rutin has been researched along with Venous-Insufficiency* in 53 studies
8 review(s) available for rutin and Venous-Insufficiency
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Ginkgo biloba, troxerutin and heptaminol chlorhydrate combined treatment for the management of venous insufficiency and hemorrhoidal crises.
Ginkor Fort® (Tonipharm, Recordati Group; GB-T-H combined treatment) comprises ginkgo biloba extract, troxerutin and heptaminol chlorhydrate. It is a venotonic and vasculoprotective agent that strengthens veins, increases vessel resistance, and reduces permeability. Thanks to these synergistic actions, it is indicated for the treatment of signs and symptoms of venous insufficiency (VI) and signs related to the hemorrhoidal crisis. This review recapitulates the rationale for using venotonics to manage VI and discusses available evidence on the use of GB-T-H combined treatment to manage VI and hemorrhoidal crisis.. Papers were retrieved by a PubMed search using different keywords. No language or publication date restrictions were used. Documents from the Authors' literature collection were also considered. Papers were selected for inclusion according to their relevance to the topic.. Preclinical and clinical studies showed that the GB-T-H combined treatment acts on both the acute phase symptoms and the pathogenetic mechanisms of the VI, through the prevention of the hypoxia-induced activation of endothelial cells, the reduction of the capillary tone and the hemostatic activity. This leads to the long-term slowing of the disease progression, suggesting that the GB-T-H combined treatment can manage the acute clinical manifestations and as a prevention measure with prolonged use in both VI and hemorrhoidal crises. In the available study, the GB-T-H combined treatment showed excellent tolerability.. Available literature evidence and extensive clinical experience support the use of the GB-T-H combined treatment as an effective and safe option for treating and preventing the clinical manifestation of VI and hemorrhoidal crisis. Topics: Endothelial Cells; Ginkgo biloba; Heptaminol; Humans; Hydroxyethylrutoside; Phytotherapy; Plant Extracts; Venous Insufficiency | 2022 |
A systematic review of the efficacy and tolerability of hydroxyethylrutosides for improvement of the signs and symptoms of chronic venous insufficiency.
Rutoside (rutin; quercetin rutinoside) is a glycoside found in various plant products, including apples, citrus fruits and cranberries. Hydroxyethylrutosides (HR) are semisynthetic derivatives sold as standardized products for the treatment of chronic venous insufficiency (CVI). Commercially available products include Relvène(®) (France), Venoruton(®) (Switzerland) and Paroven(®) (United Kingdom). However, the evidence for their efficacy is inconclusive. The aim of this systematic review was to evaluate the evidence of efficacy and tolerability of hydroxyethylrutosides for CVI.. We searched electronic databases such as the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and CINAHL, and publisher databases, conference proceedings and references lists for randomized controlled trials published in English and non-English languages. We also performed hand searches for additional trials. We included all trials that assessed the effectiveness of HR for CVI. Comparisons include HR (with or without compression bandaging) vs. placebo (with or without compression bandaging) or HR vs. compression bandaging alone. Two review authors independently selected studies, extracted data and assessed risks of bias in the included trials.. The search identified 1474 records. Only 15 trials involving 1643 participants met our inclusion criteria. A meta-analysis based on similar studies that compared HR with placebo showed that HR significantly reduced symptoms of pain (SMD -1·07, 95% CI -1·44 to -0·70), symptoms of heavy legs (OR 0·50; 95% CI 0·28-0·91) and cramps (SMD -1·07, 95% CI -1·45 to -0·69). No serious adverse effect due to HR was reported.. The findings showed that HR produced modest improvements in several symptoms of CVI. However, all the included trials were of limited quality, and therefore, better-quality trials are still required to draw firm conclusions on the usefulness of HR for CVI. Topics: Chronic Disease; Humans; Hydroxyethylrutoside; Phytotherapy; Randomized Controlled Trials as Topic; Rutin; Venous Insufficiency | 2015 |
Pharmacological treatment of primary chronic venous disease: rationale, results and unanswered questions.
The aim of this article was first to review the complex pathophysiological mechanisms responsible for symptoms and signs of primary chronic venous disease (CVD) that allow the identification of targets for pharmacological treatment. The results of CVD treatment with venoactive drugs (VADs) were emphasised and presented in the form of recommendations. The last section raises key questions to be answered to improve protocols for good clinical trials and to draw up future guidelines on these agents.. The literature has been reviewed here using PubMed and Embase.. Venous hypertension appears to underlie all clinical manifestations of primary CVD. Inflammation is key in wall remodelling, valve failure and subsequent venous hypertension. Changes in the haemodynamics of veins are transmitted to the microcirculation, resulting in capillary alteration leading to oedema, skin changes and eventually venous ulceration. Venous symptoms may be the result of interplays between pro-inflammatory mediators and nerve fibres located in the venous wall. Therefore, venous inflammation constitutes a promising therapeutic target for pharmacological intervention, and some available VADs could attenuate various elements of venous inflammation. Based on recent studies, reviews and guidelines, tentative recommendations for the use of VADs were proposed and strong recommendations were given to two of them (micronised purified flavonoid fraction and oxerutins).. VADs should be accorded a better role in the management of CVD. However, larger and more definitive clinical trials are needed to improve the existing recommendations. Topics: Anticoagulants; Blood Viscosity; Capillaries; Capillary Permeability; Capillary Resistance; Chronic Disease; Diosmin; Edema; Humans; Hydroxyethylrutoside; Inflammation; Lymphatic System; Pain; Skin Diseases; Vasodilator Agents; Veins; Venous Insufficiency | 2011 |
Pharmacological treatment in patients with C4, C5 and C6 venous disease.
A range of surgical, endovenous, physical and medical treatments are available for patients with chronic venous disease. The aim of this review was to evaluate the evidence for pharmacological agents used for the treatment of chronic venous disease.. A literature search was performed using Pubmed, Embase, Cochrane and Google Scholar databases. The initial search terms 'varicose vein', 'venous ulcer', 'venous disease' and 'lipodermatosclerosis' were used to identify relevant clinical studies of pharmacotherapy in patients with chronic venous disease (C4-C6).. A huge range of naturally occurring and synthetic drugs have been studied in patients with chronic venous disease. For patients with C4 venous disease, micronized purified flavonoid fraction (MPFF), oxerutin, rutosides and calcium dobesilate may reduce venous symptoms and oedema. MPFF and pentoxifylline have been shown to improve venous ulcer healing when used in addition to multilayer compression bandaging. The clinical benefits of other medications remain unproven. Reliability of meta-analyses was limited by study heterogeneity, small sample sizes and lack of long-term follow-up.. In prospective randomized studies, MPFF (Daflon(®)), other flavonoid derivatives and pentoxifylline have demonstrated clinical benefits in patients with C4-C6 venous disease. Pharmacotherapy should be part of a range of treatment options in the modern management of patients with chronic venous disorders. Topics: Calcium Dobesilate; Cardiology; Chronic Disease; Compression Bandages; Drug Therapy; Flavonoids; Humans; Hydroxyethylrutoside; Hypertension; Pentoxifylline; Randomized Controlled Trials as Topic; Rutin; Treatment Outcome; Vascular Diseases; Venous Insufficiency | 2010 |
Three treatments for chronic venous insufficiency: escin, hydroxyethylrutoside, and Daflon.
Escin, hydroxyethylrutoside (HR), and Daflon have been shown to be safe and effective for the treatment of chronic venous insufficiency (CVI). They seem to work differently than compression therapy, suggesting that they would usefully augment this therapy. All three phlebotonics attenuate the drop in adenosine triphosphate in venous endothelial cells during hypoxia. This attenuates (1) the inflammation response, (2) the attraction of neutrophils, (3) damage to the veins, and (4) the release of growth factors. These factors otherwise would perpetuate venous insufficiency and contribute to varicose veins. Additional independent effects that would be useful for the treatment of CVI are that they reduce permeability and fragility; HR, Daflon, and perhaps escin increase venous tone; escin inhibits hyaluronidase; Daflon and probably HR are attracted to the veins. With regard to similarity, no differences in effect have been established among these phlebotonics. Topics: Chronic Disease; Clinical Trials as Topic; Diosmin; Escin; Humans; Hydroxyethylrutoside; Venous Insufficiency | 2000 |
Meta-analysis of hydroxyethylrutosides in the treatment of chronic venous insufficiency.
The efficacy of O-(beta-hydroxyethyl)-rutosides (HR) in chronic venous insufficiency (CVI) was assessed by using a meta-analysis on the basis of randomized trials. Analyzed parameters were clinical symptoms related to CVI, i.e. pain of the legs, nocturnal cramps, tired legs, swelling sensations and restless legs. The treatments had to be administered for at least 4 weeks and the average HR dose chosen was 1000 mg/day. On a total of 21 evaluated trials, 15 were selected that included 1973 patients. The placebo-treated group showed a significant (p < 0.01) improvement of patients (i.e., disappearance of the symptoms) as follows: pain 27%, cramps 26%, tired legs 22%, swelling 35% and restless legs 26%. Compared to placebo, the mean additional improvement in favour of HR was 11% for pains, 12% for cramps, 12% for restless legs, 14% for swelling and 24% for tired legs. All these improvements were significant (p < 0.01). The results were robust and stood up to the treatment effect to all meta-analyses across subgroups of randomized clinical trials. In conclusion, this meta-analysis shows that, despite the high response rate to placebo therapy, the effect of HR therapy is significantly superior in the treatment of symptoms related to CVI. Topics: Adult; Aged; Female; Humans; Hydroxyethylrutoside; Male; Middle Aged; Treatment Outcome; Venous Insufficiency | 1994 |
Hydroxyethylrutosides. A review of its pharmacology, and therapeutic efficacy in venous insufficiency and related disorders.
