Manual lymphatic drainage adds no further volume reduction to Complete Decongestive Therapy on breast cancer-related lymphoedema: a multicentre, randomised, single-blind trial

BACKGROUND: We investigated the comparability of Complete Decongestive Therapy (CDT) including manual lymphatic drainage (MLD) vs. without MLD in the management of arm lymphoedema in patients with breast cancer. METHODS: Patients randomised into either treatment including MLD (T+MLD) or treatment without MLD (T-MLD) received treatment 2xweekly for 4 weeks. The primary outcome was the volume reduction (%) of arm lymphoedema at 7-month follow-up. The secondary outcomes were volume reduction after the end of treatment, circumference of the arm, patient experience of heaviness and tension, and health status. RESULTS: Despite difficulties enrolling the planned number of patients (160), 77 were randomised and 73 (38 in T+MLD, 35 in T -MLD) completed the trial In both groups, the volume of lymphoedema decreased significantly, with no difference between groups (1.0% [95% CI, -4.3;2.3%]): the precision in the 95% confidence interval indicates that the efficacy was comparable; the mean (SE) changes at month 7 were -6.8%(1.2) and -5.7% (1.2) in the T+MLD and T-MLD, respectively. There were no statistically significant differences with respect to any of the secondary outcomes. The results were robust and the conclusion was not sensitive even to various alternative assumptions or analytic approaches to data analysis. CONCLUSION: Manual lymphatic drainage adds no further volume reduction in breast cancer patients.