Physical therapies in the decongestive treatment of lymphedema: A randomized, non-inferiority controlled study

Objective: To assess whether the treatment with intermittent pneumatic compression plus multilayer bandages is not inferior to classical trimodal therapy with manual lymphatic drainage in the decongestive lymphedema treatment. Study Design: Randomized, non-inferiority, controlled study to compare the efficacy of three physical therapies’ regimens in the Decongestive Lymphatic Therapy. Participants: 194 lymphedema patients, stage II–III with excess volume > 10% were stratified within upper and lower limb and then randomized to one of the three treatment groups. Baseline characteristics were comparable between the groups. Intervention: all patients were prescribed 20 sessions of the following regimens: Group A (control group): manual lymphatic drainage + Intermittent Pneumatic Compression + Bandages; Group B: pneumatic lymphatic drainage + Intermittent Pneumatic Compression + Bandages; and Group C: only Intermittent Pneumatic Compression + Bandages. End-point: Percentage reduction in excess volume (PREV). Results: All patients improved after treatment. Global mean of PREV was 63.9%, without significant differences between the groups. The lower confidence interval of the mean difference in PREV between group B and group A, and between group C and group A were below 15%, thus meeting the non-inferiority criterion. Most frequent adverse events were discomfort and lymphangitis, without differences between groups. A greater baseline edema, an upper-limb lymphedema and a history of dermatolymphangitis were independent predictive factors of worse response in the multivariate analysis. Conclusions: Decongestive lymphatic therapy performed only with intermittent pneumatic compression plus bandages is not inferior to the traditional trimodal therapy with manual lymphatic drainage. This approach did not increase adverse events.

Randomized Trial of Decongestive Lymphatic Therapy for the Treatment of Lymphedema in Women With Breast Cancer

Purpose Because of its morbidity and chronicity, arm lymphedema remains a concerning complication of breast cancer treatment. Although massage-based decongestive therapy is often recommended, randomized trials have not consistently demonstrated benefit over more conservative measures. Patients and Methods Women previously treated for breast cancer with lymphedema were enrolled from six institutions. Volumes were calculated from circumference measurements. Patients with a minimum of 10% volume difference between their arms were randomly assigned to either compression garments (control) or daily manual lymphatic drainage and bandaging followed by compression garments (experimental). The primary outcome was percent reduction in excess arm volume from baseline to 6 weeks. Results A total of 103 women were randomly assigned, and 95 were evaluable. Mean reduction of excess arm volume was 29.0% in the experimental group and 22.6% in the control group (difference, 6.4%; 95% CI, −6.8% to 20.5%; P = .34). Absolute volume loss was 250 mL and 143 mL in the experimental and control groups, respectively (difference, 107 mL; 95% CI, 13 to 203 mL; P = .03). There was no difference between groups in the proportion of patients losing 50% or greater excess arm volume. Quality of life (Short Form-36 Health Survey) and arm function were not different between groups. Conclusion This trial was unable to demonstrate a significant improvement in lymphedema with decongestive therapy compared with a more conservative approach. The failure to detect a difference may have been a result of the relatively small size of our trial.