Table 1.
Study | Design | Study Groups | Study Objective | Duration | Inclusion Criteria | Primary Evaluation Criteria | Efficacy Results |
---|---|---|---|---|---|---|---|
Henriet (1995)17 | Multicentric randomized double-blind study | Diosmin 600 (n=34) MPFF 500 (n=35) |
To compare: Diosmin 600 mg once a day and MPFF 500 mg twice a day | 28 days | Women 18 to 45 y suffering ≥6 months from functional symptoms of CVD (pain and/or heaviness in the lower limbs) | Weekly patient self-assessment (VAS) of pain/heaviness at D0, D7, D14, D21 and D28 | Change from baseline of pain/heaviness assessed by patients significantly improved: p < 0.0001 at each time point from D7 to D28 No difference between groups |
Maruszynski (2004)18 | Multicentric randomized double-blind study | Diosmin 600 (n=59) MPFF 500 (n=60) |
To compare: Diosmin 600 mg once a day and MPFF 500 mg twice a day | 28 days | Women 20 to 60 y with CVD symptoms (C0-C3) | Weekly patient self-assessment (sum of individual scores of functional symptoms) at D0, D7, D14, D21 and D28 | Significant decrease in symptoms in both groups No difference between treatment groups |
Steinbruch (2020)19 | Multicentric non-inferiority single-blind randomized study | Diosmin 600 (n=57) MPFF 1000 (n=57) |
To assess the non-inferiority of diosmin 600 mg once a day compared to MPFF 1000 mg once a day | 6 months | Patients with CVD symptoms (C0-C3) between 20 and 60 mm of a 100-mm VAS (patient self-assessment) | Self-assessment (VAS) at M0, M2, M4 and M6 of venous symptoms in CVD patients | Non-inferiority was demonstrated Significant improvement of symptoms from M2, maximal at M6, in both groups (p < 0.0001) |
Abbreviations: CVD, chronic venous disease; D, day; M, month; MPFF, micronized purified flavonoid fraction; VAS, visual analog scale; y, years.