Vitamins C and E do nothing to prevent heart disease in men?

The discussion of the Linus Pauling vitamin C/lysine invention for chronic scurvy

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Vitamins C and E do nothing to prevent heart disease in men?

Post Number:#1  Post by chimp » Sun Nov 09, 2008 1:18 pm

http://news.yahoo.com/s/ap/20081109/ap_on_he_me/med_vitamins_heart_disease

The new one is the Physicians Health Study, led by Drs. Howard Sesso and J. Michael Gaziano of Harvard-affiliated Brigham and Women's Hospital in Boston.

It involved 14,641 male doctors, 50 or older, including 5 percent who had heart disease at the time the study started in 1997. They were put into four groups and given either vitamin E, vitamin C, both, or dummy pills. The dose of E was 400 international units every other day; C was 500 milligrams daily.

After an average of eight years, no difference was seen in the rates of heart attack, stroke or heart-related deaths among the groups.



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Re: Vitamins C and E do nothing to prevent heart disease in men?

Post Number:#2  Post by ofonorow » Mon Nov 10, 2008 4:15 am

Sure, because these doctors all died prematurely, probably of cancer..

Seriously, can anyone find at least the abstract of this or its title? Thx. 500 mg is a low dosage, but according to the nurses study, this should have prevented at least 30% of the "events" in the study group. I'd be very surprised if this report accurately describes the study results.
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Re: Vitamins C and E do nothing to prevent heart disease in men?

Post Number:#3  Post by EHSAL » Mon Nov 10, 2008 6:59 am

Here's the link to the full article, Owen...

http://jama.ama-assn.org/cgi/content/full/2008.600

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Re: Vitamins C and E do nothing to prevent heart disease in men?

Post Number:#4  Post by ofonorow » Mon Nov 10, 2008 3:06 pm

The PHS II represents the first large-scale, long-term trial of individual vitamin C supplementation in the prevention of cardiovascular disease in men. The Women's Antioxidant Cardiovascular Study (WACS) also tested 500 mg/d of vitamin C in 8171 women at higher risk of cardiovascular disease, and there was no effect on major cardiovascular end points.28 Other primary and secondary prevention trials have considered vitamin C as part of a vitamin combination, in which no cardiovascular benefits were observed.32-35


It is an amazing statement that this is the first long-term trial of vitamin C supplementation in the prevention of cardiovascular disease in men. Taking the paper at face value, the first thing to remember is that 500 mg is 1/10 the Pauling recommended dosage (5000 mg), or an order of magnitude smaller than the amount of vitamin C that Pauling recommended.

500 mg is 1/3 of the dosage that Willis used in the 1950s in which about 1/3 of the plaques became smaller.

There was nothing obviously wrong from the study paper. It seems like a reasonable attempt to measure any benefit from vitamins C/E, and one would think doctors, interested in science and the outcome, would be good subjects for a questionaire based study.

This study did not try to measure plaques, but cardiovascular endpoints - heart attack, stroke, death, etc. I am trying to understand the reason for the Phase I and Phase II, for it seemed strange that more than half dropped out during Phase I. (If anyone understands what happened, please post.) And the numbers in both groups, the study group and the placebo group, for both vitamins were obviously similar, almost too similar.

It does seem to be a great deal of effort to simply cook the books, but we would have to know what the expected rates were from other studies to know if these results are in the ball park. For example, if the mortality or morbidity rate in this study were say 30% less than other studies, it might indicate some benefit to both groups. (Perhaps the placebo group was taking vitamin C on their own.) If these numbers in both groups are worse than "normal", then perhaps the doctors were following their own advice any taking statin drugs?

I'll reserve judgment for now, but it does not seem unreasonable, but neither does it nullify the Pauling theory. It doesn't help it, and it would be VERY hard to repeat, so it isn't good science on that criteria alone.
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Re: Vitamins C and E do nothing to prevent heart disease in men?

