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The study compared, by a prospective, randomized method, 6 treatment options: A: Sclerotherapy; B: High-dose sclerotherapy; C: Multiple ligations; D: Stab avulsion; E: Foam-sclerotherapy; F: Surgery (ligation) followed by sclerotherapy. Results were analyzed 10 years after inclusion and initial treatment. Endpoints of the study were variations in ambulatory venous pressure (AVP), refilling time (RT), presence of duplex-reflux, and number of recurrent or new incompetent venous sites. The number of patients, limbs, and treated venous segments were comparable in the 6 treatment groups, also comparable for age and sex distribution. The occurrence of new varicose veins at 5 years varied from 34% for group F (surgery + sclero) and ligation (C) to 44% for the foam + sclero group (E) and 48% for group A (dose 1 sclero). At 10 years the occurrence of new veins varied from 37% in F to 56% in A. At inclusion AVP was comparable in the different groups. At 10 years the decrease in AVP and the increase in RT (indicating decrease in reflux), was generally comparable in the different groups. Also at 10 years the number of new points of major incompetence was comparable in all treatment groups. These results indicate that, when correctly performed, all treatments may be similarly effective. "Standard," low-dose sclerotherapy appears to be less effective than high-dose sclero and foam-sclerotherapy which may obtain, in selected subjects, results comparable to surgery.
Introduction and Background
The treatment of varicose veins is still not standardized.1-5 At the moment most treatments are not based on clear, evidence-based medicine, for large, homogeneous, randomized trials are not available. Hobbs' study, from St Mary's Hospital in London, comparing surgery and sclerotherapy, indicated that surgery is more effective on a long-term basis.1 Stripping of the long saphenous vein is not used at present in many centers on the basis that selective ligation of incompetent sites is as effective as stripping, being less traumatic and costly and allowing short-stay surgery.2-5 At the moment the combination of surgery and sclerotherapy is effectively used and appears to be very cost-effective. However, the best combination is not clear.4-9 The preservation of the long saphenous vein (LSV) for bypass grafting, or to save the collateral circulation and prevent more serious complications in case of deep venous...