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International Angiology 2002 December;21(4):305-15


lingua: Inglese

Efficacy, routine effectiveness, and safety of horsechestnut seed extract in the treatment of chronic venous insufficiency. A meta-analysis of randomized controlled trials and large observational studies

Siebert U. 1, 2, Brach M. 1, 3, Sroczynski G. 1, 2, Überla K. 1

1 Institute of Medical Informatics, Biometry and Epidemiology, Ludwig-Maximilians-University of Munich, Munich, Germany 2 Harvard Center for Risk Analysis, Harvard School of Public Health, Boston, MA, USA 3 Department of Physical Medicine and Rehabilitation, Ludwig-Maximilians-University of Munich, Munich, Germany


Background. Safe and effec­tive oral ther­a­pies for chron­ic ­venous insuf­fi­cien­cy (CVI) would pro­vide an impor­tant alter­na­tive to mechan­i­cal com­pres­sion treat­ment. Several nar­ra­tive ­reviews and one system­at­ic ­review have sum­mar­ized the effi­ca­cy of horse chest­nut seed ­extract (HCSE), but to our knowl­edge no system­at­ic ­review has includ­ed data from both ran­dom­ized con­trolled ­trials (RCTs) and large-scale obser­va­tion­al stud­ies regard­ing out­comes as well as ­adverse ­events.
Methods. Using a system­at­ic lit­er­a­ture ­search, we iden­ti­fied 13 RCTs of CVI (1,051 ­patients) and 3 obser­va­tion­al stud­ies (10,725 ­patients) that met our inclu­sion cri­te­ria. Examined out­comes were leg vol­ume, ankle and calf cir­cum­fer­ence, edema, pain, sen­sa­tion of ten­sion, swell­ing, leg ­fatigue/heavi­ness, calf ­cramps, and itch­ing. Random and fixed ­effect mod­els were used to pool out­comes and ­adverse ­events sep­ar­ate­ly for RCTs and obser­va­tion­al stud­ies.
Results. Overall, the RCTs indi­cat­ed that HCSE ­improved symp­toms in ­patients with CVI. Compared to pla­ce­bo, HCSE ­reduced leg vol­ume by 46.4 ml (95% CI, 11.3-81.4 ml) and ­increased the like­li­hood of improve­ment in leg pain 4.1-fold (95% CI, 0.98-16.8). Similarly, improve­ment prob­abil­ities were ­increased 1.5-fold (95% CI, 1.2-1.9) for edema and 1.7-fold (95% CI, 0.01-3.0) for itch­ing. There was insuf­fi­cient evi­dence to dem­on­strate HCSE’s ­effect on leg ­fatigue/heavi­ness or calf ­cramps. Observational stud­ies ­showed sig­nif­i­cant effec­tive­ness regard­ing pain, edema, and leg ­fatigue/heavi­ness. No ­severe ­adverse ­events were report­ed, and HCSE did not sig­nif­i­cant­ly ­increase mild ­adverse ­events.
Conclusions. Based on meta-anal­y­ses of RCTs and obser­va­tion­al stud­ies, HCSE ­appears to be an effec­tive and safe treat­ment for CVI. Further RCTs and care­ful­ly con­duct­ed large-scale obser­va­tion­al stud­ies are ­required to eval­u­ate the long-term effec­tive­ness and safe­ty of HCSE in rou­tine set­tings.

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