Efficacy and tolerability of a nutraceutical combination of red yeast rice, guggulipid, and chromium picolinate evaluated in a randomized, placebo-controlled, double-blind study

Iskandar, Irene; Harahap, Yahdiana; Wijayanti, Tri; Sandra, Monika; Prasaja, Budi; Cahyaningsih, Prawitasari

doi:10.1016/j.ctim.2019.102282

Cited by 7 publications

(6 citation statements)

References 21 publications

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“…Increasing attention is being paid to nutraceuticals for prevention and management of hyperlipidemia. A 2020 study by Iskandar et al [ 82 ] investigated the effects of a nutraceutical product containing red yeast rice extract on subjects who had moderate dyslipidemia. Red yeast rice has an identical structure to lovastatin and is an HMG-CoA inhibitor.…”

Section: Review Of Non-statin Treatment Optionsmentioning

confidence: 99%

Is a PCSK9 Inhibitor Right for Your Patient? A Review of Treatment Data for Individualized Therapy

Beltran

Zemeir

Kimberling

et al. 2022

IJERPH

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Introduction: In the United States, a significant amount of the population is affected by hyperlipidemia, which is associated with increased levels of serum low-density lipoprotein (LDL-C) and risk of cardiovascular disease. As of 2019, the guidelines set by the American College of Cardiology/American Heart Association advocate for the use of statins as the major contributor to lowering serum LDL-C. While proven to be effective, side effects, including muscle-related symptoms and new-onset diabetes mellitus, can make patients unable to tolerate statin therapy. Additionally, there is a subset of the population which does not approach a recommended LDL-C goal on statin treatment. Due to these findings, it was deemed necessary to review the literature of current statin-alternative lipid-lowering therapies. Methods: A systematic review of preclinical and clinical papers, and a current meta-analysis, was performed using PubMed and Google Scholar. Following the literature review, a meta-analysis was conducted using ProMeta 3. Results: Through systematic review and meta-analysis of the current literature, it is suggested that newer lipid-lowering therapies such as proprotein convertase subtilsin-kixen type 9 (PCSK9) inhibitors are a safe and effective statin alternative for the population with statin intolerance. PCSK9 inhibitors were shown to have no significant effect in causing myalgia in patients and showed no increase in adverse cardiovascular outcomes compared to a control of a current antilipemic medication regimen. Discussion: There are many statin-alternative therapies that should be investigated further as a potential replacement for patients with statin intolerance or as an addition for patients with statin resistance.

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Section: Review Of Non-statin Treatment Optionsmentioning

confidence: 99%

Is a PCSK9 Inhibitor Right for Your Patient? A Review of Treatment Data for Individualized Therapy

Beltran

Zemeir

Kimberling

et al. 2022

IJERPH

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“…Garlic powder was found to be the most effective in reducing TC and LDL and increasing HDL, as compared to all other groups. The latest study by Iskander et al [82] showed that a nutraceutical combination including g gugguluipid showed a significant reduction in TC and LDL levels after 8 weeks of consumption in a randomized, placebo-controlled double-blind trial. Another study by Kuchewar et al [83] found beneficial effects of Triphala on the lipid profile of patients with dyslipidemia.…”

Section: Adverse Effectsmentioning

confidence: 99%

A Systematic Review and Meta-Analysis of Ayurvedic Herbal Preparations for Hypercholesterolemia

