Objective: To compare the efficacy of 2.5mg versus 5mg ulipristal acetate in reducing symptoms (menstrual blood loss and pelvic pain) and volume of uterine fibroids. Design: Randomized controlled trial, conducted at All India Institute of Medical Sciences, New Delhi. Recruitment was terminated after 40 patients in June 2018,
after MHRA advisory. Methods: Women with symptomatic uterine fibroids, with PBAC score >100 with
or without pelvic pain and at least one fibroid >3cm diameter, were recruited and randomized into two groups: group 1 (n=20) received 2.5mg ulipristal acetate and group 2 (n=20) received 5mg ulipristal acetate once daily for 13 weeks. Assessment of PBAC scores and fibroid volume by ultrasound were done at baseline, after 3 months of therapy and then 3 months after discontinuation of therapy i.e. at 6 month follow-up. Liver functions were evaluated at 3 and 6 months follow-up. Results: Significant reductions in PBAC scores occurred in both groups. Median (interquartile range) of PBAC scores reduced from 282 (124–1384) to 34 (0-385), in the 2.5mg group and 362 (128–940) to 0 (0- 284) in the 5mg group showing .87.5% and 100% reduction respectively. Further reduction after 3 months on treatment was as 0 ((0- 185) and 0 (0-322), p=0.001 in group1 and 2 respectively(p=0.001), 3 months after stopping treatment, score increased to 122(0-1312) & 165(0-560) however reduction from baseline in both groups 56.7 & 54.4% respectively. Amenorrhoea occurred in 6(30%) and 13(65%), 15(75%) & 16(80%) after1mth, 3mths on therapy and 4(20%) & 1(5%) 3months after treatment in 2.5 and 5mg group respectively.
Normal periods achieved in 8(40%), 3(15%) at 1 month, 2(10%) & 1(5%) at 3mths and 4(20%) & 6(30%) cases in gp1 & 2 respectively. VAS remained significantly reduced in both groups even after stopping drug Median fibroid volumes reduced significantly in the 2.5mg group [(79.63cm3 (27.35- 148.04) to 51.3cm3 (2.52-82.86), 35.58%, p=0.002] but less in the 5mg group baseline 83.31cm3 (33.99- 309.8)] to 74.61cm3 (18.-283.64), 10.44%, p=0.526] Monitoring of liver functions showed increased SGOT and SGPT up to 222 and 399 in group 2 at 3 months follow-up which became normal in 3 months’ time. Monitoring of liver functions tests in both groups did not reveal any abnormalities. Neither dose of ulipristal suppressed estradiol. Conclusions: Treatment with 2.5mg Ulipristal acetate for 3 months is a feasible option in terms of symptoms control when compared to 5 mg dose. Rebound
phenomenon is more with higher dose. With concerns of side effects with 5 mg dose, chief aauthor suggests to give 2.5 mg dose as it can be safer option. Further larger well powered studies may be conducted with lower doses of ulipristal for fibroid management.
Original Article
English
P. 99-108