Hydroxyethylrutosides is a standardised mixture of semisynthetic flavonoids, mainly mono-, di-, tri-, and tetrahydroxyethylrutosides, which acts primarily on the microvascular endothelium to reduce hyperpermeability and oedema. In patients with chronic venous insufficiency or diabetes, hydroxyethylrutosides improves microvascular perfusion and microcirculation, and reduces erythrocyte aggregation. The preparation also has a possible protective effect on the vascular endothelium. In short to medium term placebo-controlled studies (up to 6 months) hydroxyethylrutosides therapy improved signs and symptoms of chronic venous insufficiency, including venous insufficiency associated with pregnancy and lymphoedema, and was well tolerated. However, the long term effects of hydroxyethylrutosides administration have yet to be demonstrated. The preparation also alleviated symptoms in patients with severe haemorrhoids, although there were no corresponding objective improvements. Hydroxyethylrutosides administration has been associated with reductions in retinal vascular permeability in patients with diabetic retinopathy but has no apparent effect on signs of retinal haemorrhage, although a reduction in oedema and haemorrhage has been reported in other patients receiving oral hydroxyethylrutosides in the acute phase of central retinal vein occlusion. There are only limited effective pharmacological treatment options for patients with chronic venous insufficiency or lymphoedema, and hydroxyethylrutosides clearly improves signs and symptoms of these disorders. While its role in diabetic retinopathy and haemorrhoids requires some clarification, hydroxyethylrutosides therapy shows promise as a useful additional option for the management of oedema and other symptoms of chronic venous insufficiency. Topics: Animals; Blood Circulation; Clinical Trials as Topic; Humans; Hydroxyethylrutoside; Vascular Diseases; Venous Insufficiency | 1992 |
Paroven: not much effect in trials.
Topics: Anticoagulants; Chronic Disease; Humans; Hydroxyethylrutoside; Venous Insufficiency | 1992 |
38 trial(s) available for rutin and Venous-Insufficiency
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The efficiency of O-(beta-hydroxyethyl)-rutosides in reducing the incidence of superficial venous insufficiency in patients with calf muscle pump dysfunction.
Objective We aimed to evaluate the efficiency of O-(beta-Hydroxyethyl)-rutosides (Oxerutin) in reducing the incidence of venous system disease among patients with calf muscle pump dysfunction secondary to immobilization due to lower-limb fractures. Methods A total of 60 patients with lower-limb fractures and immobilized in plaster casts were included in this study randomized into control (n = 30; mean: 30.37 ± 6.03 years; 73.3% males; no treatment) and experiment (n = 30; mean: 31.67 ± 4.76 years; 66.6% males; Oxerutin, 500 mg po q12hr) treatment groups. Doppler ultrasound was performed to evaluate the effect of oxerutin on the alterations in the venous circulation. Results Patients in the control group were determined to be more commonly affected from the below-knee immobilization in terms of venous dysfunction in the great saphenous vein in the below-knee region when compared with the patients in the oxerutin treatment group (46.7 vs. 13.3%, respectively; p = 0.011). Incidence of reflux in the small saphenous vein was more common in the control group during the healing period when compared with the experiment group (40.0 vs. 10.0%, respectively; p = 0.017). None of the patients developed venous thrombosis. Conclusions In conclusion, the impairment of the lower extremity muscle pump should be considered as an important risk factor for venous disease, and should be evaluated. O-(beta-Hydroxyethyl)-rutosides during 6-8 week cast immobilization for a lower limb fracture may be an effective prophylactic regimen in reducing the incidence of reflux in the below-knee superficial veins. Topics: Adult; Female; Follow-Up Studies; Fracture Fixation; Humans; Hydroxyethylrutoside; Incidence; Leg Injuries; Male; Postoperative Complications; Prospective Studies; Saphenous Vein; Ultrasonography, Doppler, Color; Venous Insufficiency | 2017 |
Veno-active drugs for chronic venous disease: A randomized, double-blind, placebo-controlled parallel-design trial.
Our current understanding of the pathophysiology of chronic venous disease (CVD) suggests that veno-active drugs (VAD) can provide effective symptom relief. Few studies have conducted head-to-head comparisons of VAD and placebo while also assessing objective measures (such as water plethysmography findings and tibiotarsal joint range of motion) and patient-reported quality of life outcomes.. To compare the effects of different VAD on limb volume reduction, tibiotarsal range of motion, and quality of life.. 136 patients with CVD (CEAP grades 2-5) were randomly allocated into four groups to receive micronized diosmin + hesperidin, aminaphthone, coumarin + troxerutin, or placebo (starch). Patients were administered a questionnaire consisting of a quality of life (QoL) measure designed specifically for persons with CVD, and underwent tibiotarsal joint angle measurement and water plethysmography of the lower extremity before and 30 days after pharmacological intervention. Assessors were blind to the treatment groups.. Nine patients dropped out of the trial. Data collected from the 127 remaining patients was considered for statistical analysis. There were no differences in tibiotarsal joint range of motion. Volume reductions ≥100 mL were more frequent in the diosmin + hesperidin group than in any other group. QoL scores were best in the aminaphthone group, and between-group differences were found on individual analysis of questionnaire items.. Use of VAD was associated with significant improvements in QoL as compared with placebo. VAD may be effective for providing symptom relief in patients with CVD. Topics: Biomechanical Phenomena; Brazil; Cardiovascular Agents; Chronic Disease; Coumarins; Diosmin; Double-Blind Method; Drug Therapy, Combination; Edema; Female; Foot Joints; Hesperidin; Humans; Hydroxyethylrutoside; Male; para-Aminobenzoates; Plethysmography; Quality of Life; Range of Motion, Articular; Recovery of Function; Surveys and Questionnaires; Time Factors; Treatment Outcome; Venous Insufficiency | 2014 |
Calcium dobesilate and oxerutin: effectiveness of combination therapy.
Chronic venous insufficiency (CVI) is an important cause of discomfort and inability to work. Hydroxyethylrutosides (Venoruton); 0-[beta-hydroxyethyl]-rutosides) has been used for decades for the treatment of CVI. Studies have reported symptomatic relief and a decreased capillary filtration after the administration of the oral preparations. Calcium dobesilate is a synthetic venoactive drug acting on several levels. It inhibits capillary permeability; it has antioxidant properties; and it inhibits the synthesis of prostaglandins and thromboxanes, reducing platelet and erythrocyte aggregation, as well as blood viscosity. The aim of this study is to determine whether the combination of both drugs is more effective in decreasing patients' complaints.. One hundred and fifty patients with primary venous insufficiency were randomized into three groups: Group A receiving calcium dobesilate only, Group B receiving oxerutin only and Group C receiving both calcium dobesilate and oxerutin. Patients were evaluated with a questionnaire before and four weeks after treatment regarding following parameters: itching, fatigue, heaviness, numbness, cramp, swelling and sensitiveness. Patients rated their symptoms from 0 to 4 (0: absent; 1: mild; 2: moderate; 3: severe; 4: very severe).. Complaints, which were scored by patients before and after treatment, decreased. Among the single-drug groups, itching score decreased more in Group B, whereas scores of fatigue, heaviness, numbness, cramp and swelling decreased more in Group A. But the difference was not significant, statistically. But all complaints decreased significantly in Group C. Difference of scores after treatment revealed no statistical significance in Group A and B, but scores of Group C produced a significant difference when compared with Group A and B.. Results demonstrate that a combination of calcium dobesilate and oxerutin shows a better improvement of complaints. These observations have to be confirmed in larger series with objective tests. Changes of quality of life after a combination therapy might also be of interest. Topics: Adult; Anticoagulants; Calcium Dobesilate; Chronic Disease; Drug Synergism; Drug Therapy, Combination; Female; Hemostatics; Humans; Hydroxyethylrutoside; Male; Middle Aged; Quality of Life; Surveys and Questionnaires; Treatment Outcome; Venous Insufficiency | 2010 |
Clinical improvement in chronic venous insufficiency signs and symptoms with Venoruton® (HR): an 8-month, open-registry, cost-efficacy study.
