A randomized control trial to assess efficacy of Mifepristone in medical management of uterine fibroid.

BACKGROUND

Fibroids are the most common benign tumours of uterus. Heavy menstrual bleeding is the commonest concern for which medical attention is sought. Hysterectomies for leiomyoma constitute a third of all hysterectomies. Thus, healthcare cost to society due to uterine leiomyomas is of considerable importance.

METHODS

A prospective study was conducted at tertiary care hospital of armed forces. 120 women in pre-menopausal age group with complaints of menorrhagia, Pictorial Bleeding Assessment Chart (PBAC) scoring ≥100 and at least one fibroid ≥2.5 cm in size were recruited in the study. Patients in Group 1 were given Tab Tranexemic acid (500 mg) and Tab Mefenemic acid (500 mg) three times a day during menstrual bleeding for a period of 6 months. Patients in Group 2 were given Tab Mifepristone 50 mg twice a week. They were followed up at 1, 3 and 6 months of starting the medicine. Results were statistically analysed using Microsoft Excel sheet and paired -test.

RESULTS

The average age was 40 years in the Group 2 and 45 years in Group 1. A size reduction of 36.99% in intramural and 39.39% in submucosal fibroids after six months of treatment with Mifepristone resulted in marked clinical improvement. 10% patients had side effects. In 30% of patients symptoms reappeared during the follow up period.

CONCLUSION

Mifepristone when given in bi-weekly doses was found to be safe, efficacious, and cost effective as compared to treatment with tranexemic acid and mefenemic acid for management of fibroid uterus.