Chronobiology and Clinical Activity of Dation 500 mg in Chronic Venous Insufficiency

Abstract

Objective:

To assess the chronobiological effect on therapeutic activity of Daflon 500 mg and to determine the optimum method of administration.

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.

Interventions:

Oral administration daily of 1000 mg of Daflon 500 mg for 2 months 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 improve ment was observed between the first (DO) and the last visit (D60) concerning all symptoms. Oedema disappeared in a mean percentage of patients ranging between 26% and 43%, according to the group and the side affected (p <0.001). For the most affected leg, a significant decrease (p <0.001) of ankle and calf circumferences was observed in each group. The first significant improvement, in comparison to DO, occurred between D15 and D30 for all symptoms and ankle circumference. The comparison between the groups did not disclose any difference concerning the improvement of symptoms and signs.

Conclusion:

In this study, Daflon 500 mg demonstrated its therapeutic activity in chronic venous insufficiency, irrespective of the daily drug administration schedule.