This study evaluated the clinical efficacy of Venoruton (O-(beta-hydroxyethyl)-rutosides) (HR) (Novartis Consumer Healthcare) in subjects with severe chronic venous insufficiency (CVI).. Patients were included in an average 8-month follow-up registry. At the end of the study 3 spontaneous groups emerged: a group treated with HR 2 g/day, a second group with HR 1 g/day and elastic stockings, and another group with stockings only. The age range was between 45 and 55. The 3 resulting groups were comparable clinically and for age/sex distribution. There were no differences in ambulatory venous pressure (AVP) at inclusion; microcirculatory and clinical evaluations were comparable.. At 8 months there was a decrease in skin resting flux in all groups. Better results (P<0.05) were obtained in the group using the higher dosage and the associated treatment. Stockings alone were less effective (P<0.05). There was significant decrease (P<0.05) in capillary filtration (RAS) in all groups with an advantage in the combination group (P<0.021). HR alone was more effective (P<0.05) than compression alone. There was an improvement in the symptomatic score in all groups with better results (P<0.5) in the combined group; HR alone was more effective (P<0.025) than compression alone. The clinical severity score was reduced (P<0.05) in all groups with better results in the combined group. HR alone was more effective (P<0.05) than compression alone. The venous disability score indicated that HR alone was more effective (P<0.025) than compression. No side effects or tolerability problems were observed with HR. Compliance of HR was also very good. A cost comparison was made considering a comparable control groups (cost of best standard management=100%). Cost in group A was 44% of standard costs; cost in group B (HR+stockings) was 48% of standard costs, and cost in group C (stockings only) was 67% (P<0.05).. The study confirms the long-term efficacy of HR in CVI patients. Controlling signs/symptoms and edema in CVI with HR also prevents the most severe complications of CVI. Topics: Adult; Aged; Blood Pressure Monitoring, Ambulatory; Chronic Disease; Cost-Benefit Analysis; Female; Humans; Hydroxyethylrutoside; Laser-Doppler Flowmetry; Male; Microcirculation; Middle Aged; Registries; Stockings, Compression; Venous Insufficiency | 2010 |
Circulating endothelial cells in venous blood as a marker of endothelial damage in chronic venous insufficiency: improvement with venoruton.
Damage to endothelial cells is common in vascular disorders and in reactions associated with transplantation. An elevated number of circulating endothelial cells indicates the extent of endothelial damage in a variety of disorders. In chronic venous insufficiency (CVI), the number of endothelial cells is abnormally increased, and this can be considered an important indication of endothelial damage. A group of 23 subjects with two levels of CVI (severe and very severe with previous ulcerations) with an increased endothelial cell count (seen by microscopy) was studied and treated for 4 weeks with oral Venoruton (0-[beta-hydroxyethyl]-rutosides) (1 g/day) to evaluate the effects of treatment on the circulating endothelial cells in blood taken from a peripheral leg vein. The controls comprised two groups with comparable age and sex distribution, one of healthy individuals and one of CVI subjects. After 4 weeks, a significant decrease was noted in endothelial cells both in subjects with CVI and in those with very severe CVI with previous ulcerations. This study suggests that endothelial cells may play a significant role in venous disease, being both an indication of severe disease and a further problem in itself. The use of Venoruton appears to decrease the number of circulating endothelial cells. This suggests an important role of this compound in protecting the endothelium and offers new potentially important therapeutic options that are not limited only to venous disease. Topics: Blood Circulation; Cell Count; Chronic Disease; Endothelial Cells; Endothelium, Vascular; Female; Humans; Hydroxyethylrutoside; Male; Middle Aged; Vasoconstrictor Agents; Venous Insufficiency | 2006 |
Single copy of variant CYP2A6 alleles does not confer susceptibility to liver dysfunction in patients treated with coumarin.
Coumarin, used in the treatment of chronic venous diseases, is mainly metabolized to non-toxic 7-hydroxy-coumarin by CYP2A6. At least, 3 variant alleles, CYP2A6*2, CYP2A6*3 and CYP2A6*4A, have been shown to encode catalytically defective proteins. Sporadic elevation of liver enzymes has been reported on the chronic administration ofcoumarin. We sought to determine if susceptibility to coumarin-associated liver dysfunction is genetically determined by polymorphism in CYP2A6 and impairment of the 7-hydroxylation ofcoumarin. Additionally, we were interested in the effect of polymorphism on smoking because of the predominant role of CYP2A6 in the metabolism of nicotine.. The investigation was performed prospectively within a randomized double-blind clinical trial of the coumarin-containing drug SB-LOT (90 mg coumarin + 540 mg troxerutin/d) vs. placebo in 231 German patients with chronic venous insufficiency. Monitoring of the hepatic status involved regular measurements of liver function during the 16-week treatment. Genotyping of CYP2A6 was carried out by means of PCR and confirmed by DNA sequencing analysis.. The allelic frequencies of the variant CYP2A6*2 and CYP2A6*3 alleles were 0.023 and 0.014, respectively. There was no significant difference in the incidence of liver dysfunction between heterozygotes with CYP2A6*2, CYP2A6*3 and wild-type homozygotes. CYP2A6 polymorphism had no significant effect on smoking behavior.. No evidence was obtained that the studied polymorphism in CYP2A6 is a determinant of the coumarin-associated liver dysfunction. Topics: Adult; Aged; Anticoagulants; Aryl Hydrocarbon Hydroxylases; Chemical and Drug Induced Liver Injury; Coumarins; Cytochrome P-450 CYP2A6; Double-Blind Method; Drug Combinations; Female; Gene Frequency; Genotype; Humans; Hydroxyethylrutoside; Liver Diseases; Liver Function Tests; Male; Middle Aged; Mixed Function Oxygenases; Polymorphism, Genetic; Prospective Studies; Smoking; Venous Insufficiency | 2003 |
Flight microangiopathy on long-haul flights: prevention of edema and microcirculation alterations with Venoruton.
The aim of this study was the evaluation of the effects of Venoruton (HR) on the prevention and control of flight microangiopathy and edema in subjects with varicose veins flying for more than 7 hours. A group of 80 patients with varicose veins, edema, and initial skin alterations due to chronic venous hypertension were included. Measurements of skin laser Doppler (LDF) resting flux (RF), PO2 and rate of ankle swelling (RAS), were made before and after the flights (within 2 hours before the flights and within 2 hours after the flights). The length of the flights was between 7 and 9 hours; all seats were in coach class. The two groups (treatment and control) were comparable for age and sex distribution. The variation (decrease) in PO2 was significant in both groups. In subjects treated with HR the decrease in PO2 was smaller (p < 0.05). The decrease in LDF-RF was significant in both groups with a higher flux at the end of the flight in the treated subjects (p < 0.05). The venoarteriolar response was decreased at the end of the flights. The decrease was less evident in the treatment group (p < 0.05). The increase in RAS was significant in the control group while it was limited in the HR group. In conclusion, HR is useful for reducing the increased capillary filtration and in controlling edema in patients with chronic venous disease in long-haul flights. HR is effective to control flight microangiopathy associated with edema. Topics: Adult; Aerospace Medicine; Ankle; Edema; Female; Humans; Hydroxyethylrutoside; Hypertension; Male; Microcirculation; Oxygen; Partial Pressure; Skin; Time Factors; Treatment Outcome; Ultrasonography; Varicose Veins; Vasoconstrictor Agents; Venous Insufficiency | 2003 |
HR (Venoruton1000, Paroven, 0-[beta-hydroxyethyl]-rutosides) vs. Daflon 500 in chronic venous disease and microangiopathy: an independent prospective, controlled, randomized trial.
The aim of this study was to demonstrate whether and how HR (Venoruton(1000), Paroven, 0-[beta-hydroxyethyl]-rutosides) and Daflon (diosmin, 500 mg) were comparatively effective in improving the microcirculation in venous hypertension and microangiopathy.. A group of 90 patients with severe venous hypertension due to chronic venous insufficiency, ankle swelling, and lipodermatosclerosis were included. After informed consent, patients were randomized into a Venoruton and a Daflon (DF) group: patients in the Venoruton group received oral HR (2 g/day for 8 weeks); those in the Daflon group received three 500-mg tablets daily every 8 hours. The two groups were comparable for age and sex distribution. The mean age was 41 years (SD +/- 11) in the Venoruton group (46 patients) and 41.3 (SD +/- 12) in the DF group (44 patients).. There were no differences in microcirculatory parameters between the Venoruton and DF treatment groups at inclusion. There was no significant change between inclusion and measurements at 8 weeks in the DF group. In comparison, a significant decrease (P < .05) in RF (resting skin flux) and RAS (rate of ankle swelling) was observed in the Venoruton group (P < .001). The decrease in capillary filtration was associated with improvement in signs and symptoms (measured by an analogue scale line) (P < .05). Symptomatic improvement was clinically and statistically significant and important only in the Venoruton group. No side effects and no drop-outs were observed.. Venous microangiopathy was improved by the treatment with Venoruton. The comparison with Daflon indicates that HR is comparatively more effective both on microcirculatory parameters and on signs and symptoms. Topics: Adult; Chi-Square Distribution; Chronic Disease; Diosmin; Female; Humans; Hydroxyethylrutoside; Hypertension; Male; Middle Aged; Prospective Studies; Statistics, Nonparametric; Venous Insufficiency | 2002 |
The efficacy and safety of a coumarin-/troxerutin-combination (SB-LOT) in patients with chronic venous insufficiency: a double blind placebo-controlled randomised study.
