COMPARISON OF LEG COMPRESSION STOCKING AND ORAL HORSE-CHESTNUT SEED EXTRACT THERAPY IN PATIENTS WITH CHRONIC VENOUS INSUFFICIENCY

Background Diseases of the venous system are widespread disorders some times associated with modern civilisation and are among the major conc erns of social and occupational medicine. This study was carried out t o compare the efficacy (oedema reduction) and safety of compression st ockings class II and dried horse chestnut seed extract (HCSE, 50 mg ae scin, twice daily). Methods Equivalence of both therapies was examined in a novel hierarchical statistical design in 240 patients with chron ic venous insufficiency. Patients were treated over a period of 12 wee ks in a randomised, partially blinded, placebo-controlled, parallel st udy design. Findings Lower leg volume of the more severely affected li mb decreased on average by 43.8 mL (n=95) with HCSE and 46.7 mL (n=99) with compression therapy, while it increased by 9.8 mL with placebo ( n=46) after 12 weeks therapy for the intention-to-treat group (95% CI: HCSE: 21.1-66.4; compression: 30.4-63.0; placebo: 40.0-20.4). Signifi cant oedema reductions were achieved by HCSE (p=0.005) and compression (p=0.002) compared placebo, and the two therapies were shown to equiv alent (p=0.001); in this design, however, compression could not be pro ven as standard with regard to oedema reduction in the statistical tes t procedure. Both HCSE and compression therapy were well tolerated and no serious treatment-related events were reported. Interpretation The se results indicate that compression stocking therapy and HCSE therapy are alternative therapies for the effective treatment of patients wit h oedema resulting from chronic venous insufficiency.