Are studies of supplements or diets sometimes designed to fail?

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BillyBob@388
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   Posted 9/11/2017 11:02 PM (GMT -7)   
And by fail, I mean designed to fail to show any benefit for the supplement or maybe for a diet that does not meet the normal medical low fat, low cholesterol recommendations? I have noticed on numerous studies over the years that they didn't look at what I thought(and of course, that's what is important, right, what I think? ;) ) was important. For example, a study of maybe low fat diets vs low carb, where the carbs are never really reduced enough to get the claimed benefits, so it is no surprise when they find little difference. Then, to add insult to injury, there may STILL be some small benefit to the so called low carb( in reality, not low but only somewhat lower carb) in most areas looked at, like weight loss and HDL and triglycerides(not usually LDL though), but naturally enough: not statistically significant.

Every time I see one of these studies over the years i think: "why the heck did they do that? They have the money and the people all together to actually look at whatever it is, but then they don't really look at it. Why?"And of course the inevitable conclusion: No dif in low fat vs hi fat diets", or whatever it is being studied.

I have seen this approach used on numerous different things studied over the years, though obviously not always. I think there is even a name for it: "the tiny parachute" approach. Throw 10 Placebo(no parachute or fake parachute)guys out of the airplane, all ten die. Throw 10 men out of the plane with a 12" diameter parachute: all 10 die, or maybe 9 die. Conclusion: no difference in mortality if parachute is used vs no parachute", or maybe if only 1 extra lived, "no statistical difference".

I just read a new study that came to my in box from Medscape that I can't help but feel was designed to be very unlikely to have a statistical dif, and sure enough the conclusion is: "no benefit".

So this was a study of high dose Vit D vs higher dose vitamin D vs colds, in children 1 to 5 years old(Mean age was 2.7 years). One group got 400 iu/day, the other group got 2000 iu/day. Isn't 400 iu a pretty stout dose for a young child and maybe even toddlers? Indeed, serum vitamin D levels for the 400 iu group was a solid 36.8 vs 48.7 for the high dose. 36.8 is pretty good, maybe all that is needed to provide benefits in fighting colds. Which raises the question: why the heck didn't they give a placebo of zero IUs? In order to tell us if there is some value in taking vitamin D to fight colds, or not? This seems like a missed opportunity. But why would they miss such an opportunity? They ask the question: "However, it is not known whether supplementation of vitamin D during the winter would lower the risk for viral upper respiratory tract infections (URTIs) among children, because of methodological limitations of previous clinical trials.". Well why didn't they try to find out by comparing zero supplementation to both 400 and 200 IU?

Instead, both groups are very well supplemented, both groups high dose considering the participants are small children, and when it comes to common colds (URTIs), what is their conclusion? "The investigators conclude that high doses of vitamin D do not reduce the number of wintertime viral URTIs among healthy children aged 1 to 5 years and that supplementation is not indicated to prevent such infections.". How about a comparison to true placebo before you make such a claim, guys?

But while that is the headline, and even though both groups are well supplemented, there is a little detil that seems to not be highlighted: When it comes to the much more important flu(and I bet all these kids had flu shots) "Incidence of influenza was 50% lower in the high-dose group (IRR, 0.50; 95% CI, 0.28-0.89), but only 16 cases (4.4% of all infections) occurred in that group, and only 31 (8.5% of all infections) occurred in the standard-dose group.". 50% lower? Good grief, I bet it is not that much lower with flu shots! And if higher dose compared to just high dose was 50% lower, wouldn't you love to see the flu incidence for zero supplementation, especially since they say "supplementation is not indicated to prevent such infections."? Why wasn't "flu reduced 50%" the headline?

