THE ROLE OF EDEMA PROTECTIVE DRUGS IN THE TREATMENT OF CHRONIC VENOUSINSUFFICIENCY - A REVIEW OF EVIDENCE BASED ON PLACEBO-CONTROLLED CLINICAL-TRIALS WITH REGARD TO EFFICACY AND TOLERANCE

Objective: To review the therapeutic efficacy and tolerability of oede ma protective agents such as diosmin, horse chestnut extract and O-(be ta-hydroxyethyl)-rutosides in the treatment of chronic venous insuffic iency (CVI). Data selection: Relevant clinical studies were selected i f they were performed using a double-blind, placebo-controlled design with validated instrument measurement of objective criteria and measur ement of subjective criteria by standardized methods. Data synthesis: Judgement of clinical effectiveness of drug treatment with venoprotect ive/venotropic agents was based on the signs and symptoms of CVI. Meas urements accepted for consideration included reduction of leg oedema, related subjective symptoms, improvement of haemodynamics and microcir culation, and improved healing of venous ulcers. Tolerability of the c ompounds in therapeutic use was assessed by comparing the frequency of side-effects in treatment and placebo groups. Conclusion: Oedema prot ective agents such as diosmin, horse chestnut extract and O-(beta-hydr oxyethyl)-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 he aling rates. The extent of oedema reduction in patients with CVI is eq uivalent to the reduction achieved by compression therapy with elastic stockings as seen in a recent clinical study. Combined treatment of o edema 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 effic acy with excellent safety of use confirmed in a large number of patien ts treated in clinical trials.