Polidocanol Plus Glucose Versus Glucose Alone for the Treatment of Telangiectasias: Triple Blind, Randomised Controlled Trial (PG3T)

Autor(es)

Bertanha, Matheus ^[1] ; Yoshida, Winston B. ^[1] ; Bueno de Camargo, Paula A. ^[1] ; Moura, Regina ^[1] ; de Paula, Denia Reis ^[2] ; Padovani, Carlos R. ^[3] ; Sobreira, Marcone L. ^[1]

Afiliação do(s) autor(es)

^[1] Sao Paulo State Univ Julio de Mesquita Filho, Dept Surg & Orthoped, UNESP, Botucatu Med Sch, Botucatu, SP - Brazil

^[2] Sao Paulo State Univ Julio de Mesquita Filho, Botucatu Med Sch, UNESP, Botucatu, SP - Brazil

^[3] Sao Paulo State Univ Julio de Mesquita Filho, Botucatu Biosci Inst, UNESP, Dept Stat, Botucatu, SP - Brazil

• Tipo de documento: Artigo Científico
• Fonte: EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY; v. 61, n. 1, p. 128-135, JAN 2021.
• Citações Web of Science: 1

Resumo

Objective: The aim of this study was to compare the effectiveness and safety of two sclerosing agents used to treat telangiectasias in the lower limbs: 0.2% polidocanol 70% hypertonic glucose (HG) vs. 75% HG alone. Methods: A prospective, randomised, triple blind, controlled, parallel group trial with patients randomly assigned in a 1:1 ratio between January and December 2015, with a two month follow up, from a single academic medical centre in Brazil, was carried out. Participants were women aged 18-65 years with telangiectasias on the lateral aspect of one thigh, classified as C1EpAsPn who underwent sclerotherapy in a single session with 0.2% polidocanol 70% HG or 75% HG alone to treat the telangiectasias on an area limited by a rectangular template. The primary effectiveness endpoint was elimination of 75% of the telangiectasias within 60 days vs. the pre-treatment pattern. The length of vessels was measured on images obtained before and after treatment using ImageJ software. Safety outcomes were analysed immediately, 7 days, and 60 days after the treatment, and included pigmentation. Results: A total of 115 patients were included, 98 of whom completed the study. Sclerotherapy with 0.2% polidocanol 70% HG was significantly more effective than with 75% HG alone to treat telangiectasias in the target area (82.2% vs. 63.9%; p < .001); considering a minimum improvement of 75%, there was a 0.49 risk reduction (95% confidence interval 0.24-0.98; p = .047). No severe adverse events occurred in either group. Pigmentation was the most common minor adverse event and was significantly shorter in length in the group treated with 0.2% polidocanol 70% HG (median 0 cm vs. 0.5 cm, respectively; p = .033). Conclusion: Polidocanol 0.2% plus 70% HG had better results than 75% HG alone in sclerosing telangiectasias. No severe adverse events occurred. Pigmentation occurred in both groups and was shorter in length in the group treated with 0.2% polidocanol + 70% HG. (AU)

• Processo FAPESP: 12/11034-0 - Estudo clínico randomizado e duplo cego comparando dois métodos de escleroterapia para veias reticulares e telangiectasias em membros inferiores
• Beneficiário: Marcone Lima Sobreira
• Modalidade de apoio: Auxílio à Pesquisa - Regular