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Protocol development in integrative medicine is not typically a simple process. Individuals require individualized care, and what works for one patient may not work for another.

To establish these protocols, we first developed a Rating Scale that could be used to discern the rigor of evidence supporting a specific nutrient’s therapeutic effect.

The following protocols were developed using only A through C-quality evidence.

Class
Qualifying studies
Minimum requirements
A
Systematic review or meta-analysis of human trials
 
B
RDBPC human trials
2+ studies and/or 1 study with 50 + subjects
C
RDBPC human trials
1 study

High cholesterol is one of the key markers when evaluating risk of cardiovascular disease, stroke, and related problems. According to the National Health and Nutrition Examination Survey (NHANES), in 2015-2016, 12.5% of adults had high total cholesterol, with men having a higher rate of prevalence. In conjunction, 18% of adults had low high-density lipoprotein (HDL) cholesterol. (14)

Achieving a healthy cholesterol serum level has a valuable impact on decreasing risk for these events, and every bit helps. A decrease of 1 mmol/L in total cholesterol correlates with lower ischemic heart disease mortality. (15) Problems with blood pressure amplify the risks found with dyslipidemia, and were found to proportionally impact risk reduction when lowering cholesterol. (15)

Based on current research findings presented below, the ingredients in this protocol have demonstrated efficacy in improving cholesterol profile and potentially cardiovascular outcomes.

Red yeast rice (Monascus purpureus)

1200-2400 mg, once per day, minimum 8 to 12 weeks (10)

  • Patients with dyslipidemia who were unable to continue statin use due to myalgia experienced decreased low-density lipoprotein (LDL) cholesterol by 43 mg/dL (1.11 mmol/L)  at 12 weeks, and 0.90 mmol/L at 24 weeks, when taking 1800 mg twice daily, compared to baseline and placebo (1)
  • A meta-analysis showed weighted mean difference in total cholesterol levels decreased by 0.91 mmol/L, triglycerides by 0.41 mmol/L, and LDL cholesterol by 0.73 mmol/L as well as increased high-density lipoprotein (HDL) by 0.15 mmol/L (10)
  • Monocolin K-rich red yeast rice was found to be more effective in lowering total cholesterol and LDL cholesterol when compared to GABA-rich red yeast rice in patients with hyperlipidemia (24)
  • A meta-analysis showed that in a number of small trials, red yeast rice was found to have similar effects to statins in ability to improve cholesterol profile (12)
Red yeast rice in the Fullscript catalog

200 mg, once per day, minimum 3 months (23)

  • Systematic review and meta-analysis of seven trials found supplementation effective in reducing triglyceride levels observed with consistent supplementation (20)
  • Meta-analysis of eight trials found total cholesterol decrease of 1.07 (standardized mean difference) and HDL increased by 1.30 (standardized mean difference) in patients with coronary artery disease (6)
  • Patients with dyslipidemia supplemented with 120 mg of CoQ10 for 24 weeks experienced a decrease in blood pressure, serum triglyceride, and LDL cholesterol; as well as an increase in total antioxidant diastolic blood pressure, and ApoA-I, demonstrating in an overall decrease in cardiovascular disease risk factors, when 120 mg per day (26)
  • After supplementing with 200 mg for 1 week, an increase in serum CoQ10 correlated with improved HDL cholesterol as well as inhibition of monocyte-derived macrophage foam cell formation, suggesting overall improvement in cardiovascular health (25)
Coenzyme Q10 (CoQ10) in the Fullscript catalog

Omega-3 fatty acids

 2-4 g, total per day, minimum 3 months (Dose varies greatly based on EPA/DHA content) (23)(5)(9)

  • By reducing VLDL, both EPA, and DHA when administered independently resulted in reduced fasting circulating triglyceride levels (13)
  • Systematic review of six studies found supplementation of EPA or DHA greater than 2 g per day (with greater than or equal to 90% purity) was found to have a triglyceride concentration lowering effect, with DHA having a more significant impact at decreasing triglyceride concentration (5)
  • Systematic review and meta-analysis found when given omega-3 fatty acids during statin therapy, an improvement in decreasing total cholesterol was demonstrated (2)
  • Fasting serum triglyceride decreased by 25.9%, 25.5%, and 30.9% in groups supplemented with 2, 3, and 4 grams of omega-3 fatty acids respectively in patients with severe hypertriglyceridemia (8)
  • When given in addition to rosuvastatin, 4 g per day of omega 3 fatty acids decreased triglyceride levels by 26.3% (11.4% in placebo) and non-HDL-C by 10.7% (2.2% in placebo), with combined supplementation showing the greatest impact in patients with residual hypertriglyceridemia (9)
Omega-3 fatty acids in the Fullscript catalog

