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Introduction: Mesenchymal stem cells (MSCs) have promising regenerative properties in tissue repair and anti-inflammatory responses. This study aimed to investigate the effects of MSCs and their combination with micronized purified flavonoid fraction (MPFF) in a croton oil-induced hemorrhoids model on tissue edema, inflammation, and underlying molecular mechanisms. Material and methods: MSCs were isolated and characterized for their adherence, differentiation capacity, and immunophenotyping. Croton oil-induced hemorrhoid mouse models were established to assess tissue edema, inflammation, tumor necrosis factor (TNF-α) expression, transforming growth factor-β (TGF-β) expression, collagen ratio, and MMP-9 activity. The effects of MSCs and their combination with MPFF (diosmin-hesperidin) were evaluated through histological examinations, western blot analysis, and gelatin zymography. Results: Characterization confirmed the MSCs’ plastic adherence, osteogenic differentiation potential, and immunophenotype (positive for CD90 and CD29, negative for CD45 and CD31). Treatment with MSCs alone or in combination with MPFF significantly reduced tissue edema, inflammation, TNF-α expression, and MMP-9 activity. Additionally, MSCs increased TGF-β expression, and collagen type I/III ratio, and accelerated wound healing by resolving inflammation. Conclusions: These findings suggest that MSCs play a crucial role in modulating TNF-α, TGF-β, collagen remodeling, and MMP-9 activity, highlighting their promising role in hemorrhoid treatment and wound healing processes. Further research is warranted to fully elucidate the intricate mechanisms and optimize MSC-based therapies for clinical applications in hemorrhoidal disease management. [ABSTRACT FROM AUTHOR]

Aim: Real-world evidence on the management of hemorrhoidal disease (HD) is limited. This international study collected clinical practice data on the effectiveness of conservative treatments for acute HD on symptoms and quality of life (QoL), providing perspectives of treatment modalities from different continents. Patients & methods: The 4-week observational prospective CHORALIS study involved adult outpatients consulting for spontaneous complaints of hemorrhoids (graded using Goligher classification) and prescribed conservative treatments according to usual clinical practice. Assessments were: anal pain/discomfort (visual analog scale [VAS]), other signs/symptoms (patient questionnaire), Patient Global Impression of Change (PGI-C) questionnaire and disease-specific QoL (HEMO-FISS-QoL questionnaire). Results: Of 3592 participants, 3505 were analyzed (58.4% male; age 40.5 ± 13.7 years; history of HD in 48.4%; 72.1% Goligher grade I and II). Pain and discomfort were the most common symptoms. Most treatments were venoactive drugs (VADs; 90.9%), particularly micronized purified flavonoid fraction (MPFF; 73.7%) and diosmin (14.6%). All VAD-based therapies improved signs/symptoms (number/intensity/frequency of pain, discomfort, bleeding, swelling, itching and soiling) and QoL. MPFF was associated with a significantly greater proportion of patients with no symptoms (48.8 vs diosmin 34.4%, p < 0.001), pain disappearance (69.7 vs diosmin 52.8%, p < 0.001), treatment impact at 1 week rated on PGI-C as ‘very much better’ (30.5 vs diosmin 17.9%, p < 0.001) and shorter times to improvement (mean ± SD 3.9 ± 1.5 days vs diosmin 4.2 ± 1.7 days). Conclusion: In this prospective real-world study of patients with acute HD, conservative therapies consisting mainly of VADs, including MPFF, improved the clinical signs and symptoms of disease, as well as QoL. This study evidence supports clinical advantages associated with VADs, mostly MPFF, for effectively managing acute HD.

Evidence suggests that chronic venous disease (CVD) may be a cardiovascular disorder, as patients with CVD are prone to developing arterial (atherosclerosis) and venous (thromboembolism) diseases. This may be partly explained by shared risk factors. Thus, patients with CVD or cardiovascular disease require careful history-taking and physical assessment to identify coexisting pathologies and risk factors. This article summarises a symposium at the XIX World Congress of the International Union of Phlebology held in Istanbul, Turkey, in September 2022. Common pathophysiological features of CVD and cardiovascular disease are endothelial injury, hypercoagulability and systemic inflammation. In CVD, inflammation primarily affects the microcirculation, with changes in capillary permeability, vein wall and valve remodelling and increase in oxidative stress. Once patients develop symptoms/signs of CVD, they tend to reduce their physical activity, which may contribute to increased risk of cardiovascular disease. Data show that the presence of CVD is associated with an increased risk of cardiovascular disease, including peripheral arterial disease and heart failure (HF), and the risk of adverse cardiovascular events increases with CVD severity. In addition, patients with cardiovascular disease, particularly those with HF, are at increased risk of venous thromboembolism (VTE) and should be assessed for VTE risk if they are hospitalised with cardiovascular disease. Therefore, CVD management must include a multi-specialty approach to assess risk factors associated with both the venous and arterial systems. Ideally, treatment should focus on the resolution of endothelial inflammation to control both CVD and cardiovascular disease. International guidelines recommend various conservative treatments, including venoactive drugs (VADs), to improve the symptoms/signs of CVD. Micronized purified flavonoid fraction (MPFF) is a VAD, with high-quality evidence supporting its use in relieving symptoms/signs of CVD and improving quality of life. Moreover, in large-scale observational studies, MPFF has shown superior effectiveness in real-world populations compared with other VADs. 3qqUjcBFSDSz8_qvuiGNf1 Video Abstract. (MP4 97173 kb) Plain Language Summary: Blood vessel disease can affect both arteries and veins; when it affects arteries, it is called cardiovascular disease, and when it affects veins, it is called chronic venous disease (CVD). In most cases, the underlying disease process is similar, irrespective of the type of blood vessels affected, and the risk of both CVD and cardiovascular disease is increased by age, smoking, overweight/obesity and diabetes. If cardiovascular disease affects arteries in the legs, the symptoms can be similar to that of CVD, with pain, feelings of leg heaviness or tiredness and skin changes. CVD and cardiovascular disease are usually treated by different specialists. A symposium was held at the XIX World Congress of the International Union of Phlebology in Istanbul, Turkey, in September 2022, to raise awareness of the relationship between the two conditions. The speakers described the common disease processes in CVD and cardiovascular disease, and how patients with CVD are at increased risk of cardiovascular disease, and vice versa. They reiterated the importance of thoroughly assessing patients with either cardiovascular disease or CVD to see if both arterial and venous disease were present. When patients have CVD, international treatment guidelines recommend various conservative treatments, including venoactive drugs, to improve symptoms and signs. There is high-quality evidence to support the use of the venoactive drug, micronized purified flavonoid fraction (MPFF), to improve quality of life and relieve a broad range of CVD symptoms/signs. Large-scale observational studies support the effectiveness of MPFF in a real-world population of patients with CVD compared with other venoactive drugs. [ABSTRACT FROM AUTHOR]

