The Australian Polidocanol (Aethoxysklerol) Study

BACKGROUND: An ongoing study of the safety and effectiveness of polidocanol by 98 investigators in Australia infecting 16,804 limbs over 2 years. OBJECTIVE: To evaluate the complications of polidocanol and compare its effectiveness and complications with sodium tetradecyl sulphate (STD) and hypertonic saline. METHODS: A single-arm prospective study of polidocanol complications and its effectiveness as a sclerosant was performed. This was compared with each investigator's previous experience with other sclerosing agents. Patients had either varicose veins or venule ectasias and/or spider veins (telangiectasia). A total of 16,804 limbs were injected by 98 investigators. Sclerotherapy was performed with 0.5% or 1% polidocanol for telangiectasias or spider veins, and with 3% polidocanol for varicose veins. The effectiveness of the sclerotherapy and any complications were reported during a 2-year period. RESULTS: There were very few complications reported with polidocanol. There were no reported deaths or anaphylaxis. The investigators with previous experience of other sclerosants considered that the effectiveness of polidocanol was superior to STD (85%) and hypertonic saline (84%). Ninety percent of investigators considered that polidocanol had less frequent complications than STD, and 80% considered that these were less severe. Seventy-four percent considered that polidocanol had fewer side effects than hypertonic saline, and 74% considered that these were less severe. CONCLUSIONS: Polidocanol is an effective sclerosant that has few complications.