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Rivista di Angiologia

Official Journal of the International Union of Angiology, the International Union of Phlebology and the Central European Vascular Forum
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International Angiology 1999 December;18(4):337-42


lingua: Inglese

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.

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