Effectiveness and safety of a product containing diosmin, coumarin, and arbutin (Linfadren®) in addition to complex decongestive therapy on management of breast cancer-related lymphedema
Mené en Italie sur 50 patientes atteintes d'un lymphœdème associé à un cancer du sein, cet essai randomisé évalue l'efficacité, du point de vue de la réduction du volume excessif du membre supérieur et de la réduction des déficiences du bras, de l'épaule et de la main, de l'ajout d'un produit à base de diosmine, coumarine et arbutine à un drainage lymphatique manuel
Purpose : To assess the effectiveness and safety of a product containing diosmin, coumarin, and arbutin (Linfadren®) in addition to complex decongestive therapy (CDT) on the management of patients with a breast cancer-related lymphedema (BCRL). Methods : Fifty outpatients (average age of 56.2 ± 2.7 years, range 28–71) with a BCRL were enrolled for this study. Patients were randomly assigned (1:1 ratio) to receive either CDT consisting of skin care, manual lymphatic drainage, remedial exercises, and elastic compression garment (control group, n = 25) or CDT plus Linfadren® (study group, n = 25). Patients were evaluated before and after treatment and 3 months after the end of treatment. Primary outcomes were reduction of upper limb excess volume (EV) and percentage reduction of excess volume (%REV). Secondary outcomes were improvement in Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire, and patient’s perception of treatment effectiveness (PPTE). Results : Addition of Linfadren® to CDT yielded an additional reduction of primary outcomes both after treatment (EV, − 521 ml vs. − 256 ml, P < 0.0001; %REV, − 66.4% vs. − 34%, P = 0.02) and at 3-month follow-up (EV, − 59 ml vs. + 24 ml, P < 0.0001; %REV, − 73.6% vs. − 31.4%, P = 0.004). Moreover, statistically significant differences were found between the two groups for the secondary outcomes after treatment (QuickDASH, P = 0.006; PPTE, P = 0.03) and at 3-month follow-up (QuickDASH, P = 0.006; PPTE, P = 0.02). No patient showed adverse events. Conclusions : Linfadren® in addition to CDT was a safe and effective therapy for reducing BCRL and was better than CDT alone.