LEG EDEMA PROTECTION FROM A BUCKWHEAT HERB TEA IN PATIENTS WITH CHRONIC VENOUS INSUFFICIENCY - A SINGLE-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL-TRIAL

Objectives: The efficacy of a buckwheat herb tea was determined in pat ients with chronic venous insufficiency (CVI) in a single-centre, rand omised, double-blind, placebo-controlled clinical trial. Methods: Sixt y-seven male and female patients (22-74 years) with CVI were randomly divided into two groups after a 2-week run-in period. They received ei ther buckwheat herb tea (Fagopyrum esculentum) or a placebo tea for a period of 3 months. The main outcome measure was the lower leg volume determined by ultrasound. Subjective symptoms were assessed by a clini cal symptom score system. The femoral vein diameters were measured by B-scan sonography. In a subgroup of patients capillary permeability wa s determined by cutaneous fluorescence angiography. Results: Although the mean partial leg volume did not change in the treatment group (fro m 2041 to 2073 ml), it increased in the placebo group by 110 ml (from 1972 to 2082 ml) according to intent to treat. The difference between the groups was significant. The subjective clinical symptoms were sign ificantly reduced in both groups. The mean diameters of the femoral ve ins were reduced and capillary permeability was improved, but neither change was statistically significant. No drug-related adverse effects were observed. Conclusion: CVI is a very placebo-sensitive condition. The treatment with buckwheat herb tea is safe and could have a favoura ble influence on patients with CVI such that further oedema developmen t is prevented.