Introduction: VEIN STEP was conducted to collect international data on the management of chronic venous disease (CVD) and to assess the effectiveness of conservative treatments for the relief of CVD signs and symptoms. Methods: This international, observational, prospective, longitudinal, cohort study recruited adult outpatients consulting for symptomatic CVD. The primary objective was the effectiveness of conservative treatments on symptoms, signs and quality of life in a real-life setting assessed using a range of patient-reported outcome measures: 10-cm Visual Analog and Patient Global Impression of Change scales for symptoms; Venous Clinical Severity Score for physician assessment of signs; and 14-item ChronIc Venous Insufficiency Questionnaire (CIVIQ-14) for quality of life. At inclusion, patients were prescribed conservative treatment according to the physicians' usual practice. Follow-up visits took place at weeks 2 and 4, with an optional week 8 visit. Results: The analysis set comprised 6084 subjects (78% female) from nine countries with a mean age of 50.6 ± 13.8 years and BMI of 28.0 ± 4.9 kg/m2. The most common CEAP classifications were C1 (23.0%), C2 (31.6%), and C3 (30.7%). Conservative therapy consisted of oral venoactive drugs (VADs; 95.8% of subjects) including micronized purified flavonoid fraction (MPFF 75.5%) and diosmin (18.8%), compression (52.0%), and topicals (31.5%). Conservative therapy led to global symptom improvement in 89% of patients after 2 weeks and 96% at 4 weeks. Pain, leg heaviness, cramps, and sensation of swelling were improved in 82%, 71%, 45.5%, and 46% of patients, respectively. Conservative therapy was associated with a decrease over time in patient-assessed global symptom intensity: – 2.37 ± 1.73 (P < 0.001) and physician-assessed disease severity – 1.83 ± 2.82 (P < 0.001). Among the VADs, MPFF-based conservative therapy was associated with the greatest reduction in symptom and sign intensity. Improvements in CIVIQ-14 were observed with all treatments but were greatest for MPFF. Conclusion: In this prospective study conducted in the real-world setting, treatment with conservative therapy, in particular MPFF, was associated with meaningful improvements in the clinical signs and symptoms of disease as well as in quality of life in patients with CVD. Trial Registration: ClinicalTrials.gov identifier NCT04574375. Plain Language Summary: Study Aim: The VEIN STEP study aimed to gather global data on managing chronic venous disease (CVD) and evaluate the usefulness of conservative (non-surgical) treatments for improving CVD signs and symptoms. Methods: Persons included in the study group had symptomatic CVD and were visiting outpatient clinics. The main aim was to measure how well treatments improved symptoms, physical signs of the illness, and quality of life. Different methods were used to measure these aspects, such as rating symptoms on a 10-point scale and using questionnaires completed by patients and doctors. Study Findings: 6084 participants from nine countries joined the study. They were mostly women (78%) with an average age of around 50. Common symptoms included leg pain and leg heaviness. Treatments consisted mainly of drugs active on vein function, like MPFF and diosmin, along with compression stockings and creams. Conservative treatment led to symptom improvement in 89% of patients after 2 weeks and 96% at 4 weeks. Pain and leg heaviness improved in most patients (82% and 71% over the same period) while cramps, and swelling showed improvement in 45.5% and 46% of patients, respectively. Patients reported a significant decrease in symptom intensity, and doctors observed a reduction in disease severity. MPFF was associated with the highest reduction in symptom intensity. Improvements in quality of life were observed with all treatments but were greatest for MPFF. Conclusion: The study highlights that conservative treatments, especially MPFF, are associated with significant improvements in the clinical signs and symptoms of patients with CVD as well as in their quality of life. [ABSTRACT FROM AUTHOR]

Введение. SARS-CoV-2 сопровождается развитием дисфункции венозного эндотелия, которая может привести к развитию персистирующей флебопатии нижних конечностей, снижаю щей качество жизни пациентов.Цель. Оценить эффективность фармакологической терапии пациентов с постковидной флебопатией.Introduction. SARS-CoV-2 is accompanied by the development of venous endothelial dysfunction, which can lead to the development of persistent phlebopathy of the lower limbs, reducing the quality of life of patients.Objective. To evaluate the efficacy of pharmacological therapy in patients with postcocclusive phlebopathy.Materials and methods. 178 patients (125 women), mean age 34.8 ± 3.2 years, who underwent SARS-CoV-2, for their first veno-specific complaints received micronized purified flavonoid fraction (MPFF) 1,000 mg per day for 90 days. Complaints were monitored using a 10-cm visual analog scale and the CIVIQ-20 questionnaire. All patients underwent ultrasound examination of the venous system of both lower extremities and photoplethysmography. Laboratory biochemical examination with determination of endothelial dysfunction marker levels was performed in 30 patients before and after treatment.Results. After 90 days of phlebotropic therapy, there was a significant reduction in the severity of all venous-specific complaints, except for intradermal vein dilation. The global quality of life index increased from 64.4 ± 11.2 to 86.6 ± 9.1% (p < 0.001). There was an improvement in photoplethysmography (PPG) scores. Return blood-flow time and tibial venous muscle pump strength increased significantly (p < 0.05) by 4.3 s and 3.5%, respectively. The 30 patients who underwent biochemical examination in the first blood samples obtained from the great saphenous vein showed a significant increase in IL-1 concentration (7.8 ± 0, 7 pg/ml), IL-6 (18.7 ± 1.8 pg/ml), VEGF (187.8 ± 11.6 pg/ml), TNF (7.8 ± 0.9 pg/ml), histamine (22.4 ± 11.4 nmol/L) and hsCRB (5.4 ± 0.3 mg/L), indicating that a proinflammatory phenotype of venous endothelium was formed. After 90 days of MOFF administration, these indices significantly decreased. The levels of IL-1 and IL-6 decreased by 3.2 and 10.4 pg/ml, respectively, the values of VEGF and TNF decreased by 114.6 pg/ml and 2.9 pg/ml. There was a gradual normalization of histamine and hsCRB to 6.1 ± 4.1 nmol/L and 1.1 ± 0.9 mg/L.Conclusions. The data obtained indicate that the appearance of veno-specific symptoms and syndromes in patients who have undergone SARS-CoV-2 may be due to the development of phlebopathy, the correction of which requires the use of pharmacological drugs with relevant mechanisms of action.

Introduction. Chronic vein diseases in general and varicose veins of the lower extremities in particular represent a serious medical and social problem.The aim was to study the influence of the therapy of venous outflow disorders on the treatment results of osteoarthritis of the knee joints in patients with varicose veins in combination with osteoarthritis of the knee joints.Materials and methods. The study included 105 patients with varicose veins combined with knee osteoarthritis who had previously received treatment for osteoarthritis of the knee joints but had not received or had received extremely irregular therapy for varicose veins. The follow-up period for the patients was 12 months. The patients underwent the first course of phlebotropic drugs for 2 months from the start of the study. Then this course was repeated twice at 3-month intervals. The standard phlebotropic drug was a micronized purified flavonoid fraction. Compression knitwear was recommended in all patients. Class 2 stockings or tights with an ankle pressure of 23–32 mmHg were used in the vast majority of cases. Treatment of osteoarthritis included the use of nonsteroidal anti-inflammatory drugs, disease-modifying agents (chondroitin sulfate, glucosamine sulfate), and physical therapy.Results. The VCSS scale reduced the degree of chronic venous insufficiency in the clinical group. At inclusion in the study, the average score in the clinical group was 7.1 ± 1.9, after 6 months the result was 6.1 ± 1.5, and after 12 months – 6.0 ± 1.2 points. In the control group, where patients did not receive therapy for varicose veins, there were no dynamics. The results of joint syndrome against the background of correction of venous outflow disturbances – decrease of Leken and WOMAC index values, decrease of pain syndrome according to the visual analogue scale. All this led to a decrease in the patients' need for taking analgesics.Conclusions. Out of 100 patients with joint pathology, 68 patients were diagnosed with varicose veins. These diseases aggravate each other, but we can assume that the venous pathology is primary. A vicious circle is set in motion – progression of osteoarthritis due to the disturbances of venous outflow, and varicosity due to the deterioration of muscular-venous pump functioning.

