Enough Is Enough: Stop Wasting Money on Bad Nutritional Research
By Dr Ira Bernstein - The media has been having a frenzy the week before Christmas playing into the hands of the editors of the Anals of In...
http://gcingles.blogspot.com/2013/12/enough-is-enough-stop-wasting-money-on.html
By Dr Ira Bernstein -
The media has been having a frenzy the week before Christmas playing into the hands of the editors of the Anals of Internal Medicine (typo intentional). The headline of the editorial (December 17, 2013) reads “Enough Is Enough: Stop Wasting Money on Vitamin and Mineral Supplements” (Eliseo Guallar, Saverio Stranges, Cynthia Mulrow, Lawrence J. Appel, and Edgar R. Miller III)
There are three published articles in the journal:
1) Vitamin and Mineral Supplements in the Primary Prevention of Cardiovascular Disease and Cancer: An Updated Systematic Evidence Review for the U.S. Preventive Services Task Force. This was a review of previously published studies that the authors deemed were of fair or good quality. Many of the studies looked at individual or paired vitamins (usually not a good idea if you are looking at endpoints such as cancer or heart disease and you are supplementing one or two nutrients. This is a recipe for failure.)
The biggest multivitamin studies in this review were 1) Supplementation in Vitamins and Mineral AntioXidants Study (SU.VI.MAX) amongst 13017 men and women living in France and examined a 5-ingredient multivitamin (that was a waste of time) and 2) Physicians’ Health Study II (PHS-II) testing the efficacy of a 30 ingredient commercial multivitamin among 14641 U.S. male physicians. I have commented on this study in previous posts. This so called comprehensive vitamin was none other than Centrum Silver (which is rated 1.5 stars out of 5 in Nutrisearch Comparative Guide to Nutritional Supplement, by Lyle MacWilliam). It isn’t Dr. Bernstein who can prove the limited benefits of a nearly useless supplement. The scientists who understand the science of cell function and have determined according to the best science of the day what nutrients are essential and in what optimal amounts for best cell function. Regardless the PHS-II study still did find a borderline statistically significant benefit for fatal myocardial infarction and reduced overall cancer incidence after 11.2 years of follow-up.
Single and paired vitamins and minerals found little consistent evidence to support or refute a health effect on all-cause mortality or the incidence of cardiovascular disease or cancer for supplementation with vitamins A, C, or D; folic acid; selenium; or calcium (totally not surprising at all).
The authors of the review concluded that even though these two multivitamin trials showed “lower overall cancer incidence in men, the lack of an effect for women (they were not studied in the PHS-II study) , the borderline significance in men in both trials and the lack of any effect on CVD in either study makes it difficult to conclude that multivitamin supplementation is beneficial”.
2) The next study published is entitled “Long-Term Multivitamin Supplementation and Cognitive Function in Men: A Randomized Trial.” This was a subset of the Physicians’ Health Study (II). This compared Centrum Silver versus placebo in male physicians aged 65 or older. They found that there was no difference in mean cognitive change over time between the multivitamin and placebo groups or in the mean level of cognition at any of the 4 assessments. The authors acknowledged that a limitation of the study was that “Doses of vitamins may be too low or the population may be too well-nourished to benefit from a multivitamin”. Dr. Bernstein and the scientists will reiterate that the benefits of a marginal vitamin such as Centrum Silver with RDA levels of nutrients and some poor quality ingredients such as synthetic vitamin E (d-l alpha tocopherol) will have marginal benefits. I would never anticipate any benefit on cognition with such a regimen.
