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CL BALANCE

SCIENTIFIC RESEARCH ON THE FOLLOWING INGREDIENTS:

Bergamot (Citrus bergamia)

Clinical application of bergamot (Citrus bergamia) for reducing high cholesterol and cardiovascular disease markers

Abstract

The bergamot is a citrus fruit native to southern Italy with traditional uses that include improving immune response and cardiovascular function. There are a variety of phytochemicals that have been found in the bergamot including brutieridin and melitidin as well as other flavonoids, flavones O-glucosides and C-glucosides. Multiple clinical trials have provided evidence that different forms of orally administered bergamot can reduce total cholesterol and low-density lipoprotein cholesterol. In vitro mechanistic studies have provided evidence that polyphenols from the bergamot can alter the function of AMPK and pancreatic cholesterol ester hydrolase (pCEH). The use of bergamot in multiple clinical trials has consistently shown that it is well tolerated in studies ranging from 30 days to 12 weeks. This mini-review reports on the clinical studies performed with different forms of bergamot along with their effectiveness in reducing total cholesterol and LDL cholesterol in patients with hypercholesterolemia.

Source: Mirielle C. Nauman and Jeremy J. Johnson. “Clinical application of bergamot (Citrus bergamia) for reducing high cholesterol and cardiovascular disease markers” Integrative Food Nutrition and Metabolism (2019): 10.15761/IFNM.1000249.

Red Yeast

The effects of red yeast rice dietary supplement on blood pressure, lipid profile, and C-reactive protein in hypertension: A systematic review

Abstract

Interest is increasing regarding the potential health effects of red yeast rice (RYR) consumption, which is described as a "natural statin" in China. This review aims to evaluate the efficacy of RYR on blood pressure (BP), lipid profile, and C-reactive protein (CRP) in treating hypertension. Seven electronic databases including the Cochrane Central Register of Controlled Trials, EMBASE, PubMed, the Chinese National Knowledge Infrastructure (CNKI), the Chinese Scientific Journal Database (VIP), the Chinese Biomedical Literature Database (CBM), and the Wanfang database were searched. To investigate the role of RYR for hypertension, randomized controlled trials for the use of RYR either as monotherapy or in combination with conventional medicine versus placebo, no intervention, or conventional medicine for hypertension were identified. A total of 21 trials containing 4558 patients were analyzed, the majority of which had low methodological quality. "RYR plus conventional therapy" exhibited significant lowering effects on serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and CRP but exhibited no significant effect on systolic BP, diastolic BP, triglycerides (TG), and high-density lipoprotein cholesterol (HDL-C) compared with "placebo plus conventional therapy." "RYR plus conventional therapy" showed significant lowering effects on systolic BP, TC, LDL-C, and CRP but no effect on diastolic BP, TG, and HDL-C compared with "placebo plus conventional therapy." No significant difference in BP and lipid profile between "RYR plus conventional therapy" and "statins plus conventional therapy" was observed. "RYR plus statins" appeared to be more effective in lowering BP, TC, TG, and LDL-C but without a significant difference in HDL-C compared to statins. No serious adverse events were reported. The results of this meta-analysis suggested some supportive but limited evidence regarding RYR for hypertension. Further rigorously designed trials are warranted before RYR could be recommended to hypertensive patients.

Source: Xingjiang Xiong, Pengqian Wang, Xiaoke Li, Yuqing Zhang, and Shengjie Li. “The effects of red yeast rice dietary supplement on blood pressure, lipid profile, and C-reactive protein in hypertension: A systematic review” Critical Reviews in Food Science and Nutrition (2017): 57(9):1831-1851.

Berberine HCl (Berberis aristate)

Efficacy of Berberine Alone and in Combination for the Treatment of Hyperlipidemia: A Systematic Review

Abstract

The objective of this review is to identify, summarize, and evaluate clinical trials of berberine for the treatment of hyperlipidemia and other dyslipidemias. A literature search for randomized, controlled trials of berberine that assessed at least 2 lipid values as endpoints resulted in identification of 12 articles that met criteria. The majority of evaluated articles consistently suggest that berberine has a beneficial effect on low-density lipoprotein (reductions ranging from approximately 20 to 50 mg/dL) and triglycerides (reductions ranging from approximately 25 to 55 mg/dL). Common study limitations included lack of reporting of precision in their endpoints, description of blinding, transparency in flow of patients, and reporting of baseline concomitant medications. Berberine could serve as an alternative for patients who are intolerant to statins, patients resistant to starting statin therapy but who are open to alternative treatments, and for low-risk patients not indicated for statin therapy.

