Effectiveness of Micronized Purified Flavonoid Fraction on Quality of Life in Patients with Chronic Venous Disease: A Systematic Review and Meta-analysis

Chronic venous disease (CVD) substantially impacts patients’ quality of life (QoL) owing to leg symptoms such as pain, swelling, and discomfort. The aim of this meta-analysis was to evaluate the effects of micronized purified flavonoid fraction (MPFF) treatment on QoL in patients with CVD. A systematic review conducted in December 2023 identified studies investigating the efficacy of oral MPFF treatment (1000 mg daily for at least 1 month) on QoL in patients with CVD. Eligible prospective studies included randomized controlled trials (RCTs) and non-RCTs (comparative, single-arm, and observational studies). Medline, Embase, and Cochrane databases were searched. Mean changes (MC) from baseline to the last postbaseline value in the global QoL score (0–100) were estimated using single-group random-effects meta-analysis. Secondary outcomes included all dimensions of QoL score (pain, physical, social, and psychological) and CVD symptom scores (using 10-cm visual analog scale [VAS]) and percentage of patients with complete resolution for heaviness and cramps. Risk of bias was assessed using the Cochrane tools. In total, 10 of 317 studies were retained for the analysis. These studies conducted worldwide included 5654 patients allocated to MPFF treatment; nearly all (99.6%) were treated for at least 2 months. Mean (standard deviation [SD]) age was 45.6 (6.7) years, with mostly females (81.3%) and overweight (body mass index [BMI] of 25.9 [3.5] kg/m2) patients. The distribution of Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) classes was: 37.3% (C2), 24.0% (C3), 21.2% (C1), 14.1% (C4), and 3.2% (C0s). Two studies had low risk of bias, four had some concerns, and four had high risk. There was no strong evidence of publication bias (Egger’s test P = 0.083). Patients’ global QoL score significantly improved post treatment: MC of − 17.1 (95% confidence interval (CI) [− 20.0, − 14.1], I2 = 96.3%), with greater reductions observed over longer treatment durations, from − 13.0 (− 17.7, − 8.3) for 1–2 months to − 20.0 (− 24.6, − 15.5) for 6 months treatment (all P < 0.001). Sensitivity analysis excluding studies with a high risk of bias showed consistent results with the main analysis. Subgroup analysis between RCTs and non-RCTs showed comparable reductions across both study designs. QoL dimensions showed improvements in pain, physical function, psychological well-being, and social engagement (all P < 0.001). MPFF treatment also significantly alleviated CVD symptoms such as pain, heaviness, and discomfort, with improvements demonstrated by VAS scores (all P < 0.001). A significant percentage of patients reported complete resolution of heaviness (78.7%) and cramps (95.3%), both P < 0.001. Heterogeneity was high across studies (I2 > 80% in most analyses). This meta-analysis showed that MPFF treatment was associated with improvements in QoL globally and across all dimensions for patients with CVD. The findings highlight the importance of a patient-centered approach in managing CVD and provide additional evidence of the clinical benefits of MPFF in enhancing patient-important outcomes. However, the exact magnitude of this clinical impact remains to be confirmed through further investigation. International Prospective Register of Systematic Reviews (PROSPERO), CRD42023476525. Chronic venous disease often causes symptoms such as leg pain, heaviness, cramps, and discomfort. These symptoms can affect daily activities, sleep, and emotional well-being. To understand the effect of a treatment called micronized purified flavonoid fraction (a plant-based medicine commonly used for vein related symptoms) on these symptoms and patient quality of life, we combined results from ten clinical and real-world studies. Together, these studies included more than 5600 patients. We found that this treatment improved patients’ quality of life, including their physical comfort, emotional health, and social activities. The treatment also reduced the severity of common symptoms, and many patients experienced complete relief from heaviness and cramps. These results suggest that micronized purified flavonoid fraction is an effective, patient-focused treatment option for chronic venous disease. However, more research is needed to better understand the exact size of these benefits and how they may differ among patients.