A randomized trial comparing treatments for varicose veins

Julie Brittenden*, Seonaidh C. Cotton, Andrew Elders, Craig R. Ramsay, John Norrie, Jennifer Burr, Bruce Campbell, Paul Bachoo, Ian Chetter, Michael Gough, Jonothan Earnshaw, Tim Lees, Julian Scott, Sara A. Baker, Jill Francis, Emma Tassie, Graham Scotland, Samantha Wileman, Marion K. Campbell

*Corresponding author for this work

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Abstract

BACKGROUND

Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain.

METHODS

In a randomized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of foam, laser, and surgical treatments. Primary outcomes at 6 months were disease-specific quality of life and generic quality of life, as measured on several scales. Secondary outcomes included complications and measures of clinical success.

RESULTS

After adjustment for baseline scores and other covariates, the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery (P=0.006) but was similar in the laser and surgery groups. There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life. The frequency of procedural complications was similar in the foam group (6%) and the surgery group (7%) but was lower in the laser group (1%) than in the surgery group (P<0.001); the frequency of serious adverse events (approximately 3%) was similar among the groups. Measures of clinical success were similar among the groups, but successful ablation of the main trunks of the saphenous vein was less common in the foam group than in the surgery group (P<0.001).

CONCLUSIONS

Quality-of-life measures were generally similar among the study groups, with the exception of a slightly worse disease-specific quality of life in the foam group than in the surgery group. All treatments had similar clinical efficacy, but complications were less frequent after laser treatment and ablation rates were lower after foam treatment. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN51995477. opens in new tab.)

Original languageEnglish
Pages (from-to)1218-1227
Number of pages10
JournalNew England Journal of Medicine
Volume371
Issue number13
DOIs
Publication statusPublished - 25 Sep 2014

Keywords

  • Varicose veins
  • alternative treatments
  • sclerotherapy
  • clinical trials
  • health service research

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    Brittenden, J., Cotton, S. C., Elders, A., Ramsay, C. R., Norrie, J., Burr, J., Campbell, B., Bachoo, P., Chetter, I., Gough, M., Earnshaw, J., Lees, T., Scott, J., Baker, S. A., Francis, J., Tassie, E., Scotland, G., Wileman, S., & Campbell, M. K. (2014). A randomized trial comparing treatments for varicose veins. New England Journal of Medicine, 371(13), 1218-1227. https://doi.org/10.1056/NEJMoa1400781