Currently browsing posts about: Supplements

Here’s another one that several readers have asked me about: Multivitamin Supplementation Improves Memory in Older Adults: A Randomized Clinical Trial.  Authors: Lok-Kin Yeung, Daniel M. Alschuler, Melanie Wall, Howard D. Sesso, JoAnn E. Manson, Adam M. Brickman.  American Journal of Clinical Nutrition. DOI:https://doi.org/10.1016/j.ajcnut.2023.05.011

The study: “Participants were randomly assigned to a daily multivitamin supplement (Centrum Silver) or placebo and evaluated annually with an Internet-based battery of neuropsychological tests for 3 y.”  Primary outcome measure: change in episodic memory (immediate recall performance on the ModRey test, after 1 y of intervention).  Secondary outcome measures: changes in episodic memory over 3 y of follow-up,  and in performance on neuropsychological tasks of novel object recognition and executive function over 3 y.

Results: “Compared with placebo, participants randomly assigned to multivitamin supplementation had significantly better ModRey immediate recall at 1 y, the primary endpoint (t(5889) = 2.25, P = 0.025), as well as across the 3 y of follow-up on average (t(5889) = 2.54, P = 0.011). Multivitamin supplementation had no significant effects on secondary outcomes…we estimated that the effect of the multivitamin intervention improved memory performance above placebo by the equivalent of 3.1 y of age-related memory change.”

Conflict of interest: HDS, JEM, and AMB received investigator-initiated grant support to their institutions from Mars Edge. Pfizer Consumer Healthcare (now Haleon) provided support through the partial provision of study pills and packaging. HDS received investigator-initiated grants from Pure Encapsulations and Pfizer Inc and honoraria and/or travel for lectures from the Council for Responsible Nutrition, BASF, NIH, and the
American Society of Nutrition during the conduct of the study. No funding sources had a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and the decision to submit the manuscript for publication.

Funding: This work was supported by an investigator-initiated grant from Mars Edge, a segment of Mars Inc dedicated to nutrition research. Pfizer Consumer Healthcare (now Haleon) provided support through the
partial provision of study pills and packaging.

Comment:  This study continues to surprise me.  As I’ve written before, it is part of the COSMOS trial, which is also supported by grants from NIH and a private foundation.  In my previous post on it, I noted that despite being funded by Pfizer (which makes Centrum Silver multivitamin supplements), the study did not show benefits of the supplement for prevention of cardiovascular disease or cancer—a rare exception to the rule that industry-funded studies tend to favor the sponsor’s interests.  But here we go again, this time with an equally surprising result but for a different reason: most multivitamin studies have shown no benefits whereas this one says if you take Centrum Silver, it will give you another three years of no loss in memory.  Wow!  I’ll be Pfizer is thrilled.

Here’s what the NIH National Center for Complementary and Integrative Health says about multivitamins:

I give high praise to NutraIngredients.com for doing full disclosure in the title of an article: “Industry study concludes whey promotes muscular strength and endurance, independent of diet.”

Whey protein supplementation promotes muscle mass increase and selective increases in muscular strength and endurance from resistance exercise, independent of dietary influence, according to a new industry-funded study.

I looked up the study.

The Federal Trade Commission has issued a Health Products Compliance Guide.

This amazing publication takes on the Dietary Supplement Health and Education Act of 1994.  That act effectively removed the FDA from regulating dietary supplements.  It also allowed supplement labels to make “structure/function” claims that the supplement supported some structure or function of the body, whether or not there was much in the way of scientific evidence to back up those claims (in contrast, FDA-authorized claims must be scientifically substantiated).

Now the FTC is saying:

Marketers of health-related products, including dietary supplements, should be familiar with the requirements under both FDA law and FTC law that labeling and advertising claims be truthful, not misleading, and substantiated.  The FTC approach generally requires that health-related claims be backed by competent and reliable scientific evidence substantiating that the representations are true.

Marketers cannot suggest unsubstantiated benefits, safety, or other characteristics.

Example 4:  An ad for an infant formula states that an ingredient added to the formula can reduce the symptoms of colic.  The ad includes an unrelated chart from a pediatric journal showing that, as a general principle, the length of time that colicky babies cry tends to decrease over the first 12 weeks of life…Using the graph in an ad for the infant formula likely implies that the formula, rather than the babies’ ages, causes the decrease in crying time.

Claims have to be qualified.

Example 10:  An energy drink contains an ingredient that, when consumed daily over an extended period, can result in a significant increase in blood pressure.  Even absent any representation about the product’s safety, the marketer should disclose this potentially serious risk.

Qualifying information must be clear and straightforward.

Example 13:  A company has results from two studies suggesting that its supplement helps to maintain healthy cholesterol levels.  There are, however, significant limitations to each of the studies… The company makes a claim in advertising that “promising, preliminary scientific studies show that our product may be effective in reducing cholesterol.”  The use of the words “promising,” “preliminary,” and “may” is unlikely to sufficiently convey the limitations of the science.

