EFFECT OF LOW DOSE MIFEPRISTONE (25 MG) ON LEIOMYOMA– A PROSPECTIVE RANDOMIZED DOUBLE BLIND CLINICAL STUDY

Dr.S.Anuradha; Dr.P.Geetha Kumari

Volume : VII, Issue : XII, December - 2017

EFFECT OF LOW DOSE MIFEPRISTONE (25 MG) ON LEIOMYOMA– A PROSPECTIVE RANDOMIZED DOUBLE BLIND CLINICAL STUDY

Dr. S. Anuradha, Dr. P. Geetha Kumari

Abstract :

AIM

To evaluate the effect of low dose Mifepristone (25mg) on leiomyoma symptoms and uterine leiomyoma in women with symptomatic leiomyomata.

METHODS

In this prospective randomized double blind clinical trial 80 women with symptomatic myoma were included. Uterine size >20wks, myoma>15cm were excluded. Variables as baseline uterine size uterine volume, myoma size, volume, hemoglobin, endometrial histology were taken. Patients were randomized and were given drug or placebo for 3 months. Bleeding and pain scores were checked on monthly visits. After 3 months ultrasound and endometrial biopsy were repeated on completion of therapy. Changes in above parameters were tabulated for analysis

RESULTS

80 patients (40 Patients in drug group i.e., group M and 40 patients in placebo group i.e., group C) completed treatment. Menstrual blood loss Index reduced from 150.75+30.14 to 0.00 + 0.0 at the end of 3 months in group M and in Group C there is a slight increase in menstrual blood loss index from 157.5+ 31.77 to 164.00+ 32.02. Mean uterine volume reduced from 212.5206+146.56 to 130.9515 + 96.84 (38.38%) in group M at the end of 3 months and in group c there is a slight increase in uterine volume by 4.91%(187.1148+157.48 to 196.3003 + 157.93) Mean myoma volume reduced by 43.84% in group M where as there is a slight increase in myoma volume by 4.34% in group c at the end of 3 months. Mean hemoglobin level raised from 8.57+ 0.79 to 10.09 + 0.99 in group M. In group c, hemoglobin level drop from 9.44 + 1.11 to 8.78 + 0.93 was observed at the end of 3 months. Repeat endometrial histopathology did not reveal any complex hyperplasia or atypia in either group. )

CONCLUSION

Three months treatment of 25mg Mifepristone effectively controls bleeding, reduces the volume of uterus as well as myoma with a rise in hemoglobin status. This avoids blood transfusion and hysterectomy in a lot of symptomatic myoma cases.