To evaluate the effectiveness and safety of oral administration of Linfadren ® in addition to conventional treatment in patients with post-trauma/surgery persistent hand edema. Design: Parallel-group randomized controlled trial. Setting: Outpatient rehabilitation center. Subjects: A total of 60 outpatients (mean age 48.5 (standard deviation (SD) = 12.3) years) with posttrauma/surgery persistent hand edema. Interventions: Patients were randomized to either receive six-week conventional treatment plus Linfadren ® (Study Group) or conventional treatment (Control Group). Main Measures: Primary outcome was hand edema as measured by figure-of-eight method. Secondary outcomes were hand function, patient's overall perceived treatment effectiveness and rescue medication request. Tolerability of Linfadren ® was also evaluated. Assessments were performed at baseline, at the end of treatment and three months after the end of treatment. Results: All patients completed the six-week program and 57 patients (95%) completed the threemonth follow-up. At six weeks, the Study Group had significantly greater improvement in hand edema (423.3 (SD = 23.8) mm vs 439.4 (SD = 22.6) mm; P = 0.009) and upper limb function (Quick Disabilities of Arm, Shoulder and Hand questionnaire: 23.6 (SD = 13.6) vs 37.7 (SD = 15.9); P = 0.005) compared to the Control Group. Moreover, the percentage of patients who perceived treatment as effective was
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