Efficacy of O-(beta-hydroxyethyl)-rutosides at high dosage in counteracting the unwanted activity of oral contraceptives on venous function

Abstract

In a double-blind study the effect of a high dosage of O-(beta-hydroxyethyl)-rutosides (HR) was tested in women taking oral contraceptives and suffering from venous insufficiency of the lower limbs. Ten patients were treated for 28 days with HR (3 g/day) and ten with a placebo. In basal conditions and after therapy, the symptoms of venous disorders and the venous function, by means of strain gauge plethysmography, was evaluated in both groups. The results showed an increase of venous capacitance and a reduction of venous tone in the subjects treated including those without symptoms in the lower limbs. The HR treatment resulted in a significant improvement of the venous function parameters and of the symptoms in lower limbs.

PIP: Venous insufficiency of the lower limbs in oral contraceptive users was treated with Venoruton 1000 (o-(beta-hydroxyethyl)-rutoside) at a high dose of 3 g/day in a double-blind, placebo controlled trial. 20 women aged 19-42, who had taken pills 3 months to 7 years (mean 30.2 months) were randomly assigned to treatment vs. placebo. The soluble powder was prepared in sachets indistinguishable from placebos. Venous function was assessed by strain gauge plethysmography (Periflow, Janssen Scientific, Beerse, Belgium), and the following parameters were determined: maximal venous incremental volume, maximal venous incremental volume time, maximal venous outflow, time of total emptying, index of venous distensibility, index of venous tone, and venous pressure. Subjective symptoms were evaluated on a scale of 0-5: pain, swelling, nocturnal cramps, tingling, heaviness and restless legs. Basal measurements showed high values of venous capacity, distensibility, and reduced venous tone. After 28 days of treatment, several venous parameters were significantly improved in the test group vs. placebo: maximal venous incremental volume at 40 and 60 mm Hg (venous capacity), index of venous distensibility and index of venous tone. There was significant improvement in subjective reports of pain, swelling, heavy legs and restless legs in the treated over placebo group. No side effects or changes in laboratory findings were observed.