Comparative clinical efficacy and tolerability of oxerutins and horse chestnut extract in patients with chronic venous insufficiency.
Oxerutins (O-(beta-hydroxyethyl)rutosides, HR, Venoruton) and horse chestnut extract (HCE) are active principles of first priority for the pharmacological treatment of chronic venous insufficiency (CVI). The efficacies of both compounds were shown in numerous, double-blind, randomized, placebo controlled clinical trials. Besides the direct comparison of the two compounds the aim of the study was to investigate the initial dose/maintenance dose concept for HR. 137 female, postmenopausal patients with CVI II finished the study according to protocol. Following one week placebo run-in the patients were treated either with 1000 mg/d HR, 600 mg/d HCE or 1000 mg/d for 4 weeks and than with 500 mg/d HR within the initial dose/maintainance dose concept for 12 weeks and observed for further 6 weeks. A main confirmative criterion was the volume reduction of the leg. Subjective criteria were descriptively evaluated. HR (1000 mg/d) was proven to be equivalent or better, reducing the leg volume (AUB0-18) by -5273 +/- 11418 ml.d compared to -3187 +/- 10842 ml.d under HR (1000 mg/d and 500 mg/d), and -3004 +/- 7429 ml.d under HCE-treatment. Both compounds exhibit a substantial carry-over effect. The maintenance posology of HR is able to stabilize the therapeutic obtained under initial dose conditions.
Rehn
D
D
Zyma GmbH, Medizin und Entwicklung, Munich, Germany.
Unkauf
M
M
Klein
P
P
Jost
V
V
Lücker
P W
PW
D000368:Aged; D001458:Bandages; D002908:Chronic Disease; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006896:Hydroxyethylrutoside / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D007866:Leg / Q000033:anatomy & histology; D008833:Microcirculation; D008875:Middle Aged; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D010946:Plants, Medicinal / Q000737:chemistry*; D014662:Vasoconstrictor Agents / Q000009:adverse effects / Q000627:therapeutic use*; D014689:Venous Insufficiency / Q000188:drug therapy / Q000473:pathology / Q000628:therapy*
D006896:Hydroxyethylrutoside; D010936:Plant Extracts; D014662:Vasoconstrictor Agents; C005865:troxerutin