Oxerutins in the prevention of recurrence in chronic venous ulceration: randomized controlled trial

The value of oxerutins [O-(beta-hydroxyethyl)-rutosides] in the prevention of venous ulcer recurrence was investigated in a double-blind randomized controlled trial of 138 patients with recently healed chronic venous ulcers. Oxerutins in the form of Paroven 500 mg twice daily or identical placebo were given, and all patients were provided with elastic compression stockings. At follow-up 3 months later, patients were assessed for re-ulceration and for tablet and stocking compliance. Oxerutins (n = 69) and placebo (n = 69) groups were well matched for age, sex, duration of previous ulceration and deep vein thrombosis. Cumulative re-ulceration by life-table analysis at 12 and 18 months was 22 and 32 per cent respectively for placebo, and 23 and 34 per cent respectively for oxerutins (P = 0.93). Recurrence was more frequent in patients who complied with both tablets and stockings, suggesting that compliance was influenced by continued symptoms (P = 0.006). This trial failed to demonstrate that oxerutins influenced ulcer recurrence.