Industry Reacts to Study “Wrongly” Comparing Supplements to Rx

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Supplements and vitamins on a white background. Selective focus. Medicine.

Washington, D.C.—A recent Cleveland Clinic trial compared common dietary supplements to a low-dose cholesterol-lowering medication (a statin). The study was funded by AstraZeneca, which markets Rosuvastatin. Researchers looked at the funder’s low-dose statin, placebo, and six supplements—fish oil, cinnamon, garlic, turmeric, plant sterols, and red yeast rice—over a four-week period for impact on low-density lipoprotein-cholesterol (LDL-C).

The study, “Supplements, Placebo, or Rosuvastatin (SPORT)” was presented during a science session at the American Heart Association’s Scientific Sessions 2022 and published in the Journal of the American College of Cardiology. The researchers’ conclusion: The supplements did not lower “bad” cholesterol when compared to the prescription drug.

“If you’re taking over-the-counter supplements for heart health or for cholesterol lowering, you should reconsider,” said Luke Laffin, M.D., study author and co-director of the Center for Blood Pressure Disorders in the Heart, Vascular & Thoracic Institute at Cleveland Clinic, in a Cleveland Clinic news release. “Unfortunately, many U.S. consumers believe cholesterol health supplements are safer than prescription medications and believe supplements are as effective, or more effective, than statins.”

Senior study author Steven Nissen, M.D., Chief Academic Officer of the Heart, Vascular & Thoracic Institute at Cleveland Clinic, added, “Dietary supplement sales are estimated at nearly $50 billion annually in the United States and many supplements are marketed as natural alternatives for heart protection and cholesterol management. For management of high cholesterol, supplements are often used by patients in place of statins, in the absence of high-quality data. This represents a major public health concern.”

Nutrition Experts Weigh in on Findings

“SPORT completely misses the point of supplementation by comparing the effects of a prescription drug to dietary supplements in a short-term study,” said Andrea Wong, Ph.D., Senior Vice President, Scientific and Regulatory Affairs, Council for Responsible Nutrition (CRN). “Dietary supplements are not intended to be quick fixes and their effects may not be revealed during the course of a study that only spans four weeks, particularly on a multifactorial condition like high cholesterol. This is a major—and author-acknowledged—limitation of the study. The most enthusiastic supporters of supplements wouldn’t expect disease markers to improve in 28 days from supplement use, even in conjunction with dietary changes and exercise.  

Consumer Healthcare Products Association (CHPA) Senior Vice President of Dietary Supplements Duffy MacKay agreed: “Dietary supplementswhich are regulated as foodsshould never be confused with prescription medications, which are specifically intended to diagnose, cure, mitigate, treat, or prevent specific diseases. Consumers should also not expect supplements to act like prescription drugs, but rather as products that support overall health and wellnesssuch as heart health, joint health, or gut health. Yet, here is another scientific study comparing the strength of prescription drugs against dietary supplements. Additionally, given the short four-week treatment timeline investigated in this study, the expectation for dietary supplements to produce drug-like effects is unfounded, as non-pharmacological interventions typically require more time to see results.

Raising another concern, Dr. Wong noted, “Even more perplexing is the researchers’ selection of the supplements in the study. It’s as if the study was set up for misdirection and failure of the supplements. While all the supplements included in the study are well-recognized for their benefits related to heart health, only three are marketed for their cholesterol-lowering benefits. The other ingredients are better known for their effects on other health outcomes (like improvement of triglycerides or insulin modulation), so it is unclear why they were chosen to be assessed for their effects on LDL cholesterol.

“As for broader cardiovascular benefits,” Dr. Wong continued, “the U.S. Food and Drug Administration (FDA) has expressly authorized a health claim for plant sterols and reduced risk of coronary heart disease and permits the use of claims for omega-3 fatty acids and reduced risk of coronary heart disease and hypertension. But these outcomes typically take more than 28 days to achieve.”

Dietary Supplements Play a Role

MacKay noted that each of the supplement ingredients included in this trial has previously been shown to benefit overall heart health when used as part of a multi-pronged approach, which often includes the implementation of diet and lifestyle changes. “If an individual is experiencing symptoms related to high cholesterol or heart disease, it’s important to work with a healthcare provider to develop a treatment plan, which may include supplement ingredients based on the person’s unique needs.”  

Dr. Wong added that prescription drugs and dietary supplements play roles in achieving better health. “Supplements are not intended to replace medications or other medical treatments,” she stressed. “Instead, they support and maintain health, and in conjunction with a healthy diet, physical activity, and regular check-ups with a healthcare professional, they can help reduce disease risk.” 

CRN added that CRN Foundation’s Supplements to Savings report includes data on dietary supplement ingredientsincluding omega-3 fatty acids and their impact on coronary artery disease. The report details projected implications for U.S. healthcare stakeholders in the number of events potentially avoidable with the use of each supplement and economic benefits that could accrue from use of each supplement by an at-risk individual. Read details here.

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