ORIGINAL ARTICLES   

International Angiology 2003 September;22(3):250-62

Copyright © 2003 EDIZIONI MINERVA MEDICA

language: English

Meta-analysis of clinical trials of Cyclo 3 Fort in the treatment of chronic venous insufficiency

Boyle P. ¹, Diehm C. ², Robertson C. ^{3, 4}

¹ Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy 2 Klinikum Karlsbad, Langensteinbach Akademishes Lehrkrankenhaus der Universitat Heidelberg, Karlsbad, Germany 3 Department of Statistics and Modelling Science, University of Strathclyde, Glasgow, Scotland 4 Scottish Centre for Infection and Environmental Health, Glasgow, Scotland

Aim. Chron­ic ­venous insuf­fi­cien­cy (CVI) of the lower limbs is a major cause of mor­bid­ity and var­i­cose veins ­affect 20% to 60% of ­adults in the west­ern world. The treat­ment of ­patients with CVI ­attempts to ­reduce both clin­i­cal symp­toms and the devel­op­ment of chron­ic ­venous dis­ease. A meta-anal­y­sis using data from all clin­i­cal ­trials and stud­ies of Cyclo 3 Fort, a com­bi­na­tion of root ­extract of the Rus­cus acu­lea­tus plant (150 mg per cap­sule), hes­per­i­din meth­yl chal­cone (150 mg) and ascor­bic acid (100 mg), was car­ried out to esti­mate the over­all ­effect on the symp­toms and sever­ity of chron­ic ­venous insuf­fi­cien­cy.
Meth­ods. The meta-anal­y­sis includ­ed 20 pla­ce­bo con­trolled, ran­dom­ised, dou­ble blind stud­ies and 5 ran­dom­ised stud­ies ­against a com­par­a­tor drug. There were 6 sin­gle arm stud­ies of Cyclo 3 Fort alone with no pla­ce­bo arm. In all stud­ies the ­response to Cyclo 3 Fort was com­pared to base­line val­ues. In total there was infor­ma­tion from 10246 sub­jects.
­Results. On a 4 point symp­tom sever­ity scale, where 0 cor­re­sponds to no symp­toms and 3 to ­severe symp­toms, Cyclo 3 Fort sig­nif­i­cant­ly reduc­es the sever­ity of pain by 0.44 (0.12) ­points; ­cramps 0.26 (0.08), heavi­ness 0.53 (0.11), and par­a­es­the­sia 0.29 (0.10) com­pared to pla­ce­bo. There is also a sig­nif­i­cant reduc­tion in ­venous capac­ity of 0.70 (0.19) ml/100 ml with Cyclo 3 Fort com­pared to pla­ce­bo. We also found reduc­tions in the sever­ity of oede­ma 0.43 (0.20) ­points, and decreas­es in calf and ankle cir­cum­fer­ence, 0.73 (0.37) cms and 1.17 (0.83) cm, respec­tive­ly, among ­patients treat­ed with Cyclo 3 Fort com­pared to pla­ce­bo which were not sta­tis­ti­cal­ly sig­nif­i­cant.
Con­clu­sion. ­Despite ques­tions sur­round­ing the var­i­abil­ity of data qual­ity and sam­ple size of some of the stud­ies, we con­clude that in ­patients with CVI Cyclo 3 Fort sig­nif­i­cant­ly reduc­es the sever­ity of the symp­toms com­pared to pla­ce­bo. This study is a ­strong and objec­tive dem­on­stra­tion of the clin­i­cal effi­ca­cy of Cyclo 3 Fort in treat­ing ­patients with CVI.