Vitamin D And Fish Oil Supplements Disappoint In Long-Awaited Study Results

But when they make it into a drug and can sell it for big bucks, it works great
https://www.nbcnews.com/health/heart-health/drug-fish-oil-cuts-risk-heart-attack-stroke-study-finds-n934701
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“I think this is going to be a landmark study,” said Dr. Michael Blaha, director of clinical research at the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease. “It’s remarkable.”

Tudpock18 said...
Coincidentally, I had just watched the "NBC Nightly News" where a feature story presented the opposite headline from this very same study. https://www.nbcnews.com/health/heart-health/drug-fish-oil-cuts-risk-heart-attack-stroke-study-finds-n934701

"I think we’ve stumbled onto something here in terms of a new class of drugs,” said Dr. Deepak Bhatt, a professor of medicine at Harvard Medical School and executive director of interventional cardiovascular programs at Brigham and Women’s Hospital in Boston. “Honestly, I think it’s as exciting as the statin era, when statins were first becoming available and we were learning about all the things that they can do. I view this as a similar sort of breakthrough"

There were multiple conclusions from the study and I guess the "headline" depends on the perspective of who is reporting it...(NPR vs. NBC in this case).

Jim

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I think your last sentence nailed it. At first I thought "well, looks like this is it for vitamin D"(I don't take fish oil). And it is surely disappointing for those of us who have held out hope for various more natural helpers.

But then I remember how this directly contradicts the RCTs I have posted regarding vitamin D vs breast cancer, and how my(stage 4 breast cancer 8 years ago) niece's doctor has her on 10,000 iu/day. So I read the study and immediately a question of possible bias arises. Why? Because the headline is "Vitamin D AND Fish oil Mostly Disappoint". OK, so mostly but not completely.

So I keep reading, and soon I see this: "While the overall results were disappointing, there appeared to be a beneficial effect when it came to one aspect of heart disease and fish oil: heart attacks." Well, wait a minute, that sounds important, but it is not in the headline? I wonder why? Continuing:

"A secondary analysis showed taking fish oil lowered the risk of heart attack by about 28 percent, which is a "statistically significant" finding, says Dr. JoAnn Manson, who is chief of the division of preventive medicine at the Brigham and Women's Hospital in Boston. She led the research.

Those who appeared to benefit the most were people who didn't ordinarily eat much fish in their day-to-day diet, as well as African-Americans, Manson says.

African-Americans in the study experienced a 77 percent lower risk of heart attack compared with taking a placebo, which is a "dramatic reduction," Manson says. Further research is needed to confirm these findings, she adds, but, "in the meantime, it would be reasonable for African-Americans to talk with their health care providers about whether they may be candidates for taking fish oil supplements." ". You think? Might be reasonable to ask your doctor about this 77% reduction in heart attacks? Really?

WTH? Why isn't this study headlining that if you don't want to die of a heart attack, if you would like to lower your MI risk by 77 freaking %, you might consider fish oil? This makes me at least question everything else in the study. It reminds me of examples from my "Are studies ever designed to fail" threads where the headlines were " RCT shows vitamin D of no help for colds" when first of all, they were comparing a high enough dose of vitamin D (rather than placebo) to an even higher dose of Vit D, (who knows how much improvement there might have already been from the lower- but adequate- dose?) and most of all both studies failed to mention that deadly flu was reduced an additional 50% compared to whatever the lower dose may- or may not- have done! Why would any one take the time and spend the money to do such crazy studies?

So now this fish oil craziness vs the headline has me questioning everything they are saying. Plus I will add that, re: the vitamin D, 2000 iu per day over 5 years might not be enough to see "significant" improvements during that time,
we might be seeing yet another example of the "tiny parachute" approach. IOW, parachutes that are too small do not save lives, therefore parachutes do not save lives. 30 minutes of southern sun at the swimming pool can generate 10,000 iu!

But still, when digging into the results(why am I bothering now that I am suspicious of the source? I don't know, trying to find the truth I guess), I see that, good for them, there are no significant differences in the health of all groups. Except, a slightly higher diabetes rate among the vitamin D group. Which, just by the averages, probably guarantees slightly worse out come fr all cancers and heart disease right there. So the vitamin D group should have done SLIGHTLY worse right there. I wonder why they didn't place the vitamin D folks in the lowest diabetes group, rather than the highest? But, again, just a slight issue. But enough to cause a slight disadvantage for vit D group.