Down below, they do admit(but not reflected in the headline: "Limitations of the study were gaps in parental submission of swabs and reporting of URTIs (resulting in a possible underestimate of URTI incidence), and lingering effects of sustained sun exposure during the summer months (which would detract from a possible benefit of higher supplementation levels of the vitamin months later). ..........Study limitations include the possibility that children may have had URTIs without nasal swabs being submitted and the lack of placebo group, precluding determination of whether 400 IU/daily protected against infections........In addition, baseline 25-hydroxyvitamin D serum levels at the end of the summer were relatively high, which could have contributed to the lack of effect of high-dose vitamin D supplementation, as children with lower baseline serum 25-hydroxyvitamin D levels may benefit more from vitamin D supplementation. ..........". And of course, despite impressive results without even comparing to 0 IUs(placebo), the ever present "More studies are needed to determine whether high-dose vitamin D supplementation may be associated with lower risk for influenza.". But CDC says flu shots reduce the flu about 50 to 60%(during the good years anyway) and I'll bet you a dollar that is compared to NO flu shot and NOT to a lower dose shot.

Studies like this are why I feel I will be long dead before we ever really know what the benefits(or harms) of certain foods or supplements really are. Here was a chance to find out compared to placebo, but they didn't take it, and their conclusion is: no benefit(but just don't look at those flu results). It's enough cause the paranoid among us to think someone just doesn't want us to know.

www.medscape.org/viewarticle/884182?nlid=117430_2713&src=wnl_cmemp_170911_mscpedu_nurs&uac=158102PN&impid=1430844&faf=1
Somebody said...
Can High-Dose Vitamin D Reduce the Risk for the Common Cold in Kids?
Authors: News Author: Ricki Lewis, PhD; CME Author: Laurie Barclay, MDFaculty and Disclosures

CME / ABIM MOC / CE Released: 8/18/2017

Valid for credit through: 8/18/2018
Clinical Context

Low 25-hydroxyvitamin D levels are associated with increased risk for viral upper respiratory tract infections, based on epidemiological studies. Furthermore, vitamin D increases synthesis of cathelicidin, an antimicrobial peptide in respiratory epithelium, which reduces disease severity and influenza virus replication in vitro.

However, it is not known whether supplementation of vitamin D during the winter would lower the risk for viral upper respiratory tract infections (URTIs) among children, because of methodological limitations of previous clinical trials. The goal of this randomized clinical trial was to evaluate whether high-dose (2000 IU/d) vs standard-dose (400 IU/d) vitamin D supplementation was associated with lower incidence of wintertime URTIs in young children.
Study Synopsis and Perspective

Daily high-dose vitamin D during the winter months did not reduce the incidence of viral URTIs among children aged 1 to 5 years, according to results of a study published in the July 18 issue of JAMA.

Gemlin
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Date Joined Jul 2015
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   Posted 9/12/2017 1:07 AM (GMT -7)   
BillyBob-

In my humble opinion.

Any study of supplements on healthy people with normal diets will never show any benefits because there is no way to improve our bodies immune system if there aren't any specific deficiency present.
Suggesting that if someone on a normal diet takes supplements, it will improve the immune function, is plain wrong. That's why scientific studies have never found any evidence for such a hypothesis.

Diet is another thing - there are healthy diets and there unhealthy diets.

Subdenis
Regular Member


Date Joined Aug 2017
Total Posts : 221
   Posted 9/12/2017 1:12 AM (GMT -7)   
One critical aspect of research are the hypothesis because they drive everything in a study, including sample audience, the control group, etc. To eliminate bias many studies have to have very narrow parameters. Most of the studies I read do not show the formal hypothesis, which may inform the narrowness of the study. Finally, the threats to the study which are often listed as limitations show the weakness in the results. That is why criticism of studies is often found in that the results are not replicable.

I am surprised in a way at how unclear research is on the role of diet and supplements. I choose to believe there is enough data to suggest a heart healthy diet is a good diet generally. I am taking a turn on my diet and going dairy free. Denis
65 YO healthy man, PSA 4.1/2 for couple years PSA 5/1/17 4.6, Multiparametric MRI, 5/15/17 showed lesion. 13 core biopsy 3 positive 3+3 and one positive in lesion, may be overlap All cores less than 30% 8/22/17 - second opinion Yale pathology shows small amount of (3+4) in one core, < 5%, ordered decipher to inform next steps Leaning towards Active Surveillance. Thanks, Denis

BillyBob@388
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Date Joined Mar 2014
Total Posts : 2600
   Posted 9/12/2017 7:53 AM (GMT -7)   
Gemlin said...
BillyBob-

In my humble opinion.