3) The final study is entitled “Oral High-Dose Multivitamins and Minerals after Myocardial Infarction: A Randomized Trial. To me, this was actually the most interesting trial because it took higher risk patients (those who recently had a heart attack) but for some reason they decided to throw in chelation therapy as part of the trial. The high dose vitamin regimen was from TACT (Trial to Assess Chelation Therapy) containing 28 vitamin, minerals and other ingredients. By comparison, the highest rated multivitamin product in the Comparative Guide to Nutritional Supplements, being USANA Essentials contains 43 ingredients). Although they don’t identify the brand of supplement used in TACT, my guess is that it would rate around a 3 star product based on my eyeballing the ingredients and comparing with a 5-star product). Anyways, this trial had 1708 mostly male patients, median age 65. Unfortunately, almost 50% of the subjects dropped out of the trial. This makes data analysis virtually useless in a now much smaller trial as there were too few subject to begin with. The authors wrote: “The high-dose vitamins used in TACT showed an 11% relative reduction in the primary composite end point (time to total death, recurrent myocardial infarction, stroke, coronary revascularization, or hospitalization for angina) relative to the placebo group that was not statistically significant. Thus, although this trial does not support the routine use of this high-dose oral multivitamin regimen for all patients who have had MI, the reduced statistical power due to a small difference between groups, as well as nonadherence to the study regimen, limits the conclusion of nonefficacy....”. So, even though this was a horrendously compromised study that should have never been published, there was still a slight benefit seen in the high-dose vitamin regimen.
Despite all of this, the editors of the Annals of Internal Medicine have made some very strong comments as if the lord has spoken and stated “Other antioxidants, folic acid and B vitamins, and multivitamin and mineral supplements are ineffective for preventing mortality or morbidity due to major chronic diseases....we believe that the case is closed – supplementing the diet of well-nourished adults with (most) mineral or vitamin supplements has no clear benefit and might even be harmful. These vitamins should not be used for chronic disease prevention. Enough is enough.” I hear thunder and see bolts of lightning and perhaps even the parting of the Red Sea by these authoritarians. The only thing missing in the commentary is as follows “The editors of this journal greatly acknowledge the generous support of Merck, Pfizer, Bayer, Bristol Myers Squibb, Johnson and Johnson, Astra Zeneca, Glaxo Smith Kline etc.”
I will add my own few words to the discussion. It is widely acknowledged that it is extremely difficult to conduct large clinical trials with nutritional supplements. It is most common to read these medical experts like the editors of the Annals write “This message (avoid vitamins) is especially true for the general population with no clear evidence of micronutrient deficiencies, who represent most supplement users in the United States and other countries.” Nothing could be further than the truth. Absolutely everybody in Canada is vitamin D deficient or insufficient unless supplementing. I see vitamin B12 insufficiency in a huge portion of my practice. The list of nutritional deficiencies caused by pharmaceutical products is extensive, well documented and rarely picked up by physicians who do not go looking for them when medications are prescribed. These deficiencies may produce symptoms that are then treated with other pharmaceuticals rather than correcting the underlying problem.
When conclusions are made of the entire nutritional industry based on Centrum studies one really has to take these conclusions with a grain of salt. Anybody who has an understanding of cellular nutrition and the nutritional product spectrum are aware of vastly different qualities of products. I fully endorse the concept that all one a day multivitamin are for the most part useless when looking to optimize cellular health. The scientists that understand the cell, like Dr. Myron Wentz are miles ahead of the clinical trials that we would like to see, but may never get to see to provide the so called evidenced based science that health care providers are trained to look for to determine so called best practices.
3) The final study is entitled “Oral High-Dose Multivitamins and Minerals after Myocardial Infarction: A Randomized Trial. To me, this was actually the most interesting trial because it took higher risk patients (those who recently had a heart attack) but for some reason they decided to throw in chelation therapy as part of the trial. The high dose vitamin regimen was from TACT (Trial to Assess Chelation Therapy) containing 28 vitamin, minerals and other ingredients. By comparison, the highest rated multivitamin product in the Comparative Guide to Nutritional Supplements, being USANA Essentials contains 43 ingredients). Although they don’t identify the brand of supplement used in TACT, my guess is that it would rate around a 3 star product based on my eyeballing the ingredients and comparing with a 5-star product). Anyways, this trial had 1708 mostly male patients, median age 65. Unfortunately, almost 50% of the subjects dropped out of the trial. This makes data analysis virtually useless in a now much smaller trial as there were too few subject to begin with. The authors wrote: “The high-dose vitamins used in TACT showed an 11% relative reduction in the primary composite end point (time to total death, recurrent myocardial infarction, stroke, coronary revascularization, or hospitalization for angina) relative to the placebo group that was not statistically significant. Thus, although this trial does not support the routine use of this high-dose oral multivitamin regimen for all patients who have had MI, the reduced statistical power due to a small difference between groups, as well as nonadherence to the study regimen, limits the conclusion of nonefficacy....”. So, even though this was a horrendously compromised study that should have never been published, there was still a slight benefit seen in the high-dose vitamin regimen.