Berberine alone and in combination with other dietary supplements provides an average LDL percentage lowering capability of 20% to 30%. Moderate-intensity statin medications have been proven to lower LDL cholesterol by 30 to 50% and high-intensity statins lower LDL even further, upward of 50%. The American Heart Association and American College of Cardiology released clinical guidelines for cholesterol management that no longer recommend specific LDL goals, but suggest 4 statin benefit groups in which the use of statins is recommended not only for their benefits related to cholesterol lowering but also for their established efficacy in preventing nonfatal and fatal cardiovascular disease. Statins are recommended in individuals with clinical ASCVD, LDL >190 mg/dL, diabetes mellitus aged 40 to 75 years with LDL 70 to 189 mg/dL and without clinical ASCVD, or LDL 70 to 189 mg/dL and ASCVD risk at least 7.5%. Studies included in this review consistently assess effects of berberine and combination dietary supplements on surrogate lipid endpoints. While this information is necessary to gauge the lipid-lowering potential of berberine, future studies should focus on this product’s ability to reduce ASCVD in order to determine the relative clinical benefit compared to statins. Based on available studies, berberine alone or in combination with other dietary supplements could serve as an alternative for patients who are intolerant to statins, patients resistant to starting statin therapy but who are open to alternative treatments, and for low-risk patients not indicated for statin therapy (i.e., do not fall into 1 of the 4 statin benefit groups).

Source: Laura M. Koppen, PharmD, Andrea Whitaker, PharmD, Audrey Rosene, PharmD, and Robert D. Beckett, PharmD, BCPS. “Efficacy of Berberine Alone and in Combination for the Treatment of Hyperlipidemia: A Systematic Review” Journal of Evidence-Based complementary & Alternative Medicine (2017): 22(4): 956–968.

Policosanol (Sugar Cane Wax)

Policosanol: clinical pharmacology and therapeutic significance of a new lipid-lowering agent

Abstract

Background: Policosanol is a mixture of higher primary aliphatic alcohols isolated from sugar cane wax, whose main component is octacosanol. The mixture has been shown to lower cholesterol in animal models, healthy volunteers, and patients with type II hypercholesterolemia.

Methods: We reviewed the literature on placebo-controlled lipid-lowering studies using policosanol published in peer-reviewed journals as well as studies investigating its mechanism of action and its clinical pharmacology.

Results: At doses of 10 to 20 mg per day, policosanol lowers total cholesterol by 17% to 21% and low-density lipoprotein (LDL) cholesterol by 21% to 29% and raises high-density lipoprotein cholesterol by 8% to 15%. Because higher doses have not been tested up to now, it cannot be excluded that effectiveness may be even greater. Daily doses of 10 mg of policosanol have been shown to be equally effective in lowering total or LDL cholesterol as the same dose of simvastatin or pravastatin. Triglyceride levels are not influenced by policosanol. At dosages of up to 20 mg per day, policosanol is safe and well tolerated, as studies of >3 years of therapy indicate. There is evidence from in vitro studies that policosanol may inhibit hepatic cholesterol synthesis at a step before mevalonate generation, but direct inhibition of the hydroxy-methylglutaryl-coenzyme A reductase is unlikely. Animal studies suggest that LDL catabolism may be enhanced, possibly through receptor-mediated mechanisms, but the precise mechanism of action is not understood yet. Policosanol has additional beneficial properties such as effects on smooth muscle cell proliferation, platelet aggregation, and LDL peroxidation. Data on efficacy determined by clinical end points such as rates of cardiac events or cardiac mortality are lacking.

Conclusions: Policosanol seems to be a very promising phytochemical alternative to classic lipid-lowering agents such as the statins and deserves further evaluation.

Source: Ioanna Gouni-Berthold, and Heiner K. Berthold. “Policosanol: clinical pharmacology and therapeutic significance of a new lipid-lowering agent” American Heart Journal (2002): 143(2):356-65.

References:
  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6497409/
  2. https://pubmed.ncbi.nlm.nih.gov/26167669/
  3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5871262/
  4. https://pubmed.ncbi.nlm.nih.gov/11835043/