Placebo-Controlled Trial of Naftazone in Women with Primary Uncomplicated Symptomatic Varicose Veins

Abstract

Objective: To evaluate the effectiveness and best time course of prescription of 30 mg/day oral naftazone (N) in women with primary uncomplicated symptomatic varicose veins (PUSVV). Design: Double-blind, placebo (P)-controlled study. Setting: Multicentre study, coordinated by a University hospital in Paris, France. Patients: 270 women with PUSVV. Interventions: Treatment with naftazone (three dosage regimens) or placebo for 14 days. Main outcome measures: Comparison by ANOVA, at day 0 and after 14 days of treatment, of (1) clinical disability, using an analogue scale 100 mm long and (2) morning and evening leg volumes. Results: The reduction in disability at day 14 was 32 ± 23 mm in the N group versus 24 ± 20 in the P group, F = 6.35, p = 0.01. Best clinical efficacy was obtained in the subgroup given 30 mg N once a day at midday (35 ± 22 mm). Differences between morning leg volumes on days 0 and 14 were 19.3 ± 74 ml in the N group versus 5.5 ± 50 in the P group, p = 0.059. Conclusion: Naftazone was more effective than placebo for the clinical improvement of women with PUSVV.