Hydroxyethylrutosides in Elderly Patients with Chronic Venous Insufficiency: Its Efficacy and Tolerability

Abstract

The efficacy and tolerability of O-(β-hydroxyethyl)-rutosides (HR) in elderly patients (aged over 65 years) with chronic venous insufficiency or varicose veins was studied in a multi-centre, double-blind, randomised, placebo-controlled trial. Of the 104 patients entered into the trial, data from 102 were available for analysis of tolerability and from 86 for efficacy. Treatment was for 6 months, with monthly examinations. Three different dosages were used due to slight differences in the registered dosage in various countries: (1) 250 mg 4 times daily (1 g/ day), UK, n = 19 patients; (2) 300 mg 3 times daily (900 mg/ day), FRG and Belgium, n = 55, and (3) 300 mg 4 times daily (1,200 mg/day), The Netherlands, n = 30. Each centre had its own placebo control group. The HR-treated group (n = 41) showed a significantly greater reduction in the total symptom score, 5.7 ± 2.4 to 2.3 ± 1.8, than in the placebo group, 4.4 ± 3.0 to 3.0 ± 2.4 (p < 0.01). Of the 5 studied symptoms there was also a significant (p < 0.05) improvement in leg cramps, heavy legs and restless legs. No significant differences between the two groups were seen for aching pains and paraesthesia. A small reduction was also seen in ankle and calf circumferences, which became significant at the end of the trial (p < 0.05). Pitting oedema of the leg (p < 0.01) and eczema of the leg (p < 0.05) also improved significantly greater than in the control group. Tolerability, as reflected in adverse events and monitoring of a range of 31 laboratory tests, was comparable in the HR group to that of the placebo group. HR appears to be an effective and well-tolerated treatment for symptoms related to chronic venous insufficiency or varicose veins in elderly patients.

Parenteral Troxerutin and Carbazochrome Combination in the Treatment of Post-hemorrhoidectomy Status: A Randomized, Double-blind, Placebo-controlled, Phase IV Study

“…The results of the present study demonstrate that this fixed combination is also effective in the postsurgery period and are consistent with those from previous studies in the treatment of hemorrhoidal crisis [8][9][10][11][14][15] . Edema, inflammation, pruritus, and bleeding were notably improved by the active treatment compared with placebo.…”

“…Since hemorrhoids are a form of chronic venous insufficiency, flavonoids, alone or in combination with other drugs, have been widely used in patients before treatment with more aggressive procedures like sclerotherapy or surgery [9][10] .…”

“…Flavonoids, such as troxerutin, have been shown to be safe and effective agents for the treatment of chronic venous insufficiency [9][10][11] .…”

Basic pathophysiological and molecular mechanisms of chronic venous diseases and their pharmacological correction

“…Рутозиды представляют собой класс веноактивных флавоноидов, обладающих противовоспалительными свойствами и уменьшающих симптомы ХЗВ [51][52][53][54][55][56]. Рутозид является мощным ингибитором гена, обеспечивающего воспалительный ответ в активированных макрофагах, культивируемых in vitro, снижает синтез NO, интерлейкинов 1 и 6, ФНОα [52,53].…”

“…Рутозиды являются агонистами венозных α 1 -адренергических рецепторов, блокируют инактивацию норадреналина, тем самым обеспечивают поддержание тонуса сосудов [55,56]. В ряде клинических исследований у пациентов с ХЗВ, получавших рутозиды, значительно уменьшились отек и объем ноги, тяжесть, судороги, зуд, однако эффективность этих препаратов в лечении и профилактике рецидивов венозных язв не доказана [54,56].…”