title: Quality of live as measured by the CIVQ 20. Questionnaire following oral mesoglycan treatment of patients with chronic venous disease.
abstract: OBJECTIVE
  Several studies have demonstrated the effective antithrombotic action of mesoglycan to treat chronic venous disease (CVD). The study aimed to assess clinical and quality of life (QoL) (CIVIQ 20 questionnaire) improvements in mesoglycan-treated patients with clinical, etiological, anatomical and pathophysiological (CEAP) stages 2 and 3.
  
  
  METHODS
  The open, multicentre, uncontrolled, observational, prospective study involved treating patients with 50 mg x 2/day mesoglycan for 2 months and measuring improvement to lower-limb edema and QoL in the Global, Physical, Pain, Psychological, and Social Dimensions of the Chronic Venous Disease Quality-of-Life Questionnaire (CIVIQ 20) at the first, baseline visit (V1), at the end of treatment (V2) and 2 (V3) and 4 months after treatment completion (V4). At the last visit (V4), patient disease status was assessed objectively (by the treating physician) and subjectively (by the patient). The study population was divided into three groups: 1) patients with only varicose veins; 2) patients with only lower-limb edema; 3) patients with varicose veins and edema (ITT population).
  
  
  RESULTS
  Seventy-five centers enrolled 1066 patients (ITT population); 914 patients completed the study. Mesoglycan treatment produced significant improvement of edema and lower-limb circumference at every visit, in both patients with edema alone and those with edema and varicose veins (paired sample t-test P<0.001). QoL improved significantly in all questionnaire dimensions in all three patient groups even after treatment was concluded (V2). Improvement continued up to the end of the study observation period (V4) (paired sample t-test P<0.001). Objective clinical improvement of the underlying CVD was found in 76.82% of patients with varicose veins alone, in 82.83% of patients with edema alone, and in 76.7% of patients with varicose veins and edema. Patients' own subjective assessment of improvement was 82.0%, 79.39% and 79.39% respectively for the three groups.
  
  
  CONCLUSIONS
  Results showed mesoglycan treatment to improve QoL significantly in patients with CVD as measured by a specific questionnaire like the CIVIQ 20. The extent of average edema reduction observed at the last visit (4 months after the end of drug treatment), suggests mesoglycan might have an etiological role, modifying the physiological factors underlying CVD and not just affording temporary improvement of symptoms.
authors.affiliation: Director Master on Vascular Diseases, S. Giovanni Hospital, Rome, Italy - allegra@mclink.it.
authors.forename: C
authors.initials: C
authors.lastname: Allegra
authors.forename: P L
authors.initials: PL
authors.lastname: Antignani
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D004487:Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D005260:Female; D006025:Glycosaminoglycans / Q000008:administration & dosage*; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014648:Varicose Veins / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D014689:Venous Insufficiency / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology
chemical_list: D006025:Glycosaminoglycans; C040617:mesoglycan