CHRONOBIOLOGY AND CLINICAL ACTIVITY OF DAFLON-500-MG IN CHRONIC VENOUS INSUFFICIENCY

Objective: To assess the chronobiological effect on therapeutic activi ty of Daflon 500 mg and to determine the optimum method of administrat ion. Design: Multicentre, randomized, double-blind, controlled trial. Setting: Hospital outpatient clinics for vascular diseases in Hungary. Patients: Three hundred and twenty ambulatory patients with symptoms of chronic venous insufficiency randomized to three groups. Interventi ons: Oral administration daily of 1000 mg of Daflon 500 mg for 2 month s in three different ways (morning or evening or morning and evening). Main outcome measures: Symptoms and clinical signs of chronic venous insufficiency. Results: In each group, a statistically significant imp rove ment was observed between the first (DO) and the last visit (D60) concerning all symptoms. Oedema disappeared in a mean percentage of p atients ranging between 26% and 43%, according to the group and the si de affected (p <0.001). For the most affected leg, a significant decre ase (p <0.001) of ankle and calf circumferences was observed in each g roup. The first significant improvement, in comparison to D0, occurred between D15 and D30 for all symptoms and ankle circumference. The com parison between the groups did not disclose any difference concerning the improvement of symptoms and signs. Conclusion: In this study, Dafl on 500 mg demonstrated its therapeutic activity in chronic venous insu fficiency, irrespective of the daily drug administration schedule.