Efficacy and safety of sclerotherapy using polidocanol foam: a controlled clinical trial.

OBJECTIVE

To assess the efficacy and safety of sclerotherapy performed with polidocanol foam compared to liquid polidocanol.

METHODS

Controlled clinical trial with 1 year follow up in which each patient acted as his/her own control. A total of 75 patients (six men and 69 women) with reticular or postoperative varices were enrolled and sclerotherapy was performed with liquid and with foam (Tessari method) using the same quantity of sclerosant for homogeneous varicose regions, to a total of 150 procedures. The sclerosant concentration was adjusted according to the vein diameter as assess by ultrasonography. The foam group was given 50% lower concentrations of sclerosant than liquid sclerosant group. Clinical assessment (pain, inflammation, pigmentation) and ultrasound examination (diameter of the lumen and length of sclerosed vein) were carried out at 15, 30, 90, and 365 days.

RESULTS

Foam allowed complete sclerosis at 90 days in 94.4% of patients compared with 53% for liquid (p<.001) and also allowed a more extensive venous sclerosis (10.1cm compared with 7.2 cm; p<.001). Pain, signs of inflammation, and pigmentation appeared more often with foam sclerosis, with significant difference. The degree of satisfaction was similar for both techniques.

CONCLUSIONS

Efficacy of venous sclerosis with foam seems to be greater than with liquid although there is a higher risk of minor secondary effects.