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Randomized Controlled Trial Multicenter Study Comparative Study
Uterine-Artery Embolization or Myomectomy for Uterine Fibroids.
- Isaac Manyonda, Anna-Maria Belli, Mary-Ann Lumsden, Jonathan Moss, William McKinnon, Lee J Middleton, Versha Cheed, Olivia Wu, Fusun Sirkeci, Jane P Daniels, Klim McPherson, and FEMME Collaborative Group.
- From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.
- N. Engl. J. Med. 2020 Jul 30; 383 (5): 440-451.
BackgroundUterine fibroids, the most common type of tumor among women of reproductive age, are associated with heavy menstrual bleeding, abdominal discomfort, subfertility, and a reduced quality of life. For women who wish to preserve their uterus and who have not had a response to medical treatment, myomectomy and uterine-artery embolization are therapeutic options.MethodsWe conducted a multicenter, randomized, open-label trial to evaluate myomectomy, as compared with uterine-artery embolization, in women who had symptomatic uterine fibroids and did not want to undergo hysterectomy. Procedural options included open abdominal, laparoscopic, or hysteroscopic myomectomy. The primary outcome was fibroid-related quality of life, as assessed by the score on the health-related quality-of-life domain of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire (scores range from 0 to 100, with higher scores indicating a better quality of life) at 2 years; adjustment was made for the baseline score.ResultsA total of 254 women, recruited at 29 hospitals in the United Kingdom, were randomly assigned: 127 to the myomectomy group (of whom 105 underwent myomectomy) and 127 to the uterine-artery embolization group (of whom 98 underwent embolization). Data on the primary outcome were available for 206 women (81%). In the intention-to-treat analysis, the mean (±SD) score on the health-related quality-of-life domain of the UFS-QOL questionnaire at 2 years was 84.6±21.5 in the myomectomy group and 80.0±22.0 in the uterine-artery embolization group (mean adjusted difference with complete case analysis, 8.0 points; 95% confidence interval [CI], 1.8 to 14.1; P = 0.01; mean adjusted difference with missing responses imputed, 6.5 points; 95% CI, 1.1 to 11.9). Perioperative and postoperative complications from all initial procedures, irrespective of adherence to the assigned procedure, occurred in 29% of the women in the myomectomy group and in 24% of the women in the uterine-artery embolization group.ConclusionsAmong women with symptomatic uterine fibroids, those who underwent myomectomy had a better fibroid-related quality of life at 2 years than those who underwent uterine-artery embolization. (Funded by the National Institute for Health Research Health Technology Assessment program; FEMME Current Controlled Trials number, ISRCTN70772394.).Copyright © 2020 Massachusetts Medical Society.
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