Rutosides for treatment of post-thrombotic syndrome.

Systematic review of 3 randomized trials in adults with post-thrombotic syndrome after venography-proven deep venous thrombosis. Participants were treated in outpatient settings in the Netherlands, Spain, and Italy, with study durations ranging from 8 weeks to 12 months.

Rutosides were given orally as 0-(β-hydroxyethyl)-rutosides in doses of 900 mg/day for 6 months, 1200 mg/day for 8 weeks, or 2000 mg/day in two divided doses for 12 months. Comparators included placebo, elastic compression stockings, and hidrosmina in one trial.

There was no evidence that rutosides improved post-thrombotic syndrome more than placebo or elastic compression stockings. Across the three studies (233 participants), the main findings were largely null: in one trial, improvement in tiredness was 46% with rutosides versus 26% with placebo, but oedema/swelling reduction was 20/41 versus 18/42 and pain reduction was 16/41 versus 14/42; in another, improvement was 26/40 with rutosides versus 28/40 with elastic compression stockings. The review concluded that the available evidence is limited and of low or very low quality, providing no evidence for the use of rutosides in PTS. Mild side effects were reported in one study.

Evidence came from only 3 small trials with 233 total participants and substantial variation in dose, duration, and comparator. Overall certainty was low or very low, and adverse event reporting was incomplete, limiting confidence in the safety and efficacy assessment.