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A Journal on Phlebology
Acta Phlebologica 2013 April;14(1):39-44
Placebo controlled efficacy of class 2 elastic stockings (23-32 mmHg) in reduction of edema in CVI of the lower limbs
Mariani F. 1, 2, Bucalossi M. 1, 2, Mancini S. 1, 3
1 The Compression Therapy Study Group (CTG), Colle di Val d’Elsa, Siena, Italy;
2 Vascular Surgery Unit, Valdisieve Clinic, Pontassieve, Florence, Italy;
3 Department of Medical Sciences, Surgical Sciences and Neurosciences, Siena, Italy, University
Aim: The aim of the study is to compare the efficacy of class II below-knee compression stockings MCS (BSN medical-Jobst® UltraSheer RAL, pressure at the ankle 23 to 32 mmHg) to that of placebo stockings PS (pressure at the ankle 3 to 6 mmHg) in reducing venous edema of the lower limbs in patients consulting in general practice for CVI stage CEAP 3.
Methods: A 1-week randomized, placebo-controlled clinical trial comparing the efficacy of MCS to that of PS in reducing venous edema of the lower limb (stage CEAP 3). Treatment efficacy was assessed by the following criteria: the thickness of the subcutaneous tissue with the presence of edema at the ankle (point B1) and the calf (point C) measured by duplex scan sonography (probe 6-10 mHz); the circumferences of the ankle (point B1) and the calf (point C). Practicability of use of the MCS compared with the treatment with the PS, including treatment time to reduce oedema, comfort/discomfort, assessment of tolerability (VAS and modified Venkatraman questionnaire). Data were analyzed using SPSS 13.01 (SPSS, Inc., Chicago, IL, USA), Chi Square test and Student t-tests.
Results: Edema was significantly reduced after 3 days of treatment with MCS: 22 patients (84.6%) had no oedema. A further improvement occurred between days 3 and 7 for the MCS treatment groups, edema was reduced in 25 patients (96.2%). The mean time of edema reduction is 3,5 days for MCS. MCS is effective to reduce leg circumference and subcutaneous thickness at point B1 and C, the mean reduction of circumferences at point B1 was 3.4 cm, at point C was 1,23 cm. PS is unable to reduce oedema, leg circumferences and subcutaneous thickness. The differences between the two treatment groups are statistically significative in favour to MCS.
Conclusion: Our placebo-controlled clinical trial comparing the efficacy of MCS to that of PS shows that compression stockings (23-32 mmHg at the ankle) are effective and well tolerated in the treatment phase of oedema.