Assertions about the strength of evidence must be accurate.

Example 16: An ad for a supplement includes the statement “Scientists Now Agree!” in discussing the product’s benefit.  This statement likely conveys to consumers that the state of science supporting the benefit has reached the level of scientific consensus.  Unless the advertiser possesses evidence demonstrating that scientists have reached that consensus, the claim is false.

Marketers must consider the totality of the science.

Example 30:  An advertiser wants to claim that a supplement will substantially reduce body fat.  The advertiser has two controlled, double-blind studies showing a modest but statistically significant loss of fat at the end of a six-week period.  However, there is an equally well-controlled, double-blind 12-week study showing no statistically significant difference between treatment and control groups.  Assuming other aspects of methodology are similar, the studies taken together suggest that, if the product has any effect on body fat, it would be very small and may not persist over time.  Given the totality of the evidence, the claim is unsubstantiated.

Here’s the press release. 

The bottom line:  The FTC is requiring evidence for health claims on supplements.

This will affect claims for thousands of supplement products.

Enforcement anyone?  This should be fun to watch.

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I received an email from the American Kratom Association, an organization I did not know existed. (now, I do).

Landmark Bipartisan Bill Regulating Kratom in the United States Introduced in Congress

Bill will ensure consumers have continued access to safe, regulated kratom products

The American Kratom Association is elated to announce Federal Kratom Consumer Protection Act legislation has been filed in both the Senate and House. This is a monumental moment for kratom consumers and a significant step towards protecting the rights of millions of Americans. The fight is far from won, but we are only arriving at this exciting event because of the support of so many amazing advocates.

What is kratom?  It depends on whom you ask.

The American Kratom Association says:

Kratom is a plant that has been used safely for centuries in Southeast Asia and in the United States since the early 1970s. ..for a variety of health and wellness purposes, including for an energy boost, increased focus, reducing anxiety, and as a personal harm reduction tool for managing acute and chronic pain.   [see KratomAnswers.org for details]

The U.S.  Drug Enforcement Administration agrees that Kratom has a long history of use in Southeast Asia.   But, it says,

Consumption of its leaves produces both stimulant effects (in low doses) and sedative effects (in high doses), and can lead to psychotic symptoms, and psychological and physiological dependence….In the U.S., the abuse of kratom has increased markedly in recent years…The FDA has not approved Kratom for any medical use. In addition, DEA has listed kratom as a Drug and Chemical of Concern.

The FDA says kratom is an unapproved drug and writes cease-and-desist letters to its sellers.

This begins to sound  just like what’s going on with hemp and marijuana in New York State (see yesterday’s post).

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Happy new year to all.!

And now, back to my Monday postings of industry-funded studies.  Today’s is about the popular herbal supplement, ashwagandha.   This is typically taken to reduce stress and improve a wide variety of health problems, but little science backs up those contentions.  Hence, this study, which I learned about from reading an account of it: Single ashwagandha dose may exert cognitive performance: Study.  That headline was all it took to get me to ask my usual question: Who paid for this?

The study: Effects of Acute Ashwagandha Ingestion on Cognitive Function. Int. J. Environ. Res. Public Health 2022, 19(19), 11852; https://doi.org/10.3390/ijerph191911852

Methods: The study assessed performance on the Berg–Wisconsin Card Sorting (BCST), Go/No-Go (GNG), Sternberg Task (STT), and Psychomotor Vigilance Task (PVTT) tests.   Participants took a placebo or ashwagandha (ASH) extract (NooGandha^®, Specnova Inc., Boca Raton, FL, USA).

Conclusions: Acute supplementation with 400 mg of ashwagandha improved selected measures of executive function, helped sustain attention, and increased short-term/working memory.

Funding: “This study was funded as a fee-for-service project awarded to the Human Clinical Research Facility at Texas A&M University from Specnova, Inc. (Boca Raton, FL, USA)…Specnova was not involved in any way in data collection, analysis of the data, or the writing of the manuscript.”

Comment: Specnova, you will not be surprised to learn, is a supplier of supplement ingredients.  The company ordered the study to its specifications.  It got the result it wanted, as funders almost invariably do.  Despite booming sales of ashwagandha, so little is known about its properties that the National Center for Complementary and Integrative Medicine does not even have a fact sheet for it among its reviews of herbal supplements.  Industry-sponsored research to the rescue!  And of course it “was not involved in any way…”  It didn’t have to be.  Funding is usually enough to induce unconscious bias on its own.

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The FDA’s food operations are under siege over problems with infant formula, the Fresh Harvest recall, and all its other food safety and regulatory problems.

As you saw yesterday, it has plenty of time for educational initiatives.

This one is called “Supplement Your Knowledge.”  Its purpose is to help inform health care professionals, consumers, and educators about the hazards of dietary supplements.

How is the FDA helping with this?

