A double-blind, randomized, parallel-group, placebo-controlled trial of O-(β-hydroxyethyl)-rutosides in chronic arm oedema resulting from breast cancer treatment

Objective: To assess the efficacy of O-(β-hydroxyethyl)rutosides (HR) in the treatment of breast-cancer related lymphoedema. Design: A double-blind, randomized, parallel-group, placebo-controlled clinical trial. Setting: Lymphoedema clinic, Royal Marsden Hospital, London, UK. Patients: Forty-six females with unilateral lymphoedema of the arm secondary to therapy for carcinoma of the breast. Main outcome measures: Arm volume, symptom assessment on a five-point scale. Results: The difference in arm volumes was significantly better for HR than placebo at 6 months, but not at 1-5 months. Conclusion: HR appears to stabilize the patients' condition against increasing lymphoedema in the placebo group.