Garlic (Allium sativum)

400-600 mg, once per day, minimum 12 weeks (22)(19)

  • Increase in HDL (high-density lipoprotein) in addition to a decrease in alipoprotein B and an increase in the LDL/alipoprotein B ratio was observed after supplementation with 6 g/day aged black garlic for 12 weeks (7)
  • Supplementation decreased total cholesterol by 11.5%, decreased LDL by 13.8% and increased HDL cholesterol by 11.5% in men aged 35-70 with mild hypocholesterolemiam when given 600 mg per day (19)
  • Meta-analysis of 14 papers found hyperlipidemia improved as demonstrated by n improvement in total cholesterol (21)
  • Inflammation decreased as demonstrated by a decrease in arterial stiffness index, high-sensitivity C-reactive protein, LDL cholesterol, and total antioxidant status in obese patients compared to placebo, when given 400 mg per day (22)
  • A meta-analysis showed that, when use of garlic supplementation was continued for at least 2 months, a decrease in total serum cholesterol by 8% and decreased risk of coronary event by 38% was observed in people 50 years of age (17)
  • Garlic supplementation in patients with hypertension decreased blood pressure, helped to decrease slightly elevated cholesterol and increase immune function as shown by a decrease in blood pressure, and improvement in blood lipids when treated for a minimum of 2 weeks (16)
Garlic (Allium sativum) in the Fullscript catalog

L-Carnitine

2 g per day, minimum of 12 weeks (4)(11)

  • Patients with hyperlipidemia demonstrated a decrease in lipoprotein (a) by 19.4% compared to 6.7% in placebo group when supplemented with 2 g per day of L-carnitine for 12 weeks; similar decreases in total cholesterol, LDL, apolipoprotein (b), and triacylglycerols (4)
  • Decreased oxidation of LDL cholesterol occurred as demonstrated by a decrease in oxidized LDL levels by 15.1 U/L compared to 3.0 U/L in placebo, and LDL cholesterol by 0.45 mmol/L compared to 0.16 mmol/L in placebo in patients with type 2 diabetes when given 2 g per day (11)
  • Decreases in plasma lipoprotein (a) were observed in hypercholesterolemic patients newly diagnosed with type 2 diabetes when supplemented with 1g twice per day of L-carnitine compared to placebo (3)
  • 77.8% of patients with elevated Lp(a) experienced a reduction in lipoprotein (a) when supplemented compared to 38.9% in placebo; patients with a higher elevation at baseline experienced more significant decreases in Lp(a) with 2 g per day supplementation (18)
L-Carnitine in the Fullscript catalog

Disclaimer

The Fullscript Integrative Medical Advisory team has developed or collected these protocols from practitioners and supplier partners to help health care practitioners make decisions when building treatment plans. By adding this protocol to your Fullscript template library, you understand and accept that the recommendations in the protocol are for initial guidance and may not be appropriate for every patient.