Aims: To investigate the effectiveness and tolerability of adjunctive micronized purified flavonoid fraction (MPFF) in patients with chronic venous disease (CVD). Patients & methods: This observational study included adults (≥18 years) with clinical-etiology-anatomy-pathophysiology (CEAP) class C4 CVD for whom MPFF was indicated. Outcomes included changes in subcutaneous adipose thickness, venous clinical severity score, CVD symptoms (using a visual analogue scale) and tolerability. Results: Of 381 patients, 365 completed the study. After 6 months, subcutaneous adipose tissue thickness, venous clinical severity score and visual analogue scale scores significantly improved (all p < 0.001 vs baseline). No adverse drug reactions occurred. Conclusion: Adjunctive MPFF treatment improves skin and subcutaneous tissue conditions in CVD patients. Clinical Trial Registration: NCT04138576 (ClinicalTrials.gov). [ABSTRACT FROM AUTHOR]

Introduction. It has been for a long time considered that treatment of trophic venous ulcers and varicose eczema should be operative only. However, practice shows that such treatment doesn’t guarantee the complete healing of an ulcer or eczema and doesn’t always prevent the recurrence of pathological processes. It suggests the need for an integrated approach to the treatment of trophic venous ulcers and varicose eczema.Aim. Analyze the effectiveness of various methods of non-surgical treatment of venous trophic ulcers (TU) and varicose eczema (VE) to create an optimal algorithm for managing this category of patients in outpatient practice.Materials and methods. A prospective comparative cohort study of 252 patients with C4-C6 CVD classes (CEAP) was conducted. 178 people (71%) had venous TU , 74 (29%) – VE. 3 groups of patients were formed: 1 gr. – (n = 68) was treated with traditional medicines and standard topical therapy (control); 2 gr. – (n = 90) received MOFF, elastic compression (Pütterbinde bandage), systemic antibiotic therapy for TU and corticosteroids for VE, dressings using Hartmann wound coverings; 3 gr. – (n = 94) in addition to the treatment similar to group 2, sclerotherapy (ST) of pathological venous reflux was performed. The follow-up lasted 6 months (8 visits) with a comprehensive clinical, laboratory and instrumental assessment. Statistical processing of the results was carried out using the STATISTICA software package (StatSoft, Inc., 2001, version 6.0).Results. By the end of the study, the following positive trends were registered in group 2 compared to group 1: the total VCSS index was 1.5 times lower, and according to the 10 – point VAS – 3 times; TU healing/ VE remission occurred 2 months earlier, complete healing of TU was noted in 75% of patients vs 63%, remission of VE-in 81% vs 47%. The combination of elimination of pathological reflux by CT and MOFF therapy (group 3 patients) was particularly effective. When comparing group 1 with group 3, it turned out that in the latter, by the end of the study, the total VCSS index was 3 times lower; the total indicator for the 10 – point VAS was 5.5 times lower for TU, 10 times higher for VE; TU healing/VE remission occurred 4 months earlier, complete healing was noted in TU in 88% of patients vs 63%, remission of VE in 96% vs 47%. Based on the obtained data, therapeutic algorithms were proposed for the management of patients with venous TU and VE in outpatient settings.Conclusions. Conservative treatment of venous TU and VE can be an alternative to surgical treatment, or an addition to it. MOFF is the most effective venotonic of complex action prescribed for the treatment of TU/VE in the form of monotherapy. Sclerosing therapy is a full-fledged element of the complex treatment of venous TU. The use of the proposed treatment algorithms makes it possible to speed up the healing process of venous TU and achieve remission of VE by three times.

Objectives: We sought to determine the baseline demographic and clinical characteristics of patients with Chronic Venous Disease (CVD) across the Caribbean, and to evaluate patients' compliance to conservative therapy and the effectiveness of such therapy in reducing patients' CVD symptoms. Method: Patients were enrolled into the VEIN Act Program, and their demographic data, CVD symptoms (and their intensity) and CEAP C-classification was recorded at the first visit. Patients were prescribed conservative therapy, and symptom intensity and patient compliance and satisfaction evaluated at a follow-up visit. Results: We enrolled 193 patients into the study, most of which (76%) were female, between 39–78 years (80%) and within the C2-C4a classes (56.1%). Pain (61.1%) and heaviness (58.5%) were the most common symptoms. Patient compliance to the prescribed treatment was relatively high for all modalities (>75%) and most patients (92.1%) were at least somewhat satisfied with their treatment. Conclusions: Patient compliance to conservative therapy for management of CVD is high across the Caribbean, and such therapy is effective in reducing intensity of CVD symptoms. [ABSTRACT FROM AUTHOR]

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Phlebotropic therapy is an important component of the pathogenetic treatment of chronic venous insufficiency (CVI) of the lower extremities. Venoactive drugs, which have proven their effectiveness and safety in a variety of studies, are widely represented in international and Russian clinical guidelines and standards. However, there is no consensus on the regulation of phlebotropic therapy and, above all, its duration in different clinical classes of CVI. In addition, there are no clear indications on the methods of treatment efficacy monitoring, which can be used in real clinical practice. The presented systematized review of the literature data on micronized purified flavonoid fraction not only reveals the possibilities of phlebotropic therapy of different clinical classes and forms of CVI, but also suggests effective regulations for the use of this drug in specific situations. The data concerning the efficacy of phlebotropic therapy in real clinical practice at the initial stages of CVI (C0s-C1s), in the treatment of C2s (varicose superficial veins with venospecific symptoms), C3 (chronic venous edema), C4 (trophic skin disorders), as well as in stages C5-C6 and C6r (venous trophic ulcers) are presented in details. In addition, the results of studies on the use of micronized purified flavonoid fraction in phlebosclerosing treatment are presented. The duration of phlebotropic therapy is in direct relation to the severity of the disease and the response to the ongoing treatment. The important role is played not only by personalization of treatment according to specific symptoms and syndromes, but also, if possible, by objective control of their dynamics.