The objective was to evaluate the oedema-protective effect of a vasoactive drug (coumarin/troxerutin [SB-LOT]) plus compression stockings in patients suffering from chronic venous insufficiency after decongestion of the legs as recommended by the new guidelines.. 231 patients were randomly assigned medical compression stockings plus SB-LOT (90 mg coumarin and 540 mg troxerutin per day) or medical compression stockings plus placebo for the first 4 weeks and SB-LOT or placebo for the second 12 weeks of the study. The primary efficacy endpoint was the lower leg volume measured by well-established water plethysmometry.. 226 patients were evaluated. After ceasing compression stockings, an edema protective effect was detected in the SB-LOT-group but not in the controls. Recurrence of leg volume increase was by 6.5 +/- 12.1 ml and by 36.7 +/- 12.1 ml in the SB-LOT and placebo group, respectively (p = 0.0402). The local complaint score and general aspects of quality of life were also superior for the SB-LOT-group (p = 0.0041). Significant differences were also observed with regard to clinical global impression and therapeutic effect. No serious adverse drug reaction or clinically relevant impairment of laboratory parameters occur.. This study confirms the oedema-protective effect of SB-LOT in chronic venous insufficiency and provides a treatment option for patients who discontinue compression after a short time. Topics: Administration, Oral; Adult; Aged; Bandages; Combined Modality Therapy; Coumarins; Delayed-Action Preparations; Double-Blind Method; Drug Combinations; Edema; Female; Humans; Hydroxyethylrutoside; Male; Middle Aged; Treatment Outcome; Venous Insufficiency | 2002 |
HR (Paroven, Venoruton; 0-(beta-hydroxyethyl)-rutosides) in venous hypertensive microangiopathy: a prospective, placebo-controlled, randomized trial.
The aim of this study was to demonstrate whether HR (Paroven-Venoruton; 0-(beta-hydroxyethyl)-rutosides), was effective in improving the microcirculation in venous hypertension and microangiopathy. Sixty patients with severe venous hypertension due to chronic venous insufficiency, ankle swelling, and lipodermatosclerosis were included. After informed consent, patients were randomized into a treatment group and a placebo group. Patients in the treatment group received oral HR (2 g/day for 8 weeks); those in the placebo group received a comparable placebo.. The two groups were comparable for age and sex distribution. The mean age was 45 years (SD 9) in the treatment group (31 patients) and 45.5 (SD 10) in the placebo group (29 patients). There were no differences between the placebo and treatment groups at inclusion. There was no change between inclusion and measurements at 8 weeks in the placebo group. A significant decrease (P < 0.05) in flux at rest and rate of ankle swelling was observed in the treatment group. The decrease in capillary filtration was associated with improvement in signs and symptoms (P < 0.05). The difference in flux, sign and symptoms, and filtration was clinically important at 8 weeks in the treatment group when compared with the placebo group. No adverse effects were observed.. Venous microangiopathy was improved by HR treatment. Topics: Adult; Edema; Female; Humans; Hydroxyethylrutoside; Hypertension; Male; Microcirculation; Middle Aged; Placebos; Prospective Studies; Skin Ulcer; Treatment Outcome; Vascular Diseases; Vasoconstrictor Agents; Venous Insufficiency | 2002 |
Treatment of edema and increased capillary filtration in venous hypertension with HR (Paroven, Venoruton; 0-(beta-hydroxyethyl)-rutosides): a clinical, prospective, placebo-controlled, randomized, dose-ranging trial.
The variation of capillary filtration rate (CFR) and ankle edema (AE) were evaluated in three groups of patients with venous hypertension with ambulatory venous pressure > 42 mmHg and in healthy subjects before and after treatment for four weeks with HR (Paroven, Venoruton; 0-(beta-hydroxyethyl)-rutosides), a venoactive drug acting on the microcirculation and on capillary permeability. Group A (30 patients) was treated with HR 500 mg tid; group B (30 patients) was treated with 1 g tid; group C (30 patients) was treated with placebo; group D (10 healthy subjects) was treated with HR 1 g/day in a randomised study. CFR was assessed by venous occlusion plethysmography. Subjective symptoms of venous hypertension were assessed by an analogue scale line considering four symptoms: swelling sensation, restless lower extremity, pain and cramps, and tiredness.. There were no significant differences for sex and age distribution among the groups; no significant differences were found for ambulatory venous pressure and refilling time and parameters of venous hypertension among groups. There was a significant difference between normal subjects and patients. There were no drop-outs and observed intolerance. In group A, there was a significant decrease of CFR (P < 0.01) after treatment. In group B (2 g/day), the decrease was greater than that in group A (P < 0.05). In group C (placebo) there was no significant difference before or after treatment. The variations in analogue score was higher with the higher dosage. The score of group A fell from 7.8 (SD 1.3) to 4 (1). Group B's score fell from 7.9 (2) to 3.1 (1.2). In group C (placebo) there was no change. The decrease in the score in the groups of patients was correlated with the variation in edema and CFR.. HR is effective in venous edema and hypertension. Its effects are dose-related. Topics: Adult; Dose-Response Relationship, Drug; Edema; Female; Humans; Hydroxyethylrutoside; Hypertension; Male; Microcirculation; Middle Aged; Placebos; Plethysmography; Treatment Outcome; Vasoconstrictor Agents; Venous Insufficiency | 2002 |
Variations in plasma free radicals in patients with venous hypertension with HR (Paroven, Venoruton; 0-(beta-hydroxyethyl)-rutosides): a clinical, prospective, placebo-controlled, randomized trial.
The aim of this study was to demonstrate whether HR (Paroven, Venoruton; 0-(beta-hydroxyethyl)-rutosides), was effective in improving levels of plasma free radicals (PFRs) in patients with chronic venous insufficiency (CVI) and venous microangiopathy. Patients were randomized into the treatment group, which received oral HR (1g sachets, twice daily, for 4 weeks), and a placebo group, which received comparable placebo. Below-knee Sigvaris stockings were used during the study. PFRs were measured with the D-Rom test at the finger and at a vein of the leg in an area of CVI. The mean age of included subjects was 46 years (SD 11) in the treatment group (20 patients; 6 females) and 46.4 (SD 8) in the placebo group (20 patients; 7 females). There were no differences between placebo and treatment groups at inclusion in age and sex distribution and in parameters indicating venous hypertension. The decrease of PFRs levels in the treatment group was significant, both at the finger and in the distal blood taken in areas of CVI. There there were no significant changes in the control group. In areas of venous hypertension, PFRs values were on average higher than at the finger (systemic) level (P < 0.05). In parallel with the progressive decrease in PFRs associated with treatment, the analogue score was significantly decreased at 2 (P < 0.05) and 4 weeks (P < 0.02) in the HR group. No changes were observed in the placebo group. No adverse effects were observed. In conclusion, HR treatment is effective in decreasing both the systemic and local values of PFRs and therefore may have a positive effect on the evolution of CVI. Topics: Adult; Female; Free Radicals; Humans; Hydroxyethylrutoside; Hypertension; Male; Middle Aged; Placebos; Prospective Studies; Skin Ulcer; Treatment Outcome; Varicose Veins; Vascular Diseases; Venous Insufficiency | 2002 |
An open-label, randomized multicenter study comparing the efficacy and safety of Cyclo 3 Fort versus hydroxyethyl rutoside in chronic venous lymphatic insufficiency.
The present study was designed to compare the safety and efficacy of a combination of Ruscus aculeatus, hesperidin methyl chalcone, and ascorbic acid (Cyclo 3 Fort) versus that of hydroxyethyl rutoside in treatment of chronic venous lymphatic insufficiency. This open-label, randomized multicenter study was conducted on outpatients treated for 90 days. The patients were from three different regions of Argentina. Eighty patients, men and women, 30 to 70 years of age, with symptoms of chronic venous lymphatic insufficiency, ie, heavy, tired, swollen, or painful legs, were enrolled and assigned to two groups: one group treated with Cyclo 3 Fort, the other with rutoside. The symptoms were assessed at baseline, and after 30, 60, and 90 days. The patient was asked to assess subjective symptoms, and the physician measured the size of the affected limbs. The efficacy was rated on a 3-point scale and safety was evaluated by the number of side effects. The results show that when all patients were comparable at baseline, after 90 days, patients treated with Cyclo 3 Fort reported more rapid and complete regression of symptoms than those in the rutoside group, a statistically significant difference (p < 0.01). Likewise, a significant reduction in affected limb size was observed in both groups but persisted after 90 days in the Cyclo 3 Fort group only (p < 0.01). Cyclo 3 Fort was safe and more effective than rutoside in the treatment of venous lymphatic insufficiency, and the Cyclo 3 Fort efficacy is probably associated with its unique mechanism of action. Topics: Adult; Aged; Chronic Disease; Female; Humans; Hydroxyethylrutoside; Lymphatic Diseases; Male; Middle Aged; Plant Extracts; Treatment Outcome; Vasodilator Agents; Venous Insufficiency | 2000 |
[Effectiveness and safety of hydroxyethyl-rutosides in the local treatment of symptoms of venous insufficiency during air travel].
