HR, 0-(beta-hydroxyethyl)-rutosides, in comparison with diosmin+hesperidin in chronic venous insufficiency and venous microangiopathy: an independent, prospective, comparative registry study.
The aim of this independent study was to investigate differences in efficacy between HR, (0-[beta-hydroxyethyl]-rutosides) and D+H (500 mg, diosmin+hesperidin) in patients with chronic venous insufficiency (CVI). A first group of 90 patients with severe venous hypertension (CVI, ankle swelling) were randomized into an HR or a D+H group. The HR group received oral HR (2 g/day, 8 weeks); the D+H group received a 500 mg tablet 3 times daily for 8 weeks. A second group of comparable patients was included in a registry following the same study format. Patients were openly included; the 2 treatments were administered with the same methods and procedures. Clinical conditions were comparable to those described in the randomized study. Patients treated for at least 8 weeks were included in the registry. A number of physicians (specialists or general practitioners) included patients when they considered that clinical conditions were compatible with using 1 of the 2 treatments on the basis of their personal evaluation and experience. When cases were compatible with the registry, the prescribing physician communicated the case. Patients were evaluated without interfering with the treatment. Main targets of evaluation were skin flux at rest (RF), strain-gauge-derived rate of ankle swelling (RAS), and analogue symptoms score (ASLS). Ninety subjects completed the study in the first group; 122 in the second, registry group (total of 212 patients). The first and second (registry) groups and the 2 treatment groups were comparable for age and sex distribution. The pooled mean age was 42 years (SD +/-5.5) in the HR group (46+62 patients) and 41.5 (SD +/-6) in the D+H group (44+60 patients). Considering pooled data there were no differences in microcirculatory parameters between the pooled treatment groups at inclusion. A significant decrease (p<0.05) in RF and RAS was observed in the HR group at 8 weeks. The decrease in resting skin flux and in capillary filtration was associated with a significant improvement in signs/symptoms (analogue scale line) from an average of 9.4 (range 3-10) to 3.3 (4-6) (p<0.05). Significantly smaller variations were observed in the D+H group. The decrease in RF was 47.6% in the HR group vs 15.7% in the D+H group. The decrease in RAS was 40.9% in the HR group vs 12.8% in the D+H group. The decrease in ASLS was 64.8% in the HR group vs 12.9% in the comparative group. In conclusion venous microangiopathy and edema were improved by the treatment with HR both in the randomized study and in the pooled analysis. The comparison with D+H indicates that HR is comparatively more effective both on microcirculatory parameters and on signs/symptoms of CVI.
Cesarone
M R
MR
Irvine2 Vasc Lab and Physiology, Department of Biomedical Sciences, Chieti University, San Valentino Vascular Screening Project, Italy.
Belcaro
G
G
Pellegrini
L
L
Ledda
A
A
Di Renzo
A
A
Vinciguerra
G
G
Ricci
A
A
Gizzi
G
G
Ippolito
E
E
Fano
F
F
Dugall
M
M
Acerbi
G
G
Cacchio
M
M
D000284:Administration, Oral; D000328:Adult; D001783:Blood Flow Velocity / Q000187:drug effects; D002198:Capillary Fragility / Q000187:drug effects; D002199:Capillary Permeability / Q000187:drug effects; D004145:Diosmin / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004487:Edema / Q000188:drug therapy; D005260:Female; D006569:Hesperidin / Q000627:therapeutic use*; D006801:Humans; D006896:Hydroxyethylrutoside / Q000627:therapeutic use*; D017078:Laser-Doppler Flowmetry; D007866:Leg / Q000098:blood supply; D008297:Male; D008833:Microcirculation / Q000187:drug effects; D008875:Middle Aged; D011446:Prospective Studies; D012042:Registries; D012867:Skin / Q000098:blood supply; D014689:Venous Insufficiency / Q000188:drug therapy*; D014690:Venous Pressure / Q000187:drug effects*
D006896:Hydroxyethylrutoside; D004145:Diosmin; D006569:Hesperidin