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An open-label, randomised multicentre study comparing the efficacy and safety of CYCLO 3 FORT versus hydroxyethyl rutoside in chronic venous lymphatic insufficiency.
Int Angiol. 1999 Dec; 18(4):337-42.IA

Abstract

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.

Authors+Show Affiliations

Society of Phlebology of Tucuman, Argentina.No affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

10811525

Citation

Beltramino, R, et al. "An Open-label, Randomised Multicentre Study Comparing the Efficacy and Safety of CYCLO 3 FORT Versus Hydroxyethyl Rutoside in Chronic Venous Lymphatic Insufficiency." International Angiology : a Journal of the International Union of Angiology, vol. 18, no. 4, 1999, pp. 337-42.
Beltramino R, Penenory A, Buceta AM. An open-label, randomised multicentre study comparing the efficacy and safety of CYCLO 3 FORT versus hydroxyethyl rutoside in chronic venous lymphatic insufficiency. Int Angiol. 1999;18(4):337-42.
Beltramino, R., Penenory, A., & Buceta, A. M. (1999). An open-label, randomised multicentre study comparing the efficacy and safety of CYCLO 3 FORT versus hydroxyethyl rutoside in chronic venous lymphatic insufficiency. International Angiology : a Journal of the International Union of Angiology, 18(4), 337-42.
Beltramino R, Penenory A, Buceta AM. An Open-label, Randomised Multicentre Study Comparing the Efficacy and Safety of CYCLO 3 FORT Versus Hydroxyethyl Rutoside in Chronic Venous Lymphatic Insufficiency. Int Angiol. 1999;18(4):337-42. PubMed PMID: 10811525.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An open-label, randomised multicentre study comparing the efficacy and safety of CYCLO 3 FORT versus hydroxyethyl rutoside in chronic venous lymphatic insufficiency. AU - Beltramino,R, AU - Penenory,A, AU - Buceta,A M, PY - 2000/5/16/pubmed PY - 2000/6/17/medline PY - 2000/5/16/entrez SP - 337 EP - 42 JF - International angiology : a journal of the International Union of Angiology JO - Int Angiol VL - 18 IS - 4 N2 - 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. SN - 0392-9590 UR - https://www.unboundmedicine.com/medline/citation/10811525/An_open_label_randomised_multicentre_study_comparing_the_efficacy_and_safety_of_CYCLO_3_FORT_versus_hydroxyethyl_rutoside_in_chronic_venous_lymphatic_insufficiency_ DB - PRIME DP - Unbound Medicine ER -