BACKGROUND: Pneumatic compression is a frequently prescribed physical therapy for patients affected by postmastectomy lymphedema but, despite its wide use, its efficacy has not been demonstrated in phase III studies. We performed a randomized study comparing pneumatic compression versus no treatment in patients with postmastectomy lymphedema. PATIENTS AND METHODS: Patients with monolateral postmastectomy lymphedema were randomized to receive two cycles of intermittent pneumatic compression (PC group), ie, five two-hour sessions per week for two weeks, to be repeated after a five-week interval, or to no treatment (control group). The patients in both groups were instructed as to the prophylactic hygienic care of the limb. Lymphedema was assessed by the sum of differences in circumference measurements between affected and normal limbs ('delta'). Response was defined as a >= 25% reduction in delta value. RESULTS: Eighty patients entered the study. No statistically significant differences in response rates between the two groups were observed: 20% in the control group (95% CI 9% to 36%), 25% in the PC group (95% CI 13% to 41%, p = 0.59). The absolute mean decrease in delta value was 1.9 +/- 3.7 cm in the PC group and 0.5 +/- 3.3 cm in the control group. CONCLUSIONS: We demonstrated that intermittent pneumatic compression has a limited clinical role in the treatment of postmastectomy lymphedema. Efforts to prevent this complication should be undertaken.
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