title: Efficacy and safety of Aethoxysklerol® (polidocanol) 0.5%, 1% and 3% in comparison with placebo solution for the treatment of varicose veins of the lower extremities in Chinese patients (ESA-China Study).
abstract: OBJECTIVE
  To assess efficacy and safety of polidocanol (POL) versus placebo in the treatment of C1 and C2 non-saphenous varicose veins in Chinese patients.
  
  
  METHODS
  Patients were randomly assigned to POL or placebo. POL 0.5%, 1% and 3% were administered depending on varicose vein type. Response after 12 weeks was defined as Grade 4 or 5 on a digital imaging-based five-point scale (C1 veins) or occlusion and/or absence of reflux >0.5 second (C2 veins). Safety was evaluated with a five-point scale and standard safety assessments.
  
  
  RESULTS
  Two hundred and eighty-five patients were treated. POL 0.5%, 1% and 3% were each superior to placebo (P < 0.001); response rates: 87.1% versus 13.6%, 86.4% versus 12.5% and 88.6% versus 4.3%, respectively. Significantly more POL than placebo patients were satisfied/very satisfied with treatment. POL was well tolerated, with mostly symptoms at the injection site reported.
  
  
  CONCLUSIONS
  Sclerotherapy with POL 0.5%, 1% and 3% was efficacious and safe in Chinese patients.
authors: Renji Hospital, Medical College, Shanghai JiaoTong University, People’s Republic of China.
authors: J
authors: J
authors: Zhang
authors: Z
authors: Z
authors: Jing
authors: D E
authors: DE
authors: Schliephake
authors: J
authors: J
authors: Otto
authors: G M
authors: GM
authors: Malouf
authors: Y-Q
authors: YQ
authors: Gu
mesh_terms: D000328:Adult; D044466:Asian People; D002681:China; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D017060:Patient Satisfaction / Q000208:ethnology; D010919:Placebos; D000077423:Polidocanol; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D012501:Saphenous Vein / Q000000981:diagnostic imaging; D012597:Sclerosing Solutions / Q000008:administration & dosage* / Q000009:adverse effects; D015911:Sclerotherapy / Q000009:adverse effects; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014648:Varicose Veins / Q000000981:diagnostic imaging / Q000208:ethnology / Q000628:therapy*
chemical_list: D010919:Placebos; D012597:Sclerosing Solutions; D000077423:Polidocanol; D011092:Polyethylene Glycols