OBJECTIVES: 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.
RCT Entities:
OBJECTIVES: 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: E Rabe; F X Breu; I Flessenkämper; H Gerlach; S Guggenbichler; B Kahle; R Murena; S Reich-Schupke; T Schwarz; M Stücker; E Valesky; S Werth; F Pannier Journal: Hautarzt Date: 2021-01 Impact factor: 0.751
Authors: F Pannier; T Noppeney; J Alm; F X Breu; G Bruning; I Flessenkämper; H Gerlach; K Hartmann; B Kahle; H Kluess; E Mendoza; D Mühlberger; A Mumme; H Nüllen; K Rass; S Reich-Schupke; D Stenger; M Stücker; C G Schmedt; T Schwarz; J Tesmann; J Teßarek; S Werth; E Valesky Journal: Hautarzt Date: 2022-04-19 Impact factor: 1.198
Authors: Matheus Bertanha; Marcone Lima Sobreira; Carlos Eduardo Pinheiro Lúcio Filho; Jamil Victor de Oliveira Mariúba; Rafael Elias Farres Pimenta; Rodrigo Gibin Jaldin; Andrei Moroz; Regina Moura; Hamilton Almeida Rollo; Winston Bonetti Yoshida Journal: Trials Date: 2014-12-19 Impact factor: 2.279
Authors: E Rabe; F X Breu; I Flessenkämper; H Gerlach; S Guggenbichler; B Kahle; R Murena; S Reich-Schupke; T Schwarz; M Stücker; E Valesky; S Werth; F Pannier Journal: Hautarzt Date: 2021-12 Impact factor: 0.751