Six supplements commonly taken to improve heart health and lower high cholesterol were ineffective when compared to AstraZeneca’s Crestor (rosuvastatin) and placebo.
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Six supplements commonly taken to improve heart health and lower high cholesterol were found to be largely ineffective when compared to AstraZeneca’s Crestor (rosuvastatin), according to a study conducted by the Cleveland Clinic.
Data from the Supplements, Placebo or Rosuvastatin Study (SPORT) study were presented Sunday at the American Heart Association’s Scientific Sessions 2022 and published in the Journal of the American College of Cardiology. AstraZeneca funded the study but was not involved in the research.
The supplements studied included fish oil, garlic, cinnamon, turmeric, plant sterols and red yeast rice. The study compared the effect of these supplements to a 5-mg daily dose of AstraZeneca’s Crestor (rosuvastatin), a statin prescribed to lower cholesterol, and placebo.
The primary endpoint was the percent change in low-density lipoprotein (LDL) cholesterol from baseline for rosuvastatin 5 mg daily compared with placebo and each supplement after 28 days. High levels of LDL cholesterol often coincide with a higher risk of heart disease and stroke.
None of the six dietary supplements studied demonstrated any significant decrease in LDL cholesterol compared to placebo, and garlic actually showed a significant increase in LDL of 7.8 percent. In contrast, Crestor showed a notable decrease in LDL cholesterol, as well as a positive effect on blood triglycerides and total cholesterol.
Luke J. Laffin, M.D., co-director of the Center for Blood Pressure Disorders at Cleveland Clinic, told Healio that though the data was “sobering”, it was not surprising.
“When we look at the data, three-quarters of Americans take some form of dietary supplement and, unfortunately, almost 20% of those are doing so for so-called ‘heart health’ or ‘cholesterol health,’” Laffin said. “In that vein, we know there are not any peer-reviewed data to support claims made about these supplements.”
Dietary Supplements - a Polarizing Topic
Senior study author Steven Nissen, M.D., chief academic officer of the Heart, Vascular & Thoracic Institute at Cleveland Clinic, was also not surprised by the study’s findings.
Nissen has been outspoken about the ineffectiveness of dietary supplements compared to statins for years, previously referring to these supplements as “21st-century snake oil.”
“For management of high cholesterol, supplements are often used by patients in place of statins, in the absence of high-quality data,” Nissen said in a press release. “This represents a major public health concern.”
In a 2021 paper published by the American College of Cardiology, Nissen called the popularity of dietary supplements a national catastrophe.
“There is a national catastrophe brewing that no one is expecting…The source will be a range of products that most Americans and some physicians consider harmless - dietary supplements,” he wrote.
Nissen largely placed blame on the Dietary Supplement Health and Education Act of 1994, which places responsibility for ensuring the truthfulness of advertisements for dietary supplements with the Federal Trade Commission, not the FDA.
“The FTC knows nothing about drugs, so manufacturers commonly imply benefits never confirmed via formal clinical studies,” Nissen wrote. “The DSHEA’s principal sponsors (including a current powerful senior U.S. senator) were Congressional representatives from states where companies selling supplements are headquartered. Nearly two decades after DSHEA, the marketed array of worthless or harmful dietary supplements is growing daily, reaching sales of $30 billion annually.”
Despite high praise of the study by many in the medical community, some aren’t so sure about the accuracy of the findings.
The Council for Responsible Nutrition, the leading trade association for the dietary supplement and functional food industry, issued a response to the study results on Sunday. In it, Andrea Wong, senior vice president for scientific and regulatory affairs at the Council for Responsible Nutrition, pointed to the length of the trial as a “major - and author-acknowledged - limitation of the study.”
“SPORT completely misses the point of supplementation by comparing the effects of a prescription drug to dietary supplements in a short-term study,” Wong wrote. “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.”
She also criticized the supplements the researchers chose for the study, writing that 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,” Wong said. “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.”
In response, Dr. Luke Laffin, principal investigator of the SPORT trial, told BioSpace the trial duration is “consistent with widely accepted cardiovascular society endorsed guidelines.”
“Additionally, although LDL-C changes were the study’s primary endpoint, secondary endpoints such as serum triglycerides were also evaluated and demonstrated no benefit,” he added.
