Safety and effectiveness of different dosage of mifepristone for the treatment of uterine fibroids: a double-blind randomized clinical trial

Figures & data

Table 1 Characteristics of subjects by treatment group

Characteristics	Group	N	Average	SD
Age, years	10 mg	35	41.6	4.8
	5 mg	35	41.6	5.7
Weight, kg	10 mg	35	66.7	14.5
	5 mg	35	70.9	15.1
Height, metres	10 mg	35	1.6	0.1
	5 mg	35	1.6	0.1
Body mass index	10 mg	35	25.1	5.2
	5 mg	35	26.4	6.5
Pregnancies	10 mg	35	3.4	2.6
	5 mg	35	3.2	1.9
Parturitions	10 mg	35	1.0	0.9
	5 mg	35	1.0	1.1
Induced abortions	10 mg	35	1.9	1.9
	5 mg	35	1.4	1.7

Abbreviation: SD, standard deviation.

Table 2 Hot flushes and amenorrhea at study evaluations

Side effects, months	10 mg group	5 mg group	P
Hot flushes
3	8/35 (22.9)	4/33 (12.1)	0.123
6	9/35 (25.7)	5/31 (16.1)	0.171
9	8/35 (22.9)	4/31 (12.9)	0.148
Amenorrhea
3	34/35 (97.1)	33/33 (100.0)	0.164
6	34/35 (97.1)	31/31 (100.0)	0.201
9	28/35 (80.0)	31/31 (100.0)	0.004

Note: Values are presented as n(%).

Table 3 Changes in endometrial thickness during mifepristone treatment

Evaluation	Group	N	Average ± SD	CI 95% for the average	% change	P^*
Before treatment	10 mg	35	6.8 ± 2.5	5.9–7.7	–	0.220
	5 mg	35	6.2 ± 1.7	5.5–7.0	–
3 months’ treatment	10 mg	35	9.2 ± 4.5	7.7–10.7	35.3% ↑	0.013
	5 mg	33	7.0 ± 2.7	5.6–7.2	12.9% ↑
6 months’ treatment	10 mg	35	11.5 ± 6.3	9.0–12.5	69.4% ↑	0.002
	5 mg	31	7.4 ± 2.6	6.5–8.1	19.4% ↑
9 months’ treatment	10 mg	35	10.8 ± 6.6	8.8–14.0	58.8% ↑	0.013
	5 mg	31	7.6 ± 3.2	6.4–8.4	22.6% ↑

Note: ^*t-test.

Abbreviations: CI, confidence interval; SD, standard deviation.

Table 4 Changes in fibroid dimensions at study evaluations

Evaluation	Group	N	Average ± SD	CI 95% for the average	% change	P^**
Before treatment	10 mg	35	263 ± 471	78–306	–	0.073
	5 mg	35	115 ± 100	42–249	–
9 months’ treatment	10 mg	34^*	90 ± 77	9–165	65.8% ↓	0.035
	5 mg	31	55 ± 41	24–118	52.2% ↓
Follow-up at 9 months	10 mg	29	196 ± 118	132–217	25.5% ↓	0.066
	5 mg	16	130 ± 94	84–277	13.0% ↑
Follow-up at 18 months	10 mg	12	255 ± 156	135–375	3.0% ↓	0.190
	5 mg	9	169 ± 86	84–223	46.9% ↑

Notes: ^*One fibroid was not measurable;

^**t-test.

Abbreviations: CI, confidence interval; SD, standard deviation.

Table 5 Changes in uterine dimensions at study evaluations

Evaluation	Group	N	Average ± SD	CI 95% for the average	% change	P^*
Before treatment	10 mg	35	866 ± 578	499–1090	–	0.006
	5 mg	35	542 ± 362	396–1143	–
9 months’ treatment	10 mg	35	533 ± 570	347–640	38.5% ↓	0.117
	5 mg	31	361 ± 175	289–570	33.4% ↓
Follow-up at 9 months	10 mg	29	514 ± 369	328–779	40.6% ↓	0.873
	5 mg	16	533 ± 452	237–805	1.7% ↓
Follow-up at 18 months	10 mg	12	892 ± 412	582–1203	3.0% ↑	0.400
	5 mg	9	715 ± 433	373–1154	31.9 ↑

Note: ^*t-test.

Abbreviations: CI, confidence interval; SD, standard deviation.

Table 6 Prevalence (%) of fibroid symptoms at study evaluation times by treatment group

Fibroid symptoms	10 mg group	5 mg group	P
Pelvic pain
Before treatment	82.1	83.9	0.421
9 months’ treatment	2.6	11.1	0.076
Follow-up at 9 months	10.3	6.3	0.322
Follow-up at 18 months	10.0	11.1	0.469
Pelvic pressure
Before treatment	69.2	48.4	0.039
9 months’ treatment	0.0	0.0	–
Follow-up at 9 months	0.0	6.3	0.087
Follow-up at 18 months	0.0	11.1	0.139
Urinary symptoms
Before treatment	36.0	22.3	0.114
9 months’ treatment	0.0	0.0	–
Follow-up at 9 months	0.0	0.0	–
Follow-up at 18 months	0.0	11.1	0.139
Lumbar pain
Before treatment	41.0	32.3	0.225
9 months’ treatment	5.1	0.0	0.116
Follow-up at 9 months	0.0	0.0	–
Follow-up at 18 months	0.0	0.0	–
Rectal pain
Before treatment	20.5	16.1	0.320
9 months’ treatment	0.0	0.0	–
Follow-up at 9 months	0.0	0.0	–
Follow-up at 18 months	0.0	0.0	–
Dyspareunia
Before treatment	43.6	32.3	0.168
9 months’ treatment	0.0	0.0	–
Follow-up at 9 months	0.0	0.0	–
Follow-up at 18 months	0.0	0.0	–
Hypermenorrhea
Before treatment	87.9	87.1	0.465
9 months’ treatment	0.0	0.0	–
Follow-up at 9 months	6.9	6.3	0.467
Follow-up at 18 months	10.0	11.1	0.469
Metrorrhagia
Before treatment	20.5	25.8	0.300
9 months’ treatment	0.0	0.0	–
Follow-up at 9 months	0.0	0.0	–
Follow-up at 18 months	0.0	0.0	–