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Online ISSN 1827-1766
Lozano F. S. 1, Jiménez-Cossio J. A. 2
1 Vascular Surgery Department, Salamanca Hospital, Salamanca, Spain;
2 Vascular Surgery Department, “La Paz” Hospital, Madrid, Spain
AIM: In order to assess the efficacy of a drug in the treatment of chronic venous insufficiency (CVI), it is important to evaluate not only the symptoms and signs associated with the disorder but also the evolution of the patient’s quality of life. The CIVIQ quality of life questionnaire (validated in Spanish after its French original) is a useful tool to assess patient’s responses to treatment both in practice and in clinical trials.
METHODS: Open, prospective, epidemiological clinical trial in multiple centres. A total of 482 patients with CVI (CEAP 0-4) were included. After a wash-out period, they were treated with a micronized flavonoid (Daflon 500, 2 cap/day) for 6 months. The following parameters were analyzed in follow-up visits held after 60, 120 and 180 days: clinical symptoms (pain on a visual analogue scale, swelling, weightiness and cramp), calf perimeter (Leg-O-Meter®) and quality of life (CIVIQ questionnaire).
RESULTS: The drug used (Daflon 500 for 6 months) improved all of the symptoms measured (p<0.001), reduced the malleolar perimeter (p<0.001) and increased the quality of life of these patients (p<0.001).
CONCLUSION: At the end of the study, the quality of life had increased by 10.3 points (from 66.4±18.5 to 76.7±18.2).