Effectiveness and safety of micronized purified flavonoid fraction for the treatment of concomitant varicose veins of the pelvis and lower extremities

Abstract

Objective: Concomitant varicose veins of the pelvis (VVP) and lower extremities (VVLE) frequently coexist. This study evaluated the effectiveness and safety of micronized purified flavonoid fraction (MPFF) in the treatment of patients with both conditions.

Methods: Female outpatients with concomitant VVP and VVLE received MPFF 1000 mg once daily for 2 months (Group 1), or 1000 mg twice daily for 1 month followed by 1000 mg once daily for 1 month (Group 2), based on pelvic pain intensity. Change in pain intensity during treatment was evaluated on a 10 cm visual analog scale. All patients underwent transvaginal and transabdominal duplex ultrasound scanning, radionuclide phlebography of the lower extremities, and emission computer tomography of the pelvic veins at inclusion and end of treatment.

Results: In Group 1 (N = 35), MPFF was associated with a twofold reduction in pain syndrome severity (pelvic, perineal and lower leg pain) in all patients after 1 month, and a reduction in chronic pelvic pain (CPP) from 3.4 ± 1.2 to 0.83 ± 0.18 cm at 2 months. Leg pain significantly decreased from 2.8 ± 0.6 at baseline to 0.94 ± 0.11 after 2 months. In Group 2 (N = 30), MPFF decreased CPP severity from 6.3 ± 0.8 to 1.2 ± 0.12, perineal pain from 3.6 ± 0.9 to 0.88 ± 0.22 and leg pain from 4.6 ± 0.5 to 0.9 ± 0.1. Radionuclide phlebography confirmed the clinical improvement in both treatment groups, with a substantial increase in linear blood flow velocity in the internal iliac veins (∼10% in Group 1 and 35% in Group 2) and a reduction in mean transit times of the radiopharmaceutical. MPFF also reduced blood stasis in the pelvic venous plexuses. Gastralgias were reported in two patients but resolved rapidly and did not lead to treatment withdrawal.

Conclusion: Phlebotropic treatment with MPFF is an effective and safe method of conservative therapy in patients with concomitant VVP and VVLE.

Keywords:

• Micronized purified flavonoid fraction
• treatment
• varicose veins of the lower extremities
• varicose veins of the pelvis
• vulvar varicosity

Transparency

Declaration of funding

This manuscript received no funding.

Author contributions: Study concept and design: S.G.G. Writing of the manuscript: S.G.G. Reviewing the draft: S.G.G., A.V.K. Statistical analysis: Y.P.M.

Declaration of financial/other relationships

No potential conflict of interest was reported by the authors.

CMRO peer reviewers on this manuscript no relevant financial or other relationships to disclose.

Acknowledgements

Servier funded the checking and amendment of the English language but did not sponsor the study or play any role in the drafting of the text.

Notes

* Trade names: Detralex and Daflon.