BACKGROUND: The efficacy and safety of uterine-artery embolization, as compared with standard surgical methods, for the treatment of symptomatic uterine fibroids remain uncertain. METHODS: We conducted a randomized trial comparing uterine-artery embolization and surgery in women with symptomatic uterine fibroids. The primary outcome was quality of life at 1 year of follow-up, as measured by the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). RESULTS: Patients were randomly assigned in a 2:1 ratio to undergo either uterine-artery embolization or surgery, with 106 patients undergoing embolization and 51 undergoing surgery (43 hysterectomies and 8 myomectomies). There were no significant differences between groups in any of the eight components of the SF-36 scores at 1 year. The embolization group had a shorter median duration of hospitalization than the surgical group (1 day vs. 5 days, P<0.001) and a shorter time before returning to work (P<0.001). At 1 year, symptom scores were better in the surgical group (P=0.03). During the first year of follow-up, there were 13 major adverse events in the embolization group (12%) and 10 in the surgical group (20%) (P=0.22), mostly related to the intervention. Ten patients in the embolization group (9%) required repeated embolization or hysterectomy for inadequate symptom control. After the first year of follow-up, 14 women in the embolization group (13%) required hospitalization, 3 of them for major adverse events and 11 for reintervention for treatment failure. CONCLUSIONS: In women with symptomatic fibroids, the faster recovery after embolization must be weighed against the need for further treatment in a minority of patients. (ISRCTN.org number, ISRCTN23023665 [controlled-trials.com].) Copyright 2007 Massachusetts Medical Society.