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.