or suffer from heart failure.

For people who haven't had a heart attack, though, the new findings "provide no evidence of the usefulness of (omega)-3 fatty acids for preventing cardiovascular death or disease," according to the research team, led by Dr. Maria Carla Roncaglioni of the Mario Negri Institute for Pharmacological Research in Milan.

She told Reuters Health in an email that the finding argues against the use of fish oil supplements, at least among Italians, who are already exposed to the Mediterranean diet. "There is no reason to prescribe fish oil supplementation unless they have a heart attack," she said.

The researchers did see a reduction in hospital admissions for heart failure and a preventive effect in women, but "both may be due to chance, although they are consistent with two findings from other studies," the researchers said.

Alice Lichtenstein, from Tufts University in Boston and a spokeswoman for the American Heart Association, told Reuters Health the findings from the new study are further evidence that, in general, "just giving a supplement on top of a non-heart-healthy lifestyle doesn't seem to help."

"We thought vitamin E pills were going to be the answer and that turned out to be wrong. We though beta carotene as an antioxidant was going to reduce cardiovascular disease . . . and that pill didn't work," she said in a telephone interview. "It's the whole package, not just popping one pill."

The patients in the Italian study were treated by 860 general practitioners throughout the country. Their average age when they enrolled in the study was 64 years old.

Originally, the researchers had thought the main goal of their study would be to see how many people died or had a heart attack or stroke. But those events turned out to be less common than expected, probably because the patients "were rather intensively exposed to recommended preventive treatment (including healthy lifestyle habits) by their family physicians," Roncaglioni said.

Thus, the goal of the study was modified to count anyone who died or was admitted to the hospital for a heart-related cause.

Certain factors did seem to improve slightly more in the fish oil recipients, such as levels of fat and "good" cholesterol in the blood.

But other measures such as "bad" cholesterol, blood pressure and blood sugar remained similar in the fish oil and olive oil groups, and there was no difference in the proportion of patients in the two groups who needed heart medications.

Roughly two of every 100 patients died of heart disease, regardless of which group they were in. And roughly 10 of every 100 patients in each group needed to be hospitalized for a heart-related problem.

By the end of the study, 18 percent had stopped taking their fish oil and 19 percent had stopped taking their olive oil. When those volunteers were excluded from the study, there was still no significant difference between the groups in the risk of death or hospitalization for heart problems.

The rates of gastrointestinal side effects, cancer and bleeding were comparable in the two groups.

The U.S. Food and Drug Administration says olive oil has heart benefits of its own. Is it possible that using olive oil as the placebo in this study skewed the results by protecting the placebo group to some extent? Roncaglioni doesn't think so.

She said giving olive oil as a placebo probably did not bring down the overall rate of heart problems in that group because "one gram of olive oil corresponds to only 1/30th of the mean amount consumed in the Mediterranean diet," which would make it of very small benefit.

SOURCE: bit.ly/144dPhF New England Journal of Medicine, online May 8, 2013.

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2013-05-10 02:38 浏览 : 7086 回复 : 7

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2013-05-10 02:41

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视频报道:

Medscape Cardiology > Topolog
Fish Oils to Prevent Heart Disease: A Definite 'No Go'

http://www.medscape.com/viewarticle/803798

Eric Topol here. My segment is about the May 9 New England Journal of Medicine report on fish oils.^[1] This is one of the largest, most rigorous trials ever performed on fish oils and it comes from Italy -- basically from the GISSI group, with over 800 participating primary care physicians and over 12,500 patients. These patients were at high risk for heart disease -- about 60% had diabetes, 70% had hypercholesterolemia -- but they hadn't had a myocardial infarction (MI).

The Design

Patients were randomly assigned to receive a fish oil preparation with eicosapentaenoic acid and docosahexaenoic acid in quantities that had previously been shown to be useful in patients with heart failure post-infarction -- in those trials where there was a reduction in sudden cardiac death (presumably due to the ability to suppress ventricular arrhythmias). One cannot really question whether this is an efficacious dose. It was compared with placebo.

