Mifepristone 2.5 mg versus 5 mg daily in the treatment of leiomyoma before surgery

Figures & data

Figure 1 Flow chart for the trial.

Table 1 Subject characteristics by mifepristone group

Characteristics	2.5 mg (n = 71)	5 mg (n = 75)
Age	42.3 ± 5.8	42.0 ± 6.7
Body mass index (kg/m^2)	26.2 ± 4.5	27.2 ± 4.8
Gravidity	3.3 ± 1.9	3.1 ± 1.8
Parity	2.0 ± 1.1	2.1 ± 1.4
Abortion	1.8 ± 1.8	1.8 ± 1.3
Fibroids volume (mL)	106 ± 156	115 ± 114
Uterine volume (mL)	426 ± 323	527 ± 373
Endometrial thickness (mm)	6.7 ± 2.1	7.3 ± 2.7
Aspartate aminotransferase (IU)	22.6 ± 8.7	20.5 ± 9.8
Alanine aminotransferase (IU)	21.7 ± 10.1	20.2 ± 10.9
Hemoglobin (g/dL)	10.7 ± 2.2	10.9 ± 1.6
Hemoglobin (<10.0 g/dL)	23 (32.4)	18 (24.0)
Race
White	23 (32.4)	18 (24.0)
Black	18 (25.4)	18 (24.0)
Afro-Cuban	30 (42.0)	39 (52.0)

Note: Data presented as averages ± standard deviation⁺ or n(%).

Table 2 Changes in fibroid measurements (cm³) by treatment groups

Evaluation	Group	n	Mean ± standard deviation	95% confidence interval for mean	Cumulative reduction+	P*
Before treatment	2.5 mg	48	119 ± 107	87–150		0.402
	5 mg	60	140 ± 144	103–177
1 month treatment	2.5 mg	48	87 ± 95	59–114	26.7%	0.917
	5 mg	60	85 ± 102	60–112	39.3%
2 months treatment	2.5 mg	48	75 ± 75	54–97	36.9%	0.853
	5 mg	60	72 ± 90	50–96	48.6%
3 months treatment	2.5	48	73 ± 82	49–96	38.7%	0.556
	5 mg	60	64 ± 76	44–84	54.3%

Notes:

* t-test (analysis of variance);

+ concerning value before treatment in the same group.

Table 3 Changes in uterine measurements (cm³) by treatment groups

Evaluation	Group	n	Mean ± standard deviation	95% confidence interval for mean	Cumulative reduction+	P*
Before treatment	2.5 mg	48	384 ± 246	313–456		0.019
	5 mg	60	538 ± 390	437–639
1 month treatment	2.5 mg	48	377 ± 297	292–464	1.8%	0.228
	5 mg	60	449 ± 314	368–530	16.5%
2 months treatment	2.5 mg	48	359 ± 375	286–504	6.5%	0.866
	5 mg	60	369 ± 233	308–429	31.4%
3 months treatment	2.5 mg	48	347 ± 267	270–425	9.6%	0.295
	5 mg	60	407 ± 357	314–499	24.3%

Notes:

* t-test (analysis of variance);

+ concerning value before treatment in the same group.

Table 4 Prevalence of fibroid symptoms before, after 30, 60, and 90 days treatment by groups