Any study of supplements on healthy people with normal diets will never show any benefits because there is no way to improve our bodies immune system if there aren't any specific deficiency present.
Suggesting that if someone on a normal diet takes supplements, it will improve the immune function, is plain wrong. That's why scientific studies have never found any evidence for such a hypothesis.

Diet is another thing - there are healthy diets and there unhealthy diets.




Well, lot's of folks- most? - certainly look at it that way, and you may be right. But, But Gemlin, they DID find evidence for a hypothesis, even though it was not their main hypothesis which was looking at URTIs. They DID find a difference, an impressive one, in this study. They chose not to highlight it.

The flu cases were 50% lower in the children in the very high group vs the group that had only (IMO) high vitamin D, which certainly seems notable to me.(flu shots only lead to about 50% lower, and I think that is on the good years when they get lucky with the strain) And makes me wonder how these kids on even the only high dose of 400 would compare to folks who had NO supplementation, how many of those got the flu(or even colds)? But the flu dif between high and very high was notable. I can't help but think the difs would have been even higher comparing to a placebo group.

If they had just included a placebo group to tell us this info. But even though they did not compare to a group with zero supplementation, it appears to me they still have indeed found evidence for the hypothesis, (or at least for a separate hypothesis about flu and vitamin D) they simply choose not to emphasize it. They instead choose to emphasize that comparing high vitamin D to really high vitamin D, there was no advantage with the common cold.

What I can not figure out is: why didn't they look at a group that had zero vitamin D? It seems there would be a much better chance of seeing a difference(if there was any) between a zero group and 400iu(a high dose for toddlers IMO, some adults only take 400!) than between that high dose and an even higher dose.
/www.cdc.gov/flu/about/qa/vaccineeffect.htm
Somebody said...
How effective is the flu vaccine?

CDC conducts studies each year to determine how well the flu vaccine protects against flu illness. While vaccine effectiveness can vary, recent studies show vaccine reduces the risk of flu illness by about 50% to 60% among the overall population during seasons when most circulating flu viruses are like the vaccine viruses.


So the results with the flu, when comparing high Vitamin D to even higher vitamin D, about equals the flu shot during the years when the flu shot gets lucky? I'd say that shows a worthwhile benefit, and I think it would have been a much more notable difference if they compared to zero or placebo, like when comparing flu shots to no flu shot. And this might even be comparing kids who have had flu shots, they still did 50% better, but I don't see where they say whether they had flu shots or not.

Post Edited (BillyBob@388) : 9/12/2017 9:28:25 AM (GMT-6)


BillyBob@388
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Date Joined Mar 2014
Total Posts : 2600
   Posted 9/12/2017 8:23 AM (GMT -7)   
Subdenis said...
One critical aspect of research are the hypothesis because they drive everything in a study, including sample audience, the control group, etc. To eliminate bias many studies have to have very narrow parameters. Most of the studies I read do not show the formal hypothesis, which may inform the narrowness of the study. Finally, the threats to the study which are often listed as limitations show the weakness in the results. That is why criticism of studies is often found in that the results are not replicable.

I am surprised in a way at how unclear research is on the role of diet and supplements. I choose to believe there is enough data to suggest a heart healthy diet is a good diet generally. I am taking a turn on my diet and going dairy free. Denis


Exactly. Apparently flu was not part of, or at least not the primary, hypothesis. And down towards the end of the study, when I click on the link and I read the whole thing, there is a list spelling out the limitations, including no placebo group, and the fact that they were starting the study when the kids were probably at peak vitamin D levels anyway do to sunshine exposure, and a few others. But that does not keep them from concluding "supplementation is not indicated to prevent such infections.". By which they mean "very high vitamin D does no better than just plain high vit D when it comes to preventing colds, even though it reduced flu 50%". So, not indicated, which will be the take home message for many who see this study.

