Investigations of treatment options for established PTS are limited. Graduated compression stocking therapy (GCS) is often used in clinical practice despite limited research on effectiveness. We postulated that the venous hypertension seen in PTS leads to lymphatic overload and secondary lymphedema. Therefore, in patients with established PTS, we compared the efficacy of GCS alone to complex lymphedema therapy, a treatment that includes compression stocking use, exercise, patient education, skin care and manual lymphatic drainage.
In an investigator-blind randomized controlled trial of 31 patients with a clinical diagnosis of PTS and prior history of DVT, we compared GCS alone using 30–40 mm Hg compression to complex lymphedema therapy. Primary outcomes were the 1- and 3-month changes in PTS severity by the Villalta score (higher score indicates more severe PTS) and disease-specific quality of life by the VEINES QOL score (high score indicates better QOL). Analysis was by intent-to-treat.
Overall, 39% of patients enrolled in the study had moderate or severe PTS: baseline mean PTS severity score was 9.9 (SD 7.1) in the lymphedema group and 10.9 (SD 5.3) in the GCS group (p=0.66). The complex lymphedema therapy group had a reduction in mean PTS severity score of -2.4 (p=0.02) at 1 month and -2.3 (p=0.05) at 3 months follow-up. The GCS group had a reduction in PTS severity score of -2.1 (p=0.03) at 1 month and -3.3 (p=0.03) at 3 months. The improvement in PTS severity score did not differ significantly between treatment groups (p=0.61 at 3 months). Neither group had a significant change in VEINES QOL score. Patients not routinely using GCS prior to trial entry derived a greater benefit from either intervention with a decrease in PTS severity score (-8.8 in nonusers vs -1.5 in those using GCS at baseline, p=0.07) and an increase in VEINES QOL score (+1.9 vs -2.0, p=0.02). At 3 months, average self-reported GCS use was 6.7 days/wk (lymphedema therapy) and 5.9 days/wk (GCS) with 78% of patients in the lymphedema therapy group receiving manual lymphatic drainage (home or therapist). Four patients experienced recurrent thrombosis on the trial (3 in GCS group; 1 in lymphedema therapy group); 1 stocking allergy and ulcer formation was also seen in the GCS group with no cardiopulmonary complications reported in either group.
In this first clinical trial of complex lymphedema therapy for patients with established PTS, a short course of lymphedema therapy was safe and had a similar effect on PTS severity as compression stocking use.
No relevant conflicts of interest to declare.
Asterisk with author names denotes non-ASH members.