Mifepristone to treat uterine myoma:

Mifepristone versus placebo to treat uterine myoma: a double-blind, randomized clinical trial                                                                           Esteve Carbonell JL et al. – This study aimed to evaluate the efficacy, safety, and quality of life of 5 mg mifepristone per day compared with a placebo in treating uterine fibroids. The 5 mg dosage of mifepristone presented significantly superior efficacy compared to the placebo.

Methods

• A randomized, double–blind clinical study.
• Eusebio Hernández Gynecology and Obstetrics Teaching Hospital, Havana, Cuba.
• One hundred twenty–four subjects with symptomatic uterine fibroids.
• One daily capsule of 5 mg mifepristone or a mifepristone placebo over 3 months.
• 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.