Maybe if they had just had a different hypothesis, the title of the study would have been "Really high vitamin D reduces flu by 50% compared to merely high vitamin D, even in children who have been immunized against the flu"(I'm just guessing about that last part).

Again, I think this was a missed opportunity. They could have had a placebo, rather than just comparing high to very high. Why didn't they?

Fairwind
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Date Joined Jul 2010
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   Posted 9/12/2017 9:15 AM (GMT -7)   
The result usually depends on who funded the study...You get what you pay for.....
Age now 74 . Diagnosed G-9 6/2010
RALP Sept 3 2010, pos margin, one pos vesicle nodes neg. Post Op PSA 0.9 SRT, HT. 2-15-'11 PSA <0.1 10/'11, <0.1 2/12, <0.1, 4/12 <0.1, 9/12, 0.8 3/13, 0.5 6/13, 1.1, back on HT. 5/16 stay the course, Lupron, Zytiga, PSA <0.1 10/16 no change <0.1 5/17 PSA 1.6 Chemo or Provenge next..

BillyBob@388
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Date Joined Mar 2014
Total Posts : 2600
   Posted 9/12/2017 5:01 PM (GMT -7)   
Fairwind said...
The result usually depends on who funded the study...You get what you pay for.....


Bazinga! Well said, Oh Fair One! (not that I have any idea who paid for this one, we may have no way of knowing) "The researchers have disclosed no relevant financial relationships.".

I will also add, in case I have not already said it: If I wanted to design a study to show no benefit for product X, this is pretty much how I would do it, via a variation of the "tiny parachute" approach.(normal tiny parachute = using way too small a dose of whatever, then when no dif declaring no benefit period):

Take one group who are already pretty well supplied with product X, and all ready in a range which has previously been identified by multiple experts as the optimum range, they will be the "control". Then give the trial group an even higher dose of product X. And when that- as expected IMO- shows no significant (additional?)improvement over the original more than adequate dose, declare that not only is there no additional benefit to the very high dose over the simply high dose, but in general supplementation can not be recommended. Even though a serious illness, the flu, showed strong positive effect, but forget that, that is not the hypothesis we were looking at. Then for the gran finale, I would way under emphasize that part about the flu, and not include it in the head line or conclusion. Which would be such: " Study Synopsis and Perspective:
Daily high-dose vitamin D during the winter months did not reduce
the incidence of viral URTIs among children aged 1 to 5 years, according to results of a study published in the July 18 issue of JAMA. ". And just never mind that there was a 50% reduction in flu, and that there was no placebo.

Honestly, how do they have the nerve to declare that daily high dose Vit D DID NOT reduce the incidence of viral URTIs? How could they possibly know with no placebo? Surely, isn't the most they can say is that it did not reduce the incidence more than 400 IUs did, an already high dose for a toddler? We really have to take the results of most studies with a grain of salt. Bias is everywhere.

Post Edited (BillyBob@388) : 9/12/2017 6:12:01 PM (GMT-6)


mattamx
Regular Member


Date Joined Aug 2015
Total Posts : 221
   Posted 9/12/2017 5:58 PM (GMT -7)   
Of course, don't forget that there are plenty of conspiracy theorocists who believe simple vitamin supplement types of cancer cures have been suppressed by some sinister group. Is all of the information suspression and misdirection coordinated by a single "agency", or are there specialty groups that handle UFOs, energy, healthcare, etc.? 🙂 Well, who am I to say it doesn't happen?

Post Edited (mattamx) : 9/12/2017 7:39:37 PM (GMT-6)


InTheShop
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   Posted 9/13/2017 12:46 PM (GMT -7)   
it's the aliens. They don't want us to know the truth so they keep sabotaging the results. Their job has become much easier is the advent of the internet. A few false stories, some contradictions and presto - no one believes anything any more.
I'll be in the shop.
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