Double‐Blind Prospective Comparative Trial between Foamed and Liquid Polidocanol and Sodium Tetradecyl Sulfate in the Treatment of Varicose and Telangiectatic Leg Veins

Department of Dermatology and Cutaneous Biology, Thomas Jefferson University Hospitals, Filadelfia, Pennsylvania, United States
Dermatologic Surgery (Impact Factor: 2.11). 06/2005; 31(6):631-5; discussion 635. DOI: 10.1111/j.1524-4725.2005.31602
Source: PubMed


Twenty subjects were treated with either polidocanol (POL) or sodium tetradecyl sulfate (STS) to compare the efficacy and adverse sequelae of each agent.
To determine the safety and efficacy of two widely used sclerosing agents.
After the exclusion of saphenofemoral junction incompetency, each subject's leg veins were categorized by size (< 1, 1-3, and 3-6 mm in diameter). Each leg was then randomized to be treated with 0.5%, 1%, or 1% foam of POL or 0.25%, 0.5%, or 0.5% foam of STS according to vein size. An independent panel of four physicians, blinded to treatment, performed randomized photographic evaluations obtained pretreatment and 12 weeks post-treatment. Subject satisfaction index and overall clinical improvement assessment were also obtained.
An average 83% improvement was noted for all vein sizes in all subjects with both POL and STS after a single treatment. Subjects were satisfied with treatment, regardless of the sclerosing agent used or the vein size treated. There was no statistically significant difference in adverse effects between each group.
Both POL and STS are safe and effective sclerosing agents in the treatment of varicose and telangiectatic leg veins. Both are very tolerable and demonstrate similar post-treatment sequelae.

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    • "Sclerotherapy is a well-tolerated and highly efficacious treatment for varicose and telangiectatic leg veins (1). Sclerosing solutions act by inducing endothelial damage (endosclerosis), which eventually leads to endofibrosis of the treated vessels. "
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    ABSTRACT: 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: 69 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 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. There is insufficient evidence to reliably compare the effectiveness of foam sclerotherapy with other minimally invasive therapies or surgery. Evidence from high quality randomised controlled trials is required. This manuscript is based on a systematic review commissioned and funded by the National Institute for Health and Clinical Excellence (NICE) through its Interventional Procedures Programme. The Health Services Research Unit is supported by a core grant from the Chief Scientist Office of the Scottish Executive Health Department.
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