Gyawali

Vohra²,

Orme-Johnson

et al. 2021

Medicina

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Background and Objectives: Cardiovascular disease (CVD) is the leading cause of death globally and hypercholesterolemia is one of the major risk factors associated with CVD. Due to a growing body of research on side effects and long-term impacts of conventional CVD treatments, focus is shifting towards exploring alternative treatment approaches such as Ayurveda. However, because of a lack of strong scientific evidence, the safety and efficacy profiles of such interventions have not been well established. The current study aims to conduct a systematic review and meta-analyses to explore the strength of evidence on efficacy and safety of Ayurvedic herbs for hypercholesterolemia. Methods: Literature searches were conducted using databases including Medline, Cochrane Database, AMED, Embase, AYUSH research portal, and many others. All randomized controlled trials on individuals with hypercholesterolemia using Ayurvedic herbs (alone or in combination) with an exposure period of ≥ 3 weeks were included, with primary outcomes being total cholesterol levels, adverse events, and other cardiovascular events. The search strategy was determined with the help of the Cochrane Metabolic and Endocrine Disorders Group. Two researchers assessed the risk of each study individually and discrepancies were resolved by consensus or consultation with a third researcher. Meta-analysis was conducted using the inverse variance method and results are presented as forest plots and data summary tables using Revman v5.3. Results: A systematic review of 32 studies with 1386 participants found randomized controlled trials of three Ayurvedic herbs, Allium sativum (garlic), Commiphora mukul (guggulu), and Nigella sativa (black cumin) on hypercholesterolemia that met inclusion criteria. The average duration of intervention was 12 weeks. Meta-analysis of the trials showed that guggulu reduced total cholesterol and low-density lipoprotein levels by 16.78 mg/dL (95% C.I. 13.96 to 2.61; p-value = 0.02) and 18.78 mg/dL (95% C.I. 34.07 to 3.48; p = 0.02), respectively. Garlic reduced LDL-C by 10.37 mg/dL (95% C.I. −17.58 to −3.16; p-value = 0.005). Black cumin lowered total cholesterol by 9.28 mg/dL (95% C.I. −17.36, to −1.19, p-value = 0.02). Reported adverse side effects were minimal. Conclusion: There is moderate to high level of evidence from randomized controlled trials that the Ayurvedic herbs guggulu, garlic, and black cumin are moderately effective for reducing hypercholesterolemia. In addition, minimal evidence was found for any side effects associated with these herbs, positioning them as safe adjuvants to conventional treatments.

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“…It has been demonstrated on HepG2 human hepatoma cells that its extracts can inhibit cholesterol synthesis by activating AMP kinase [ 46 ]. In human hepatoma cell line HepG2 and HEK-293, BBR increased the expression of the LDL receptor (LDLR) and its half-life via the JNK/c-jun pathway and stabilized its mRNA by extracellular signal-regulated kinase (ERK) modulation [ 22 , 47 ]. Considering that proprotein convertase subtilisin/kexin type 9 (PCSK9) mediates LDLR lysosomal degradation in HepG2 cells and that BBR inhibits PCSK9, it is possible that in this way, it should also prolong LDL clearance [ 48 ].…”

Section: Lipid-lowering Molecular Mechanism Of Action and Efficacy Of Single Compound Present In The Ncmentioning

confidence: 99%

Nutraceutical Combinations in Hypercholesterolemia: Evidence from Randomized, Placebo-Controlled Clinical Trials

2021

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There is an increasing number of nutraceutical combinations (NCs) on the market for hypercholesterolemia, although clinical trials to verify their safety and efficacy are scarce. We selected fourteen randomized, placebo-controlled clinical trials (RCTs) on different lipid-lowering NCs in hypercholesterolemic subjects. We described each compound′s mechanism of action and efficacy in the mixtures and summarized the clinical trials settings and NCs safety and efficacy results. Almost all NCs resulted efficient against hypercholesterolemia; only one reported no changes. Interestingly, red yeast rice (RYR) was present in eleven mixtures. It is not clear whether the lipid-lowering efficacy of these combinations derives mainly from the RYR component monacolin K “natural statin” single effect. Up to now, few RCTs have verified the efficacy of every single compound vs. NCs to evaluate possible additive or synergistic effects, probably due to the complexity and the high resources request. In conclusion, to manage the arising nutraceutical tide against hypercholesterolemia, it could be helpful to increase the number and robustness of clinical studies to verify the efficacy and safety of the new NCs.

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Efficacy and tolerability of a nutraceutical combination of red yeast rice, guggulipid, and chromium picolinate evaluated in a randomized, placebo-controlled, double-blind study

Cited by 7 publications

References 21 publications

Is a PCSK9 Inhibitor Right for Your Patient? A Review of Treatment Data for Individualized Therapy

Is a PCSK9 Inhibitor Right for Your Patient? A Review of Treatment Data for Individualized Therapy

A Systematic Review and Meta-Analysis of Ayurvedic Herbal Preparations for Hypercholesterolemia

Nutraceutical Combinations in Hypercholesterolemia: Evidence from Randomized, Placebo-Controlled Clinical Trials

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