title: Veno-active drugs for chronic venous disease: A randomized, double-blind, placebo-controlled parallel-design trial.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  To compare the effects of different VAD on limb volume reduction, tibiotarsal range of motion, and quality of life.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: São Camilo Medical School, São Paulo, SP, Brazil belczak@gmail.com.
authors.forename: Sergio Q
authors.initials: SQ
authors.lastname: Belczak
authors.affiliation: São Camilo Medical School, São Paulo, SP, Brazil.
authors.forename: Igor R
authors.initials: IR
authors.lastname: Sincos
authors.affiliation: Medical School of the University of São Paulo, São Paulo, SP, Brazil.
authors.forename: Walter
authors.initials: W
authors.lastname: Campos
authors.affiliation: General Hospital of Carapicuiba, São Camilo University Center, São Paulo, SP, Brazil.
authors.forename: Julio
authors.initials: J
authors.lastname: Beserra
authors.affiliation: São Camilo University Center, Academic League of Angiology and Vascular Surgery São Paulo, SP, Brazil.
authors.forename: Gilberto
authors.initials: G
authors.lastname: Nering
authors.affiliation: Medical School of the University of São Paulo, São Paulo, SP, Brazil São Camilo University Center, Academic League of Angiology and Vascular Surgery São Paulo, SP, Brazil.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Aun
mesh_terms: D001696:Biomechanical Phenomena; D001938:Brazil; D002317:Cardiovascular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D003374:Coumarins / Q000627:therapeutic use; D004145:Diosmin / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004487:Edema / Q000175:diagnosis / Q000503:physiopathology; D005260:Female; D033023:Foot Joints / Q000187:drug effects / Q000503:physiopathology; D006569:Hesperidin / Q000627:therapeutic use; D006801:Humans; D006896:Hydroxyethylrutoside / Q000031:analogs & derivatives / Q000627:therapeutic use; D008297:Male; D010991:Plethysmography; D011788:Quality of Life; D016059:Range of Motion, Articular; D020127:Recovery of Function; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014689:Venous Insufficiency / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D062366:para-Aminobenzoates / Q000627:therapeutic use
chemical_list: D002317:Cardiovascular Agents; D003374:Coumarins; D006896:Hydroxyethylrutoside; D062366:para-Aminobenzoates; C016217:aminaftone; D004145:Diosmin; C005865:troxerutin; C030123:coumarin; D006569:Hesperidin
keywords: Chronic venous insufficiency; patient-reported outcomes; pharmacologic agents; plethysmography; quality of life assessment