Treatment of edema and increased capillary filtration in venous hypertension with HR (Paroven, Venoruton; 0-(beta-hydroxyethyl)-rutosides): a clinical, prospective, placebo-controlled, randomized, dose-ranging trial.
The variation of capillary filtration rate (CFR) and ankle edema (AE) were evaluated in three groups of patients with venous hypertension with ambulatory venous pressure > 42 mmHg and in healthy subjects before and after treatment for four weeks with HR (Paroven, Venoruton; 0-(beta-hydroxyethyl)-rutosides), a venoactive drug acting on the microcirculation and on capillary permeability. Group A (30 patients) was treated with HR 500 mg tid; group B (30 patients) was treated with 1 g tid; group C (30 patients) was treated with placebo; group D (10 healthy subjects) was treated with HR 1 g/day in a randomised study. CFR was assessed by venous occlusion plethysmography. Subjective symptoms of venous hypertension were assessed by an analogue scale line considering four symptoms: swelling sensation, restless lower extremity, pain and cramps, and tiredness.


RESULTS
There were no significant differences for sex and age distribution among the groups; no significant differences were found for ambulatory venous pressure and refilling time and parameters of venous hypertension among groups. There was a significant difference between normal subjects and patients. There were no drop-outs and observed intolerance. In group A, there was a significant decrease of CFR (P < 0.01) after treatment. In group B (2 g/day), the decrease was greater than that in group A (P < 0.05). In group C (placebo) there was no significant difference before or after treatment. The variations in analogue score was higher with the higher dosage. The score of group A fell from 7.8 (SD 1.3) to 4 (1). Group B's score fell from 7.9 (2) to 3.1 (1.2). In group C (placebo) there was no change. The decrease in the score in the groups of patients was correlated with the variation in edema and CFR.


CONCLUSIONS
HR is effective in venous edema and hypertension. Its effects are dose-related.
Cesarone
M R
MR
Irvine2 Vasc Lab, Department of Biomedical Sciences, Chieti University, San Valentino Vascular Screening Project, Italy.
Incandela
L
L
DeSanctis
M T
MT
Belcaro
G
G
Griffin
M
M
Ippolito
E
E
Acerbi
G
G
D000328:Adult; D004305:Dose-Response Relationship, Drug; D004487:Edema / Q000188:drug therapy*; D005260:Female; D006801:Humans; D006896:Hydroxyethylrutoside / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology*; D006973:Hypertension / Q000150:complications*; D008297:Male; D008833:Microcirculation; D008875:Middle Aged; D010919:Placebos; D010991:Plethysmography; D016896:Treatment Outcome; D014662:Vasoconstrictor Agents / Q000008:administration & dosage / Q000494:pharmacology*; D014689:Venous Insufficiency / Q000150:complications / Q000188:drug therapy*
D006896:Hydroxyethylrutoside; D010919:Placebos; D014662:Vasoconstrictor Agents; C005865:troxerutin