The role of tamoxifen in the treatment of symptomatic uterine leiomyomata -- a pilot study.
OBJECTIVE
To determine the efficacy of tamoxifen in patients with leiomyomata complaining of abdominal pains and vaginal bleeding.


METHODS
Prospective, randomized, double blind study. A total of 10 patients received for 6 months 20 mg 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.
Sadan
O
O
Department of Obstetrics and Gynecology, Edith Wolfson Medical Center, Holon, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Ginath
S
S
Sofer
D
D
Rotmensch
S
S
Debby
A
A
Glezerman
M
M
Zakut
H
H
D015746:Abdominal Pain; D000328:Adult; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004717:Endometrium / Q000000981:diagnostic imaging; D005260:Female; D006801:Humans; D007044:Hysterectomy; D007889:Leiomyoma / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000601:surgery; D008875:Middle Aged; D010048:Ovarian Cysts / Q000139:chemically induced; D010865:Pilot Projects; D010919:Placebos; D011446:Prospective Studies; D013629:Tamoxifen / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014463:Ultrasonography; D014592:Uterine Hemorrhage / Q000188:drug therapy; D014594:Uterine Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000601:surgery
D018931:Antineoplastic Agents, Hormonal; D010919:Placebos; D013629:Tamoxifen