Objective:

In an open cross-over study, the effect of two different venoactive 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 venography-proven deep venous thrombosis in the affected leg.

Interventions:

On entering the study, patients were randomly assigned to receive either Hidrosmina (Venosmil, FAES SA, Spain) 600 mg daily, or 0-(β-hydroxyethyl)-rutosides (Venoruton, Zyma SA, Switzerland) 900 mg daily. The 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.

Results:

During the first 6-month period, 12 out of 29 patients showed reduced tiredness and/or pain in the leg in comparison to the control visit. 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 subjective symptoms, but there were three patients in whom these symptoms had increased. Six months after discontinuation of therapy, subjective 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 therapy is discontinued.