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Table 2 Evolution of the primary efficacy variables in the 4 randomized groups of the Clinical Trial

From: Anastrozole and levonorgrestrel-releasing intrauterine device in the treatment of endometriosis: a randomized clinical trial

Group

Variable

Before Treatment (N), m ± SD or n(%)

3 months (DT) (N), m ± SD or n(%)

6 months (DT) (N), m ± SD or n(%)

9 months (3 m AT) (N), m ± SD or n(%)

1 year (6 m AT) (N), m ± SD or n(%)

2 years (1.5y AT) (N), m ± SD or n(%)

(1) Anastrozol + LNG-IUD

 + CS

VAS/10

(8) 5.6 ± 1.6

(8) 2.4 ± 1.2a1b2d2

(8) 2.4 ± 2.1a1d1

(8) 2.3 ± 1.3a1b2d2

(8) 2.6 ± 1.6a1b2d1

(8) 2.4 ± 1.6a1d1

Dysmenorrhea

2.1 ± 0.2

1.1 ± 0.7a1b1d1

0.6 ± 0.8a1b1d2

1 ± 0.5a2b2d2

1.2 ± 0.9a1b1d1

1.1 ± 0.7a1b1d1

Dyspareunia

(7) 1.1 ± 0.9

(7) 0.4 ± 0.5

(7) 0.6 ± 1.1

(7) 0.4 ± 0.6a1b1d1

(7) 0.9 ± 1.8

(7) 0.4 ± 0.7

CPP

1.8 ± 0.9

0.6 ± 0.5a1b1d1

0.6 ± 0.4a1b1d1

0.7 ± 0.5a1b1d1

0.8 ± 0.5a1b1d1

1.2 ± 1.6

TV ultras/ovaries

Normal or dysfunctional

7 (87.5)

5 (62.5)

6 (75)

7 (87.5)

5 (62.5)

Simple cyst or small endomet

1 (12.5)

3 (37.5)

2 (25)

1 (12.5)

2 (25)

Endometriomas (rvs)

8 (100)

0–a2b2d2

0–a2b2d2

0–a2b2d2

0–a2b2d2

1 (12.5)a1b1d1

Tumor markers

CA-125

(8) 80.5 ± 57.8

(7) 19.5 ± 10.9a1d1

(8)11.3 ± 3.6a1b2d1

(7) 24.2 ± 26.2

(7)19.7 ± 10.5a1b1d1

(8)19.5 ± 10.5a1b2d1

CA-19-9

(8) 44.9 ± 63.5

(7) 10.9 ± 8.6a1

(6) 6 ± 3.1a1b1

(6) 17.2 ± 22.1a1

(6) 12.7 ± 13.8b1

(7) 18.7 ± 26.8

(2) Anastrozole + LNG-IUD

 + TUGPA

VAS/10

(7) 6.1 ± 2

(7) 3.1 ± 3.1a1d1

(7) 3.6 ± 2.1a1b1d1

(7) 4.9 ± 2.5a1d1

(5) 3.6 ± 1.1

(4) 3.1 ± 1

Dysmenorrhea

2.1 ± 0.6

0.5 ± 0.9a1b1d1

0.6 ± 0.6a1b1d1

1.4 ± 0.4a1d1

1.5 ± 0.8

1.4 ± 1

Dyspareunia

1.6 ± 1.1

0.9 ± 1

1.1 ± 1.1

1 ± 1

0.5 ± 0.4

0.4 ± 0.2

CPP

1.4 ± 0.8

0.8 ± 0.9

1.4 ± 1.1

1.5 ± 1

1.1 ± 0.7

0.8 ± 0.5

TV ultras/ovaries

    

2 op (28.6)

3 op (42.9)

Normal or dysfunctional

1 (14.3)

0–

0–

0–

0–

Simple cyst or small endomet

3 (42.9)

1 (14.3)

1 (14.3)

0–

3 (75) (42.9)

Endometriomas (rvs)

7 (100)

3 (42.9)

6 (85.7)

6 (85.7)

5 (100) (71.4)

1 (25) (14.3)

