Mifepristone 2.5 mg versus 5 mg daily in the treatment of leiomyoma before surgery

Abstract

ObjectivesTo evaluate the efficacy and safety of 2.5 mg and 5 mg mifepristone during 3 months for the treatment of uterine fibroids before surgery.DesignMulticenter randomized clinical trial.LocationsEusebio Hernández Hospital, Havana, Cuba and the Alemán Hospital, Managua, Nicaragua.SubjectsIncluded in the study were 146 women with symptomatic uterine fibroids.TreatmentGroup I: half a tablet of 5 mg (2.5 mg) mifepristone taken orally every 24 hours, and Group II: one tablet of 5 mg mifepristone taken orally every 24 hours over a period of 3 months in both groups. Two endometrial biopsies were performed.Variables to evaluate efficacyIncrease in average hemoglobin, changes in fibroid and uterine volume, and symptomatic improvement.ResultsThe average hemoglobin at the end of treatment was 0.6 g/dL greater in the 5 mg mifepristone group (P = 0.033). In both groups there were similar reductions in fibroid volumes. Clinical improvement was more significant in the 5 mg group.ConclusionThe dose to be used should be 5 mg.

Treatment of Uterine Myoma with 2.5 or 5 mg Mifepristone Daily during 3 Months with 9 Months Posttreatment Followup: Randomized Clinical Trial

“…At the end of treatment, this study does in fact result in a significantly greater decrease in fibroid volume in the 5 mg group, P = 0.003, unlike the results of the previous study with 2.5 and 5 mg doses of mifepristone when the 2.5 mg dosage displayed a similar efficacy to that of 5 mg [22]. The 5 mg dose maintains its greater effectiveness during the first 3 months of followup, which is to say that the fibroid regrew less rapidly rather slowly in the 5 mg group, and this tendency continues up to 6 months after treatment as the fibroid volume reduction percentages were 17.6% and 27.7% in the 2.5 and 5 mg groups, respectively, with P values asymptotically significant.…”

“…In this study, as was the case in the previous study with 2.5 and 5 mg doses of mifepristone [22], there was no significant decrease in uterine volume unlike in all the others when uterine volume reduction did occur although such decreases, ranging between 45 and 50%, were certainly less than those observed in fibroids. This uterine volume reduction takes place in all studies previously published by other authors [5–7, 12, 23, 24].…”

Report on Repeated Mifepristone Treatment for Uterine Fibroids or Endometriosis

“…We can find no logical explanation for this result as there should not be any difference in the endometrial response to the action of mifepristone dependent on whether the subject suffers from uterine fibroids or endometriosis. In fact, for example, the increases in endometrial thickness in our previous studies into both conditions [4][5][6][7][8][9]25] and in both subgroups in the present study are similar. Anyway, given that the PAECs are considered to be "physiological" modifications of the endometrium, the only point of importance to be noted in this section is the non-existence of any case of endometrial hyperplasia or of any other pathology either in the post-treatment biopsies or, of course, in the pre-treatment biopsies regardless of whether it was the second, third or fourth treatment.…”

Effect of mifepristone (25 mg) in treatment of uterine myoma in perimenopausal woman

“…Hot flush, headache, nausea, fatigue, malaise and rise in liver transaminase enzymes; AST and ALT are reported in past studies. [13] This short term treatment was well tolerated; although large studies are needed to add safety information, about endometrial and breast proliferation and long term follow-up after stopping treatment. In a young reproductive age female medical therapy results may not be as good, as myoma may re-grow after discontinuation of treatment.…”