Post Number:#5  Post by Steve Brown » Mon Nov 10, 2008 5:34 pm

A proper study would follow two groups from a young age into middle age, age 20 to age 40, testing the efficacy of supplemental vitamins C and E to prevent the development of arterial plaque. This would be a good experiment to conduct on prison inmates sentenced at a young age to 20 years or more. In prison, diet and other factors, such as exercise, can be scientifically controlled. The taxpayers might as well get a useful study for their money.

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Re: Vitamins C and E do nothing to prevent heart disease in men?

Post Number:#6  Post by ofonorow » Tue Nov 11, 2008 7:48 am

Steve Brown wrote:A proper study would follow two groups from a young age into middle age, age 20 to age 40, testing the efficacy of supplemental vitamins C and E to prevent the development of arterial plaque. This would be a good experiment to conduct on prison inmates sentenced at a young age to 20 years or more. In prison, diet and other factors, such as exercise, can be scientifically controlled. The taxpayers might as well get a useful study for their money.


Well, maybe. But this suggestion too, while more controlled, would be very hard to repeat and would cover a long period. The essence of true science is repeatability.

The study under discussion seems to have made a valid attempt to measure a cardiovascular benefit, and the surprise is that they didn't even find a small benefit. I would have predicted a 10-20% difference.

I am going to ask a statistician, what are the odds that you divide 14,000 people into 2 groups, and study them for 10 years, and that the two groups have IDENTICAL event outcomes? I think it highly improbable and suggests to me that perhaps the data was "cooked" prior to submitting it to analysis. From memory, an earlier long-term study by Rimm, et. al. of Nurses at Harvard - looking at diets from questionaires - found about 670 CVD "events" in an initial population of 67000. So this previous 1% figure might be help us judge this study. Was the event rate 1%, and if not why not? I'll have to reread and see if this can be determined, as well as why half the subjects dropped out during Phase I.
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Re: Vitamins C and E do nothing to prevent heart disease in men?

Post Number:#7  Post by ofonorow » Wed Nov 12, 2008 1:12 pm

I found the 1993 Rimm study, http://content.nejm.org/cgi/content/abs ... 28/20/1450

Methods In 1986, 39,910 U.S. male health professionals 40 to 75 years of age who were free of diagnosed coronary heart disease, diabetes, and hypercholesterolemia completed detailed dietary questionnaires that assessed their usual intake of vitamin C, carotene, and vitamin E in addition to other nutrients. During four years of follow-up, we documented 667 cases of coronary disease.


The 2008 JAMA study in question,


Design, Setting, and Participants The Physicians' Health Study II was a randomized, double-blind, placebo-controlled factorial trial of vitamin E and vitamin C that began in 1997 and continued until its scheduled completion on August 31, 2007. There were 14 641 US male physicians enrolled, who were initially aged 50 years or older, including 754 men (5.1%) with prevalent cardiovascular disease at randomization. Intervention Individual supplements of 400 IU of vitamin E every other day and 500 mg of vitamin C daily.

Main Outcome Measures A composite end point of major cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, and cardiovascular disease death).

Results During a mean follow-up of 8 years, there were 1245 confirmed major cardiovascular events.


Looking at the numbers, something is strange.

If we use the earlier Rimm study as a measure of reasonableness of the JAMA data, something is not quite right, without an explanation..

Study
Rimm (1993) ------ Jama (2008)

Enrolled
39,910 ------ 14,641

Events
667 ------ 1245

Years
4 ------ 8

Events/Year

166.7 ----- 155.62

Event-Years/Person (rate)

.04 ----- 1.06 Maybe

Probability of a person having a CVD event during the study
(4 years) ----- (8 years)
.0041 ----- .0106


If my math is correct (its been a trying day, please check) the rate of CVD-events per study and the probability of being a participant and having an event is 2.58 times higher in the recent JAMA study than the earlier Harvard study.

Why?

I sent email to the author at Harvard asking for his thoughts on why the rates differ.
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Re: Vitamins C and E do nothing to prevent heart disease in men?