The trial began a decade ago, back in 2004. The patients were enrolled -- this > 12,000 patient cohort -- over a 3-year period. There was a 5-year follow-up. And this is the primary report of this very impressive Italian collaborative trial.

The only real wart in the execution of the trial was that [the investigators] had assumed too high of an event rate. The event rate of death, MI, or stroke was evaluated in a blinded fashion after 1 year, leading to a change in the primary endpoint to death from cardiovascular causes or hospitalization for cardiovascular causes.

It Really Didn't Matter

At the end of the day they had adequate power; they had actually gone a little bit past their planned recruitment -- over 11,000 participants -- because there was an issue of wanting to get every physician to recruit patients.

Basically, this 1 figure tells the whole story. I am going to try to sharpen the view of the graph. It's the primary event curve, and it looks like there's only 1 line. But there are 2 lines: placebo (which has a little bit of olive oil in it) vs the fish oil. There's no difference. No difference on any endpoint: death, stroke, MI, hospitalization, you name it.

It is interesting that there was a statistically significant better tolerance of the fish oil than there was of the placebo. It was slight (0.03), but it's an interesting footnote.

What Does This Say About Fish Oil?

I don't know about you, but I have an awful lot of patients who come to me on fish oil and I try to implore them to stop taking it. This trial arms us [with proof against fish oils] for our patients who have not had an MI, who have not had heart failure, where the worry is not suppression of ventricular arrhythmia (and even that is a little suspect). Fish oil does nothing and we cannot continue to argue about either "the right dose" or "the right preparation." It's a "nada effect."

I think this is a really important trial in cardiovascular medicine. It's also interesting that 70% of the patients [in the trial] had hypercholesterolemia and only 40% were taking statins. This group [of patients] was even more "loaded," if you will, to derive some benefit.

Fish oil is a "no-go." If it doesn't work in this group, it's hard to imagine in lesser-risk groups that it's going to have any salutary impact.

I really appreciate you tuning in to Topolog. I'll be interested in your thoughts on fish oils. It's been a fishy story for a long time.

Thank you.

2013-05-10 02:58

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Fish oil benefits, in relation to heart health, are the target of a new long-term study from Italy that found the supplement did not display a positive effect on the development of heart problems---a departure from results displayed in previous studies that suggested the supplement does have a positive effect in regard to the development of heart-related issues.

Researchers found that fish oil supplements did not prevent heart problems in people who had not previously had a heart attack.

The study, published in the New England Journal of Medicine, investigated omega-3 fatty acids, found in fish like tuna and sardines, and their effect on cardiovascular issues.

Study participants had heart disease risk factors such as high cholesterol, a history of smoking, narrowed arties or high blood pressure. Patients who experienced a heart attack in the past were prohibited from signing up for the study.

Researchers found that after five years from the start of the study, 11.7 percent of the 6,244 participants who took a one-gram fish oil capsule daily had either died or received hospital treatment related to a heart issue, in comparison to the 11.9 percent out of the 6,269 participants who received one gram of olive daily as a placebo.

The new findings "provide no evidence of the usefulness of (omega)-3 fatty acids for preventing cardiovascular death or disease," said the researchers, led by Dr. Marla Carla Roncaglioni from the Mario Negri Institute for Pharmacological Research in Milan.

Some experts say the results from this new study fortify the idea that the sole use of supplements is not going to help in heart health.

"Just giving a supplement on top of a non-heart-healthy lifestyle doesn't seem to help," Alice Lichtenstein from Tufts University in Boston and spokeswoman for the American Heart Association told Reuters Health.

"We thought Vitamin E pills were going to be the answer and that turned out to be wrong. We though beta-carotene as an antioxidant was going to reduce cardiovascular disease...and that pill didn't work. It's the whole package, not just popping one pill."

2013-05-10 03:02

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