During air travel, the length of time spent in a sitting position and the absence of muscular activity in the calves severely slow the rate of blood flow in the lower limbs. The aim of this randomized, cross-over, double-blind study was to evaluate local application of Hydroxyethyl-rutosides (O-Beta-Hydroxyethylrutosides) in the treatment of symptoms of venous insufficiency including stasis-induced edema during extended air travel on flights exceeding 6 hours. Hydroxyethyl-rutosides or placebo was applied every 3 or 4 hours throughout the flight. In the 51 subjects evaluated (both males and females) the results show statistically significant differences favoring treatment with Hydroxyethyl-rutosides both with regard to objective signs of edema: change in minimum ankle circumference was less during trips in which Hydroxyethyl-rutosides was applied, whether compared with the maximum measurement (p = 0.04) or the last measurement made during the flights, and with regard to subjective signs: several symptoms occurred significantly less frequently when the subject applied Hydroxyethyl-rutosides during the flight [pain (p = 0.03), sensation of heavy and tired legs (p = 0.04) and sensation of swelling (p = 0.02)]. the patient's overall assessment of the treatment was also favorable after using Hydroxyethyl-rutosides Gel (p = 0.01). the number of subjects complaining of edema (pitting edema, marks of shoes, difficulties putting shoes back on) was significantly lower during periods of treatment with Hydroxyethyl-rutosides Gel (p = 0.001). Local application of Hydroxyethyl-rutosides, 3 to 4 times during 6 to 14 hours is thus effective in treating the main symptoms of venous insufficiency including stasis-induced edema caused by extended periods in the sitting position during long air flights. Topics: Adult; Aircraft; Double-Blind Method; Edema; Female; Humans; Hydroxyethylrutoside; Leg; Male; Middle Aged; Time Factors; Travel; Treatment Outcome; Venous Insufficiency | 1999 |
An open-label, randomised multicentre study comparing the efficacy and safety of CYCLO 3 FORT versus hydroxyethyl rutoside in chronic venous lymphatic insufficiency.
The present study was designed to compare the safety and efficacy of a combination of Ruscus aculeatus, hesperidin methyl chalcone and ascorbic acid (CYCLO 3 FORT) versus that of hydroxyethyl rutoside in the treatment of chronic venous lymphatic insufficiency.. This open-label, randomised multicentre study was conducted on outpatients treated for 90 days. The patients were from three different regions of Argentina. Eighty patients, men and women, 30 to 70 years of age, with symptoms of chronic venous lymphatic insufficiency, i.e. heavy, tired, swollen, or painful legs were enrolled and assigned to two groups: one group treated with CYCLO 3 FORT, the other with rutoside. The symptoms were assessed at baseline, and after 30, 60, and 90 days. The patient himself was asked to assess subjective symptoms, the physician measured the size of the affected limbs. The efficacy was rated on a 3-point scale and safety was evaluated by the number of side effects.. The result data show that when all patients were comparable at baseline, after 90 days, those treated with CYCLO 3 FORT reported more rapid and more complete regression of symptoms than those in the rutoside group, a statistically significant difference (p<0.01). Likewise, a significant reduction in affected limb size was observed in both groups but persisted after 90 days in the CYCLO 3 FORT group only (p<0.01).. As a conclusion : CYCLO 3 FORT was safe and more effective than rutoside in the treatment of venous lymphatic insufficiency. And the CYCLO 3 FORT efficacy is probably associated with its unique mechanism of action. Topics: Adult; Female; Humans; Hydroxyethylrutoside; Male; Patient Satisfaction; Plant Extracts; Safety; Treatment Outcome; Varicose Veins; Vasodilator Agents; Venous Insufficiency | 1999 |
Investigation of the efficacy of oxerutins compared to placebo in patients with chronic venous insufficiency treated with compression stockings.
The aim of this study was to investigate, if the the combined treatment of compression stockings and drug treatment with oxerutins (O-(beta-hydroxyethyl)-rutosides, Venoruton) provides additional benefit for patients with chronic venous insufficiency (CVI) compared to compression treatment alone. Oxerutins belong to the group of oedema protective agents and possess anti-exudative and membrane protective activity. A total of 133 female patients with CVI grade II participated in this double-blind, randomised, multi-centre, parallel-group study with two treatment groups. The whole study lasted for 19 weeks, and consisted of a one week placebo run-in phase, 12 weeks treatment phase, followed by a 6 weeks treatment-free follow-up period. All patients received a basis compression therapy that consisted of standard compression stockings. In order to standardise initial fitting of stockings in this multi-centre setting, stockings were fitted after one week of standard diuretics starting at baseline and then stockings were worn for the following 11 weeks. Patients were randomised to receive oxerutins (2 x 500 mg daily) or matching placebo. Leg volumes (water displacement) and associated subjective symptoms (visula analogue scale) were measured during a placebo run-in period at enrolment (week - 1) and half a week later (week - 1/2), at baseline week 0), at 4, 8, 12 weeks on treatment, and again after a 3- and 6-weeks treatment-free follow-up. The primary efficacy criterion, the area under the baseline from week 0 to week 18 (AUB0-18) of leg volume changes, as measurement of the global change of leg oedema during the study, resulted in a superior reduction of -5589 ml.d for the combined treatment with oxerutins compared to -2101 ml.d for placebo (p = 0.012). The mean change of leg volume compared to baseline after 12 weeks of treatment was -63.9 ml for stockings and oxerutins, and -32.9 ml for the patients who received stockings and placebo (p < 0.05). Oxerutins showed a prolonged effect in the follow-up phase compared to placebo, with mean AUB values for week 12 to week 18 of -1769 ml.d versus -133 ml.d (p < 0.01). The study demonstrated that the combined therapy of compression stockings and drug treatment with oxerutins is significantly superior in reducing leg oedema resulting from chronic venous insufficiency compared to compression treatment alone. Topics: Aged; Bandages; Chronic Disease; Combined Modality Therapy; Double-Blind Method; Female; Humans; Hydroxyethylrutoside; Leg; Microcirculation; Middle Aged; Vasoconstrictor Agents; Venous Insufficiency | 1996 |
Comparative clinical efficacy and tolerability of oxerutins and horse chestnut extract in patients with chronic venous insufficiency.
Oxerutins (O-(beta-hydroxyethyl)rutosides, HR, Venoruton) and horse chestnut extract (HCE) are active principles of first priority for the pharmacological treatment of chronic venous insufficiency (CVI). The efficacies of both compounds were shown in numerous, double-blind, randomized, placebo controlled clinical trials. Besides the direct comparison of the two compounds the aim of the study was to investigate the initial dose/maintenance dose concept for HR. 137 female, postmenopausal patients with CVI II finished the study according to protocol. Following one week placebo run-in the patients were treated either with 1000 mg/d HR, 600 mg/d HCE or 1000 mg/d for 4 weeks and than with 500 mg/d HR within the initial dose/maintainance dose concept for 12 weeks and observed for further 6 weeks. A main confirmative criterion was the volume reduction of the leg. Subjective criteria were descriptively evaluated. HR (1000 mg/d) was proven to be equivalent or better, reducing the leg volume (AUB0-18) by -5273 +/- 11418 ml.d compared to -3187 +/- 10842 ml.d under HR (1000 mg/d and 500 mg/d), and -3004 +/- 7429 ml.d under HCE-treatment. Both compounds exhibit a substantial carry-over effect. The maintenance posology of HR is able to stabilize the therapeutic obtained under initial dose conditions. Topics: Aged; Bandages; Chronic Disease; Combined Modality Therapy; Double-Blind Method; Female; Humans; Hydroxyethylrutoside; Leg; Microcirculation; Middle Aged; Plant Extracts; Plants, Medicinal; Vasoconstrictor Agents; Venous Insufficiency | 1996 |
Investigation of the therapeutic equivalence of different galenical preparations of O-(beta-hydroxyethyl)-rutosides following multiple dose peroral administration.
Oxerutins (O-(beta-hydroxyethyl)-rutosides, HR, Venoruton) are available in different releasing galenical formulations for the treatment of chronic venous insufficiency (CVI). In order to investigate the biopharmaceutical relevance of the releasing properties of the galenical forms the therapeutic efficacy between the commercially available forms was investigated (500 mg sustained release film tablets, 300 mg sustained release film tablets, 300 mg normally releasing capsules) in comparison to an aqueous solution and placebo. In total 100 female patients with CVI grade II participated. The study was carried out following a randomized, placebo controlled design with parallel treatment groups. Following a two-week run-in phase patients were treated for 12 weeks with different posologies of HR (2 x 1/d 500 mg, 3 x 1/d 300 mg, 1 x 1000 mg/d as aqueous solution). Main criterion was the reduction of leg volume following 12 weeks treatment. Subjective criteria were descriptively evaluated. All four HR treatments were significantly superior to placebo (p < 0.0008). The different posologies had no influence on the efficacy. The therapeutic efficacy is independent of the in vitro rate of release. The available forms are regarded as bioequivalent. Topics: Aged; Biological Availability; Delayed-Action Preparations; Female; Humans; Hydroxyethylrutoside; Leg; Middle Aged; Single-Blind Method; Therapeutic Equivalency; Vasoconstrictor Agents; Venous Insufficiency | 1996 |
A comparative clinical trial of graduated compression stockings and O-(beta-hydroxyethyl)-rutosides (HR) in the treatment of patients with chronic venous insufficiency.
As overall conclusions from this study, and the two preceding comparable trials in which TcPO2 was measured in patients with (8) and without (7) stockings, we propose that: All patients with symptoms and oedema of CVI should be advised to wear suitable compressive stockings (this study); if they do wear stockings, then additional benefit may be derived from treatment with HR (8); for patients who are reluctant to wear stockings, for a variety of reasons, or in whom stockings may be contraindicated (e.g. mixed arterio-venous disease), then HR is an acceptable alternative (7 and this study). Topics: Adult; Aged; Bandages; Blood Gas Monitoring, Transcutaneous; Female; Humans; Hydroxyethylrutoside; Lymphedema; Male; Middle Aged; Venous Insufficiency | 1995 |
Fibrinolysis and hemorheology in chronic venous insufficiency: a double blind study of troxerutin efficiency.
