M. Monreal et al., A PROSPECTIVE-STUDY OF THE LONG-TERM EFFICACY OF 2 DIFFERENT VENOACTIVE DRUGS IN PATIENTS WITH POSTTHROMBOTIC SYNDROME, Phlebology, 9(1), 1994, pp. 37-40
Objective: In an open cross-over study, the effect of two different ve
noactive drugs was prospectively studied in a series of patients with
post-thrombotic syndrome. Design: Prospective, open cross-over study.
Patients: Twenty-nine patients with established unilateral deep venous
insufficiency of at least 12 months duration, and a history of venogr
aphy-proven deep venous thrombosis in the affected leg. Interventions:
On entering the study, patients were randomly assigned to receive eit
her Hidrosmina (Venosmil, FAES SA, Spain) 600 mg daily, or 0-(beta-hyd
roxyethyl)-rutosides (Venoruton, Zyma SA, Switzerland) 900 mg daily. T
he drugs were taken for 6 months. At the end of this period, the drug
was discontinued, and patients taking Hidrosmina changed to rutosides,
or vice versa, for a further 6-month period. Finally, both drugs were
discontinued, and patients were re-examined 3 and 6 months later. Res
ults: During the first 6-month period, 12 out of 29 patients showed re
duced tiredness and/or pain in the leg in comparison to the control vi
sit. Furthermore, a slight reduction was found in mean circumferences
of both the ankle and calf during this study period. During the second
6-month period of therapy, six additional patients improved their sub
jective symptoms, but there were three patients in whom these symptoms
had increased. Six months after discontinuation of therapy, subjectiv
e symptoms increased in 10 out of 29 patients, and mean circumferences
of both the ankle and calf returned to baseline values. Conclusions:
In this pilot study our findings demonstrate that venoactive drugs may
improve both objective and subjective symptoms in patients with post-
thrombotic syndrome, and that these effects disappear after drug thera
py is discontinued.