A DOUBLE-BLIND CLINICAL-TRIAL OF HYDROXYETHYLRUTOSIDES IN OBSTRUCTIVEARM LYMPHEDEMA

Objective: To study the effects of hydroxyethylrutosides (HR) in addit ion to physical treatment in obstructive arm lymphoedema. Design: Pros pective, randomized, double-blind, placebo-controlled, crossover trial . Setting: Palliative care lymphoedema clinic providing physical lymph oedema treatment. Patients: Thirty-one patients undergoing physical tr eatment for obstructive arm lymphoedema with a stable arm volume for 6 months; 22 patients completed trial. Intervention: Three grams of HR daily or placebo orally for consecutive 24-week periods. Main outcome measures: Arm volume and tonometry at 0, 24 and 48 weeks. Results: Mea n excess volume (790 ml) decreased 4% (33 ml) on HR and increased 6% ( 47 ml) on placebo, i.e. net reduction of 10% (80 ml) (t = 2.50, 20 d.f ., 0.02<p<0.05). Tissue tone decreased on HR and increased on placebo. The depth of tissue indentation measured by tonometer increased by a mean of 1.36 mm on HR (t = 2.35, 20 d.f., 0.02<p<0.05). Conclusions: H ydroxyethylrutosides reduced arm volume and tissue tone by statistical ly significant but clinically unimportant amounts when used in associa tion with palliative physical treatments. We do not recommend the use of HR in established obstructive arm lymphoedema.