title: Evaluation of the efficacy of polidocanol in the form of foam compared with liquid form in sclerotherapy of the greater saphenous vein: initial results.
abstract: BACKGROUND
  Foamed sclerosing agents have been used with enthusiasm by phlebologists for more than 5 decades. Any type of varicose veins can and has been treated with this technique. Numerous publications have stressed the advantages of foamed sclerosing agents on the basis of empiric and experimental criteria and have described various individual techniques to prepare foams. Until now, however, no comparative study for the treatment of large varicose veins with foam or liquid exists.
  
  
  OBJECTIVE
  The purpose of this first randomized, prospective, multicenter trial was to study the elimination of reflux, the rate of recanalization, and possible side effects of foam sclerotherapy (FS) compared with conventional liquid sclerotherapy for the greater saphenous vein (GSV).
  
  
  METHODS
  Eighty-eight patients were randomized into two groups: One group was treated with sclerosing foam (45 patients) and the other with sclerosing liquid (43 cases). Sclerotherapy was performed with direct puncture of the vessel under duplex guidance. The reference sclerosing agent was polidocanol in a 3% solution. The foam was prepared using the Double Syringe System (DSS) method. Only one injection of 2.0 or 2.5 mL liquid or foam was allowed, depending on the diameter of the GSV. Results were assessed according to the protocol.
  
  
  RESULTS
  Follow-up after 3 weeks showed 84% elimination of reflux in the GSV with DSS foam versus 40% with liquid sclerosant (P < 0.01). At 6 months, six recanalizations were found in the liquid group versus two in the foam group. After 1 year, no additional recanalization was observed with either foam or liquid. Longer term studies are underway. Side effects did not differ between both groups.
  
  
  CONCLUSIONS
  The efficacy of sclerosing foam (DSS) compared with sclerosing liquid in therapy of the GSV is superior, a finding that had already gained empirical recognition but for which there has not been any clinical evidence to date.
authors.affiliation: Center Hospitalier Privé Saint Martin, 18 Rue des Rocquemonts, 14050 Caen-Cedex, France. claudine.hamel-desnos@wanadoo.fr
authors.forename: Claudine
authors.initials: C
authors.lastname: Hamel-Desnos
authors.forename: Philippe
authors.initials: P
authors.lastname: Desnos
authors.forename: Jan-Christoph
authors.initials: JC
authors.lastname: Wollmann
authors.forename: Pierre
authors.initials: P
authors.lastname: Ouvry
authors.forename: Serge
authors.initials: S
authors.lastname: Mako
authors.forename: François-Andre
authors.initials: FA
authors.lastname: Allaert
mesh_terms: D004304:Dosage Forms; D006801:Humans; D000077423:Polidocanol; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011446:Prospective Studies; D012501:Saphenous Vein; D012597:Sclerosing Solutions / Q000008:administration & dosage*; D015911:Sclerotherapy; D014648:Varicose Veins / Q000188:drug therapy*
chemical_list: D004304:Dosage Forms; D012597:Sclerosing Solutions; D000077423:Polidocanol; D011092:Polyethylene Glycols