Outcomes from leiomyoma therapies: comparison with normal controls.

Abstract

To assess the severity of symptoms caused by uterine leiomyomas, their effect on health-related quality of life, and the change after treatment compared with a normal control group. A multicenter nonrandomized prospective study was completed assessing 12-month outcomes from three leiomyoma treatments. Outcome measures included the Uterine Fibroid Symptom and Quality of Life and the Short Form 36 questionnaires. Women scheduled for hysterectomy, myomectomy, or uterine artery embolization were recruited, as well as normal control group members. Questionnaires were completed at baseline and at 6 and 12 months posttreatment. Baseline characteristics were summarized using descriptive statistics. General linear models were used to examine differences among the patient groups. A total of 375 patients completed baseline enrollment: 101 normal, 107 embolization, 61 myomectomy, and 106 hysterectomy. At baseline, the mean Uterine Fibroid Symptom and Quality of Life Symptom Severity score for women in the normal control group was 15.3 (+/-14.5) and 64.8 (+/-20) for the leiomyoma patients (P<.001). At 6 and 12 months, the mean Symptom score for women in the normal control group was unchanged, while the leiomyoma treatment group score reduced to a mean of 17.8 (+/-17.5) at 12 months. Similar magnitude changes occurred among the Uterine Fibroid Symptom and Quality of Life health-related quality of life subscale scores for the normal control group members and leiomyoma patients. At 12 months, the hysterectomy group reported significantly lower symptoms and better health-related quality of life than the other two therapies (P<.001). At 12 months after treatment, all three leiomyoma therapies resulted in substantial symptom relief, to near normal levels, with the greatest improvement after hysterectomy. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00390494. II.