Post Number:#8  Post by ofonorow » Sat Nov 22, 2008 6:27 am

Here is the Harvard author's response to my questions, followed by Dr. Hickey's analysis.

Dear Owen,

Thank you for your email, and your interest in our study published last week. There are too many differences between the 2 studies you mention to make any direct comparisons (other than both studies consisting of male health professionals).

The Rimm et al study (a cohort study, the Health Professionals Follow-up Study) was conducted among male health professionals aged 40 to 75 years and initially free of coronary heart disease at baseline, and with 3-4 years follow-up. Their endpoint was different - coronary heart disease (MI, CHD death) plus percutaneous coronary interventions.

The Physicians' Health Study II participants were considerably older at baseline (aged 50+ years, and mean age 63). Rates of CHD and/or CVD increase exponentially with age. In addition, some PHS II subjects had baseline cardiovascular disease, further increasing our overall rates of major cardiovascular events. And follow-up in PHS II was much longer (mean of 8 years), which allowed these older participants to develop more events over time. And finally, our primary primary endpoint was different - a combined endpoint of MI, stroke, and CVD death.

So .... the fact that our rates of CVD were higher, even though direct comparisions are not really valid here, is not very surprising....

I hope this clarifies things for you.

Kind regards,
Howard

~~~~~~~~~~~~~~~~~~~~~~~~

Howard D. Sesso, ScD, MPH

Assistant Professor of Medicine

Division of Preventive Medicine

Brigham and Women's Hospital

900 Commonwealth Avenue East - 3rd Floor

Boston, MA 02215

(w) 617-732-8837

(f) 617-731-3843




--------------------------------------------------------------------------------
From: orfonorow@aol.com [mailto:orfonorow@aol.com]
Sent: Wednesday, November 12, 2008 5:53 PM
To: hsesso@hsph.harvard.edu
Cc: vitamincfoundation@att.net
Subject: question on Vitamin C/E Study


Dear Dr. Sesso,

Thank you for your study as published in JAMA Nov 9.

I found an earlier study by Rimm,

http://content.nejm.org/cgi/content/abs ... 28/20/1450

and I was wondering what your thoughts were on the difference between the rates
of CVD events in your study and the earlier 1993 study. The Rimm study was of 4 years,
39910 male physicians and recorded 667 CVD events.

Your population was about 1/3, but the rate of CVD (on a yearly basis) seems to be at least 3 times higher.

Thank you for your response.

Owen Fonorow
Vitamin C Foundation




--------------------------------------------------------------------------------
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From Dr. Hickey,


Hi Owen,

There are always differences between studies. It could be the age distribution of the population, the geographic location, the social circumstances, or even just the investigators!

So these statements by Sesso in response to your question can be applied to almost any two studies.

The response conveys little information other than to highlight the limitations of these large scale sociological measures (trials and epidemiology). They can be taken to apply to only a specific group under circumscribed conditions to avoid providing a useful answer to a question. Alternately, the results can be extrapolated to all and generalised as
required.

Did you see the ANH and related responses:

http://www.anhcampaign.org/

I did an early draft of one document which was completed by Rob and Damien.

Kind regards

Steve

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Re: Vitamins C and E do nothing to prevent heart disease in men?

Post Number:#9  Post by ofonorow » Sun Nov 23, 2008 5:41 am

2 Birds with 1 Stone

http://www.entertainmentandshowbiz.com/ ... 0811235822

The same study that claimed no benefit w/r heart disease now is being used to claim no benefit w/r to cancer.

I am hoping the Foundation will be able to gain access to the raw data, as I'm sure the data tells a different story, in both cases.
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Re: Vitamins C and E do nothing to prevent heart disease in men?

Post Number:#10  Post by ofonorow » Thu Nov 27, 2008 2:22 am


Hi Owen,

Unfortunately the data are not available at this time, as the PHS II remains an ongoing randomized, double-blind, clinical trial of the multivitamin component for a few more years.

Take care,
Howard



--------------------------------------------------------------------------------

Sent: Saturday, November 22, 2008 10:51 AM
To: hsesso
Subject: Re: question on Vitamin C/E Study


Dear Dr. Sesso,

Thank you very much for responding. Is there any way to obtain the raw data from you or the NIH?


