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Rivista di Angiologia
Official Journal of the , the International Union of Phlebology and the
Indexed/Abstracted in: BIOSIS Previews, Current Contents/Clinical Medicine, EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
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International Angiology 1999 December;18(4):337-42
An open-label, randomised multicentre study comparing the efficacy and safety of cyclo 3® fort versus hydroxyethyl rutoside in chronic venous lymphatic insufficiency
Beltramino R., Penenory A. *, Buceta A. M. **
From the Society of Phlebology of Tucuman, Argentina, * Society of Phlebology of Mar del Plata, ** Spanish Hospital of Buenos Aires, Buenos Aires, Argentina
Background. The present study was designed to compare the safety and efficacy of a combination of Ruscus aculeatus, hesperidin methyl chalcone and ascorbic acid (CYCLO 3 FORT®) versus that of hydroxyethyl rutoside in the treatment of chronic venous lymphatic insufficiency.
Methods. This open-label, randomised multicentre study was conducted on outpatients treated for 90 days. The patients were from three different regions of Argentina. Eighty patients, men and women, 30 to 70 years of age, with symptoms of chronic venous lymphatic insufficiency, i.e. heavy, tired, swollen, or painful legs were enrolled and assigned to two groups: one group treated with CYCLO 3 FORT®, the other with rutoside. The symptoms were assessed at baseline, and after 30, 60, and 90 days. The patient himself was asked to assess subjective symptoms, the physician measured the size of the affected limbs. The efficacy was rated on a 3-point scale and safety was evaluated by the number of side effects.
Results. The result data show that when all patients were comparable at baseline, after 90 days, those treated with CYCLO 3 FORT® reported more rapid and more complete regression of symptoms than those in the rutoside group, a statistically significant difference (p<0.01). Likewise, a significant reduction in affected limb size was observed in both groups but persisted after 90 days in the CYCLO 3 FORT® group only (p<0.01).
Conclusions. As a conclusion : CYCLO 3 FORT® was safe and more effective than rutoside in the treatment of venous lymphatic insufficiency. And the CYCLO 3 FORT® efficacy is probably associated with its unique mechanism of action.