Supplements touting CV benefits may be ‘harmful distraction’ from proven solutions
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Dietary supplements are big business in the United States and elsewhere, especially when it comes to products marketed to support CV health.
Data from the National Health and Nutrition Examination Survey assessing dietary supplement use from 2017 to 2018 show 57.6% of respondents reported taking any dietary supplement in the past 30 days, with supplement use increasing with age. Eighteen percent reported taking a supplement to support “heart health.” In 2021, people in the U.S. spent an estimated $50 billion on supplements and the supplement industry spent about $900 million on marketing, according to the North America Dietary Supplements Market Report from Grand View Research. Many supplements are marketed as natural alternatives for heart protection and cholesterol management.
For the consumer, such claims can be confusing. A 2016 research study conducted by the Association of Black Cardiologists among Black U.S. residents diagnosed with hypercholesterolemia found that 57% of respondents said they believed that dietary or herbal supplements are “more effective” than a prescription statin medication for cholesterol health.
“The supplement industry is preying on people’s unfounded fears of regulated pharmaceuticals,” Luke J. Laffin, MD, co-director of the Center for Blood Pressure Disorders at Cleveland Clinic, told Cardiology Today. “There is this sense of, ‘I want to do things naturally and that is better than getting a prescription from my physician.’ That is an erroneous belief, but trying to convince patients of that is challenging. [Many supplement] ingredients are found in nature; that is true. But they are manufactured in a plant just like everything else. The pill does not grow on a tree. There is a marketing disconnect, and we as doctors must be more proactive in explaining that to patients.”
Fighting that marketing disconnect can be difficult, according to JoAnn E. Manson, MD, DrPH, MACP, FAHA, chief of the division of preventive medicine at Brigham and Women’s Hospital and professor of medicine and the Michael and Lee Bell Professor of Women’s Health at Harvard Medical School. Misconceptions about supplements could be dangerous for people with certain CV conditions, especially if the supplements adversely interact with their medications or distract from higher-priority activities.
Experts have long called for rigorous randomized controlled trial data to assess popular dietary supplements that claim CV benefits. At the American Heart Association Scientific Sessions in November, Laffin presented data from the SPORT study, which demonstrated that daily rosuvastatin lowered LDL, total cholesterol and serum triglycerides significantly more than placebo and six common over-the-counter dietary supplements, with no supplement lowering LDL more than placebo. Manson said the SPORT findings show how important it is to ask patients about what supplements they are taking and to counsel them on CVD prevention methods.
“We already know that more than 80% of heart disease is preventable by a number of lifestyle behaviors and control of BP, cholesterol and glucose,” Manson told Cardiology Today. “To be focusing energy on finding various dietary supplements, shopping for them and taking them as part of a daily regimen can be a harmful distraction. Beyond that, just throwing dietary supplements at an unhealthy diet and sedentary lifestyle will not improve health.”
‘A much lower bar’: Supplements vs. prescriptions
A website for the popular dietary supplement SuperBeets promises consumers the berry-flavored soft chews are “clinically shown to promote normal blood pressure as part of a healthy lifestyle.” The site includes claims the supplement provides “circulatory support” and antioxidant support “to help protect against oxidative stress and damage.”
In smaller print at the bottom of the website is a required disclaimer: “These products are not intended to diagnose, treat, cure or prevent any disease.”
Similarly, makers of the garlic supplement Garlique, described as a “powerful natural ally for your heart health,” promise to “help maintain normal healthy blood pressure levels.” A turmeric supplement from Qunol purports to support a “healthy inflammation response.”
“The supplement industry uses this coded language — phrases like ‘heart health,’ or ‘anti-inflammatory,’” Laffin said. “These are phrases that don’t really mean anything. They are not backed up by data. That allows the supplement industry to get around the regulations for marketing. They cannot make a claim that a product reduces heart attacks or cholesterol in any meaningful way. It is admitted by the supplement industry, but they hide it.”
Marketing of dietary supplements is regulated under the Dietary Supplement Health and Education Act of 1994, which assigns oversight of marketing and promotion primarily to the Federal Trade Commission, rather than the FDA. That pathway is a very different one compared with the oversight required for prescription medications, according to Deepak L. Bhatt, MD, MPH,Cardiology Today Intervention Section Editor, director of Mount Sinai Heart and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai.
