Summary
A multi-centre, double blind randomized clinical triatr was designed to assess the
efficacy and safety of orally administered 0-(β-hydroxyethyl)-rutosides (HR) capsules
in the treatment of L0L patients with post-thrombotic syndrome. Seventeen patients
were excluded from the analysis for violation of the study protocol, 4l received HR
capsules (I,200 mg/day) and 43 placebo.
Mean follow-up scores at the 4th and 8th week show that the HR patients displayed
an improved state of tiredness as compared to the placebo's. The mean circumference
of the calf for the HR group decreased from 390 (± 33) mm at visit one to 382 (± 33)
mm at visit three, with a mean circumference reduction of 8.7 (± 8) mm, compared to
a steady placebo circumference of 387 (± 31) mm at all 3 visits with a mean circumference
reduction of only 2 mm (± 9). The estimated treatment effect at week 8 was −6.7 ffiffi,
95% confidence interval (−10.3, −3.0).
The mean circumference of the ankle, decreased from 243 (± 20) mm to 238 (± 20) mm
at the 4th week, contrasted with a constant placebo circumference of.24l (± 22) mm
at both visits. The estimated treatment effect at week 4 was-5.4 ffiffi, 95% confidence
intenral (−10.2, −0.6). However, at week 8, the estimated treatment effect was only
−3.4 mm; 95% corrfidence interval (−8.6, + 1.8).
In conclusion, HR capsules may show an improvement in the clinical symptoms and may
show a mean circumference reduction of the calf and ankle at the 8th week, in patients
with postthrombotic syndrome.
Keywords
Post-thrombotic syndrome - Deep vein thrombosis - Chronic venous insufficiency - 0-(β-hydroxyethyl)-rutosides