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References
  1. Becker, D. J., Gordon, R. Y., Halbert, S. C., French, B., Morris, P. B., & Rader, D. J. (2009). Red yeast rice for dyslipidemia in statin-intolerant patients: a randomized trial. Annals of Internal Medicine, 150(12), 830–839, W147–W149. https://pubmed.ncbi.nlm.nih.gov/19528562/ (C)
  2. Choi, H. D., & Chae, S. M. (2018). Comparison of efficacy and safety of combination therapy with statins and omega-3 fatty acids versus statin monotherapy in patients with dyslipidemia: A systematic review and meta-analysis. Medicine, 97(50), e13593. https://pubmed.ncbi.nlm.nih.gov/30558030/ (A) 
  3. Derosa, G., Cicero, A. F. G., Gaddi, A., Mugellini, A., Ciccarelli, L., & Fogari, R. (2003). The effect of L-carnitine on plasma lipoprotein(a) levels in hypercholesterolemic patients with type 2 diabetes mellitus. Clinical Therapeutics, 25(5), 1429–1439. https://pubmed.ncbi.nlm.nih.gov/12867219/ (B) 
  4. Florentin, M., Elisaf, M. S., Rizos, C. V., Nikolaou, V., Bilianou, E., Pitsavos, C., & Liberopoulos, E. N. (2017). L-Carnitine/Simvastatin Reduces Lipoprotein (a) Levels Compared with Simvastatin Monotherapy: A Randomized Double-Blind Placebo-Controlled Study. Lipids, 52(1), 1–9. https://pubmed.ncbi.nlm.nih.gov/27914033/ (B)
  5. Innes, J. K., & Calder, P. C. (2018). The Differential Effects of Eicosapentaenoic Acid and Docosahexaenoic Acid on Cardiometabolic Risk Factors: A Systematic Review. International Journal of Molecular Sciences, 19(2). https://doi.org/10.3390/ijms19020532 https://pubmed.ncbi.nlm.nih.gov/29425187/ (A) 
  6. Jorat, M. V., Tabrizi, R., Mirhosseini, N., Lankarani, K. B., Akbari, M., Heydari, S. T., Mottaghi, R., & Asemi, Z. (2018). The effects of coenzyme Q10 supplementation on lipid profiles among patients with coronary artery disease: a systematic review and meta-analysis of randomized controlled trials. Lipids in Health and Disease, 17(1), 230. https://pubmed.ncbi.nlm.nih.gov/30296936/ (A)
  7. Jung, E.-S., Park, S.-H., Choi, E.-K., Ryu, B.-H., Park, B.-H., Kim, D.-S., Kim, Y.-G., & Chae, S.-W. (2014). Reduction of blood lipid parameters by a 12-wk supplementation of aged black garlic: a randomized controlled trial. Nutrition , 30(9), 1034–1039. https://pubmed.ncbi.nlm.nih.gov/24976429/ (C)
  8. Kastelein, J. J. P., Maki, K. C., Susekov, A., Ezhov, M., Nordestgaard, B. G., Machielse, B. N., Kling, D., & Davidson, M. H. (2014). Omega-3 free fatty acids for the treatment of severe hypertriglyceridemia: the EpanoVa fOr Lowering Very high triglyceridEs (EVOLVE) trial. Journal of Clinical Lipidology, 8(1), 94–106. https://pubmed.ncbi.nlm.nih.gov/24528690/ (C)
  9. Kim, C. H., Han, K. A., Yu, J., Lee, S. H., Jeon, H. K., Kim, S. H., Kim, S. Y., Han, K. H., Won, K., Kim, D.-B., Lee, K.-J., Min, K., Byun, D. W., Lim, S.-W., Ahn, C. W., Kim, S., Hong, Y. J., Sung, J., Hur, S.-H., … Kim, H.-S. (2018). Efficacy and Safety of Adding Omega-3 Fatty Acids in Statin-treated Patients with Residual Hypertriglyceridemia: ROMANTIC (Rosuvastatin-OMAcor iN residual hyperTrIglyCeridemia), a Randomized, Double-blind, and Placebo-controlled Trial. Clinical Therapeutics, 40(1), 83–94. https://pubmed.ncbi.nlm.nih.gov/29223557/ (B)
  10. Liu, J., Zhang, J., Shi, Y., Grimsgaard, S., Alraek, T., & Fønnebø, V. (2006). Chinese red yeast rice (Monascus purpureus) for primary hyperlipidemia: a meta-analysis of randomized controlled trials. Chinese Medicine, 1, 4. https://pubmed.ncbi.nlm.nih.gov/17302963/ (A)
  11. Malaguarnera, M., Vacante, M., Avitabile, T., Malaguarnera, M., Cammalleri, L., & Motta, M. (2009). L-Carnitine supplementation reduces oxidized LDL cholesterol in patients with diabetes. The American Journal of Clinical Nutrition, 89(1), 71–76. https://pubmed.ncbi.nlm.nih.gov/19056606/ (C)
  12. Ong, Y. C., & Aziz, Z. (2016). Systematic review of red yeast rice compared with simvastatin in dyslipidaemia. Journal of Clinical Pharmacy and Therapeutics, 41(2), 170–179. https://pubmed.ncbi.nlm.nih.gov/26956355/ (A)