	Treatment		P*
	2.5 mg	5 mg
Pelvic pain
Before treatment	56 (83.1)	60 (80.0)	0.315
30 days after	29 (48.3)	35 (52.2)	0.330
60 days after	23 (41.8)	24 (36.9)	0.292
90 days after	19 (38.0)	13 (21.3)	0.023
Pelvic pressure
Before treatment	46 (64.8)	48 (64.0)	0.460
30 days after	30 (50.0)	23 (34.3)	0.037
60 days after	20 (36.4)	13 (20.0)	0.023
90 days after	16 (32.0)	14 (23.0)	0.143
Urinary symptoms
Before treatment	45 (63.4)	47 (62.7)	0.464
30 days after	30 (50.0)	34 (50.7)	0.467
60 days after	23 (41.8)	20 (30.8)	0.104
90 days after	11 (22.0)	13 (21.3)	0.465
Lumbar pain
Before treatment	56 (78.9)	52 (69.3)	0.095
30 days after	28 (46.7)	35 (52.2)	0.265
60 days after	25 (45.5)	22 (33.8)	0.097
90 days after	20 (40.0)	15 (24.6)	0.041
Rectal pain
Before treatment	30 (42.2)	28 (37.3)	0.272
30 days after	13 (21.7)	10 (16.7)	0.162
60 days after	10 (18.2)	5 (7.7)	0.042
90 days after	5 (10.0)	2 (3.3)	0.074
Dispareunia
Before treatment	35 (49.3)	35 (46.7)	0.375
30 days after	15 (25.0)	21 (31.3)	0.214
60 days after	11 (20.0)	11 (16.9)	0.332
90 days after	8 (16.0)	2 (3.3)	0.009
Hypermenorrhea
Before treatment	61 (85.9)	63 (84.0)	0.373
30 days after	28 (46.7)	26 (38.8)	0.186
60 days after	11 (20.0)	5 (7.7)	0.024
90 days after	4 (8.0)	5 (8.2)	0.485
Metrorrhagia
Before treatment	24 (33.8)	35 (46.7)	0.057
30 days after	7 (11.7)	12 (17.9)	0.162
60 days after	3 (5.5)	2 (3.1)	0.258
90 days after	4 (8.0)	1 (1.6)	0.054

Notes: Data presented as n(%);

* Normal approximation for proportions.

Table 5 Changes in pelvic pain intensity during evaluation

	Treatment
	Start	30 days	60 days	90 days
n	(n = 60; n = 59)	(n = 44; n = 52)	(n = 44; n = 52)	(n = 44; n = 52)
2.5 mg	6.9 ± 2.9	3.6 ± 3.9	2.4 ± 3.5	2.0 ± 3.0
Reduction (%)	–	47.8	65.2	71.0
5 mg	7.0 ± 2.5	2.9 ± 3.1	2.1 ± 3.1	1.0 ± 2.3
Reduction (%)	–	58.6	70.0	85.7
P*	0.813	0.325	0.564	0.079

Note:

* corresponds to comparison between treatment groups.

Table 6 Changes in hypermenorrhea intensity during evaluation

	Treatment
	Start	30 days	60 days	90 days
n	(n = 43; n = 55)	(n = 43; n = 55)	(n = 43; n = 55)	(n = 43; n = 55)
2.5 mg	8.5 ± 2.5	3.4 ± 4.0	1.5 ± 3.1	0.5 ± 1.9
Reduction (%)	–	60.0	82.4	94.1
5 mg	8.8 ± 2.0	3.2 ± 3.9	0.3 ± 1.2	0.3 ± 1.1
Reduction (%)	–	63.6	96.6	96.6
P*	0.454	0.866	0.024	0.455

Note:

* corresponds to comparison between treatment groups.

Table 7 Changes in endometrial thickness (mm) by treatment groups

Evaluation	Group	n	Mean ± standard deviation	Increment+	P*
Before treatment	2.5 mg	48	6.8 ± 2.0		0.098
	5 mg	60	7.6 ± 2.8
1 month treatment	2.5 mg	48	7.8 ± 3.0	14.7%	0.873
	5 mg	60	7.9 ± 3.4	3.9%
2 months treatment	2.5 mg	48	8.5 ± 2.9	25.0%	0.001
	5 mg	60	10.9 ± 3.8	43.4%
3 months treatment	2.5	48	9.4 ± 3.7	38.2%	0.267
	5 mg	60	10.3 ± 4.5	35.5%

Notes:

* t-test (analysis of variance);

+ concerning value before treatment in the same group.

Table 8 Some surgery data by mifepristone group

Surgery data	Group	n	Mean	Standard deviation	Min	Max	P
Postsurgery stay in hospital	2.5 mg	57	2.1	3.8	1	24	0.712
	5 mg	63	1.9	1.9	1	11
Hemoglobin before surgery	2.5 mg	57	11.4	1.5	8.0	14.0	0.404
	5 mg	63	11.6	1.1	9.0	14.5
Hemoglobin after surgery	2.5 mg	57	10.9	1.4	7.0	14.0	0.436
	5 mg	63	11.1	1.4	8.0	14.5
Length of surgery (min)	2.5 mg	57	95.5	35.4	43	178	0.173
	5 mg	63	87.4	29.2	35	148
Intraoperative bleeding (mL)	2.5 mg	57	500	216	100	1000	0.981
	5 mg	63	499	239	100	1000

Note: Data presented as averages ± standard deviation.