Efficacy of sclerotherapy in varicose veins-- prospective, blinded, placebo-controlled study.

OBJECTIVE: The objective of this study was to investigate the efficacy of sclerotherapy for varicose veins in a randomized blinded study.

METHODS: Twenty-five patients with varicose veins (C(2-4), E(P), A(SP), P(R)) were included. Fourteen subjects received polidocanol (Aethoxysklerol) and 11 patients received normal saline injections. Compression was applied for 1 week. One, 4, and 12 weeks later controls were performed using duplex ultrasonography. The quotient of venous by arterial volume flow was used as quantitative hemodynamic pattern. Patients and the examiner were unaware of which liquid had been injected.

RESULTS: In comparison to group 2, 76.8% of the veins treated with polidocanol were completely occluded (p<0.0001). In group 1 the venoarterial flow index decreased from 1.45+/-0.66 to 1.06+/-0.2 (p=0.05). In 11 occluded veins of 14 (group 1), the venoarterial flow index decreased from 1.5+/-0.07 to 0.98+/-0.12 (p<0.05), which is a level found in competent veins. In group 2, the venoarterial flow index remained stable increased.

CONCLUSIONS: Injection sclerotherapy using polidocanol (Aethoxysklerol) is efficient to obliterate varicose veins and to improve venous hemodynamics.