Copyright of Medicina Pro Praxi is the property of SOLEN sro and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Introduction: Lower extremity varicose vein disease is one of the common problems in vascular surgery. Clinically, this disease is accompanied by a wide range of complaints and external symptoms, which eventually lead to a worse patients’ quality of life. The integrated approach is being applied to the disease treatment, which involves the use of various phlebotropic drugs as conservative therapy along with minimally invasive surgical correction and sclerotherapy.Objective: to improve the quality of phlebotropic therapy for patients with lower extremity varicose vein disease, based on the study of factors that shape the patient’s compliance with the effective treatment of clinical symptoms. The term «compliance» means the precise and informed implementation of the doctor’s recommendations during the treatment by the patient. Most often, «compliance» is assessed by the drug use index, which is the quotient of dividing the number of days on which the full dose of the drug was taken by the duration of the entire study period. Materials and methods: The analysis of 368 + 111 patients with lower extremity varicose vein disease was carried out. Of these, 111 patients turned out to be beyond the correct study of compliance (a phlebectomy was performed in a hospital). 368 patients were divided into the following groups: Group 1: the patients, who were assigned modern surgical treatment of varicose veins (endovenous laser coagulation, scleroobliteration); Group 2: the patients, who withdrew from assigned interventions. As it turned out, the different groups of patients differed in compliance.Results. The patients who were shown and performed surgical treatment – 320 (86.9%), can be considered highly compliant with the prescribed conservative therapy – the average value of the compliance index is 0.83, compared to the representatives who refused to perform the recommended surgical procedures recommended by them – 48 (13.1%), the compliance index is 0.78.In the course of the investigation, the factors shaping compliance with phlebotropic drugs were identified, a comparative assessment was carried out on the main indicators of the effectiveness of phlebotropic drugs.Conclusion. Thus, the compliance of the patients suffering from LEVVV during the treatment with phlebotropic drugs varies depending on the multiplicity and convenience of the form of the drug, on the effectiveness of the proposed phlebotropic therapy according to the influence on the complaints and symptoms, on the psychological readiness of the patient to entrust the result of the final treatment of the disease to the surgeon.

Introduction: Mesenchymal stem cells (MSCs) have promising regenerative properties in tissue repair and anti-inflammatory responses. This study aimed to investigate the effects of MSCs and their combination with micronized purified flavonoid fraction (MPFF) in a croton oil-induced hemorrhoids model on tissue edema, inflammation, and underlying molecular mechanisms., Material and Methods: MSCs were isolated and characterized for their adherence, differentiation capacity, and immunophenotyping. Croton oil-induced hemorrhoid mouse models were established to assess tissue edema, inflammation, tumor necrosis factor (TNF-α) expression, transforming growth factor-β (TGF-β) expression, collagen ratio, and MMP-9 activity. The effects of MSCs and their combination with MPFF (diosmin-hesperidin) were evaluated through histological examinations, western blot analysis, and gelatin zymography., Results: Characterization confirmed the MSCs' plastic adherence, osteogenic differentiation potential, and immunophenotype (positive for CD90 and CD29, negative for CD45 and CD31). Treatment with MSCs alone or in combination with MPFF significantly reduced tissue edema, inflammation, TNF-α expression, and MMP-9 activity. Additionally, MSCs increased TGF-β expression, and collagen type I/III ratio, and accelerated wound healing by resolving inflammation., Conclusions: These findings suggest that MSCs play a crucial role in modulating TNF-α, TGF-β, collagen remodeling, and MMP-9 activity, highlighting their promising role in hemorrhoid treatment and wound healing processes. Further research is warranted to fully elucidate the intricate mechanisms and optimize MSC-based therapies for clinical applications in hemorrhoidal disease management., Competing Interests: The authors declare no conflict of interest., (Copyright: © 2024 Termedia & Banach.)

Aim: Real-world evidence on the management of hemorrhoidal disease (HD) is limited. This international study collected clinical practice data on the effectiveness of conservative treatments for acute HD on symptoms and quality of life (QoL), providing perspectives of treatment modalities from different continents. Patients & methods: The 4-week observational prospective CHORALIS study involved adult outpatients consulting for spontaneous complaints of hemorrhoids (graded using Goligher classification) and prescribed conservative treatments according to usual clinical practice. Assessments were: anal pain/discomfort (visual analog scale [VAS]), other signs/symptoms (patient questionnaire), Patient Global Impression of Change (PGI-C) questionnaire and disease-specific QoL (HEMO-FISS-QoL questionnaire). Results: Of 3592 participants, 3505 were analyzed (58.4% male; age 40.5 ± 13.7 years; history of HD in 48.4%; 72.1% Goligher grade I and II). Pain and discomfort were the most common symptoms. Most treatments were venoactive drugs (VADs; 90.9%), particularly micronized purified flavonoid fraction (MPFF; 73.7%) and diosmin (14.6%). All VAD-based therapies improved signs/symptoms (number/intensity/frequency of pain, discomfort, bleeding, swelling, itching and soiling) and QoL. MPFF was associated with a significantly greater proportion of patients with no symptoms (48.8 vs diosmin 34.4%, p < 0.001), pain disappearance (69.7 vs diosmin 52.8%, p < 0.001), treatment impact at 1 week rated on PGI-C as 'very much better' (30.5 vs diosmin 17.9%, p < 0.001) and shorter times to improvement (mean ± SD 3.9 ± 1.5 days vs diosmin 4.2 ± 1.7 days). Conclusion: In this prospective real-world study of patients with acute HD, conservative therapies consisting mainly of VADs, including MPFF, improved the clinical signs and symptoms of disease, as well as QoL. This study evidence supports clinical advantages associated with VADs, mostly MPFF, for effectively managing acute HD.

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. [ABSTRACT FROM AUTHOR]

Objectives: The aim of our study was to evaluate the role of flavonoids in the improvement of post-operative symptoms after endovenous thermal ablation (EVTA). Methods: A prospective comparative study of 120 consecutive patients undergoing EVTA of the greater saphenous vein associated with phlebectomies was undertaken. Patients were grouped in those receiving micronized purified flavonoid fraction (MPFF- 60 patients) agent 500 mg Bid 7 days pre- and 30 days post- operatively (MPFF group) and those in the control group (60 patients) who did not. Demographics, intra-operative details, Clinical –Etiology- Anatomy- Pathophysiology (CEAP) clinical class, 10-cm Visual Analog Scale (VAS) for pain, Venous Clinical Severity Score (VCSS) and Chronic Venous Insufficiency Quality-of-Life Questionnaire (CΙVIQ-20) were recorded. Primary outcome was the postoperative pain assessement using the VAS scale and CIVIQ pain score. Secondary outcomes included assessement of VCSS and CΙVIQ-20 scores. Results: There were no significant differences between the groups regarding demographics, clinical and procedural characteristics. Patients in MPFF group reported significantly lower VAS pain levels than control group at 7- (−3.6 ± 1.2 vs −2.7 ± 1.9, p <.0001) and 30- post-operative day (−4.9 ± 0.1 vs −4.2 ± 1, p <.0001). MPFF group also showed better outcome in terms of CIVIQ pain score at 7- (−3.7 ± 1.3 vs −3.5 ± 1.8, p =.008) and 30- post-operative day (−5.3. ± 1.1 vs −4.4 ± 1, p =.017). Both groups showed a significant improvement in VAS pain score (p =.047), global CIVIQ-20 (p =.009) and VCSS (p =.008) at 7- and 30-days post-operatively. Conclusions: Administration of flavonoids in patients undergoing EVTA associated with phlebectomies reduces pain by a small amount during early postoperative period. [ABSTRACT FROM AUTHOR]

RETRACTED ARTICLEChronic venous disease (CVD) is the most common vascular pathology that has a significant negative effect on physical and psychological health outcomes, and requires high level of public spending on healthcare. Number of CVD risk factors has been identified in recent decades, but only recently have the experts begun to discuss the role of inflammation and endothelial dysfunction. Modern knowledge enables us to identify several priority strategies and goals aimed at managing the basic pathophysiological mechanisms of the development and progression of CVD. In particular, the use of venoactive drugs, which role in enhancing vascular tone and contractility, reducing inflammation and edema and improving microcirculation and accelerating the healing of venous leg ulcers has been carefully studied and presented with positive outcomes in various publications. This review provides various pathophysiological mechanisms of the development of CVD, which present the targets for venoactive drug therapies.