“Supplements are assessed by FDA, but in the same way food is regulated,” Bhatt told Cardiology Today. “You cannot sell a poison. However, no one is checking to see if the claims a supplement may make about health have any scientific validity. In general, one can be slightly reassured that supplements are probably not very unsafe. In terms of efficacy, supplements are a complete leap of faith. There is a much lower bar for supplements vs. prescription medicines.”
For the general public, that distinction is often overlooked or misunderstood. For others, there is suspicion regarding the FDA regulatory process for prescription medications.
Some patients may express fear of taking a prescription medication like a statin due to anecdotal reports about muscle pain or other adverse effects, according to Pam R. Taub, MD, founder and director of Step Family Cardiac Wellness and Rehabilitation Center and professor of medicine at UC San Diego Health. That fear can drive patients to seek out dietary supplements, which do not have to adhere to the same advertising requirements as a pharmaceutical company marketing an FDA-approved prescription medication. According to the FDA, a supplement manufacturer usually does not have to provide the agency with the evidence it relies on to substantiate safety before or after it markets its products.
“The supplement industry has great marketing, which can be attractive for patients vs. pharma ads where every single side effect is listed,” Taub told Cardiology Today. “Cardiologists are up against well-done advertising campaigns, where the science and data are not emphasized.”
Goal to avoid harm
In a viewpoint article published in JAMA in 2018, Manson and a colleague noted some trials suggest that micronutrient supplementation in amounts that exceed the recommended dietary allowance, such as high doses of beta-carotene, folic acid, vitamin E or selenium, may have harmful effects, including increased risks for cancer, hemorrhagic stroke and even all-cause mortality. Some supplements can affect reliability of test results; high-dose vitamin B7 (Biotin) can interfere with measurement of troponin, Manson said.
There are also other potential adverse CV effects.
“High-dose fish oil has been linked to increased risk for atrial fibrillation and bleeding,” Manson said. “Ginkgo biloba, ginseng, vitamin E and even garlic in high doses have also been linked to increased risk for bleeding. Some supplements, like turmeric or glucosamine chondroitin, can interact with anticoagulants to further increase bleeding risk.”
A key principle is to avoid “mega-dosing,” Manson said, including vitamins and minerals like high-dose vitamin E or beta-carotene.
For many people, the harm may come from spending money on an expensive supplement instead of an inexpensive preventive medication for CVD, Laffin said.
“I’ll be frank: Most of these supplements probably aren’t going to do anything,” Laffin said. “They are not going to hurt you, but they are not going to help you either. However, there is always that possibility of harm, and why would you want that possibility?”
Head-to-head data ‘sobering’
To test whether supplements may have any discernable benefit on CV risk factors, Laffin and colleagues designed the SPORT study to compare popular dietary supplements with placebo and a commonly prescribed statin. Researchers randomly assigned 190 adults with an LDL between 70 mg/dL and 189 mg/dL to one of eight groups to 5 mg daily of rosuvastatin, placebo or one of six dietary supplements: fish oil (Nature Made), cinnamon (NutriFlair), garlic (Garlique), turmeric (BioSchwartz), plant sterols (Nature Made CholestOff Plus) or red yeast rice (Arazo Nutrition).
The percent LDL reduction with rosuvastatin was greater than all supplements and placebo (P < .001).
None of the dietary supplements demonstrated a significant decrease in LDL compared with placebo.
“What we saw was not necessarily surprising,” Laffin said. “Rosuvastatin lowered LDL by almost 38% and was vastly superior to any of the supplements and placebo. Additionally, supplements did not lower LDL cholesterol, inflammatory markers, total cholesterol or triglycerides any more than placebo. One of the surprising features was garlic increased cholesterol. This was sobering, and I’m glad we have this data for the public.”
Observational studies suggest possible benefits
Observational analyses suggest that some dietary supplements may have beneficial CV effects. Data published in December in the Journal of the American College of Cardiology showed supplementation of some micronutrients, in particular antioxidant supplements, may benefit CV health. The meta-analysis, which included more than 883,000 participants across hundreds of studies, found that antioxidant supplements like omega-3 fatty acids, folic acid and coenzyme Q10 were associated with reduced CVD mortality and stroke risk.
In a systematic review of 28 studies assessing the effectiveness of ginger, cinnamon, turmeric, curcumin and curcuminoids on dyslipidemia published in Current Developments in Nutrition in 2021, researchers found that the spice supplements, provided in capsule form, were associated with an improved lipid profile in adults with type 2 diabetes during trial durations ranging from 1 to 3 months. Nonrandomized observational studies are, however, subject to multiple sources of confounding.
