50 years of Aethoxysklerol® – 50 years of healthy legs
The medicinal product Aethoxysklerol® from Kreussler Pharma in Germany was first approved as a sclerosant for varicose veins half a century ago. Since then, more than 150 million patients around the world have benefitted from sclerotherapy. At the same time, a growing number of scientific studies and meta-analyses have delivered valid data on the efficacy and safety of the medicinal product and the procedure. Today sclerotherapy is the gold standard for the treatment of spider veins and reticular varicose veins and is also a patient-friendly alternative to surgical procedures for venous diseases in categories C2 to C6 of the CEAP classification.
The revolution in phlebology
It is now 50 years since Aethoxysklerol® paved the way for sclerotherapy, thus revolutionising the treatment of varicose veins. Since then, there has been the option of eliminating incompetent veins with just a minimally invasive injection. As with so many pioneering medical discoveries, the success story of Aethoxysklerol® also began with a chance finding. At the beginning of the 1930s, scientists were looking at a variety of detergents when they discovered that polidocanol had remarkable local anaesthetic properties. Further experiments showed that this substance damaged the vein walls when it was administered intravenously. For this reason polidocanol no longer came into consideration as an injectable anaesthetic. Otto Henschel, the scientific director of Kreussler Pharma at that time, recognised that it could be used for other medical purposes and turned the initial “side effect” into a potential “main effect” by using polidocanol for the targeted treatment of varicose veins. After extensive scientific testing according to the possibilities of the time, Aethoxysklerol® with the active ingredient polidocanol was granted marketing authorisation in Germany in 1966 as a sclerosant for varicose veins in the legs, haemorrhoids, and oesophageal varices.
An agent and a procedure for all types of varicose veins
The therapeutic potential of sclerotherapy with Aethoxysklerol® quickly became apparent. Continuous development of the sclerosant and the method, as well as rapid advances in imaging techniques such as Doppler and duplex ultrasonography, has allowed sclerotherapy to be used under ultrasound guidance for large varicose veins. The German Phlebology Society’s guidelines recommend sclerotherapy as the gold standard for the treatment of spider veins and reticular varicose veins, as it is not only effective, safe, and patient-friendl1,2 but can also be used to eliminate “feeder veins” of the spider veins lying deeper in the tissues. In addition to liquid sclerotherapy, the German and many other European authorities also officially approved Aethoxysklerol® for foam sclerotherapy in 2009 or later. Aethoxysklerol® and air are mixed together to produce a stable, viscous, finely bubbled foam that has even more powerful effects than the liquid sclerosant. Duplex ultrasound-guided foam sclerotherapy led to yet another revolution in phlebology, as large varicose veins can now also be treated effectively and safely under direct vision, without an anaesthetic. Foam sclerotherapy offers a minimally invasive alternative to surgical procedures, especially for branch and trunk varicose veins. The latest NICE Guideline 3 even recommends foam therapy in preference to surgical procedures in the treatment of trunk varicose veins. “Sclerotherapy is the only treatment method that can be used successfully to treat all types of varicose veins,” summarises Dr Michel Schadeck, from Paris, one of the pioneers of ultrasound-guided sclerotherapy. “Unlike all the other procedures, I can use this method for everything from small spider veins to large trunk varicose veins, and it’s particularly good for recurrent varicose veins and veins situated near ulcers. In addition, sclerotherapy can be combined with all endovenous and surgical procedures, decisively contributing to the optimal treatment of varicose veins.”
Studies on efficacy and tolerability
Since Aethoxysklerol® was first approved 50 years ago, numerous studies have confirmed the efficacy and safety of sclerotherapy.4 In the treatment of both small and large varicose veins, it has been shown to be as least as effective if not even better than the other procedures. Sclerotherapy is particularly popular with patients, as it does not require an anaesthetic or surgical intervention. Patients can resume their normal activities immediately after treatment, which is as important to elderly persons in poor health as it is to those in demanding full-time employment. “Sclerotherapy with Aethoxysklerol® is a standardised evidence-based and incredibly well-tolerated therapeutic procedure,” confirms Dr Renate Murena-Schmidt, a specialist in venous diseases from Cologne. “Patients don’t usually have any pain, they remain mobile, and are happy about symptomatic relief in the legs, as well as the good cosmetic results.”
Celebrating 50 years of attractive healthy legs
Aethoxysklerol® has long been the internationally leading sclerosant. Today it has regulatory approval in 29 different countries and can be obtained in more than 50. An estimated 150 million people around the world have been treated with this sclerosant so far, and some 17,000 more are being treated every day. “Today, the treatment of varicose veins without sclerotherapy and Aethoxysklerol® would be absolutely inconceivable,” says Prof. Tobias Görge, consultant in the Dermatology Department in Münster. “And not only the ageing population but also the increasing economic pressures on health care will probably add even more to its value.” Given these developments, it is hardly surprising that more and more doctors are familiarising themselves with the procedure by attending the courses and seminars held regularly, so that they can add sclerotherapy to the range of services they offer. This major anniversary will provide many opportunities to get to know Aethoxysklerol® and sclerotherapy. And you can also take a look at the fascinating history of Aethoxysklerol® at www.50yearshealthylegs.com.
1 Rabe E et al. European guidelines for sclerotherapy in chronic venous disorders. Phlebology. 2014 Jul;29(6):338-54.
2 Adamič M et al. Guidelines of care for vascular lasers and intense pulse light sources from the European Society for Laser Dermatology. J Eur Acad Dermatol Venereol. 2015 Sep;29(9):1661-78.
4 Lupton JR et al. Clinical comparison of sclerotherapy versus long-pulsed Nd:YAG laser treatment for lower extremity telangiectases. Dermatol Surg. 2002 Aug;28(8):694-7; Rigby KA et al. Surgery versus sclerotherapy for the treatment of varicose veins. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD004980; Rabe E et al. Efficacy and safety of great saphenous vein sclerotherapy using standardized polidocanol foam (ESAF): a randomized controlled multicentre clinical trial. Eur J Endovasc Vasc Surg 2008;35:238-45; Adam DJ et al. Recovery after ultrasound-guided foam sclerotherapy compared with conventional surgery for varicose veins. Br J Surg 2009; 96: 1262-67; Rasmussen LH et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg 2011;98:1079-87; Shadid N et al. Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein. Br J Surg 2012; 99(8):1062–70; Munia MA et al. Comparison of laser versus sclerotherapy in the treatment of lower extremity telangiectases: a prospective study. Dermatol Surg. 2012 Apr;38(4):635-9; Peterson JD et al. Treatment of reticular and telangiectatic leg veins: double-blind, prospective comparative trial of polidocanol and hypertonic saline. Dermatol Surg 2012;38:1322-30; Zhang J et al. Efficacy and safety of Aethoxysklerol® (polidocanol) 0.5%, 1% and 3% in comparison with placebo solution for the treatment of varicose veins of the lower extremities in Chinese patients (ESA-China Study). Phlebology 2012;27 (4):184–90; Parlar B et al. Treatment of lower extremity telangiectasias in women by foam sclerotherapy vs. Nd:YAG laser: a prospective, comparative, randomized, open-label trial. J Eur Acad Dermatol Venereol. 2015 Mar;29(3):549-54.