The article discusses up-to-date concepts of the prevalence, pathogenesis and clinical manifestations of chronic venous diseases and chronic venous insufficiency of the lower extremities. It discusses the current views on the mechanism of action of various phlebotrophic drugs used in the symptomatic treatment of chronic venous diseases of the lower extremities and chronic venous insufficiency, updates data on the advantages of micronized purified flavonoid fraction for the treatment of all clinical classes of chronic venous diseases.

Background: Micronized purified flavonoid fraction (MPFF) is a widely prescribed and extensively investigated venoactive drug (VAD). The standard dosage for MPFF is 500 mg administered twice daily. However, a new daily dose of 1000 mg has just been introduced., Objective: This study investigated whether a daily dose of 1000 mg MPFF could be implemented and embraced by the public and still has the same therapeutic effects as conventional pharmaceuticals., Methods: For this meta-analysis, we searched MEDLINE, Embase, Science of Web, Cochrane, and PubMed databases and forward and backward citations for studies published between database inception and March 2023. Three randomized controlled trials (RCTs) of comparison of different dosages of MPFF to evaluate whether there is a significant difference between them were included, without language or date restrictions. Due to the small sample size of the study included, we conducted a simple sensitivity test using a one-by-one exclusion method, and the results showed that the study did not affect the final consolidation conclusion. The quality of the evidence was assessed using the Cochrane risk-of-bias tool., Results: Out of 232 studies, 99 were eligible and 39 RCTs had data, all with low to moderate bias. Overall, 1924 patients (experimental group: 967, control group: 957) in 3 RCTs met the criteria. There is no significant difference in patient compliance, efficacy, clinical adverse events, and quality of life scores between MPFF 1000 mg once daily and MPFF 500 mg twice daily (standardized mean difference [SMD]: 0.049 [0.048, 0.145], p=0.321, risk ratio [RR]: 0.981 [0.855, 1.125], p=0.904, and SMD: 0.063 [0.034, 0.160], p=0.203)., Interpretation: In symptomatic chronic venous disease patients, MPFF 1000 mg once daily and MPFF 500 mg twice daily improve patient compliance, lower limb discomfort, clinical adverse events, and quality of life scores similarly. Regular medical care should recommend MPFF 1000 mg daily more often., Clinical Impact: Micronized purified flavonoid fraction (MPFF) is a popular venoactive medication (VAD) in modern medicine.MPFF is effective in treating lower extremity venous problems.Currently, besides conventional 500 mg tablets, there exist alternative dosage forms such as solutions, chewable tablets, and other novel formulations for MPFF.The excessive frequency and amount of medication may have a negative impact on patient adherence., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The high prevalence of varicose veins has been established in numerous population studies. Currently, guidelines have been developed for the treatment of patients with varicose veins for various stages of chronic venous insufficiency. Nevertheless, despite the use of modern drugs, leg compression, surgical and other interventions, it is not possible to completely reverse the symptoms of venous insufficiency. The article is devoted to the analysis of micronized flavonoid purified fraction. The development of modern drugs for chronic venous diseases is an important direction in medicine. The creation of a drug pool manufactured InRussiais a priority in the development of the country’s pharmaceutical industry. The review presents data on the study of Detravenol (Russia), which is a combination of diosmin and hesperidin (micronized purified flavonoid fraction).

The article presents up-to-date information about epidemiology, pathogenesis and clinical manifestations of chronic venous diseases and chronic venous insufficiency of the lower extremities. It discusses the mechanism of action of various phlebotrophic drugs intended for the treatment of symptoms of chronic venous diseases and chronic venous insufficiency and describes the advantages of micronized purified flavonoid fraction for the treatment of all clinical classes of chronic venous diseases.

The 19th Annual Meeting of the European Venous Forum held in the city of Athens in 28-30 June 2018 presented the long-awaited updated guidelines for the diagnosis and treatment of chronic venous diseases (CVD), the full text of which can be found in the June issue of International Angiology Journal. This publication aims at acquainting practitioners with one of the key sections of the new European guidelines devoted to the pharmacotherapy of CVD.

Chronic venous insufficiency (CVI) is the most common pathology of the peripheral vascular system. One of the main principles of conservative treatment for both small and complicated forms is pharmacotherapy with the use of venoactive drugs. The effectiveness of therapy is largely associated with the choice of phlebotrophic drug. The article discusses approaches to systemic and topical drug therapy depending on the form and stage of CVI.

Introduction: Hemorrhoidal disease (HD) is a common and recurrent problem for many adults worldwide. Venoactive drugs, such as micronized purified flavonoid fraction (MPFF; Daflon®), have been used to treat HD and their clinical benefits have been demonstrated in previous meta-analyses of clinical trials. The aim of this study was to evaluate the efficacy of MPFF across the broader spectrum of signs and symptoms following treatment of patients with HD.Methods: We performed a systematic review of the literature to identify randomized clinical trials in which MPFF treatment was compared to placebo or no treatment for acute HD or for relief of symptoms after patients had undergone medical management or a surgical procedure to remove hemorrhoids. The main endpoints investigated were bleeding, pain, pruritus, discharge or leakage, and overall improvement. There was no limit on treatment duration.Results: From 351 unique records retrieved, 11 studies reported in 13 articles were included. On the basis of findings from qualitative analysis, MPFF was reported in most studies to be beneficial in treating bleeding, pain, pruritus, anal discharge/leakage, and tenesmus, and in overall improvement. Quantitative meta-analysis of four studies indicated that MPFF treatment provided significant benefits for bleeding (odds ratio [OR] 0.082, 95% confidence interval [CI] 0.027-0.250; P < 0.001), discharge/leakage (OR 0.12, 95% CI 0.04-0.42; P < 0.001), and overall improvement according to patients (OR 5.25, 95% CI 2.58-10.68; P < 0.001) and investigators (OR 5.51, 95% CI 2.76-11.0; P < 0.001). MPFF also tended to decrease pain (OR 0.11, 95% CI 0.01-1.11; P = 0.06).Conclusion: Taken together, these results suggest that MPFF treatment can improve the most important signs and symptoms of HD. [ABSTRACT FROM AUTHOR]

Chronic venous disease (CVD) is one of the most prevalent diseases worldwide. The health condition of most patients with early stage CVD will worsen over time, and this progression increases the burden as well as the costs of treatment and reduces patient quality of life (QoL). This highlights the importance and the likely cost-effectiveness of treatment of patients with early stage CVD. Options for managing the early stages of CVD include lifestyle changes together with venoactive drugs (VAD); VADs may be used alone or in conjunction with interventional treatment of varices such as sclerotherapy, surgery, or endovenous treatments. Micronized purified flavonoid fraction (MPFF; Daflon®) is a well-studied VAD which has anti-inflammatory activities, reduces endothelial activation and leukocyte adhesion, and increases capillary resistance and integrity, to eventually improve venous tone, CVD symptoms and QoL. This article is based on previously conducted studies and does not contain any studies with human participants or animals performed by the author. [ABSTRACT FROM AUTHOR]

