Medicine or Surgery (Ms): a randomized clinical trial comparing hysterectomy and medical treatment in premenopausal women with abnormal uterine bleeding

Control Clin Trials. 2004 Feb;25(1):104-18. doi: 10.1016/j.cct.2003.08.008.

Abstract

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • African Americans
  • Contraceptives, Oral / therapeutic use*
  • Costs and Cost Analysis
  • Cyclooxygenase Inhibitors / therapeutic use*
  • Female
  • Humans
  • Hysterectomy*
  • Medroxyprogesterone Acetate / therapeutic use
  • Middle Aged
  • Obesity / complications
  • Patient Selection
  • Premenopause*
  • Quality of Life
  • Uterine Hemorrhage / complications
  • Uterine Hemorrhage / economics
  • Uterine Hemorrhage / therapy*

Substances

  • Contraceptives, Oral
  • Cyclooxygenase Inhibitors
  • Medroxyprogesterone Acetate