Total amount: € 0,00
Frequency: 3 issues
Online ISSN 1827-1766
Mancini St. 1, 2, Aloi T. L. 1, 3, Bianchi V. 1, 4, Colombo E. 1, 5, Bucalossi M. 1, 4, Izzo M. 1, 6, Macciò A. 1, 7, Pisacreta M. 1, 8, Mariani F. 1, 2
1 The Compression Therapy Study Group (CTG) Colle di Val d’Elsa, Siena, Italia;
2 Dipartimento di Scienze Mediche Chirurgiche e Neuroscienze Università di Siena, Siena, Italia;
3 Unità di Angiologia Fondazione Salvatore Maugeri I.R.C.C.S., Pavia, Italia;
4 Casa di Cura Valdisieve, Pontassieve, Firenze, Italia;
5 Dipartimento di Medicina Clinica Scuola di Spec. in Farmacologia Università dell’Insubria, Varese, Italia;
6 Studio Specialistico, Nola, Napoli, Italia;
7 Centro di Chirurgia dei Linfatici Università di Genova, Genova, Italia;
8 Unità di Chirurgia Vascolare Ospedale L. Sacco, Milano, Italia
Aim: The aim of the study was to compare the effectiveness and acceptance of the new phytodrug Fleboderm® and elastic stockings (ES) to improve chronic venous insufficiency (CVI) (CEAP 1-2) and associated cellulite symptoms. Secondary end-points are to assess the circumferences at point G (thigh) and the subcutaneous thickness in prethrocanteric area pre- and post-therapies and the tolerability of the treatments.
Methods: The study is an observational, parallel-groups, prospective, multicenter clinical trial. The 140 female patients (CVI CEAP 1-2 and associated cellulite) are divided in 2 parallel groups: 70 patients were treated with phytodrug (1 active cap+1 stick daily) and 70 patients were treated with ES (preventive/1st class) for 30 days. Data were analyzed using Wilcoxon test, and a P-value <0.05 was considered significant, Chi-square analysis was used to test categorical data.
Results: ES and the phytodrug are equally well tolerated and they are effective to improve symptoms in the 2 group of patients (P<0.001). Fleboderm® is effective to reduce the circumferences of the thigh at point G (right-left 6.4%) and subcutaneous thickness (right- 6.8%, left 8.2%), while ES is not effective (right-left 2%; right 0.9%, left 0.5%).
Conclusion: Fleboderm® and elastic stockings are equally effective to improve CVI and cellulite symptoms. Fleboderm® is more effective than elastic stockings to reduce the thickness of subcutaneous tissue and the circumferences of the thighs.