Venous leg ulcers (VLUs) are the most severe manifestation of chronic venous disease (CVD). Due to their chronic nature, high recurrence rate and slow healing time, VLUs account for 80% of all leg ulcers seen in patients with CVD. VLUs impose a heavy burden on patients that reduces their quality of life; VLUs also represent a major socioeconomic impact due to the cost and duration of care. The primary medical approach to treating VLUs is local compression therapy in combination with venoactive drug (VAD) pharmacotherapy to promote the reduction of the inflammatory reaction initiated by venous hypertension. Micronized purified flavonoid fraction (MPFF; Daflon®) is the most widely prescribed VAD. MPFF counteracts the pathophysiologic mechanisms of CVD and ulceration and has proven to be an effective adjunct to compression therapy in patients with large and chronic VLUs. Two other non-VAD drugs, pentoxifylline and sulodexide, have also been shown to improve VLU healing and are also recommended in addition to compression therapy. However, MPFF is the only VAD with the highest strength of recommendations in the 2018 guidelines for the healing of VLUs. [ABSTRACT FROM AUTHOR]

Contemporary interventional treatment of primary chronic venous disease (CVD) is mainly focused on the treatment of venous reflux. The long-term results of endovenous ablation (EVA) and high ligation and stripping are not different with respect to varicose vein recurrence, and this recurrence appears to be a manifestation of disease progression. Since inflammation is one of the key mechanisms of CVD development and progression, efforts to minimize inflammation and angiogenic potential in endovenous and surgical procedures are worthwhile. As techniques continue to be refined, surgery remains a valid option; in particular, the techniques that minimize trauma can be beneficial regarding recurrence. Medical treatment with venoactive drug therapy such as micronized purified flavonoid fraction (MPFF; Daflon®), which has proven clinical benefits in patients with CVD, can be used before and after EVA or surgery to minimize inflammation, pain, hemorrhage, and reduce CVD symptoms. [ABSTRACT FROM AUTHOR]

Sergey G Gavrilov Faculty of Medicine, Pirogov Russian National Research Medical University, Moscow, Russia Objective: Vulvar varicosity is a relatively common venous disorder in women with varicose veins of the pelvis and lower extremities and in pregnant women, but there is little information in the medical literature concerning its diagnosis and management. The aim of this study was to describe our experience with 101 women with vulvar varicosities who were examined and treated at our center during 2000–2014.Patients and methods: Patients were divided into two groups: group 1 with 61 women with varicose veins of the pelvis and enlarged vulvar veins, and group 2 with 40 pregnant women (11–38 weeks of pregnancy) with vulvar varicosities.Results: In most cases, vulvar varicosities were able to be diagnosed at clinical examination. In both groups, duplex ultrasound of the veins of the pelvis and lower extremities was used to confirm the presence of varicose veins, identify any retrograde flow, accurately determine vein diameter, and to reveal any anatomical feature of the intrapelvic veins. Treatment approaches varied significantly between the two groups from purely conservative measures during pregnancy to surgical procedures on the ovarian and vulvar veins in group 1. The venoactive agent, micronized purified flavonoid fraction, was effective at reducing the symptoms of vulvar varicosities in both groups.Conclusion: A tailored approach to the diagnosis and treatment of vulvar varicosities can significantly improve the quality of care of women with this disorder. Keywords: micronized purified flavonoid fraction, pelvic varicose veins, pelvic venous congestion, vulvar varicosities

Summary: Pigmented purpuric dermatoses (PPD) or capillaritis represent a benign condition, presenting with extravasation of erythrocytes in the skin and prominent hemosiderin deposition. The eruption runs a chronic relapsing course and is resistant to therapy. Capillary fragility, cellular immunity, and microvascular inflammation play important roles in the pathogenesis of PPD. Bioflavonoids, currently used as venoprotective agents for the management of chronic venous insufficiency, have been shown to reduce capillary fragility and permeability by inhibiting endothelial cell activation and modulating the leukocyte‐endothelium interaction. We report a case of PPD with dramatic improvement consequent to a therapy with a fixed dose combination containing flavonoids like diosmin, hesperidin, and Euphorbia prostata extract along with calcium dobesilate. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Chronic venous disease (CVD) is both prevalent and unavoidable in many people as a result of persistent or unalterable risk factors, the most important of which are advanced age, excess body weight, and family history. Given this inevitability, medical treatment is required to alleviate symptoms and slow disease progression. Venoactive drug therapy is emerging as a valuable treatment option for many CVD patients and micronized purified flavonoid fraction (MPFF) is the most widely prescribed and well-studied venoactive drug available. Recent evidence from animal models of venous hypertension and from clinical trials, as well as from systematic reviews, shows that MPFF is effective at alleviating many of the most common symptoms of CVD including leg pain, leg heaviness, sensations of swelling, cramps, and functional discomfort. In addition, MPFF improves the clinical signs of redness, skin changes, and edema, and improves quality of life. Collectively, these findings support the strong recommendation for MPFF treatment found in the 2018 international guidelines for the management of CVD.Funding: Servier. [ABSTRACT FROM AUTHOR]

Objective: Evaluation of the effectiveness of flavonoids in the postoperative management of patients with hemorrhoids., Material and Methods: A single-center randomized controlled clinical trial was conducted. Patients with stage III and IV hemorrhoids aged over 18 years who patients who underwent hemorrhoidectomy were included., The patients were divided into 2 groups - main and control. Patients in the main group were recommended to use a purified micronized flavonoid fraction - 65 patients. In the control group (70 patients), the use of this group of drugs was not expected., The observation period was 60 days. After discharge from the hospital, 5 patient visits were scheduled: on the 3rd, 7th, 21st, 40th and 60th day after surgery. Patients independently assessed the intensity of symptoms - pain, tenesmus, itching and bleeding., The randomization procedure was carried out using the method of simple randomization using envelopes., Results: 135 patients were randomized. There were no patients who dropped out of the study. The number of participants whose data were included in the analysis was 65 patients in the main group and 70 patients in the control group., Assessment of symptoms in the first 3 days of the postoperative period did not show a significant difference in the condition of the patients. Over time, we found significant changes in the dynamics of complaints between groups. After 7, 21, 40 and 60 days, a statistically significant lower severity of pain, bleeding and tenesmus was revealed among patients in the main group compared to the control group. This trend was not detected in the assessment of itching. There were no undesirable effects., Conclusion: The use of purified micronized flavonoid fraction in the postoperative management of patients with hemorrhoids can significantly reduce the degree and duration of pain, bleeding and tenesmus.