Then I find another problem that crops up a lot these days: "Among the 15,787 participants who had blood samples that could be analyzed, the mean (±SD) serum total 25-hydroxyvitamin D level at baseline was 30.8±10.0 ng per milliliter (77 nmol per liter);.........". We have seen this before, and it means some of the folks were already supplementing. Some of them might have even been supplementing with more than was given them in this study. After a year or more of taking 2000/day, my level was only 30. The vast majority of sun shine avoiding people will never have a level of 30 unless they supplement. These folks, enough o raise the mean to 30.8, had been supplementing. Therefore, all results relative to Vit D are questionable.

Next is this: " most groups had 25-hydroxyvitamin D levels close to, or above, 40 ng per milliliter (100 nmol per liter) after 1 year of supplementation with vitamin D". That is not all that high. The levels that did the best in the RCT for breast cancer were much higher than that, and the very highest levels(above 65) did the best. They even did a lot better than women with levels of 40.

Next is this: "At 2 years, the prevalence of outside use of vitamin D (>800 IU per day) was 3.8% in the vitamin D group and 5.6% in the placebo group". We have also seen this before. Even those outside the vitamin D group were allowed to supplement on their own! So, there is no actual placebo group, there is only more vs less vitamin D. Correct me if I am wrong about this. Apparently studies say they don't prohibit the "placebo" from taking some vitamin D on their own because it would be unethical. If they don't already know it is beneficial, why would it be unethical?

It continues. Now, if the vitamin D group had a bit more diabetes, then they should have done a bit worse in most areas. So, did they? No, they did not. Rather, even though they did not do "significantly better", they did do better in many areas. Prostate cancer was 88% compared to so called placebo. (a 12% improvement). Invasive cancers of any type were 4% improved. NOT worse as to be expected with more diabetes, but 4% better. A few cancers were slightly worse, with the worst being colorectal at +9%. (remember, diabetes was 4% higher pre study in the D group) But death from cancer? A considerable 17% reduction(HR .83), even with all the flaws in this study and the slightly higher diabetes rates for the Vit D group. Not too shabby IMO, even if they call it "not significant".

What about cardio vascular disease? Again, some groups it was worse and some it was better(too bad they didn't get every one's blood level up to 50 and really compare to a true placebo by making sure that group got no supplemental vitamin D on their own, maybe some day). But those needing CABG( so called open heart surgery, bypass) were 25% fewer in the vitamin D group. Death from heart attack was higher but death from stroke was lower. In the summary after only 2 years of follow up(see table 2),
1:death from any cause,
2: invasive cancer of any type
3: death from cancer
4: major cardiovascular event
WERE ALL LOWER IN THE VITAMIN D GROUP, by at least 4% and with death from cancer being 25% less. (but all still not significant, so the message is "no benefit to be had/disappointing".

So, here we are again. A study that could have really told us the low down, but about which many questions can be raised, and despite all the flaws, both fish oil and vitamin D showed some benefits, though "not significant" except for fish oil which even they could not deny was significant, and despite the headline. But the headline that they want you to know about supplementing with this dirt cheap product for which, once again, no significant SEs were mentioned? ""Vitamin D AND Fish oil Mostly Disappoint"".

Well, I don't know about that. I think I may keep on taking it while waiting for an actual good study, that compares 5000 or 10000 iu/day of vitamin D to a group that actually takes no- and has not already been taking any- vitamin D, and does not have even slightly more diabetes. YMMV

Post Edited (BillyBob@388) : 11/14/2018 9:09:12 AM (GMT-7)

Bohemond said...
I quit fish oil after the 2012 study suggested it might actually be harmful. I also chose not to get on the Vitamin D bandwagon - though I do still take a multivitamin (though I doubt anyone benefits other than the drug store) that includes vitamin D. Even so, my primary care doctor wasn't happy when I told him I'd stopped fish oil. And my former radiation oncologist wasn't happy when I told him I wasn't taking Vitamin D. My MO hasn't suggested any supplements and in fact was pleased when he reviewed my medications and saw I was taking only 20 mg lovastatin and a multivitamin.
Jim

