Dataset Information

Clinical Efficacy of Conservative Treatment with Micronized Purified Flavonoid Fraction in Female Patients with Pelvic Congestion Syndrome.

ABSTRACT:

Introduction

Pelvic congestion syndrome (PCS) may be effectively managed with conservative treatment in certain patients. Treatment with venoactive drugs is common, but supportive data are limited. This study evaluated the clinical efficacy of micronized purified flavonoid fraction (MPFF) in women with PCS.

Methods

In a single-blind, placebo-controlled study, women with duplex ultrasound diagnosis of pelvic varicose veins (PVV) and PCS were randomized to MPFF 1000 mg once daily or placebo for 2 months. Clinical manifestations of PCS were evaluated at baseline and end of treatment (M2) using three assessment tools: disease-specific quality of life (QoL) Pelvic Varicose Vein Questionnaire (PVVQ), Pelvic Venous Clinical Severity Score (PVCSS), and the Visual Analog Scale (VAS) for the main symptoms of the disease.

Results

A total of 83 women were included, 42 received MPFF and 41 received placebo. In the MPFF group, the mean global PVVQ QoL index decreased significantly from 45.1 ± 14.7 at baseline to 36.6 ± 10.6 at M2 (mean change: 8.2 ± 10.4); no significant change was observed in the control group (mean change: - 0.3 ± 4.0). The between-group difference was statistically significant (P < 0.001). Compared with control, significant improvements were observed in all four QoL parameters (pain, physical, social, psychological, all P < 0.001). The mean PVCSS summary score decreased significantly by 3.4 ± 3.4 in the MPFF group (P < 0.001) compared with a non-significant change of - 0.2 ± 1.6 in the control group (between-group difference P < 0.001). In the MPFF group, improvements were statistically significant for 6 out of 10 clinical manifestations of PCS measured using the PVCSS, including pain (mean change from baseline: 0.5 ± 0.7) heaviness (0.4 ± 0.7), discomfort (0.6 ± 0.7) and tenderness (0.3 ± 0.5). No significant improvements were observed in the control group. When measured by VAS, between-group differences were statistically significant for the overall summary score (P < 0.001) and for 8 out of 10 PCS symptoms, including: pain (mean MPFF change from baseline: 2.0 ± 2.2), heaviness (1.3 ± 2.1), discomfort (1.5 ± 2.0), tenderness (0.9 ± 1.9), and edema (1.3 ± 2.1).

Conclusion

In women with PCS, conservative treatment with MPFF was associated with improved QoL and reduced symptom severity. MPFF may be considered an effective and safe treatment option for PCS in routine clinical practice.

SUBMITTER: Akhmetzianov RV

PROVIDER: S-EPMC8586324 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Evidence-based medicine favours randomised controlled trials to limit bias and establish the effects of a treatment with statistical rigour. However, the controlled conditions and careful patient selection of randomised trials may produce results that cannot be generalised to a more diverse patient population in clinical practice. Therefore, there is growing recognition of the importance of supplementing randomised trial data with real-world evidence. Micronised purified flavonoid fraction has been investigated in several large-scale real-world studies, including the RELIEF and DECIDE studies, each of which included more than 1000 patients with chronic venous disease. These studies demonstrated a significant reduction in the prevalence and severity of chronic venous disease symptoms, and an improvement in quality of life. The chronic VEnous dIsorders maNagement and treatment effectivenesS evaluaTion in chronic vEnous disease, an international Program (VEINSTEP) study (NCT04574375), is currently underway in more than 6000 patients with chronic venous disease in nine countries. Preliminary data from one country (Morocco) indicate that chronic venous disease drug treatment, which was micronised purified flavonoid fraction in 75.7% of patients, was associated with a statistically significantly reduction in symptoms and improved quality of life. The overall results are awaited with interest. International chronic venous disease guidelines grade the evidence for micronised purified flavonoid fraction highly, as the benefits of micronised purified flavonoid fraction have been proven in randomised clinical trials and meta-analyses. Real-world studies demonstrate that the randomised evidence for micronised purified flavonoid fraction is generalisable to a clinical practice setting. Treatment decisions in chronic venous disease should consider evidence-based recommendations, including real-world data, as well as patient goals of symptom relief, functional improvement and/or better quality of life.

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