Borderline hyperlipidemia: preventive supplementation with berberine phospholipids to prevent early atherosclerosis evolution.

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

METHODS: One group used berberine supplementation and a standard management (SM), while a second comparative group used only SM.

RESULTS: No side effects were observed during the 6 months of berberine supplementation. No tolerability problems were reported. All subjects completed the registry. The groups resulted comparable. At 3 and 6 months the average total cholesterol was decreased more with berberine (P<0.05) and HDL was significantly improved (P<0.5). Triglycerides decreased in the berberine groups (P<0.05), more than in controls. Oxidative stress was significantly more decreased with berberine supplementation (P<0.05). Homocysteine (within normal values) were significantly decreased at 3 and 6 months (P<0.05). Fasting glucose was decreased in the berberine group - at 3 and 6 months - in comparison with controls (P<0.05). Also, glycosylated hemoglobin was reduced with berberine (P<0.05) more than in the SM group. Body weight was also significantly more decreased (P<0.05) with berberine supplementation. The fat proportion also decreased significantly more (P<0.05) with the supplement (P<0.05) than in controls only using the SM. Technical athero-specific measurements: the intima-media thickness (IMT) at the carotids (high-resolution ultrasound) in all subjects was stable with berberine and did not significantly change in 6 months. In SM controls the IMT increase was significant superior at 6 months (P<0.05); more time is needed in this type of observations in subjects with minimal initial alterations at the carotid bifurcations. Endothelial function: after occlusion in normal subjects, with normal arteries, reactive hyperemia (RH) - generally - increases section/flow of more than 30% (up to 50%). The included subjects at the first observation, had a minimal increase in RH after occlusion, as an expression of endothelial dysfunction associated to the hyperlipidemia. RH was significantly increased (P<0.05) with berberine, in comparison with controls, at 3 and 6 months.

CONCLUSIONS: This pilot, concept registry indicates that oral berberine administration is effective in reducing lipids (also decreasing weight, fat percentage and fasting glucose) in otherwise healthy subjects not using other drugs. A longer study, with more advanced hyperlipidemic subjects is suggested. Predictive analytics suggests that a 12-month study with 100 patients, in more advanced hyperlipidemics, also evaluating the carotid intima-media thickness for the analysis of vascular benefits, may produce a stronger clinical evaluation for this product.