Abnormal increase of erythrocyte aggregation and reduction of profibrinolytic activity are the two most frequent biological perturbations found in chronic venous insufficiency (CVI). A randomised, controlled, double blind trial was undertaken on 85 patients suffering from grade 1 and 2 CVI, to compare troxerutin with placebo. Two types of biological parameters were measured after 15 days of treatment. Erythrocyte aggregation as evaluated with a Myrenne erythroaggregometer by the indices M (stasis) and M1 (3s-1) progressed favorably in the troxerutin group. The values of M1 at D15 (p < 0.05), and the progression of M (p < 0.001) and M1 (p < 0.01) from D0 to D15, are significantly better in the troxerutin group. Progression of fibrinolytic activity at rest was not significantly different between the 2 groups. Conversely, the progression from D0 to D15 of the values after occlusion of euglobulin lysis time (p < 0.01), tPA (p < 0.01), and PAI activity (p < 0.05) are significantly better in the troxerutin group. The fibrinolysis capacity estimated by euglobulin lysis time (p < 0.01) and tPA (p < 0.05) also progressed favorably in the troxerutin group. These results confirm the anti-erythrocyte aggregation effect of troxerutin, and suggest a favorable effect on blood fibrinolytic activity. They could explain the positive action of this drug on stasis, capillary perfusion and trophic complications of CVL. Topics: Aged; Anticoagulants; Chronic Disease; Double-Blind Method; Female; Fibrinolysis; Hemorheology; Humans; Hydroxyethylrutoside; Male; Middle Aged; Placebos; Vasoconstrictor Agents; Venous Insufficiency | 1995 |
The effect of hydroxyethylrutosides on capillary filtration in moderate venous hypertension: a double blind study.
The aim of this study was to evaluate the effect of hydroxyethylrutosides on capillary filtration in subjects with mild to moderate venous incompetence--superficial varicose veins and/or deep venous disease and ankle oedema--using the vacuum suction chamber (VSC) device applied to the internal perimalleolar region and the wheal vanishing (WV) time. Subjects entered in to the study were randomised to receive either hydroxyethylrutosides (1 g twice daily for 4 weeks) or placebo for four weeks. The two groups entering and completing the study were comparable. Microcirculatory parameters (laser-Doppler resting flux, the venoarteriolar response, transcutaneous PO2 and PCO2) remained constant during the four week study in both groups. The WV time, which was comparable in the two groups at the beginning of the study decreased significantly [from a median 55 min (interquartile 955 min), to a median 45 minutes (interquartile 65-40 min) in the treated group, p < 0.01]. No change was observed in the WV time in the placebo group. Subjective symptoms measured with an analogue scale improved following treatment with hydroxyethylrutosides [foot oedema (p < 0.005), ankle oedema (p < 0.001), and paraesthesia (p < 0.01)]; only night cramps were reported less in patients receiving the placebo (p < 0.05). In conclusion, the WV time can be used to assess the beneficial effect of therapy on capillary filtration in subjects with mild-moderate venous hypertension, even after a short period of treatment, and before other microcirculatory parameters change. Furthermore, the changes observed in WV time correlate well with an improvement in patients symptoms. Topics: Ankle; Capillary Permeability; Double-Blind Method; Edema; Female; Humans; Hydroxyethylrutoside; Male; Microcirculation; Treatment Outcome; Varicose Veins; Venous Insufficiency | 1994 |
Meta-analysis of hydroxyethylrutosides in the treatment of chronic venous insufficiency.
The efficacy of O-(beta-hydroxyethyl)-rutosides (HR) in chronic venous insufficiency (CVI) was assessed by using a meta-analysis on the basis of randomized trials. Analyzed parameters were clinical symptoms related to CVI, i.e. pain of the legs, nocturnal cramps, tired legs, swelling sensations and restless legs. The treatments had to be administered for at least 4 weeks and the average HR dose chosen was 1000 mg/day. On a total of 21 evaluated trials, 15 were selected that included 1973 patients. The placebo-treated group showed a significant (p < 0.01) improvement of patients (i.e., disappearance of the symptoms) as follows: pain 27%, cramps 26%, tired legs 22%, swelling 35% and restless legs 26%. Compared to placebo, the mean additional improvement in favour of HR was 11% for pains, 12% for cramps, 12% for restless legs, 14% for swelling and 24% for tired legs. All these improvements were significant (p < 0.01). The results were robust and stood up to the treatment effect to all meta-analyses across subgroups of randomized clinical trials. In conclusion, this meta-analysis shows that, despite the high response rate to placebo therapy, the effect of HR therapy is significantly superior in the treatment of symptoms related to CVI. Topics: Adult; Aged; Female; Humans; Hydroxyethylrutoside; Male; Middle Aged; Treatment Outcome; Venous Insufficiency | 1994 |
Hydroxyethylrutosides in elderly patients with chronic venous insufficiency: its efficacy and tolerability.
The efficacy and tolerability of O-(beta-hydroxyethyl)-rutosides (HR) in elderly patients (aged over 65 years) with chronic venous insufficiency or varicose veins was studied in a multicentre, double-blind, randomised, placebo-controlled trial. Of the 104 patients entered into the trial, data from 102 were available for analysis of tolerability and from 86 for efficacy. Treatment was for 6 months, with monthly examinations. Three different dosages were used due to slight differences in the registered dosage in various countries: (1) 250 mg 4 times daily (1 g/day), UK, n = 19 patients; (2) 300 mg 3 times daily (900 mg/day), FRG and Belgium, n = 55, and (3) 300 mg 4 times daily (1,200 mg/day), The Netherlands, n = 30. Each centre had its own placebo control group. The HR-treated group (n = 41) showed a significantly greater reduction in the total symptom score, 5.7 +/- 2.4 to 2.3 +/- 1.8, than in the placebo group, 4.4 +/- 3.0 to 3.0 +/- 2.4 (p < 0.01). Of the 5 studied symptoms there was also a significant (p < 0.05) improvement in leg cramps, heavy legs and restless legs. No significant differences between the two groups were seen for aching pains and paraesthesia. A small reduction was also seen in ankle and calf circumferences, which became significant at the end of the trial (p < 0.05). Pitting oedema of the leg (p < 0.01) and eczema of the leg (p < 0.05) also improved significantly greater than in the control group.(ABSTRACT TRUNCATED AT 250 WORDS) Topics: Aged; Aged, 80 and over; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Hydroxyethylrutoside; Male; Varicose Veins; Venous Insufficiency | 1994 |
Comparison between the efficacy and tolerability of oxerutins and troxerutin in the treatment of patients with chronic venous insufficiency.
Oxerutins (Venoruton) and troxerutin (CAS 7085-55-4) are both mixtures of O-(beta-hydroxyethyl)-rutosides used for the treatment of chronic venous insufficiency. As di-O-(beta-hydroxyethyl)-rutosides and 7-mono-O-(beta-hydroxyethyl)-rutoside were found to be more active with regard to free radical scavenging compared to tri-O-(beta-hydroxyethyl)-rutoside the aim of this study was to compare oxerutins and troxerutin clinically. 12 female, post-menopausal patients with chronic venous insufficiency grade II participated in this double-blind study with random allocation to the treatment groups. They received 900 mg/day oxerutins or troxerutin for 12 weeks and were observed for 4 further weeks without treatment. Leg volumes (water displacement) and subjective symptoms (VAS, visual analogue scale) were evaluated before and following 2, 4, 8, 12 and 16 weeks. Both treatments were active in reducing leg volumes and in ameliorating subjective symptoms (mean volume reduction -167 +/- 157 ml x week). Volume reduction totalled to -261 +/- 154.2 ml x week for oxerutins and -73.2 +/- 97.1 ml x week for troxerutin. The difference is statistically significant (p = 0.04). The findings with subjective symptoms were in good accordance to the objective volume measurement. Oxerutins revealed a remarkable carry over effect. Topics: Anticoagulants; Chronic Disease; Double-Blind Method; Edema; Female; Humans; Hydroxyethylrutoside; Leg; Middle Aged; Pain; Pain Measurement; Venous Insufficiency | 1993 |
[Effect of 0-(beta-hydroxyethyl)-rutoside (Venoruton) on symptomatic venous insufficiency in the lower limbs].
Forty-three patients recruited from general practice with symptom-producing chronic venous insufficiency in the lower limbs participated in a randomized double-blind clinical trial with Venoruton (300 mg x 3) or a placebo for 28 days. Twenty-eight patients were treated with Venoruton and 19 with a placebo. None of the patients received other forms of treatment for chronic venous insufficiency. No differences were observed between the two groups as regards changes in symptoms (swelling, pain, heaviness, restlessness, itching and cramps) the subjective assessment of the discomfort in the extremities or the circumference of the limbs. Venoruton does not appear to have any effect on chronic venous insufficiency in the lower limbs. Topics: Adult; Aged; Chronic Disease; Female; Humans; Hydroxyethylrutoside; Leg; Male; Middle Aged; Venous Insufficiency | 1992 |
Acute effects of hydroxyethylrutosides on capillary filtration in normal volunteers, patients with venous hypertension and in patients with diabetic microangiopathy (a dose comparison study).
