By Michael H. Crawford, MD, Editor
SYNOPSIS: In a comparison of rosuvastatin 5 mg/day, six common dietary supplements marketed for improving heart health, and placebo, none reduced high-sensitivity C-reactive protein levels. Only rosuvastatin significantly reduced LDL cholesterol levels compared to placebo.
SOURCE: Laffin LJ, Bruemmer D, Garcia M, et al. Comparative effects of low-dose rosuvastatin, placebo, and dietary supplements on lipids and inflammatory biomarkers. J Am Coll Cardiol 2023;81:1-12.
Little information exists on the efficacy of dietary supplements marketed for cholesterol lowering. That makes this prospective, randomized trial conducted at the Cleveland Clinic of interest.
Entry criteria included age 40 to 79 years, an LDL cholesterol level of 70 mg/dL to 189 mg/dL, no history of atherosclerotic cardiovascular disease (ASCVD), not taking any cholesterol-lowering therapy, and a pooled cohort equation 10-year risk of ASCVD of 5% to 20%. Major exclusions were significant liver or kidney disease and a fasting triglyceride level higher than 200 mg/dL. Patients were randomly assigned to rosuvastatin 5 mg/day, placebo, Nature Made fish oil (2,400 mg), NutriFlair cinnamon (2,400 mg), Garlique brand garlic (with 5,000 µg of allicin), BioSchwartz turmeric curcumin (with BioPerine 4,500 mg), Nature Made CholestOff Plus (with 1,600 mg of plant sterols), or Arazo Nutrition red rice yeast (2,400 mg). Patients were told to take the recommended dose of each. Because this varied for each agent, the study was considered single-blinded. The primary endpoint was the percent change in LDL cholesterol. Secondary endpoints included the percent change in high-sensitivity C-reactive protein (hsCRP) levels, HDL cholesterol levels, and serum triglycerides levels. Safety was analyzed in anyone who took at least one dose of the assigned agent. Over 15 months, 199 subjects were randomized, and 190 completed the baseline and 28-day follow-up assessments (mean age = 64 years; 59% were women, 89% were non-Hispanic white). At baseline, mean LDL was 128 mg/dL and hsCRP was 1.4 mg/dL.
Rosuvastatin decreased LDL levels (-35%), which was significant (P < 0.001) when compared to placebo (-2.6%). The biggest decrease among the supplements was red rice yeast (-6.6%), which was not statistically significant compared to placebo. Interestingly, garlic increased LDL levels (+8%; P = 0.01) vs. placebo. Also, rosuvastatin significantly reduced triglycerides (-19%; P < 0.05). The biggest change among the supplements was cinnamon (+8.3%), which was not significant. Only plant sterols significantly changed HDL cholesterol levels compared to placebo (-7%; P = 0.02). The authors did not observe any significant changes in hsCRP with any agent. Two serious adverse events occurred, which could not be linked plausibly to treatment (liver cancer, deep venous thrombosis). Rates of other adverse events were similar across the groups, but numerically higher in the plant sterols and red rice yeast groups (28% for each vs. 16% for rosuvastatin). Laffin et al concluded that in patients with an elevated 10-year risk of ASCVD, only rosuvastatin 5 mg/day significantly reduced LDL cholesterol levels compared to the recommended doses of six common dietary supplements marketed as supporting heart health.
COMMENTARY
Americans spend $30 billion annually on dietary supplements.1 In a 2017-2018 National Center for Health Statistics survey, 57.6% of adults age 20 years and older reported using any dietary supplement in the past 30 days.2 The Dietary Supplement Health and Education Act (DSHEA) of 1994 categorized dietary supplements as food. The DSHEA cautioned dietary supplements could be harmful because of contaminants and that supplements could interfere with the efficacy of drugs.3 The U.S. Preventive Services Task Force recommends against using supplements to prevent CVD.4
It is against this background Laffin et al conducted this study. They chose patients with an elevated risk of ASCVD by using a pooled cohort equation and including patients with LDL cholesterol levels higher than 70 mg/dL. They chose to test the lowest available dose of rosuvastatin against six dietary supplements at their recommended doses that were marketed as promoting heart health. Three of these supplements are marketed for lowering cholesterol. This study showed rosuvastatin reduced LDL levels robustly, but there was not a significantly similar effect among any of the six supplements. The biggest effect was a 7% reduction with red rice yeast, which was not significant compared to placebo. Also, garlic increased LDL levels by 8%. Surprisingly, red rice yeast produced the most adverse effects, almost twice that seen with rosuvastatin. None of the tested agents lowered hsCRP levels.
The major limitations to the Laffin et al study were the small sample size and the short follow-up period. Also, there are no outcome data, and this was largely a white population. Another problem with supplements is variations in potency of the recommended doses. Although it cannot be said with certainty that all supplements are ineffective, at this point, there remains insufficient evidence to support the use of dietary supplements to improve heart health.
REFERENCES
1. National Center for Complementary and Integrative Health. Americans spend $30 billion a year out-of-pocket on complementary health approaches.
2. National Center for Health Statistics. Dietary supplement use among adults: United States, 2017-2018.
3. U.S. Food & Drug Administration. Questions and answers on dietary supplements.
4. U.S. Preventive Services Task Force. Vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer: Preventive medication. June 21, 2022.
In a comparison of rosuvastatin 5 mg/day, six common dietary supplements marketed for improving heart health, and placebo, none reduced high-sensitivity C-reactive protein levels. Only rosuvastatin significantly reduced LDL cholesterol levels compared to placebo.
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