Balla Sudha Rani1, P. Durga Kumari2, Prasad Usha3
Leiomyoma is the common benign tumour of uterus occurring in up to 20% of women with maximum incidence between 35-45 years of age leading to menorrhagia, pain and lump in abdomen. Medical treatment of leiomyoma are many with high cost and significant side effects. Mifepristone is a synthetic steroid with both anti-progesterone and anti-glucocorticoid activities.
The aim of the study was to evaluate the effect of 25 mg Mifepristone on uterine and myoma volume, haemoglobin and symptomatic improvement in cases of symptomatic leiomyoma.
MATERIALS AND METHODS
The present clinical study was conducted at a tertiary care centre at Visakhapatnam. This study was a prospective randomized double blind clinical trial. A total of 40 patients with symptomatic leiomyoma and normal endometrial histology were included in this study. After the written informed consent, symptoms like menorrhagia, dysmenorrhoea, pelvic pressure, low back ache was obtained. Severity of pain was graded according to visual analogue scale while quantification of blood loss was done using pictorial blood loss assessment chart (PBAC).
The mean age, parity and number of patients with symptoms was comparable in both the groups. After treatment, all the patients in group M had complete resolution of symptoms where as those patients in group C still continued to have the symptoms. After treatment, mean uterine volume in group M was 130.95±96.89 compared to that of 212.52±146.56 before treatment. The mean leiomyoma volume in group M, before treatment was 139.15±113.15 and after treatment was 78.15±71.18, a reduction of 43.84% was noted. In group C, the mean leiomyoma volume before treatment was 170.38±169.97 and after treatment was 177.78±171.56, an increase in volume of 4.34% was noted. The mean haemoglobin concentration in mifepristone group before treatment was 8.57±0.79 and after treatment was 10.09±0.99.
Low dose mifepristone is useful in case of symptomatic moderate sized leiomyoma, perimenopausal age group with symptomatic leiomyoma and high risk cases with uterine leiomyoma where surgery has been postponed. The clinical safety of the drug has yet to be determined by larger sample size with longer periods of treatment because of the associated risk of endometrial hyperplasia.