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I wonder what is wrong with your PCP and RO? ;)

Post Edited (BillyBob@388) : 11/13/2018 2:14:18 PM (GMT-7)

Oh my goodness, how frustrating this stuff can be:
https://www.nbcnews.com/health/heart-health/drug-fish-oil-cuts-risk-heart-attack-stroke-study-finds-n934701

And if is not bad enough that the OP study says the supplements are disappointing while also mentioning(if you read the story) the 77% reduction in heart attacks for African Americans, this expensive, prescription drug- which is simply a concentrated, purified form of fish oil( kind of like the marijuana derived drug out now for serious seizures) apparently is mainly for reducing triglycerides(TGLs). When it is very well known that it is easy to slash TGLs simply by cutting carbs. Yet the docs are still far and few between who will advise a patient to cut carbs. More likely to advise them to eat low fat, higher carb and take this drug. But not fish oil.

What reminded me to come back to this discussion right now? I just saw the commercial(mega bucks) on TV adverting this drug version of fish oil. It said to be cautious if you are allergic to fish. Sigh.

Cigafred said...
I argued this in another forum with a former poster here. Going from memory, his main point was that the 95% confidence interval for death from PC was 0.72 to 1.07 on a hazard ratio of 0.88. It crosses one, so the result could be due to chance. My feeling is that if you took, say, a 75% confidence interval then it likely would not cross one and if you offer someone with an incurable disease a cheap, fairly-safe pill that is 75% likely to help that person would most likely accept it. And certainly Billybob above has a lot of good arguments as well.

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BB says:
Here is the part that gets me, though I'm sure a statistician would tell me I am ignorant and just don't understand these things- like one who used to be around here used to actually regularly tell me. And common sense simply can not be applied to these things. But as a matter of common sense, the very first thing is it shows no harm and it is dirt cheap compared to prescription meds, almost free by comparison, especially if diet is being looked at. But setting aside all the blatant flaws in the study- at least the vitamin D leg - why are the coincidences almost always in favor of the non-prescription whatever?

For example, to again look at a quote from the actual study:
"In the summary after only 2 years of follow up(see table 2),
1:death from any cause,
2: invasive cancer of any type
3: death from cancer
4: major cardiovascular event

WERE ALL LOWER IN THE VITAMIN D GROUP, by at least 4% and with death from cancer being 25% less. (but all still not significant, so the message is "no benefit to be had/disappointing"........................."

OK, so it is "not significant", and thus the headline is that both vit D and fish oil disappoint. But if being non significant mean it could just b chance, then why isn't it at least equally chance against whatever non-prescription substance is being studied? Why does that summary quoted above have all of those major categories better with the vitamin D group, if it is actually, or might be, chance? Why doesn't the chance part kick in against the vitamin D, so that at least one of those items, say maybe death from cancer, was 25% worse? Shouldn't chance dictate a random distribution of bad results just a much as good or neutral results?

Add to that the flaws in this study such as many had already been supplementing(evidenced by the mean Vit D blood levels) and some in the placebo group supplemented extra on their own, and it is amazing that there were any results in favor of vit D, amazing there were any differences in either direction. Much less a 25% lower death from cancer result after a measly 2 years of supplementing. So the statisticians say "disappointing" because "not significant". But I say "WTH, Bro?". If it is chance, then why not chance against the vit D, rather than in favor of? Add to that that there is such a headline for both D and fish oil, while if you read in the study there was actually a very significant positive result for the fish oil vs heart attacks, and on top of that the rascals have come up with an FDA approved prescription fish oil for that very problem, and I conclude that something stinks. Is it just me? Am I the only one that suspects a massive bias in order to result in such a headline?

Lastly, here is what I think would have happened if either one of these had made deaths from cancer or anything else 25% worse, even if considered not significant by the statisticians. The headline would be " RCT study shows Vit D or fish oil may increase risk of cancer death 25%". Then it would be all over NBC nightly news: "Shocker: vitamins increase risk of death from cancer". No?

Sr Sailor said...
Don't we all like salmon?

grilled but not stuffed into a pill