The acute effects of hydroxyethylrutosides on capillary filtration were studied in 12 normal subjects, 25 patients with venous hypertension and 22 diabetics with microangiopathy. The two groups of patients randomly received a single oral dose (500 or 1000 mg) of hydroxyethylrutosides. A single dose of 500 mg was used for normal volunteers. In the following 6 hours capillary filtration was studied with straingauge plethysmography. The decrease in capillary filtration was evident within the first hour and was at its peak between the second and fourth hour. After 6 hours it was still significantly below baseline values in patients. The 1000 mg dose was significantly more effective in both groups of patients. This study confirms the efficacy of hydroxyethylrutosides in decreasing capillary filtration. It suggests that the effect of one dose lasts at least 6 hours and also that the higher dose is more effective. Topics: Adult; Capillary Permeability; Carbon Dioxide; Diabetic Angiopathies; Dose-Response Relationship, Drug; Female; Humans; Hydroxyethylrutoside; Male; Middle Aged; Oxygen; Regional Blood Flow; Skin; Venous Insufficiency | 1992 |
Evaluation of the microcirculatory effects of Venoruton in patients with chronic venous hypertension by laserdoppler flowmetry, transcutaneous PO2 and PCO2 measurements, leg volumetry and ambulatory venous pressure measurements.
The evaluation of the effects of venoactive drugs and particularly of Venoruton may be performed using microcirculatory parameters. Laserdoppler flowmetry may be used in association with PO2/PCO2 measurements. In this study we combined the microcirculatory evaluation with foot and leg volumetry to evaluate the effects of Venoruton in 15 patients with deep (popliteal vein) incompetence and venous hypertension, treated for 6 weeks. A control group of 20 patients was also evaluated. All these subjects were studied and selected according to ambulatory venous pressure measurements (AVP) and duplex scanning. Measurements were made at the internal perimalleolar region in constant temperature condition (23 degrees C). No variations of AVP or duplex scanning findings were observed after 6 weeks in both treated and untreated patients. Laserdoppler flowmetry showed a significant decrease of the resting flow (which was increased in all patients at the beginning of the study). An increased efficacy of the venoarteriolar response was also recorded together with an increased response of skin flow after increase of temperature in the perimalleolar region in patients treated with Venoruton. This was also associated with an increase of skin PO2 and with a decreased PCO2. In the control group no significant variations of these parameters were observed. Leg volume was also significantly decreased in the patients treated with Venoruton while no changes were observed in controls. In conclusion this study showed the efficacy of Venoruton in improving parameters altered in venous hypertension and the possibility of application of this microcirculatory model to study venoactive drugs used for treating venous hypertension. Topics: Anticoagulants; Blood Gas Monitoring, Transcutaneous; Clinical Trials as Topic; Female; Humans; Hydroxyethylrutoside; Lasers; Leg; Lymphedema; Male; Microcirculation; Middle Aged; Postphlebitic Syndrome; Random Allocation; Rutin; Venous Insufficiency; Venous Pressure | 1989 |
[A 3-month, randomized double-blind dose-response study with 0-(beta-hydroxyethyl)-rutoside oral solutions].
The antioedematous effect of 0-(beta-Hydroxylethyl)-rutoside (HR)-drinking solutions with 600, 900, 1200 and 1500 mg active substance was tested in a randomized double-blind study against placebo with 30 female patients in the change of life. The decrease of the oedemas was measured by recording the change in the leg volume. The patients valued the symptoms "tired and heavy legs", "tenseness" and "tingling sensation". After 3 months the daily taking of HR-drinking solutions showed a significant decrease of leg volume. At the end of the treatment there was no significant difference between the four verum groups. Topics: Administration, Oral; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Hydroxyethylrutoside; Lymphedema; Middle Aged; Randomized Controlled Trials as Topic; Rutin; Venous Insufficiency | 1989 |
[Dose-response study with O-(beta-hydroxyethyl)-rutoside oral solution].
Topics: Clinical Trials as Topic; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Hydroxyethylrutoside; Lymphedema; Middle Aged; Rutin; Venous Insufficiency | 1987 |
Efficacy of O-(beta-hydroxyethyl)-rutosides at high dosage in counteracting the unwanted activity of oral contraceptives on venous function.
In a double-blind study the effect of a high dosage of O-(beta-hydroxyethyl)-rutosides (HR) was tested in women taking oral contraceptives and suffering from venous insufficiency of the lower limbs. Ten patients were treated for 28 days with HR (3 g/day) and ten with a placebo. In basal conditions and after therapy, the symptoms of venous disorders and the venous function, by means of strain gauge plethysmography, was evaluated in both groups. The results showed an increase of venous capacitance and a reduction of venous tone in the subjects treated including those without symptoms in the lower limbs. The HR treatment resulted in a significant improvement of the venous function parameters and of the symptoms in lower limbs.. Venous insufficiency of the lower limbs in oral contraceptive users was treated with Venoruton 1000 (o-(beta-hydroxyethyl)-rutoside) at a high dose of 3 g/day in a double-blind, placebo controlled trial. 20 women aged 19-42, who had taken pills 3 months to 7 years (mean 30.2 months) were randomly assigned to treatment vs. placebo. The soluble powder was prepared in sachets indistinguishable from placebos. Venous function was assessed by strain gauge plethysmography (Periflow, Janssen Scientific, Beerse, Belgium), and the following parameters were determined: maximal venous incremental volume, maximal venous incremental volume time, maximal venous outflow, time of total emptying, index of venous distensibility, index of venous tone, and venous pressure. Subjective symptoms were evaluated on a scale of 0-5: pain, swelling, nocturnal cramps, tingling, heaviness and restless legs. Basal measurements showed high values of venous capacity, distensibility, and reduced venous tone. After 28 days of treatment, several venous parameters were significantly improved in the test group vs. placebo: maximal venous incremental volume at 40 and 60 mm Hg (venous capacity), index of venous distensibility and index of venous tone. There was significant improvement in subjective reports of pain, swelling, heavy legs and restless legs in the treated over placebo group. No side effects or changes in laboratory findings were observed. Topics: Adult; Contraceptives, Oral; Double-Blind Method; Female; Humans; Hydroxyethylrutoside; Plethysmography; Random Allocation; Rutin; Venous Insufficiency | 1987 |
[The behavior of blood clotting and its inhibitors under long term treatment with 5,6-benzo-alpha-pyrone (coumarin). Double blind study].
The analyses on hemostaseological variables are recorded in connection with blood tests in the course of a double-blind study in 41 patients suffering from chronic venous insufficiency of higher degrees of severity. They were treated in addition to compression measures with two active ingredients, a coumarin (5,6-benzo-alpha-pyrone)/troxerutin combination (Venalot Depot) (n = 20) or benzarone (n = 21) receiving 3 X 2 dragees daily for 6 weeks. Good clinical efficacy and the improvement of symptoms were observed together with almost no side-effects. The coagulation analysis showed no influence of the active principles on the global coagulation or the clotting factors and the inhibitors and factors of the fibrinolysis. In particular there was no phenprocoumon-like effect on the blood clotting system. Topics: Anticoagulants; Benzbromarone; Blood Coagulation; Clinical Trials as Topic; Coumarins; Double-Blind Method; Drug Combinations; Humans; Hydroxyethylrutoside; Partial Thromboplastin Time; Random Allocation; Rutin; Time Factors; Venous Insufficiency | 1985 |
General practice treatment of symptoms of venous insufficiency with oxerutins. Results of a 660 patient multicentre study in the UK.
Topics: Clinical Trials as Topic; Double-Blind Method; Female; Humans; Hydroxyethylrutoside; Male; Middle Aged; Rutin; United Kingdom; Vasodilator Agents; Venous Insufficiency | 1983 |
A double blind trial of oral O. B-hydroxyethyl rutosides for stasis leg ulcers.
Topics: Aged; Clinical Trials as Topic; Double-Blind Method; Humans; Hydroxyethylrutoside; Leg Ulcer; Middle Aged; Rutin; Venous Insufficiency | 1981 |
A double-blind trial of O-(beta-hydroxyethyl)-rutoside in patients with chronic venous insufficiency.
Topics: Chronic Disease; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Hydroxyethylrutoside; Male; Middle Aged; Rutin; Venous Insufficiency | 1981 |
Effect of HR (O-(beta-hydroxyethyl)-rutosides) on the impaired venous function of young females taking oral contraceptives. A strain gauge plethysmographic and clinical open controlled study.
