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        Low-Dose Mifepristone Shrinks Fibroids, Curbs Symptoms

        A DGReview of :"Low-dose mifepristone for uterine leiomyomata"
        Obstetrics & Gynecology

        04/02/2003
        By Anne MacLennan


        Comparable results in shrinking uterine fibroids and improving symptoms have been found when using either 5 or 10 mg doses of mifepristone, researchers in the United States have found.

        Postmenopausal women have few side effects from either of these dosages, and the investigators suggest that research is now needed to assess the long-term safety and efficacy of low-dose mifepristone.

        Dr S H Eisinger and colleagues from the University of Rochester, New York, compared the effect of the two low doses of mifepristone on uterine leiomyoma size and symptoms, as well as any side effects.

        In the open-label study, 40 premenopausal women with large, symptomatic leiomyomata were randomised to receive either 5 or 10 mg of the drug, daily for six months.

        Uterine volume was measured at bimonthly intervals by sonography. Serum concentrations of haemoglobin levels, follicle-stimulating hormone and liver enzymes were obtained and endometrial samples, symptoms and menstrual bleeding were assessed.

        Overall, 19 of 20 women taking 5 mg of mifepristone and all 20 of those taking 10 mg completed the entire six months of the study.

        Mean uterine volume shrank by 48% in the 5-mg group and by 49% in the 10-mg group, a difference that was not significant. In both groups, leiomyoma-related symptoms were also comparably reduced.

        Amenorrhoea occurred in 60% to 65% of both groups, and haemoglobin levels increased by 2.5 g/dL in anaemic subjects.

        Incidence of hot flashes increased significantly over baseline in the 10-mg group but not in the 5-mg group.

        Simple endometrial hyperplasia occurred in 28% of all of the women in the study, but there was no difference between groups in this, and no atypical hyperplasia was noted.
        Obstet Gynecol 2003 Feb;101:2:243-50. "Low-dose mifepristone for uterine leiomyomata"

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