Medicine or Surgery (Ms): a randomized clinical trial comparing hysterectomy and medical treatment in premenopausal women with abnormal uterine bleeding.
Hysterectomy may be overused as treatment for abnormal uterine bleeding due to benign causes in reproductive women. Medical therapies are an alternative, and there is a need for randomized trials comparing the outcomes of these approaches. Women of reproductive age who continued to have bothersome abnormal uterine bleeding after cyclic hormonal treatment with medroxyprogesterone acetate (MPA; 10-20 mg for 10-14 days/month) for 3-5 months were invited to participate in a randomized trial of hysterectomy versus other medical therapies. Participating gynecologists were free to choose the particular surgical (transabdominal or transvaginal) or medical (generally oral contraceptives and/or a prostaglandin synthetase inhibitor) approaches. Outcomes during 2 years of follow-up include quality of life (primary), sexual function, clinical effectiveness and cost. We screened 1557 women to find 413 who began 3-5 months of MPA; 215 completed this treatment, of whom 102 still had bothersome symptoms, and of these 38 consented to be randomized. Another 25 women with bothersome symptoms after a documented history of 3 months of cyclic MPA were also randomized, for a total of 63. The average age of randomized women was 41; 54% were African-American, and they reported uterine bleeding 12 days/month on average, heavy bleeding 6 days/month. Anemia (hematocrit<32) was present in 38% of African-Americans and 15% of Caucasians (p=0.05). Two thirds of the women had fibroids and 80% reported pelvic pain. Obesity was common (45% had a body mass index (BMI)>30), and associated with a longer duration of symptoms (12 vs. 4 years for BMI<25; p=0.02) and a greater prevalence of incontinence (44% vs. 16%; p=0.046). Although recruitment was difficult, we have completed enrollment in a randomized clinical trial comparing surgical and medical treatments for abnormal uterine bleeding.
Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 South 19th Street, NHB-219, Birmingham, AL 35249-7333, USA. evarner@uabmc.edu
R Edward
RE
Varner
Christine C
CC
Ireland
Robert L
RL
Summitt
Holly E
HE
Richter
Lee A
LA
Learman
Eric
E
Vittinghoff
Miriam
M
Kuppermann
Eugene
E
Washington
Stephen B
SB
Hulley
D000328:Adult; D001741:Black or African American; D003276:Contraceptives, Oral / Q000627:therapeutic use*; D003365:Costs and Cost Analysis; D016861:Cyclooxygenase Inhibitors / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007044:Hysterectomy; D017258:Medroxyprogesterone Acetate / Q000627:therapeutic use; D008875:Middle Aged; D009765:Obesity / Q000150:complications; D018579:Patient Selection; D017697:Premenopause; D011788:Quality of Life; D014592:Uterine Hemorrhage / Q000150:complications / Q000191:economics / Q000628:therapy*
D003276:Contraceptives, Oral; D016861:Cyclooxygenase Inhibitors; D017258:Medroxyprogesterone Acetate