The role of tamoxifen in the treatment of symptomatic uterine leiomyomata - a pilot study

Objectives: To determine the efficacy of tamoxifen in patients with leiomyo mata complaining of abdominal pains and vaginal bleeding. Study Design: Pro spective, randomized, double blind study. A total of 10 patients received f or 6 months 20 mg tamoxifen daily, and 10 women received placebo. All patie nts underwent serial pelvic and ultrasound exams and endometrial sampling w as performed prior to initiation of treatment. After 5 years, the patients were interviewed again. Results: Uterine size was not affected by the use o f tamoxifen. Patients reported a blood loss decrease of 40-50% at the end o f the study (P = 0.0001). In the control group a slight increase in blood l oss was reported. Hemoglobin levels remained unchanged in both groups. In t he study group patients reported after 4 months of treatment a substantial decrease in the intensity of pain (P = 0.018). Seven patients in the study group and one patient in the control group developed ovarian cysts. Conclus ions: Treatment with tamoxifen added only marginal benefit while causing un acceptable side effects. Tamoxifen does not seem to be a useful adjunct in the treatment of symptomatic uterine leiomyomata and its use for this indic ation should be discouraged. (C) 2001 Elsevier Science Ireland Ltd. All rig hts reserved.