Journal du sang et de la lymphe

Complex α-Lypoic Acid, Ginkgoselect Phytosome and Leucoselect Phytosome in Patients with Chronic Venous Insufficiency of the Lower Limbs: Therapeutic Effectiveness and Impact on Quality of Life

Abstract

Giuseppe Camporese, Enrico Bernardi, Cristiano Bortoluzzi, Dimitrios Kontothanassis, Chiara Tonello, Michela Nardin and Franco Noventa

Background: Chronic venous disease (CVD) is a common clinical condition, especially relevant for its impact on public health and its related economic burden. Veno-Active Drugs (VAD) are an heterogeneous group of drugs, widely used in the treatment of CVD. In the last years some food supplements, similar to VAD but with different compounds concentrations raised some confusion in this field. The complex Lypoic acid, Ginkgoselect phytosome and Leucoselect phytosome is a food supplement based on molecules exhibiting different but synergic activities never prospectively tested in patients with CVD. Methods: Consecutive ambulatory patients with objectively documented CVD and a CEAP “C” up to 5 were eligible for the study. Patients were to take 1 fast-slow tablet of the complex twice-daily for 2 months, followed by 1 fast-slow tablet once-daily for other 4 months, for a total of 6 months. Presence and magnitude of CVD-related signs and symptoms (with “C” of the CEAP classification), evaluation of patients’ quality of life (with VEINES-QoL/Sym questionnaire) and assessment of safety and tolerability of the complex at baseline and after 2 and 6 months (with revised Venous Clinical Severity Score, rVCSS) were recorded. Results: 97 patients enrolled and evaluated. The proportion (65%) of the patients with a rVCSS score>5 at baseline decreased to 35% at 6 months (P <0.001). The number of patients with a scoring of “none” for the item “Pain or other discomfort” increased from 8% at baseline to 54% at 6 months (P=0.001). The pairwise comparison yielded significant results between the 3 time-points for the rVCSS (p<0.00001) and the VEINES-Sym (p<0.00001), while for the VEINES-QoL score between the baseline and the end of the study only (p=0.0016). Conclusion: The complex Lypoic acid, Ginkgoselect phytosome and Leucoselect phytosome seems beneficial for reducing leg complaints, and effectively improves QoL in patients with CVD.