The Role of Oedema Protective Drugs in the Treatment of Chronic Venous Insufficiency: A Review of Evidence Based on Placebo-Controlled Clinical Trials with Regard to Efficacy and Tolerance

Abstract

Objective: To review the therapeutic efficacy and tolerability of oedema protective agents such as diosmin, horse chestnut extract and O-(β-hydroxyethyl)-rutosides in the treatment of chronic venous insufficiency (CVI). Data selection: Relevant clinical studies were selected if they were performed using a double-blind, placebo-controlled design with validated instrument measurement of objective criteria and measurement of subjective criteria by standardized methods. Data synthesis: Judgement of clinical effectiveness of drug treatment with venoprotective/venotropic agents was based on the signs and symptoms of CVI. Measurements; Accepted for consideration included reduction of leg oedema, related subjective symptoms, improvement of haemodynamics and microcirculation, and improved healing of venous ulcers. Tolerability of the compounds in therapeutic use was assessed by comparing the frequency of side-effects in treatment and placebo groups. Conclusion: Oedema protective agents such as diosmin, horse chestnut extract and O-(β-hydroxyethyl)-rutosides are an appropriate option in the management of CVI. The clinical efficacy can be measured objectively and quantified by assessing oedema reduction or in the case of venous ulcers by ulcer healing rates. The extent of oedema reduction in patients with CVI is equivalent to the reduction achieved by compression therapy with elastic stockings as seen in a recent clinical study. Combined treatment of oedema protective agents and compression therapy has a better clinical benefit compared with treatment with either alone. The compounds have a favourable benefit/risk ratio. They combine proven therapeutic efficacy with excellent safety of use confirmed in a large number of patients treated in clinical trials.