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

BACKGROUND AND

OBJECTIVE

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.

METHODS

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.

RESULTS

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).

CONCLUSIONS

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.

PROTOCOL REGISTRATION: International Prospective Register of Systematic Reviews (PROSPERO), CRD42023476525.