Background:
Foam sclerotherapy is a potential treatment for lower limb venous disease.
Methods:
A systematic review, with no restriction on study design, to assess the safety and efficacy of foam sclerotherapy.
Results:
67 studies were included. For serious adverse events including pulmonary embolism and deep vein thrombosis, the median event rates were less than 1%. Median rate for visual disturbance was 1.4%. Median rates for some other adverse events were more common, including headache (4.2%), thrombophlebitis (4.7%), matting/skin staining/pigmentation (17.8%) and pain at the site of injection (25.6%). Median rate for complete occlusion of treated veins was 87.0% and for recurrence or development of new veins was 8.1%. Evidence from meta-analysis for complete occlusion suggests that foam sclerotherapy is associated with a lower rate compared with with surgery (RR 0.86, 95% CI 0.67 to 1.10) and a higher rate compared with liquid sclerotherapy (RR 1.39, 95% CI 0.91 to 2.11). However, there was substantial heterogeneity across the studies in the meta-analysis.
Conclusion:
Serious adverse events were rare. A high quality RCT with follow-up of at least three years is required to determine the comparative effectiveness of foam sclerotherapy and its place in clinical practice.