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

Abstract 

Objectives: To determine the efficacy of tamoxifen in patients with leiomyomata complaining of abdominal pains and vaginal bleeding. Study Design: Prospective, randomized, double blind study. A total of 10 patients received for 6 months 20mg tamoxifen daily, and 10 women received placebo. All patients underwent serial pelvic and ultrasound exams and endometrial sampling was performed prior to initiation of treatment. After 5 years, the patients were interviewed again. Results: Uterine size was not affected by the use of tamoxifen. Patients reported a blood loss decrease of 40–50% at the end of the study (P=0.0001). In the control group a slight increase in blood loss was reported. Hemoglobin levels remained unchanged in both groups. In the 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. Conclusions: Treatment with tamoxifen added only marginal benefit while causing unacceptable side effects. Tamoxifen does not seem to be a useful adjunct in the treatment of symptomatic uterine leiomyomata and its use for this indication should be discouraged.

Keywords:  Tamoxifen, Leiomyomata, Bleeding, Pain, Ovarian cyst, Endometrium