1. In this randomized controlled trial, patients with adenomyosis that received mifepristone were found to have decreased adenomyosis-associated dysmenorrhea intensity at 12 weeks.
Evidence Rating Level: 1 (Excellent)
Adenomyosis, characterized by the presence of ectopic endometrial glands and stroma in the myometrium, is diagnosed in approximately 20% of reproductive-aged people with a uterus. Mifepristone, a selective progesterone receptor modulator found to have applications for endometriosis and uterine fibroids, has shown promise in preclinical and small sample studies as a potential therapy for adenomyosis. This double-blind, multicenter, and placebo-controlled randomized clinical trial was conducted to evaluate the efficacy of mifepristone for adenomyosis compared to traditional treatment. 134 eligible patients aged 18 to 50 years diagnosed with adenomyosis were enrolled from 10 hospitals in China between May 2018 and April 2019. Patients were randomized in a 1:1 ratio, with 66 patients assigned to the mifepristone group (mean [SD] age, 40.2 [4.6] years) and 68 patients assigned to the placebo group (41.7 [5.0] years). After 12 weeks of treatment the mean (SD) change in VAS scores, a tool used to evaluate adenomyosis-associated dysmenorrhea intensity, was significantly lower in the mifepristone group (between-group difference, −5.68; 95% CI, −6.37 to −4.99; P < .001). Furthermore, the remission rates for dysmenorrhea in the mifepristone group were significantly better than those in the placebo group (effective remission: 91.8% vs 23.1% of patients; complete remission: 88.5% vs 6.2% of patients; P < .001). Compared to the placebo group, patients in the mifepristone group showed significant improvements in all secondary outcomes (P < .001) — menstrual blood loss, hemoglobin levels, CA125 levels, platelet counts, and uterine volume — with no significant difference in adverse outcomes. Overall, these findings suggest that administering a daily dose of 10 mg of mifepristone over a period of 12 weeks proved to be both safe and effective in managing adenomyosis.
Click to read the study in JAMA Network Open
Image: PD
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