Borderline hyperlipidemia preventive management with Berberine PL in asymptomatic prevention of early atherosclerosis.

Background: The aim of this pilot, efficacy supplement registry was to use a supplementary management with berberine to control hyperlipidemia. The supplement Berberine (Berbevis™ as Sophy^® tablets) was used to control lipids and to evaluate (as a natural, preventive management) the early evolution of subclinical atherosclerosis in subjects (otherwise healthy, not using drugs) with borderline hyperlipidemia.

Methods: The registry involved two groups of subjects not using drugs for a total of 50 subjects and three months of supplementation.

Results: The registry groups using standard management (SM) or SM and supplement were resulted comparable. No side effects were observed during the three months of berberine supplementation. No tolerability problems were reported. All subjects managed with berberine completed the three-month registry. Compliance was >97% (% of correctly used tablets). Total cholesterol was significantly decreased with berberine (P<0.05) and HDL was significantly improved (P<0.5) with supplementation. Triglycerides decreased in the berberine groups (P<0.05) and the levels of CoQ10 remained within normal values in supplemented subjects. Oxidative stress - measured in Carr units - was significantly decreased with berberine (P<0.05). Routine blood tests remained within normal values during the registry. Body weight was significantly more decreased (P<0.05) with berberine in comparison with standard management. The fat proportion also decreased (P<0.05) with berberine supplementation and the abdominal fat thickness (in the peri-umbilical area) was significantly decreased after berberine supplementation (P<0.05).

Conclusions: This pilot registry indicates that berberine administration is effective in reducing lipids (decreasing weight, fat percentage and abdominal fat) in otherwise healthy subjects not using drugs. A longer study, with more advanced hyperlipidemic subjects is suggested. Predictive analytics according to Siegel suggests that a six-month study with 60 patients, in more advanced hyperlipidemic, also evaluating the intima-media thickness for the analysis of vascular benefits, may produce a stronger evaluation for this product.