A Double-Blind,Randomized,Parallel-Group,Placebo-Controlled Trial of O-(β-Hydroxyetnyl)-Rutosides in Chronic Arm Oedema Resulting from Breast Cancer Treatment

Abstract

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.