Despite all of this, the editors of the Annals of Internal Medicine have made some very strong comments as if the lord has spoken and stated “Other antioxidants, folic acid and B vitamins, and multivitamin and mineral supplements are ineffective for preventing mortality or morbidity due to major chronic diseases....we believe that the case is closed – supplementing the diet of well-nourished adults with (most) mineral or vitamin supplements has no clear benefit and might even be harmful. These vitamins should not be used for chronic disease prevention. Enough is enough.” I hear thunder and see bolts of lightning and perhaps even the parting of the Red Sea by these authoritarians. The only thing missing in the commentary is as follows “The editors of this journal greatly acknowledge the generous support of Merck, Pfizer, Bayer, Bristol Myers Squibb, Johnson and Johnson, Astra Zeneca, Glaxo Smith Kline etc.”
I will add my own few words to the discussion. It is widely acknowledged that it is extremely difficult to conduct large clinical trials with nutritional supplements. It is most common to read these medical experts like the editors of the Annals write “This message (avoid vitamins) is especially true for the general population with no clear evidence of micronutrient deficiencies, who represent most supplement users in the United States and other countries.” Nothing could be further than the truth. Absolutely everybody in Canada is vitamin D deficient or insufficient unless supplementing. I see vitamin B12 insufficiency in a huge portion of my practice. The list of nutritional deficiencies caused by pharmaceutical products is extensive, well documented and rarely picked up by physicians who do not go looking for them when medications are prescribed. These deficiencies may produce symptoms that are then treated with other pharmaceuticals rather than correcting the underlying problem.
When conclusions are made of the entire nutritional industry based on Centrum studies one really has to take these conclusions with a grain of salt. Anybody who has an understanding of cellular nutrition and the nutritional product spectrum are aware of vastly different qualities of products. I fully endorse the concept that all one a day multivitamin are for the most part useless when looking to optimize cellular health. The scientists that understand the cell, like Dr. Myron Wentz are miles ahead of the clinical trials that we would like to see, but may never get to see to provide the so called evidenced based science that health care providers are trained to look for to determine so called best practices.
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Having been a practicing physician for almost 22 years, I have seen how the evidence for clinical practice evolves. Much of what we did 10 years ago is virtually verboten now (eg hormone replacement therapy. Where was the evidence to support its use for so many decades when in fact it was causing more harm than benefit?). A few years ago, we were putting all our post menopausal patients of bisphosphonates (Fosamax and Actonel) for PREVENTION of osteoporosis. Today, that is out the window. The countless stream of pharmaceuticals that have come and gone due to harm is too immense to quantify. I’m not here to blast the who pharma industry. As a clinician with a full time practice, I need the right medications still at the right time for the right people. However, with a better understanding of cellular nutrition, I have seen how my own patients have benefited from optimal nutritional supplementation as I have seen my own health improve from illness.
The editors of the Annals of Internal medicine complain that sales of the U.S. supplement industry continues to grow, reaching $28 billion in annual sales in 2010. I would add that there is a lot more room for growth there. One day we will be able to say: “See, I told you so!”
I will conclude by saying: Eat well, exercise and continue to take or to start taking quality multivitamin and mineral supplements. Do not let the Annals of Internal Medicine mislead you or detract you from the experts in cellular health who are not out to make a quick buck but have a genuine understanding for keeping your cells healthy.
The editors of the Annals of Internal medicine complain that sales of the U.S. supplement industry continues to grow, reaching $28 billion in annual sales in 2010. I would add that there is a lot more room for growth there. One day we will be able to say: “See, I told you so!”
I will conclude by saying: Eat well, exercise and continue to take or to start taking quality multivitamin and mineral supplements. Do not let the Annals of Internal Medicine mislead you or detract you from the experts in cellular health who are not out to make a quick buck but have a genuine understanding for keeping your cells healthy.
