Six studies (n=166) were included: 3 randomised controlled studies (n=73 randomised plus 20 women who were not randomised) and 3 non-randomised before-and-after studies (n= 73).
Uterine and leiomyoma volumes.
Mifepristone (all doses combined) reduced uterine volumes by 27 to 49% and reduced leiomyoma volumes by 26 to 74%. Two studies showed greater reductions in leiomyoma volume with increased duration of treatment: a reduction of 21% at 2 months versus 48% at 6 months in one study, and 24% at 1 month versus 56% at 3 months in the other. Studies showed large variations in individual responses to treatment.
One study (n=20) found no change in leiomyoma volume 3 to 9 months after stopping treatment. Another study (n=45) found no increase in uterine volume at 3 months, but found leiomyoma growth in 8 (18%) of 45 women 6 months after stopping treatment.
One randomised controlled trial found similar reductions in leiomyoma volume for mifepristone and GnRH agonist, while another found no statistically significant difference in uterine volume between mifepristone and GnRH agonist.
Mifepristone reduced dysmenorrhoea and pelvic pain in 46 (75%) of 61 women and improved pelvic pressure in 35 (70%) of 50 women. The rates of amenorrhoea ranged from 63% (1 study) to 100% (4 studies, n=118). All patients resumed menstruation 2 to 6 weeks after stopping treatment.
Hot flushes were reported by 38% of women. Other adverse events reported were joint pain, fatigue, dizziness, nervousness and loss of appetite.
Endometrial hyperplasia was found in 10 of 36 women (28%) screened after 6 months using endometrial biopsy (1 study). After re-evaluation of the histology, 5 specimens were downgraded from hyperplasia. No cases of complex or atypical hyperplasia were found.
Transaminases were raised transiently in 7 (4%) of 164 women.