Mifepristone associated with significant adenomyosis symptom remission
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Key takeaways:
- Dysmenorrhea remission rates with mifepristone were significantly better vs. placebo.
- Mifepristone improved menstrual blood loss, hemoglobin level, CA125 level, platelet count and uterine volume.
Use of mifepristone 10 mg daily resulted in significant symptom remission in adenomyosis and may be a treatment option for this patient population, according to study findings.
“Some small-sample studies in China have reported that mifepristone may be safe and effective for the treatment of adenomyosis,” Xuan Che, PhD, from the Women’s Hospital at the School of Medicine at Zhejiang University and Jiaxing University Affiliated Women and Children Hospital, Jiaxing, China, and colleagues wrote. “However, it is still controversial whether mifepristone can be used in the treatment of adenomyosis and whether its curative effect is better than that of traditional therapy.”
Che and colleagues conducted a multicenter, placebo-controlled, double-blind, randomized clinical trial with 126 women who reported adenomyosis pain symptoms included in the efficacy analysis. Participants were from 10 hospitals in China. All participants were randomly assigned to oral mifepristone (10 mg; n = 61; mean age, 40.2 years) or placebo (n = 65; mean age, 41.7 years) daily for 12 weeks.
The primary outcome was change in reported adenomyosis-associated dysmenorrhea intensity after 12 weeks. Secondary outcomes included change in menstrual blood loss, increased hemoglobin level in participants with anemia, CA125 level, platelet count and uterine volume after 12 weeks.
Mean visual analog scale change for pain was –6.63 among women who received mifepristone compared with –0.95 among women who received placebo. Total dysmenorrhea remission rates among women in the mifepristone group were significantly better compared with the placebo group for effective remission (91.8% vs. 23.1%) and complete remission (88.5% vs. 6.2%).
Researchers observed significant improvements with mifepristone treatment vs. placebo for median menstrual blood loss (135 vs. 114), mean change in hemoglobin level (2.13 vs. 0.48 g/dL), mean change in CA125 level (–62.23 vs. 26.89 U/mL), mean change in platelet count (–28.87 vs. 2.06 103/µL) and mean change in uterine volume (–29.32 vs. 18.39 cm3).
In addition, researchers noted no significant difference between mifepristone and placebo groups in safety, and participants reported no serious adverse events.
“The result showed that adenomyosis-associated dysmenorrhea intensity was significantly reduced after mifepristone treatment,” the researchers wrote. “Regardless of how severe the intensity of dysmenorrhea, the total efficacy for dysmenorrhea was satisfactory.”