• For consumers: Public education videos and fact sheets.
• For educators: Curriculum guide, Science and Our Food Supply: Examining Dietary Supplements (2021 Edition).
• For healthcare professionals: In collaboration with the American Medical Association (AMA), a continuing medical education (CME) program, free.  This includes three videos and companion education materials available on the FDA’s Healthcare Professionals website.  Physicians should go to the AMA Ed Hub^TM

The FDA is worried about harm from thousands of products that are largely unregulated, thanks to the Dietary Supplement Health and Education Act of 1994 (DSHEA).  This act took the FDA out of the business of regulating supplements, allowed supplement manufacturers to claim pretty much anything they want about supplements (regardless of evidence), and left ghe matter of what’s actually in the bottles as a matter of faith.

More than half of American adults take supplements of one kind or another, despite lack of evidence that they do any good at all for reasonably healthy people.  Fortunately, most are harmless.

The FDA wants to encourage supplement users to report adverse effects from the ones that aren’t.

I’m guessing the AMA wants to discourage physicians from inappropriately suggesting supplements and encourage them to recognize adverse events when they see them.

Congress passed DSHEA.  It will take another act of Congress to  protect the public from supplements that contain what they shouldn’t, don’t contain what they should, and otherwise mislead the public about what they can do.

Related Information

• To report a problem: the Safety Reporting Portal.
• Dietary Supplements Social Media Toolkit
• Additional information on dietary supplements:  www.fda.gov/dietarysupplements.
• Constituent Update 
• Dietary Supplements Education Initiative  
• Information for Consumers on Using Dietary Supplements
• Dietary Supplements

I found this discussion on David Allison’s remarkably useful weekly collection of articles about obesity and energetics.  His listings include articles in categories, one of them “Scientific Rigor & Scholarly Dialogue.”

I was particularly interested in this example:

• Article: Efficacy of Vitamin C for the Prevention and Treatment of Upper Respiratory Tract Infection. A Meta-Analysis in Children.
• Letter: Meta-Analysis on Vitamin C and the Common Cold in Children May Be Misleading.
• Reply: Authors’ Response to Letter to the Editor: “Meta-Analysis on Vitamin C and the Common Cold in Children May Be Misleading”.
• Retraction: Efficacy of Vitamin C for the Prevention and Treatment of Upper Respiratory Tract Infection. A Meta-Analysis in Children.
• Summary: Vitamin C and the Common Cold in Children: Severe Flaws in the Meta-Analyses by Vorilhon et al. (2019).

This took me back to one of my all-time-favorite research studies: Ascorbic Acid for the Common Cold: A Prophylactic and Therapeutic Trial.  JAMA;1975;231:1038-1942.

Linus Pauling wrote Vitamin C and the Common Cold in 1970.  NIH investigators wondered if there was anything to it.  They got 300 volunteers to take vitamin C or a placebo and measured the number of colds and their duration in both groups.

When they first looked at the data, it looked like the volunteers who were taking vitamin C had fewer and shorter colds.   Exciting!

But these were highly rigorous investigators.

They examined the data closely and noticed that an unusually large number of participants had dropped out of the trial, especially those in the placebo group (44%).  They guessed that participants thought they knew what they were taking and dropped out if they “knew” they were taking the placebo.

They reanalyzed the data to account for participants thought they were taking.

The final result: volunteers who thought they were taking vitamin C reported fewer and shorter colds, regardless of whether they were taking vitamin C or the placebo.

Those who thought they were taking the placebo had more and longer colds, regardless of whether they were taking the placebo or vitamin C.

Comment: This study provides compelling evidence for the placebo effects of vitamin C.  Placebo effects are powerful. I’m all for them.  The authors of the recently retracted study should have read this one first.

I am not much of a fan of dietary supplements and have to admit to confirmation bias; I collect studies that provide evidence for skepticism about how well they work.

So when a reader, Arya Afrashteh, sent this study, I gave it some attention.

The study:  Dietary Supplements as Source of Unintentional Doping.  Vanya Rangelov Kozhuharov, Kalin Ivanov, and Stanislava Ivanova.  Biomed Res Int. 2022; 2022: 8387271. Published online 2022 Apr 22. doi: 10.1155/2022/8387271

The rationale:  Athletes are not supposed to take performance-enhancing drugs but they are permitted to take dietary supplements.  Are these safe?

Method: A review of the literature on unapproved substances found in dietary supplements.

Results: 875 of 3132 supplements contained undeclared substances.

Conclusion: ~28% of the analyzed dietary supplements pose a potential risk of unintentional doping.

Comment:  Between one-quarter and one-third of dietary supplements taken for performance enhancement contained unlabled substances that could test as unapproved drugs.

This is a result of the Dietary Supplement Health and Education Act of 1994 (DSHEA) that basically deregulated dietary supplements.  It took supplements out from under the control of the FDA.

All the FDA can do is write warning letters, which it occasionally does.

But unless the FDA is checking, you cannot be sure that what is in the supplements is accurately reflected by their labels.  Sports supplements, it seems, are prime examples of why this is a problem.

Caveat emptor.