Non-Interactions of Berberine Supplementation in Borderline Hyperlipidemia Prevention (Asymptomatic Early Atherosclerosis Subjects) and Under Chronic Therapies: A Pilot Registry Study (BERINT)

The aim of this pilot, non-interaction, supplement registry study was to evaluate the possible interactions between chronic therapies, as antiplatelet agents, anticoagulants, anti-hypertensives, diabetic management and thyroid management, and a formulation of berberine supplementation (Berbevis™ as Sophy® tablets) that resulted effective to control borderline hyperlipidemia (as a natural, preventive management), the early evolution of asymptomatic atherosclerosis. No side effects or tolerability issues were observed during the add-on of the supplement. The compliance was very good, with >96% of the capsules correctly used. The control and supplement groups resulted comparable. There was no significant variation in bleeding time, platelets and routine blood tests. Also, anticoagulant values were comparable in berberine and control group (INR and factor Xa). The relative results for antihypertensives, antidiabetics and drugs for thyroid management, show non-interaction and the groups were comparable. Berberine supplementation did not change the main target measurements at end-observation. The thyroid management was extended to 8 weeks without changes in the hormones values. In the absence of major risk conditions, after berberine supplementation no evidence of negative interaction during undergoing selected chronic therapies were reported. Non-interaction profiles must be considered for any supplement used in large number of patients, in order to avoid any possible unusual side effects or tolerability problems.