Tumor markers

CA-125

(7) 90.4 ± 37.6

(7) 69.8 ± 105.7

(7) 74 ± 70.9

(6) 63.9 ± 31.1

(5) 71.1 ± 71.6

(4) 50.6 ± 36.1

CA-19-9

(6) 58.9 ± 71

(7) 21.3 ± 16.5

(6) 64.9 ± 100.8

(5) 29.8 ± 22.2

(4) 46 ± 56.3

(4) 17.5 ± 11.8

(3) LNG-IUD, No Anastrozol

 + CS

VAS/10

(9) 5.6 ± 2.2

(9) 2.9 ± 2a1d1

(9) 3.1 ± 1.8a1d1

(9) 3.5 ± 1.9a1b1d1

(8) 4 ± 2a1b1d1

(6) 2.8 ± 1.1

Dysmenorrhea

1.7 ± 0.6

0.8 ± 0.7a1b1d1

0.8 ± 0.7a1b2d1

1.4 ± 0.9

1.5 ± 1

(5) 1.3 ± 1

Dyspareunia

1.4 ± 1

(8) 0.8 ± 1

(8) 0.7 ± 0.5a1b1d1

(8) 0.7 ± 0.7a1b1d1

(7) 0.9 ± 0.7a1d1

(5) 0.4 ± 0.5

CPP

1.7 ± 1

0.8 ± 0.9

1 ± 0.7

0.8 ± 0.8

1 ± 1

(5) 0.4 ± 0.5

TV ultras/ovaries

Normal or dysfunctional

8 (88.9)

8 (88.9)

5 (55.6)

5 (62.5)

3 (50)

Simple cyst or small endomet

0–

1 (11.1)

1 (11.1)

2 (25)

2 (33.3)

Endometriomas (rvs)

9 (100)

1 (11.1)

0–

2 (22.2)

1 (12.5)

1 (16.7)

Tumor markers

CA-125

(9) 56.3 ± 12.9

(8) 11.4 ± 7.9 a1b2

(9)12.4 ± 8.9a2b2d2

(9) 16 ± 9.1a2b2d2

(8)16.7 ± 10.8a1b2d2

(6) 21.2 ± 19a1b1d1

CA-19-9

(8) 38 ± 19.4

(6) 10.2 ± 4a1

(8) 14.8 ± 11.3a1d1

(8) 11.9 ± 6.5a1b1d1

(7) 12.1 ± 6.8a1b1d1

(6) 25.5 ± 22.2

(4) LNG-IUD, No Anastrozol

 + TUGPA

VAS/10

(7) 4.6 ± 2.2

(7) 3.4 ± 1.8

(7) 3 ± 1.3

(7) 3.2 ± 1.5

(6) 3.6 ± 1.6

(2) 4.3 ± 2.5

Dysmenorrhea

1.6 ± 0.7

1.4 ± 0.9

1.1 ± 0.9

1.4 ± 0.6

1.3 ± 0.5

(1) 1

Dyspareunia

(4) 0.9 ± 1

(6) 0.3 ± 0.4

(6) 0.3 ± 0.4

(5) 0.2 ± 0.4

(4) 0.5 ± 1

(1) 2

CPP

1.6 ± 1.1

1.1 ± 0.9

1.1 ± 0.9a1d1

0.9 ± 0.7

1.1 ± 0.9

(1) 2

TV ultras/ovaries

    

(1 op, 14.3%)

(3 op, 42.9%)

Normal or dysfunctional

1 (14.3)

0–

0–

1 (16.7) (14.3)

1 (50) (14.3)

Simple cyst or small endomet

2 (28.6)

0–

0–

1 (16.7) (14.3)

0–

Endometriomas (rvs)

7 (100)

4 (57.1)

7 (100)

7 (100)

4 (66.7) (57.1)

1 (50) (14.3)

Tumor markers

CA-125

(7) 87 ± 42

(7)26.9 ± 18.1a1b1d1

(7)26.6 ± 21.9a1b1d1

(7)42.2 ± 37.8a1b1d1

(6) 43.2 ± 24.2a1d1

(2) 51.7 ± 3.4

CA-19-9

(6) 36.6 ± 37.4

(5) 15.1 ± 14.3

(6) 12.3 ± 13a1

(5) 21.2 ± 22.3

(5) 18.5 ± 13.2

(2) 18.9 ± 13.7

  1. Data are n(%), mean ± standard desviation (SD). Nonparametric tests (for two related samples) between values before treatment and at 3 m, 6 m, 9 m, 1y and 2y.– Test of ranges with Wilcoxon signs: a1 = p < 0.05, a2 = p < 0.01; a3 = p < 0.001. Signs test: b1 = p < 0.05, b2 = p < 0.01, b3 = p < 0.001. Mc Nemar test (for dichotomous variants): c1 = p < 0.05, c2 = p < 0.01; c3 = p < 0.001. Marginal homogeneity test: d1 = p < 0.05, d2 = p < 0.01, d3 = p < 0.001. Only significant results are indicated. DT, during treatment; AT, after treatment; CS, conservative surgery; TUGPA, transvaginal ultrasound-guided puncture-aspiration; VAS, visual analogic scale; CPP, chronic pelvic pain; TV ultras, transvaginal ultrasound; endomet, endometrioma; rvs, rectovaginal septum; op, operated