TREATMENT OF CHRONIC VENOUS DISEASES WITH ORAL GLYCOSAMINOGLYCANS - AMETAANALYSIS OF DOUBLE-BLIND, PLACEBO-CONTROLLED STUDIES

This meta-analysis combines the results of seven double-blind, placebo -controlled trials conducted to test the efficacy and tolerability of an oral preparation of sulphomucopolysaccharides (glycosaminoglycans [ GAGs]) in patients with uncomplicated chronic venous insufficiency. A total of 105 patients received GAGs (one 200-lipoprotein-lipase-releas ing unit tablet TID for 120 days); 110 received a matching placebo. At baseline and at the end of the treatment, the presence of signs/sympt oms of venous insufficiency (edema, pain, cramps, and a sense of heavi ness) was evaluated using a four-point analogic scale; at the end of t he treatment, a global assessment was made (improved or unchanged/wors ened). The results for each variable were binomially transformed (impr oved or unchanged/worsened) and then analyzed by distributing the data in 2 x 2 contingency tables and calculating the odds ratios for each study, and the combined estimate. The active treatment was significant ly superior to placebo in terms of all of the signs/symptoms and the g lobal assessment (odds ratios: edema, 5.58; pain, 4.14; cramps, 4.33; heaviness, 4.55; global assessment, 5.90). These results show that tre atment with GAGs leads to an improvement in the signs/symptoms of veno us stasis in a large number of patients with chronic venous insufficie ncy.