Background Epistaxis is a very common ENT emergency with the idiopathic variety being the commonest type. Daflon® is a mixture of flavonoids with beneficial vascular effects that may help in the treatment of epistaxis. Objective To assess the efficacy and safety of Daflon® in the treatment of idiopathic epistaxis. Methods This is an open-label randomized clinical trial conducted on patients with idiopathic epistaxis comparing 1 group receiving Daflon® for 1 month and a second group receiving Daflon® for 3 months with a control group receiving nothing. The groups were evaluated regarding the number of visits to an emergency room and the number of patients needing cautery as indicators for the control of epistaxis. Also, the severity of epistaxis was assessed using epistaxis severity score (ESS) before and after treatment. We followed the patients for 1 year to determine the long-term effect of both drug protocols. Results The study included 450 patients distributed equally among the 3 study groups. The administration of Daflon® whether for 1 month or 3 months resulted in a significant improvement in our indicators for control of epistaxis including the number of patients visiting an emergency room and those needing cauterization after the failure of light nasal packing when compared with control group. Also, the severity of epistaxis as defined by the ESS was significantly less at the end of each treatment period and at 1-year follow-up when compared with the pretreatment severity. However, the use of Daflon® for 3 months was associated with a significantly more epistaxis control at 1-year follow-up when compared with the 1-month administration. Conclusion Daflon® is a very effective and safe method for controlling idiopathic epistaxis. However, the daily use of Daflon® for 3 months has a more significant long-term beneficial effect than 1 month of use. [ABSTRACT FROM AUTHOR]

Introduction: The aim of this study was to assess the impact of adding long-term micronized purified flavonoid fraction (MPFF) to standard treatment of femoropopliteal deep vein thrombosis (DVT).Methods: This pilot, comparative, open-label study with blinded outcome assessor enrolled patients with a first episode of femoropopliteal DVT confirmed by duplex ultrasound scanning (DUS). All participants were randomly allocated to one of two treatment groups: (1) control that received a standard treatment with oral rivaroxaban, and (2) experimental that involved additional treatment with MPFF 1000 mg/day. Both drugs were used for 6 months. Patients were followed for the whole treatment period and underwent DUS every 2 months to determine the degree of recanalization by popliteal (PV), femoral vein (FV), and common femoral vein (CFV) compressibility. Thrombi extension were assessed by the modified Marder score. At the end of the follow-up period, patients were assessed with Villalta and venous clinical severity scales (VCSS). Patients with a Villalta score ≥ 5 were diagnosed with post-thrombotic syndrome (PTS).Results: Sixty patients were randomized to the control or MPFF groups (n = 30 in each group). There were 40 men and 20 women with a mean age ± SD of 56.3 ± 13.4 years. Clinically unprovoked DVT was recognized in 65% of cases and left side localization in 45%. The mean baseline Marder score was 15.0 ± 4.8 and 11.1 ± 4.3 in the experimental and control groups, respectively (p = 0.002). At 6 months, the mean Villalta score in the MPFF group was significantly lower compared with control (2.9 ± 2.7 versus 5.8 ± 3.0; p < 0.0001). PTS was diagnosed in six patients (20%) and 17 patients (57%) in the experimental and control groups respectively (p = 0.007). A significant difference between the groups was also observed for the VCSS value (2.3 ± 1.9 versus 4.9 ± 1.9; p < 0001). After 6 months of treatment the Marder score decreased to 0.8 ± 1.6 and 2.8 ± 3.5 in the experimental and control groups, respectively (p = 0.006). In the MPFF group, there was a greater reduction in the Marder score (p < 0.0001) and more rapid rate of recanalization for the FV (p < 0.0001), with a non-significant trend for the CFV (p = 0.130) and PV (p = 0.204) compared with the control group. Full recanalization of the PV at 6 months was observed in 24 patients (80%) who had received MPFF, and only 17 patients (57%) in the control group (p = 0.095).Conclusion: The addition of MPFF to standard therapy for DVT in the form of oral rivaroxaban can reduce the incidence of PTS at 6 months in patients with proximal DVT and increase the speed of deep vein recanalization.Funding: Les Laboratoires Servier funded the article processing fees, editorial assistance, and open access fee for this manuscript. [ABSTRACT FROM AUTHOR]

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Introduction: Sclerotherapy is a common technique for the removal of intradermal veins. This study examined the rationale for prescribing micronized purified flavonoid fraction (MPFF) in clinical, etiological, anatomic, pathophysiologic (CEAP) class C1 patients with dilated intradermal veins scheduled for sclerotherapy.Methods: In a national, multicenter, observational program, physicians recruited CEAP C1s patients scheduled for sclerotherapy. The decision to prescribe adjuvant MPFF (1000 mg/day for 6 weeks beginning 2 weeks before sclerotherapy) was made according to usual practice. Disease severity and treatment outcomes were assessed at baseline and 4 weeks post-sclerotherapy using a visual analog scale (VAS) as well as quality-of-life (CIVIQ-14) and patient satisfaction (Darvall) questionnaires.Results: A total of 70 physicians recruited 1150 patients: 1071 (93%) women, 79 (7%) men. Mean age (± SD) was 40.7 ± 10.7 years (range 18-74) and mean body mass index was 23.6 ± 3.3 kg/m2. Reticular veins were observed in 42.1% of patients and 57.9% had telangiectasias. MPPF was prescribed to 905 patients (79%). Sclerotherapy was associated with statistically significant decreases in mean VAS scores for leg heaviness, pain, sensation of swelling, night cramps, and itching. For each symptom, MPFF-treated patients showed a more pronounced improvement than those undergoing sclerotherapy alone: mean VAS pain score with MPFF decreased from 1.90 ± 2.30 to 0.30 ± 0.62 versus 1.72 ± 1.93 to 0.52 ± 0.99 with sclerotherapy alone; mean VAS leg heaviness score with MPFF decreased from 2.80 ± 2.43 to 0.47 ± 1.07 versus 2.38 ± 2.23 to 0.76 ± 0.85 with sclerotherapy alone. Patient quality-of-life indicators improved with symptom resolution, particularly pain, and for each indicator the observed improvement was greater with MPFF. The outcomes of treatment exceeded patient expectations. Fewer patients experienced sclerotherapy-induced hyperpigmentation with adjunctive MPFF versus sclerotherapy alone (33.9% versus 41.2%, respectively, P = 0.034). No adverse events related to MPFF were observed.Conclusion: Resolution of venous symptoms post-sclerotherapy was greater in patients treated with MPFF compared with those undergoing sclerotherapy alone, supporting the rationale for use of MPFF in patients undergoing sclerotherapy.Funding: Servier. [ABSTRACT FROM AUTHOR]

