PLACEBO-CONTROLLED TRIAL OF NAFTAZONE IN WOMEN WITH PRIMARY UNCOMPLICATED SYMPTOMATIC VARICOSE-VEINS

Objective: To evaluate the effectiveness and best time course of presc ription of 30 mg/day oral naftazone (N) in women with primary uncompli cated symptomatic varicose veins (PUSVV). Design: Double-blind, placeb o (P)-controlled study. Setting: Multicentre study, coordinated by a U niversity hospital in Paris, France. Patients: 270 women with PUSVV. I nterventions: Treatment with naftazone (three dosage regimens) or plac ebo for 14 days. Main outcome measures: Comparison by ANOVA, at day 0 and after 14 days of treatment, of (1) clinical disability, using an a nalogue scale 100 mm long and (2) morning and evening leg volumes, Res ults: The reduction in disability at day 14 was 32 If: 23 mm in the N group versus 24 +/- 20 in the P group, F = 6.35, p = 0.01. Best clinic al efficacy was obtained in the subgroup given 30 mg N once a day at m idday (35 +/- 22 mm). Differences between morning leg volumes on days 0 and 14 were 19.3 +/- 74 mi in the N group versus 5.5 +/- 50 in the P group, p = 0.059.