Efficacy of Use of Long-Term, Low-Dose Mifepristone for the Treatment of Fibroids

Abstract

Background Fibroid or myoma is the commonest reported tumor of uterus, and is one of the important reasons for hysterectomy in our setting. Different drugs are available for medical management of fibroid uterus including mifepristone, a progesterone antagonist. Varying dosage regimen for mifepristone was studied as medical management of fibroid uterus. The aim of the project was to study the effect of mifepristone on the symptoms and size of fibroids, especially using a low-dose regimen for 6 months. In addition, any symptomatic improvement of menorrhagia and dysmenorrhea was also studied. Methods The study was designed as an observational prospective ''before-after'' study. Women diagnosed with uterine fibroids attending OPD of a tertiary care hospital were selected according to the inclusion criteria. A total of 36 patients were enrolled in the study. Sample size was calculated to study changes in various parameters after 6 months treatment with mifepristone 50 mg once a week. Baseline investigations were performed and menstrual blood loss was assessed using pictorial blood assessment charts. Fifty milligrams of mifepristone weekly was used, and patient assessed at 1 and 6 month. They were also further followed up till 3 months after stopping the drug to 123 observe the changes in menstrual pattern, fibroid volume, hemoglobin and liver function tests. Baseline endometrial biopsy and another at 6 month on cessation of drug therapy were done for all patients.Results Majority of the study population comprised of perimenopausal women, i.e., 41-45 years (44 %). Fifty percent of the patients were Para 2 and belonged to the perimenopausal age-group (18 out of 36). The dominant presenting symptom was menorrhagia associated with dysmenorrhea and pelvic pain. After 6 months of treatment with mifepristone, the mean fibroid volume reduced from 204.33 to 113.16 cm 3 (n = 33); p B 0.001, and the percentage mean volume reduction of the fibroid in the study population was 44.57 % (range 1.10-100 %). Immediate reduction in bleeding PV was observed in 100 %, and 88.89 % (32/36) patients attained amenorrhea. The mean hemoglobin increased from 9.18 to 10.82 g/dl (p = 0.001).There was a transient rise in mean transaminases (AST/ ALT) levels at 6 months which reverted to normal at 9 months follow-up.Conclusion To conclude, 6 months therapy with 50 mg of mifepristone given weekly is efficacious and acceptable for the treatment of symptomatic leiomyoma, especially in a select group of patients. Although its use as a primary medical therapy is limited due to recurrence of fibroid after stopping treatment, it is useful for perimenopausal women whose myoma would regress after menopause, and younger infertile patients with small-size deep intramural myomas not easily accessible to either hysteroscopic or laparoscopic surgery. It is also beneficial as a preoperative adjunct, in patients with preoperative severe anemia and large fibroids where surgery is technically difficult. Mode of surgery can be changed to a lessinvasive vagina...

<p>Uterine fibroids: an update on current and emerging medical treatment options</p>

“…Recently, different administration schedules were evaluated in two Indian trials, using weekly or biweekly doses of 50 mg claiming good results 126,127. Using the vaginal route for the administration of 10 mg daily of MFP, treatment significantly reduced the volume of fibroids 128…”

Mifepristone therapy in symptomatic leiomyomata using a variable dose pattern with a favourable outcome

“…The study showed that after 6 months of therapy, the fibroid volume reduced by 44.57% and bleeding per vaginam decreased by 100%. [ 7 ]…”

Mifepristone: A Safe Method of Medical Abortion and Self-Managed Medical Abortion in the Post-Roe Era

“…[40][41][42][43] Although hysterectomy is the definitive treatment, myomectomy is an alternative for those who desire to preserve their uterus, and medical approaches are also of great interest. 41,44 Several pieces of evidence indicate that progesterone may be involved in the pathogenesis of leiomyoma, making antiprogestins, such as mifepristone, an attractive therapeutic option. 43 Various dosages of mifepristone have been used in different studies, and 10-20 mg/d seems to provide the most benefit, and higher doses increased the risk of adverse effects, such as hot flushes, elevated aspartate aminotransferase and alanine aminotransferase levels, endometrial hyperplasia, and antiglucocorticoid effects.…”