  13. Oscarsson, J., & Hurt-Camejo, E. (2017). Omega-3 fatty acids eicosapentaenoic acid and docosahexaenoic acid and their mechanisms of action on apolipoprotein B-containing lipoproteins in humans: a review. Lipids in Health and Disease, 16(1), 149. https://pubmed.ncbi.nlm.nih.gov/28797250/ (A)
  14. Products – Data Briefs – Number 290 – October 2017. (2019, June 6). https://www.cdc.gov/nchs/products/databriefs/db290.htm https://www.cdc.gov/nchs/products/databriefs/db290.htm (F)
  15. Prospective Studies Collaboration, Lewington, S., Whitlock, G., Clarke, R., Sherliker, P., Emberson, J., Halsey, J., Qizilbash, N., Peto, R., & Collins, R. (2007). Blood cholesterol and vascular mortality by age, sex, and blood pressure: a meta-analysis of individual data from 61 prospective studies with 55,000 vascular deaths. The Lancet, 370(9602), 1829–1839. https://pubmed.ncbi.nlm.nih.gov/18061058/ (A)
  16. Ried, K. (2016). Garlic Lowers Blood Pressure in Hypertensive Individuals, Regulates Serum Cholesterol, and Stimulates Immunity: An Updated Meta-analysis and Review. The Journal of Nutrition, 146(2), 389S – 396S. https://pubmed.ncbi.nlm.nih.gov/26764326/ (A)
  17. Ried, K., Toben, C., & Fakler, P. (2013). Effect of garlic on serum lipids: an updated meta-analysis. Nutrition Reviews, 71(5), 282–299. https://pubmed.ncbi.nlm.nih.gov/23590705/ (A)
  18. Sirtori, C. R., Calabresi, L., Ferrara, S., Pazzucconi, F., Bondioli, A., Baldassarre, D., Birreci, A., & Koverech, A. (2000). L-carnitine reduces plasma lipoprotein(a) levels in patients with hyper Lp(a). Nutrition, Metabolism, and Cardiovascular Diseases: NMCD, 10(5), 247–251. https://pubmed.ncbi.nlm.nih.gov/11213533/ (C)
  19. Sobenin, I. A., Andrianova, I. V., Demidova, O. N., Gorchakova, T., & Orekhov, A. N. (2008). Lipid-lowering effects of time-released garlic powder tablets in double-blinded placebo-controlled randomized study. Journal of Atherosclerosis and Thrombosis, 15(6), 334–338. https://pubmed.ncbi.nlm.nih.gov/19060427/ (C)
  20. Suksomboon, N., Poolsup, N., & Juanak, N. (2015). Effects of coenzyme Q10 supplementation on metabolic profile in diabetes: a systematic review and meta-analysis. Journal of Clinical Pharmacy and Therapeutics, 40(4), 413–418. https://pubmed.ncbi.nlm.nih.gov/25913756/ (A)
  21. Sun, Y.-E., Wang, W., & Qin, J. (2018). Anti-hyperlipidemia of garlic by reducing the level of total cholesterol and low-density lipoprotein: A meta-analysis. Medicine, 97(18), e0255. https://pubmed.ncbi.nlm.nih.gov/29718835/ (A)
  22. Szulińska, M., Kręgielska-Narożna, M., Świątek, J., Styś, P., Kuźnar-Kamińska, B., Jakubowski, H., Walkowiak, J., & Bogdański, P. (2018). Garlic extract favorably modifies markers of endothelial function in obese patients -randomized double blind placebo-controlled nutritional intervention. Biomedicine & Pharmacotherapy = Biomedecine & Pharmacotherapie, 102, 792–797. https://pubmed.ncbi.nlm.nih.gov/29604599/ (B)
  23. Tóth, Š., Šajty, M., Pekárová, T., Mughees, A., Štefanič, P., Katz, M., Spišáková, K., Pella, J., & Pella, D. (2017). Addition of omega-3 fatty acid and coenzyme Q10 to statin therapy in patients with combined dyslipidemia. Journal of Basic and Clinical Physiology and Pharmacology, 28(4), 327–336. https://pubmed.ncbi.nlm.nih.gov/28541926/ (C)
  24. Wang, T.-J., Lien, A. S.-Y., Chen, J.-L., Lin, C.-H., Yang, Y.-S., & Yang, S.-H. (2019). A Randomized Clinical Efficacy Trial of Red Yeast Rice (Monascus pilosus) Against Hyperlipidemia. The American Journal of Chinese Medicine, 47(2), 323–335. https://pubmed.ncbi.nlm.nih.gov/30871361/ (B)
  25. Yan, X., Shen, T., Jiang, X., Tang, X., Wang, D., Li, H., & Ling, W. (2015). Coenzyme Q10 consumption promotes ABCG1-mediated macrophage cholesterol efflux: a randomized, double-blind, placebo-controlled, cross-over study in healthy volunteers. Molecular Nutrition & Food Research, 59(9), 1725–1734. https://pubmed.ncbi.nlm.nih.gov/26081100/ (C) 
  26. Zhang, P., Yang, C., Guo, H., Wang, J., Lin, S., Li, H., Yang, Y., & Ling, W. (2018). Treatment of coenzyme Q10 for 24 weeks improves lipid and glycemic profile in dyslipidemic individuals. Journal of Clinical Lipidology, 12(2), 417–427.e5. https://pubmed.ncbi.nlm.nih.gov/29454678/ (B)

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