Venoactive drug treatment for patients with pelvic varicose veins: Results of the single-center, randomized, open-label study (VENOTREAT).

Abstract

Background: The efficacy of venoactive drug (VAD) treatment for pelvic venous disorder (PeVD) has not been fully investigated. This study was aimed at evaluating the efficacy and safety of different diosmin-containing agents in women with PeVD. Methods: VENOTREAT was a single-center, randomized, open-label study included 150 women with symptomatic PeVD, who were allocated for the 2-month therapy a once-daily intake of: (1) micronized purified flavonoid fraction (MPFF) 1000 mg; (2) diosmin 600 mg, or (3) hesperidin and diosmin combination (HDC) 1000 mg. The effects on chronic pelvic pain (CPP), the time to pain relief, as well as adverse events (AEs) were investigated. Results: Patients receiving MPFF reported a CPP reduction, using visual analog scale (VAS) scores, from 5.7 ± 0.8 to 2.8 ± 0.4 (p = 0.001) by day 7 and its elimination by day 28 in all cases. In the diosmin and HDC groups, the CPP reduction became significant by day 14 (VAS scores from 5.3 ± 0.6 to 3.7 ± 0.3 and from 5.1 ± 0.3 to 3.5 ± 0.2, respectively, both p = 0.001), and pain was eliminated after 2 months in 37 and 35, and decreased in the remaining 13 and 15 patients to VAS scores 1.07 ± 0.2 and 1.1 ± 0.07, accordingly. AEs included headache, nausea, gastralgia, and diarrhea and were reported in 7.3% of cases in general and in 6%, 8%, and 8% of patients in the MPFF, diosmin, and HDC groups, respectively. No serious AEs were observed. Conclusion: VAD treatment is effective and safe for eliminating CPP in PeVD. MPFF provides a faster and greater effect on venous CPP of venous origin. ClinicalTrials.gov Identifier: NCT06584799.