Time course of the anti-oedematous effect of different dose regimens of O-(beta-hydroxyethyl) rutosides in healthy volunteers.
The aim of this study was to compare the efficacy of two posologies of hydroxyethylrutosides (HR) as maintenance dose for the reduction of leg oedema. The increase in leg volume induced by standing motionless for one hour was measured in 12 healthy young male volunteers by a highly sensitive water displacement method. The volume increase (approx. 87.8 units) was found to be very reproducible after a one-week placebo run-in period. The mean value after 3-weeks treatment at 1000 mg/day HR was reduced to 85.2 +/- 8.7 units. The subjects were then randomised to 3 groups and further measurements were made after additional 3, 5, 6 and 7 weeks. On placebo, the values returned to baseline within 5-6 weeks. On 500 mg/day, the values continued to oscillate around the values at randomisation (i.e., the effect was maintained). On continuing the dose unchanged at 1000 mg/day, the volume increases continued to fall progressively to 79.1 +/- 7.7 at the end of the further 7 weeks. After analysis of all mean volume changes relative to the values at time of randomisation, it was found that the 1000 mg/day dose showed a significant greater antioedematous effect than placebo (p = 0.0001) or 500 mg/day (p = 0.0028). Also the 500 mg/day dose was superior to placebo (p = 0.0328). We conclude that, after initial treatment for 3 weeks with 1000 mg/day, a dose of 500 mg/day is adequate to maintain the resultant anti-oedematous effect.(ABSTRACT TRUNCATED AT 250 WORDS)
Rehn
D
D
Zyma GmbHa, München, Fed. Rep. of Germany.
Nocker
W
W
Diebschlag
W
W
Golden
G
G
D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004487:Edema / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D006896:Hydroxyethylrutoside / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use*; D007866:Leg; D008297:Male; D011187:Posture; D012016:Reference Values; D013997:Time Factors
D006896:Hydroxyethylrutoside