3 groups of women were studied to determine the relationship of venous disease to use of oral contraceptives (OCs) by strain gauge plethysmography. Group A consisted of 14 women taking OCs and having symptoms of venous disorders in their legs but no evident venous disease. Group B was 12 women also taking OCs but with no leg symptoms. And Group C was 14 control women not taking OCs and with no leg symptoms. Plethysmography indicated that in Group A venous capacitance and venous distensibility were significantly higher, whereas venous tone was significantly lower than in controls. Also, Group B showed a significant but slightly inferior impairment of these parameters. No differences in venous pressure or in venous outflow were seen in the 3 groups. The effects of HR (O-)beta-hydroxyethyl)-rutoside), a flavonoid, were investigated and showed that the drug provoked a significant decrease in venous capacitance with increase in venous tone and decrease in venous distensibility in Group A patients. Findings were evident after 1 month of treatment (2 gm/day by os). Leg symptoms also improved significantly. Therefore use of this agent may prevent pill-induced venous damage. Topics: Adolescent; Adult; Clinical Trials as Topic; Contraceptives, Oral; Female; Humans; Hydroxyethylrutoside; Plethysmography; Rutin; Venous Insufficiency | 1980 |
[Clinical, placebo-controlled double-blind study of venoruton in the treatment of chronic venous insufficiency. Importance of the selection of patients].
Topics: Adult; Aged; Chronic Disease; Drug Evaluation; Female; Humans; Hydroxyethylrutoside; Male; Middle Aged; Placebos; Rutin; Venous Insufficiency | 1980 |
Paroven in the treatment of chronic venous insufficiency.
Topics: Chronic Disease; Clinical Trials as Topic; Double-Blind Method; Eczema; Edema; Humans; Hydroxyethylrutoside; Placebos; Restless Legs Syndrome; Rutin; Surveys and Questionnaires; Varicose Ulcer; Venous Insufficiency | 1979 |
[Hormonal contraceptives, peripheral venous insufficiency and the use of a phlebodynamic agent].
Topics: Adult; Anticoagulants; Clinical Trials as Topic; Contraceptives, Oral; Contraceptives, Oral, Hormonal; Drug Evaluation; Estrogens; Female; Flavonoids; Heptaminol; Humans; Hydroxyethylrutoside; Intrauterine Devices; Pregnancy; Progestins; Venous Insufficiency | 1976 |
8 other study(ies) available for rutin and Venous-Insufficiency
Article | Year |
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Venoruton®: post thrombotic syndrome. Clinical improvement in venous insufficiency (signs and symptoms) with Venoruton®. A five-year, open-registry, efficacy study.
This registry evaluation was conducted in post-thrombotic syndrome (PTS) patients (with a minimum five-year follow up). The study evaluated: 1) variations in peripheral edema with an analogue scoring system; 2) ankle circumference at the PTS limb in comparison with the normal contralateral limb.. The difference was expressed in percent increase in circumference measured at the PTS limb; 3) other end-points were observed in a five-year follow-up that created a specific PTS registry. Subjects could follow a management system including: 1) compression; 2) compression and Venoruton® (1 g/day); 3) compression and Venoruton® (2 g/day).. The groups of patients with chronic venous insufficiency (CVI) resulted comparable. The occurrence of a new deep venous thrombosis (DVT) episode was considered a drop out. At five years there were four new DVTs (in 90 patients) in the compression group. There was one case (90 patients included) in the compression and HR (1 g) group and no DVT in group 3. The outcome in groups 2 and 3 was significantly better (0.05) than in group 1. The need for surgery or sclerotherapy (for larger varicose veins), the occurrence of lipodermatosclerosis and ulcerations were significantly lower in the HR groups with a better outcome in the higher dose group (P<0.05). The number of ulcerations were also significantly reduced in the HR groups. The difference in ulcerations was significantly better in the higher dose group in comparison with the other groups (P<0.05). The edema score was significantly reduced at five years in the HR groups (P<0.05) in comparison with the compression group. The higher dose resulted more effective in controlling edema. Both edema score and ankle circumference at five years were significantly lower (P<0.05) in the HR-treated groups with a significant decrease in edema score and ankle circumference in the higher dosage group.. The study confirms the long-term efficacy of HR in PTS, CVI patients. Controlling signs/symptoms and edema in CVI with HR prevents the most severe complications of CVI including lipodermatosclerosis and venous ulcerations. An early therapeutic program including exercise, risk factor controls, compression an edema-controlling treatment with HR is effective in decreasing the classic complications of PTS syndrome. The important restrictions and difficulties to the use of elastic stockings (in regions with warmer climates) are not applicable to HR that is well tolerated and can be used all the time alone or in association with compression. Topics: Adult; Ankle; Combined Modality Therapy; Edema; Female; Humans; Hydroxyethylrutoside; Male; Middle Aged; Postthrombotic Syndrome; Registries; Secondary Prevention; Stockings, Compression; Treatment Outcome; Venous Insufficiency | 2011 |
[Effectiveness of Troxerutin in association with Pycnogenol in the pharmacological treatment of venous insufficiency].
The purpose of our study was to assess the different effectiveness of Troxerutin in association with Pycnogenol compared to the effects obtainable with the same pharmacological principle in monotherapy in patients suffering from venous insufficiency.. Seventy patients with venous insufficiency of the lower extremities at the first stages of the CEAP classification (Cs1,3; Es; As 1; invalidity score 2, clinical score 1-2) were selected and subdivided into 2 groups: one of 50 and one of 20. All patients reported the following symptoms either associated or in isolation: heaviness, cramps, pruritus and pain at palpation. Evaluation of the degree of venous insufficiency was carried out by means of echo-Doppler at recruitment. The 1st group received Troxerutin (470 mg) associated with Pycnogenol (20 mg) in a dose of 1 g/day per os for 60 days; the 2nd group Troxerutin alone (300 mg) in a dose of 2 tablets twice a day per os for 60 days. Controls were set up at 30 and 60 days from the start of treatment and after a period of 3 months from the end of treatment to assess the effects on the symptomatology over time. The effectiveness of the drugs on symptomatology reported by both groups was assessed by means of an analysis of the qualitative variation of the symptoms using the score-scales method: 3=severe; 2=moderate; 1=slight; 0=absent and this variation was expressed as a percentage decrease and analysed using Student's test.. The results of our study after 30 days of treatment highlighted a clinical improvement in all patients with the disappearance of symptoms (score from 3 to 1) in 50% of patients in the 1st group and in 35% in the 2nd with a peak of 96% in patients of the 1st group and 80% in the 2nd at the end of treatment (60 days). This result held stable in the course of follow-up for 96% of patients in the 1st group (p<0.001) and for 50% of those in the 2nd group (p<0.005).. Comparison between the 2 groups showed that the group which received Troxerutin associated with Pycnogenol reported greater therapeutic effectiveness than the control group as regards both the rapidity of disappearance of the symptoms and as regards maintenance of the cure obtained. Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Analysis of Variance; Data Interpretation, Statistical; Drug Therapy, Combination; Female; Flavonoids; Follow-Up Studies; Humans; Hydroxyethylrutoside; Male; Middle Aged; Plant Extracts; Platelet Aggregation Inhibitors; Time Factors; Treatment Outcome; Vasoconstrictor Agents; Venous Insufficiency | 2004 |
[New aspects in the pathogenesis of chronic venous insufficiency and the place of localized action of Venoruton].
Topics: Anticoagulants; Antioxidants; Chronic Disease; Endothelium, Vascular; Humans; Hydroxyethylrutoside; Veins; Venous Insufficiency | 2002 |
Pharmacodynamics and pharmacokinetics of Veliten (rutine, alpha-tocopherol and ascorbic acid) in patients with chronic venous insufficiency.
The aim of this study was to evaluate the pharmacodynamics and pharmacokinetics of a single oral dose of Veliten in 12 patients affected by chronic venous insufficiency. In particular, the pharmacokinetics of two components of Veliten, namely rutine and alpha-tocopherol, were considered, while with respect to pharmacodynamics, studies were made of venous function, haemocoagulative and fibrinolytic balance, and haemorheological parameters. Correlation between such changes and plasma drug levels was also evaluated. We found a significant increase of venous tone, venous capacity and venous distension after drug intake, as well as a significant activation of fibrinolysis (globally evaluated with euglobulin lysis time), related to a slight increase of plasminogen tissue activator. These changes appeared concomitantly with maximal plasma levels of rutine. We did not find any modifications of coagulative and haemorheological parameters. Topics: Administration, Oral; Adolescent; Adult; Anticoagulants; Blood Coagulation; Female; Fibrinolysis; Humans; Hydroxyethylrutoside; Male; Plasminogen Activators; Time Factors; Venous Insufficiency; Vitamin E | 1994 |
[Venoruton in chronic venous insufficiency].
Topics: Chronic Disease; Humans; Hydroxyethylrutoside; Leg; Venous Insufficiency | 1993 |
[Modifications induced by long-term treatment with high doses of 0-(beta-hydroxyethyl)-rutoside in chronic venous insufficiency].
Topics: Adult; Dose-Response Relationship, Drug; Female; Humans; Hydroxyethylrutoside; Rutin; Varicose Veins; Venous Insufficiency | 1989 |
[Comparative capillaroscopic study of certain bioflavonoids and total triterpenic fractions of Centella asiatica in venous insufficiency].
Topics: Adult; Capillaries; Diosmin; Drug Tolerance; Female; Flavonoids; Humans; Hydroxyethylrutoside; Plant Extracts; Triterpenes; Venous Insufficiency | 1984 |
[Therapeutic investigations with venosan in veinous disease in the legs (author's transl)].
Topics: Adult; Aged; Drug Combinations; Female; Hemorrhoids; Humans; Hydroxyethylrutoside; Inositol; Leg; Male; Middle Aged; Nicotinic Acids; Propylamines; Rutin; Venous Insufficiency | 1976 |