Pycnogenol® relieves chronic venous insufficiency (CVI) in diabetics: a supplement registry study.

ABSTRACT

BACKGROUND: The aim of this supplement registry study was to evaluate the efficacy of Pycnogenol® in controlling signs and symptoms of chronic venous insufficiency (CVI), diabetic microangiopathy and microcirculatory parameters - in diabetic patients with CVI and microangiopathy. These CVI patients are eligible for medical procedures as their incompetent superficial veins can be treated with repeated sclerotherapy and or local surgery according to needs. METHODS: During this registry study, only non-interventional managements were used. The effects of the use of elastic compression with standard management (SM) was compared to Pycnogenol® intake (150 mg/day) and SM, without using elastic compression for 8 weeks. RESULTS: Fifty-eight diabetic patients with CVI completed the study with 28 subjects supplemented with Pycnogenol® and 30 in the control group. The two groups completing 8 weeks were comparable at baseline. After 8 weeks, no side effects were observed; the compliance was optimal with >98.5% of the supplement capsules correctly used. The tolerability to stockings was lower (73% of stockings were not fully used for the whole day). There were no dropouts. Venous pressures were comparable in the two groups at baseline. Microcirculatory and clinical measurements of the patients were comparable at inclusion. After 8 weeks, the differences between Pycnogenol® and elastic compression were statistically significant for skin resting flux (RF), rate of ankle swelling (RAS), transcutaneous PO2 and PCO2 indicating a significant improvement in microcirculatory perfusion with Pycnogenol® in comparison with elastic compression. In parallel, clinical symptoms assessed by the Composite Symptom Score (CSS), the venous Clinical severity Score (VCSS) and the Venous Disability Score (VDS), were significantly lower in the Pycnogenol® group than in the compression group, indicating a significant clinical effect of Pycnogenol® compared to elastic compression (P<0.05). Pycnogenol® showed important antioxidant properties and lowered oxidative stress as seen also in previous studies. CONCLUSIONS: This registry study confirms the clinical and microcirculatory efficacy of Pycnogenol® in CVI in diabetics. The study indicates the significant supplementary, clinical role of Pycnogenol® in the management of this common clinical condition over a short period of time, possibly preventing ulcerations.