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Re: Vitamins C and E do nothing to prevent heart disease in men?

Post Number:#11  Post by ofonorow » Mon Dec 01, 2008 12:56 pm

So many questions.

If they won't release the data, then we are free to speculate on how they cooked the books. Let me count the ways. (Feel free to expand on this list, as if it matters. Studies like these are designed to influence medical doctors.)

1. Placebo group consumed the same amount of vitamin C, either on the side or in their food. Intentionally or unintentionally. The subjects were doctors.

2. Something else dominated the results, e.g. statin drugs taken by both groups.

3. The events were not weighted on the value of importance. In other words, with out seeing the raw data, how do we know whether the events in the vitamin group were mostly "angina pains" while the events in the placebo groups were mostly "heart attack"? (I suspect something along these lines become the number of "events" at least doubled from an earlier study of doctors.)

4. The groups were not randomized fairly.

5. The study was stopped (reported) when the two groups results were identical. (Medicine is famous for stopping studies as soon as the drug under study starts looking worse than placebo. Ergo they must have sophisticated ways to monitor study results real-tie.)

6. The pills were sabotaged and didn't contain vitamin C (E) or the right amount.

7. ??
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Re: Vitamins C and E do nothing to prevent heart disease in men?

Post Number:#12  Post by Steve Brown » Mon Dec 01, 2008 2:51 pm

[redundant post deleted]

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Re: Vitamins C and E do nothing to prevent heart disease in men?

Post Number:#13  Post by DanSco » Mon Dec 01, 2008 3:27 pm

7. The vitamin E was synthetic in a soft jell capsule full of trans-fat.
-DanSco

Note: I am not a doctor nor do I pretend to be one on the internet. Do not duplicate what I do without a pat on the head from your doctor and a note from your mommy.

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Re: Vitamins C and E do nothing to prevent heart disease in men?

Post Number:#14  Post by eternalwhitebelt » Tue Dec 09, 2008 12:31 pm

A bit off topic.


As to vitamin c or e being synthetic or natural. At this point in time I do not believe there is enough research to prove one is better than the other. Vitamins in food do appear to absorb better. This is clear. Some make issue with one needing less of the vitamin. This may be true. But if one is using a so called natural vitamin supplement,even if it absorbs better,what is the cost factor as opposed to just taking more of the cheaper synthetic version? I believe synthetic would still be cheaper.

Now specifically Vitamin E. I have read in other post that the d version is superior to the dl version.
This is true. But again all one need to do is up the dosage of the dl version.Some may think it wont work because its a synthetic.But it is dl.There are roughly 50% d and 50% l isomers .The l isomers may not serve a function? But the d is still d and will work the same as a natural d version supplement.You just may have to up the dose.

As far as the beta, gamma, and delta. Some research points to good possibilities.Others that they may in fact be damaging. Again, from a cost stand point,there may be other supplements that are cheaper and do what these versions may in terms of benefits.And to my understanding Alpha is still the most active and the one that most research has been done on.

I also believe that the Vitamin e standards and absorptions were originally done with synthetic E,do to cost factor. I am unclear if there are new standards based on just the natural d version.

This post is not entirely in response to this thread but also in response to other post I have read.Some in the c complex forum,but not allowed to post there.

Some questions, how much transfat can there be in a little capsule of vitamin e? Is it so much that one really needs to worry about it. Would the antioxidant values of the Vitamin e not destroy most if not all of its negative possibilities? Is there also a possible problem with gel caps?

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Re: Vitamins C and E do nothing to prevent heart disease in men?

Post Number:#15  Post by ofonorow » Wed Dec 10, 2008 3:58 am

These are good points, and my only reason for "conceding" natural vitamin E to the naturalists has to do with the fact that I don't believe the actual vitamin E molecule is known, is it? How do you synthesize something you don't know its exact chemical character?
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