“There is reason to think that as part of a healthy, plant-based diet, cinnamon and turmeric — spices that have been around for millennia — might have CV and cancer benefits,” Bhatt said. “However, without being tested in a large randomized clinical trial, we simply cannot endorse them as supplements. Sure, I would rather take a bunch of turmeric to, say, fight inflammation, but it would probably be better if I just used the treadmill every day.”
In the COSMOS study, a randomized, double-blind, placebo-controlled trial that assessed cocoa flavanol supplementation for CVD prevention among older adults, cocoa extract did not significantly reduce total CV events but reduced CVD death by 27%.
“We are hoping to continue to test the cocoa flavanols and other bioactives,” said Manson, a lead investigator for COSMOS. “These are large placebo-controlled trials where we test for efficacy and safety and the overall benefit-to-risk ratio.”
Manson cautioned that no supplement is a substitute for a healthy diet.
There are some supplements that have beneficial data for very specific conditions, such as nutritional deficiencies, Taub said. But for most healthy people, these benefits are not observed, according to Taub.
‘Be cautious’
Laffin said clinicians should not expect patients to ask about supplements or mention that they are taking supplements, even when asked directly.
“We are pretty good about asking patients what prescription medicines they are taking; however, people often fail to mention what else they are taking,” Laffin said. “We must ask patients, ‘Are you taking any over-the-counter medications or dietary supplements?’”
If a patient is taking supplements, provide the data regarding any potential risks, Laffin said.
“The goal for most doctors is to have people on the least medications possible, but with risk factors controlled,” Laffin said.
Taub said cardiologists should advise patients to “be cautious” of supplements, as most do not have strong data to support their use. In addition, patients should be consulting with their treating clinician before starting any supplement, as there could be potential drug-drug interactions.
To get the full benefit of any vitamin or mineral touted in television ads, Taub recommended a different solution.
“In general, I encourage patients to incorporate beneficial ingredients in their diet,” Taub said. “Plant-based whole foods are the best way to get these beneficial ingredients. For example, instead of taking a turmeric supplement, it is better to eat healthy foods with turmeric, as it is more bioavailable when taken in its natural form.”
Manson acknowledged that, for many people, the simplicity of taking a supplement can hold appeal, compared with making complex behavioral changes.
“People prefer to pop a pill; it is extremely appealing and seductive,” Manson said. “In reality, popping a pill when you have an unhealthy diet and sedentary lifestyle is not going to improve health. The focus should be on controlling BP, cholesterol and other risk factors. Together with healthy lifestyle behaviors, that will eliminate the vast majority of CV events.”
- References:
- An P, et al. J Am Coll Cardiol. 2022;doi:10. 1016/j.jacc.2022.09.048.
- Association of Black Cardiologists. Research study reveals Black consumer attitudes on treatment for cholesterol. Available at: abcardio.org/recent-news/research-study-reveals-black-consumer-attitudes-on-treatment-for-cholesterol/. Published Sept. 30, 2016. Accessed Feb 6, 2023.
- FDA. Questions and answers on dietary supplements. Available at: fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements. Accessed Feb. 10, 2023.
- Jia J, et al. JAMA. 2022;doi:10.1001/jama. 2022.9167.
- Laffin LJ, et al. J Am Coll Cardiol. 2023; doi:10.1016/j.jacc.2022.10.013.
- Manson JE, et al. JAMA. 2018;doi:10.1001/jama.2017.21012.
- North American Dietary Supplements Market Report, 2021-2028. Available at: grandviewresearch.com/industry-analysis/north-america-dietary-supplements-market. Accessed Feb. 10, 2023.
- Sesso HD, et al. Am J Clin Nutr. 2022; doi:10.1093/ajcn/nqac055.
- SuperBeets. Available at: humann.com/products/superbeets-superfood. Accessed Feb. 6, 2023.
- For more information:
- Deepak L. Bhatt, MD, MPH, can be reached at deepak.bhatt@mountsinai.org; Twitter: @dlbhattmd.
- Luke J. Laffin, MD, can be reached at laffinl@ccf.org; Twitter: @ljlaffin.
- JoAnn E. Manson, MD, DrPH, MACP, FAHA, can be reached at jmanson@rics.bwh.harvard.edu.
- Pam Taub, MD, can be reached at ptaub@health.ucsd.edu; Twitter: @pamtaubmd.
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