Scope A systematic review of the clinical literature concerning medical management of chronic venous disease with the venoactive therapy Micronized Purified Flavonoid Fraction was conducted in addition to an investigation of the hemodynamics and mechanism of chronic venous disease. Methods The systematic review of the literature focused on the use of Micronized Purified Flavonoid Fraction (diosmin) which has recently become available in the US, in the management of chronic venous disease. The primary goal was to assess the level of evidence of the role of Micronized Purified Flavonoid Fraction in the healing of ulcers, and secondarily on the improvement of the symptoms of chronic venous disease such as edema. An initial search of Medline, Cochrane Database for Systematic Reviews and Google Scholar databases was conducted. The references of articles obtained in the primary search, including a Cochrane review of phlebotonics for venous insufficiency, were reviewed for additional studies. Studies were included if patients had a diagnosis of chronic venous disease documented with Doppler and Impedance Plethysmography. Studies excluded were those that had patients with arterial insufficiency (Ankle Brachial Index < .6), comorbidity of diabetes, obesity, rheumatological diseases, or if other causes of edema were present (congestive heart failure, renal, hepatic or lymphatic cause), or if the patient population had recent surgery or deep vein thrombosis, or had been using diuretics (in studies of edema). Other elements of the study design were to note specifically the type of compression therapy used in conjunction with Micronized Purified Flavonoid Fraction. Results The literature review yielded 250 abstracts, 65 of which met criteria for further review and 10 papers were selected for consideration in the systematic review. Conclusion In summary, the general level of evidence supports the recommendation that the use of medical therapy with Micronized Purified Flavonoid Fraction has beneficial outcomes without serious adverse events. In the United States, diosmiplex is the only available prescription formulation of Micronized Purified Flavonoid Fraction. It is derived from the rinds of oranges and is categorized as a medical food and not as a drug; and may be a particularly attractive therapy for many chronic venous disease patients because of its favorable safety profile. The Working Group for chronic venous disease concurs with previous guidance by the International European Society for Vascular Surgery in 2015 which recommended the use of Micronized Purified Flavonoid Fraction for the healing of venous ulcers, alone and adjunctive to compression therapy, and for the reduction in symptoms of chronic venous disease such as edema. [ABSTRACT FROM AUTHOR]

Treatment of chronic venous disorders combines surgical and conservative treatment, which includes compression therapy and pharmacotherapy. The purpose of this paper is to discuss the current regiment of pharmacotherapy regarding chronic venous disorders, which includes the use of venoactive drugs, of which a preparation of micronized diosmin and troxerutin have the best documented beneficial effects. In patients with peripheral edema the use of diuretics in combined therapy together with a venoactive drug can be recommended in the case of coexisting co-morbidities that increase venous pressure in the lower extremities. Medication accelerating the healing of venous ulcers include preparations of micronized diosmin, aspirin, pentoxifylline, sulodexide and iloprost. Pharmacotherapy should also prevent, or at least decrease the risk of venous ulcer recurrence. Unfortunately, as yet no known drug has a documented lowering effect on the rate of venous ulcer recurrence. [ABSTRACT FROM AUTHOR]

Abstract: Although the antiinflammatory and antiangiogenic properties of dexamethasone and acetylsalicylic acid have been studied extensively, their effects on lymphangiogenesis in regenerating tissues remain mostly unknown. We studied in rats the pharmacological modulation and the effect of a remote inflammatory stimulus on the lymphatic regeneration upon damage after a surgical procedure. A micronized purified flavonoid fraction bearing antiinflammatory and lymphagogue properties, was also used. An incisional wound and interruption of the afferent lymphatic vessels to the popliteal and axillary lymph nodes of adult rats were made in dorsal thigh and hypochondrium, respectively. The progress of lymphatic regeneration was evaluated 3, 7, 14 and 21 days after surgery. 99mTc-dextran lymphoscintigraphy and Evans blue dye uptake were used to evaluate the lymphatic flow and the kinetics of lymphatic regeneration. In control conditions, lymphatic regeneration took 14 days to be accomplished. In the presence of a remote inflammatory response, which conceivably yielded inflammatory mediators to the incisioned lymphatic vessels, that time was shortened to 7 days. In both conditions, lymphatic regeneration was inhibited by dexamethasone and acetylsalicylic acid and accelerated by the micronized purified flavonoid fraction. These findings indicate that lymphatic regeneration in an incisional wound may be significantly modulated by dexamethasone, aspirin and a micronized purified flavonoid fraction, and these results call our attention for the possibility to pharmacologically stimulate the recovery of a lymphatic failure due to a traumatic event, or to inhibit its function in order to limit the lymphatic spread of cytokines or neoplastic cells. [Copyright &y& Elsevier]

Objective: To evaluate the efficacy of an anti-inflammatory and capillary regulator drug, micronized purified flavonoid fraction (MPFF), in the prevention of postoperative formation of adhesions. Design: A double-blind, controlled study evaluated the efficacy of MPFF in reducing postoperative adhesion formation in a rat model. Setting: Animal care facility of an academic research setting. Animal(s): Thirty Sprague-Dawley female rats randomly divided into three groups. Intervention(s): Starting on day of surgery, group 2 rats received oral MPFF (100 mg/kg per day for 7 days). Group 3 rats were intraperitoneally injected with 5 mL of saline (containing 200 mg/kg per day of MPFF for 3 days). Control rats received no medication. A standardized surgical trauma was applied in all animals. Three weeks after surgery, the rats were killed, and the adhesions were scored according to macroscopic and microscopic scales. Main Outcome Measure(s): Postoperative adhesions. Result(s): Both oral and intraperitoneal administration of MPFF reduced the scores of adhesions according to macroscopic and microscopic scales. There was no difference between the routes of administration. Conclusion(s): A statistically significant reduction in postoperative formation of adhesions was observed after oral and intraperitoneal administration of MPFF in our experimental animal model. However, further studies are required to reveal its mechanism of action. [Copyright &y& Elsevier]

Abstract: Background:: Infrared photocoagulation (IRP) is commonly used in the treatment of hemorrhoids, but rectal bleeding can persist after this procedure. Adjuvant therapy may thus be considered for more definitive control of symptoms, particularly bleeding. Objective:: The goal of this study was to compare the efficacy of a treatment combining IRP and oral micronized purified flavonoid fraction (MPFF) versus each treatment used alone on bleeding cessation in patients with grades I, II, and III acute internal hemorrhoids. Methods:: This was a prospective, randomized, controlled, single-blind study. Consecutive outpatients were randomly assigned to a treatment combining MPFF and IRP or to each treatment separately. For each patient, bleeding status was reported at day 0 (day of inclusion) and compared with that at day 5 after treatment by observers blinded to treatment assignment. Follow-up visits were planned at days 7, 30, 60, and 90 of therapy, including monitoring of treatment-related side effects and self-reporting by patients of any problem related to hemorrhoidal disease. Results:: A total of 351 patients (180 women, 171 men) were enrolled in the study. Their mean age was 49.2 years (range, 29–71 years). Hemorrhoids were grade I in 33.6% (118 patients), grade II in 48.7% (171 patients), and grade III in 17.7% (62 patients) of the study population. Patients were randomly assigned to each of the 3 treatment groups (117 patients in each), with no significant difference between groups in the age, sex, or distribution of grade of hemorrhoids. The percentage of patients with no bleeding after 5 days of treatment was higher in the combined treatment group (74.8%) compared with MPFF alone (59.6%; P = 0.023) or with IRP alone (55.6%; P = 0.004). MPFF alone was as effective as IRP alone at stopping bleeding. Patients with grades I and II hemorrhoids responded significantly better (82.5% and 61.7%, respectively) to either treatment than those with grade III hemorrhoids (22.9%; P &#60; 0.001). Of the 216 patients who were followed up for 90 days, 3 had a gastrointestinal adverse event, and 19 had a relapse of bleeding. Conclusion:: Five days of treatment combining MPFF with IRP significantly reduced bleeding status in these study patients with grades I and II acute internal hemorrhoids compared with each treatment used alone. [Copyright &y& Elsevier]