Efficacy and Safety of Armolipid Plus®: An Updated PRISMA Compliant Systematic Review and Meta-Analysis of Randomized Controlled Clinical Trials

Abstract

Armolipid Plus® is a multi-constituent nutraceutical that claims to improve lipid profiles. The aim of this PRISMA compliant systematic review and meta-analysis was to globally evaluate the efficacy and safety of Armolipid Plus® on the basis of the available randomized, blinded, controlled clinical trials (RCTs). A systematic literature search in several databases was conducted in order to identify RCTs assessing the efficacy and safety of dietary supplementation with Armolipid Plus®. Two review authors independently identified 12 eligible studies (1050 included subjects overall) and extracted data on study characteristics, methods, and outcomes. Meta-analysis of the data suggested that dietary supplementation with Armolipid Plus® exerted a significant effect on body mass index (mean difference (MD) = −0.25 kg/m2, p = 0.008) and serum levels of total cholesterol (MD = −25.07 mg/dL, p < 0.001), triglycerides (MD = −11.47 mg/dL, p < 0.001), high-density lipoprotein cholesterol (MD = 1.84 mg/dL, p < 0.001), low-density lipoprotein cholesterol (MD = −26.67 mg/dL, p < 0.001), high sensitivity C reactive protein (hs-CRP, MD = −0.61 mg/L, p = 0.022), and fasting glucose (MD = −3.52 mg/dL, p < 0.001). Armolipid Plus® was well tolerated. This meta-analysis demonstrates that dietary supplementation with Armolipid Plus® is associated with clinically meaningful improvements in serum lipids, glucose, and hs-CRP. These changes are consistent with improved cardiometabolic health.

Nutraceuticals in the Management of Dyslipidemia: Which, When, and for Whom? Could Nutraceuticals Help Low-Risk Individuals with Non-optimal Lipid Levels?

“…The lipid-lowering properties of RYR (3 mg MonK), policosanols (10 mg), and berberine (500 mg) are the most studied in RCT and the only one for which meta-analyses of RCTs are available. A recent meta-analysis of 12 randomized double-blind placebo-controlled clinical trials including 1050 subjects suggested that dietary supplementation with this nutraceutical combination exerts a significant effect on body mass index (mean difference (MD) = − 0.25 kg/m 2 , p = 0.008) and serum levels of LDL-C (MD = − 26.67 mg/ dL, p < 0.001), TG (MD = − 11.47 mg/dL, p < 0.001), HDL-C (MD = 1.84 mg/dL, p < 0.001), high-sensitivity C-reactive protein (hs-CRP; MD = − 0.61 mg/L, p = 0.022), and fasting glucose (MD = − 3.52 mg/dL, p < 0.001) [93]. This combination has also been tested in adult and elderly patients previously intolerant to statins [94,95], being well tolerated in the 80% of cases.…”

A descriptive study of commercial herbal dietary supplements used for dyslipidemia—Sales data and suspected adverse reactions

“…On the contrary, it comes out as a safe alternative in improving the lipids profile in clinical practice. Systematic literature describes no increased risk of neither musculoskeletal nor gastrointestinal disorders of the multi‐ingredient preparation made of berberine, policosanols, astaxanthin, monacolin, folic acid, and CoQ 10 (Cicero et al, 2021). It is therefore difficult to recommend the supplement to the consumer.…”

Combined Supplementation of Coenzyme Q10 and Other Nutrients in Specific Medical Conditions

“…For patients with metabolic syndrome, the combination of CoQ 10 and red yeast rice provided benefits to their blood pressure, lipid, and glycemic biomarkers in another 2018 RCT [ 195 ]. A recent 2021 meta-analysis of 12 RCTs also supported the beneficial impacts on serum lipids, glucose, and CRP with the combination of CoQ 10 , red yeast extract, policosanols, berberine, folic acid, and astaxanthin [ 196 ].…”