title: A randomized trial comparing treatments for varicose veins.
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.).
authors.affiliation: From the Division of Applied Medicine (J. Brittenden), the Health Services Research Unit (S.C.C., A.E., C.R.R., J.N., G.S., S.W., M.K.C.), and the Health Economics Research Unit (E.T., G.S.), University of Aberdeen, and the Department of Vascular Surgery, NHS Grampian, Aberdeen Royal Infirmary (P.B.), Aberdeen; the School of Medicine, Medical and Biological Sciences, University of St. Andrews, St. Andrews (J. Burr); the Department of Vascular Surgery, Royal Devon and Exeter Hospital, Exeter (B.C.); the Department of Vascular Surgery, Hull Royal Infirmary, Hull (I.C.); the School of Surgery, University of Leeds (M.G.), and Vascular Surgery, St. James University Hospital (J.S.), Leeds; Vascular Surgery, Gloucestershire Royal Hospital, Gloucester (J.E.); Vascular Surgery, Freeman Hospital, Newcastle upon Tyne (T.L.); the Vascular Surgical Unit, Royal Bournemouth Hospital, Bournemouth (S.A.B.); and the School of Health Sciences, City University London, London (J.F.) - all in the United Kingdom.
authors.forename: Julie
authors.initials: J
authors.lastname: Brittenden
authors.forename: Seonaidh C
authors.initials: SC
authors.lastname: Cotton
authors.forename: Andrew
authors.initials: A
authors.lastname: Elders
authors.forename: Craig R
authors.initials: CR
authors.lastname: Ramsay
authors.forename: John
authors.initials: J
authors.lastname: Norrie
authors.forename: Jennifer
authors.initials: J
authors.lastname: Burr
authors.forename: Bruce
authors.initials: B
authors.lastname: Campbell
authors.forename: Paul
authors.initials: P
authors.lastname: Bachoo
authors.forename: Ian
authors.initials: I
authors.lastname: Chetter
authors.forename: Michael
authors.initials: M
authors.lastname: Gough
authors.forename: Jonothan
authors.initials: J
authors.lastname: Earnshaw
authors.forename: Tim
authors.initials: T
authors.lastname: Lees
authors.forename: Julian
authors.initials: J
authors.lastname: Scott
authors.forename: Sara A
authors.initials: SA
authors.lastname: Baker
authors.forename: Jill
authors.initials: J
authors.lastname: Francis
authors.forename: Emma
authors.initials: E
authors.lastname: Tassie
authors.forename: Graham
authors.initials: G
authors.lastname: Scotland
authors.forename: Samantha
authors.initials: S
authors.lastname: Wileman
authors.forename: Marion K
authors.initials: MK
authors.lastname: Campbell
mesh_terms: D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D057194:Intention to Treat Analysis; D053685:Laser Therapy / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011183:Postoperative Complications; D011788:Quality of Life; D012501:Saphenous Vein / Q000601:surgery; D015911:Sclerotherapy / Q000009:adverse effects / Q000379:methods; D012720:Severity of Illness Index; D018084:Ultrasonography, Interventional; D014648:Varicose Veins / Q000145:classification / Q000601:surgery / Q000628:therapy*