Mifepristone versus placebo to treat uterine myoma: a double-blind, randomized clinical trial.

Objective: To evaluate the efficacy, safety, and quality of life of 5 mg mifepristone per day compared with a placebo in treating uterine fibroids.

Design: Randomized, double-blind clinical study.

Location: Eusebio Hernández Gynecology and Obstetrics Teaching Hospital, Havana, Cuba.

Subjects: One hundred twenty-four subjects with symptomatic uterine fibroids.

Treatment: One daily capsule of 5 mg mifepristone or a mifepristone placebo over 3 months.

Variables In Evaluating Safety: Changes in fibroid and uterine volumes, changes in symptom prevalence and intensity, and changes in quality of life.

Results: Three months into treatment, fibroid volume was reduced by 28.5% in the mifepristone group with an increase of 1.8% in the placebo group (P = 0.031). There were significant differences between the groups with respect to pelvic pain prevalence (P = 0.006), pelvic pressure (P = 0.027), rectal pain (P = 0.013), hypermenorrhea (P < 0.001), and metrorrhagia (P = 0.002) at the end of treatment. Amenorrhea was 93.1% and 4.3% in the mifepristone and placebo groups, respectively (P < 0.001). Treatment side effects were significantly greater in the mifepristone group. Estradiol levels did not differ significantly between the placebo and mifepristone groups at the end of treatment. Improvement in quality of life was significantly greater in the categories of "symptoms" (P = 0.004) and "activity" (P = 0.045) in the mifepristone group.

Conclusion: The 5 mg dosage of mifepristone presented significantly superior efficacy compared to the placebo.