A Double-Blind Clinical Trial of Hydroxyethylrutosides in the Treatment of the Symptoms and Signs of Chronic Venous Insufficiency

Abstract

Objective: To study the safety and efficacy of hydroxyethylrutosides (HR) in patients with chronic venous insufficiency (CVI) (Widmer grade II) and examine any correlation with objective measurements (plethysmography and Tc Po2). Design: Double-blind, randomized, placebo-controlled, multicentre trial. Setting: One outpatient university angiology clinic, one outpatient angiology clinic in a military hospital and one private angiological consultation, all in the Paris area. Patients: One hundred and nine patients with grade II Widmer CVI, confirmed by echo-Doppler and plethysmography. Elastic stockings were excluded. After five exclusions, 53 received HR and 51 placebo. Interventions: Patients randomized to one sachet of 1 g HR twice daily (or placebo) for 2 months, after a 1 month placebo run-in period. Examinations on entry to the trial (T–1), after 1 month run-in (T–0) and after 1 (T+1) and 2 months (T+2) treatment. Main outcome measures: These were measured at each of the four visits. Primary outcome: minimal ankle and maximal calf circumferences. Secondary outcomes: five individual leg symptoms and total symptom score, pitting oedema. Plethysmography (six calculated variables) and Tc Po2. Results: The reduction of both ankle and calf circumferences was significantly greater in the HR group ( p<0.0001), as was pitting oedema ( p<0.001), the five individual symptoms and the total symptom score ( p<0.001). Of the plethysmographic findings, there was a significant reduction in maximum venous outflow ( p<0.001 at T+1 and p<0.05 at T+2). Overall there was no significant change in Tc Po2. Conclusions: HR is an effective and well-tolerated treatment for leg oedema and symptoms of patients with CVI.

Consensus statement on the symptom‐based treatment of chronic venous diseases

“…For various drugs, there is good evidence with regard to their symptomatic effi cacy [ 26,[42][43][44][45][46][47][48][49][50][51][52][53][54] . The use of standardized red vine leaf extract (AS 195), standardized horse chestnut extract, and oxerutin results in signifi cant reduction of edema.…”

A systematic review of the efficacy and tolerability of hydroxyethylrutosides for improvement of the signs and symptoms of chronic venous insufficiency

“…Table shows the characteristics of the fifteen trials included in the review . The trials were published between 1983 and 2002 and conducted mainly in European countries.…”

“…The trials were published between 1983 and 2002 and conducted mainly in European countries. Eight trials compared HR with placebo, while five trials compared HR (used with compression bandages) vs. placebo (used with compression bandages). One trial compared HR (used with compression bandages) vs. compression bandage alone while another trial compared troxerutin, a component of HR (used with compression bandages) vs. placebo (used with compression bandages).…”

“…However, none of the trials described the blinding of personnel or outcome assessors. Only two trials adequately addressed incomplete outcome data because there were no dropouts, while 13 trials either have unequal or missing outcome data. Five trials were judged to be free of selective outcome reporting as these trials reported all prespecified outcomes mentioned in their method section.…”

Konsensuspapier zur symptomorientierten Therapie der chronischen Venenerkrankungen

“…Die symptomatische Wirksamkeit ist mit guter Evidenz für verschiedene Medikamente dokumentiert . Standardisierter roter Weinlaubextrakt (AS 195), standardisierter Rosskastaniensamen‐Extrakt und Oxerutin reduzieren signifikant die Ödeme.…”