Table 1 Baseline Characteristics

From: Ductal lavage followed by observation versus oral corticosteroids in idiopathic granulomatous mastitis: A randomized trial

 

No. (%) of participantsa

Characteristics

Ductal lavage followed by observation group (n=69)

Oral corticosteroids group (n=71)

Age, median (IQR), y

34.0 (32.0–39.0)

36.0 (32.0–41.0)

Premenopausal status

69 (100.0%)

67 (94.4%)

BMI, median (IQR), kg/m²

22.6 (20.8–24.4)

21.6 (19.8–24.9)

Breast size

  

   A cup

14 (20.3%)

10 (14.1%)

   B cup

39 (56.5%)

40 (56.3%)

   C+ cup

16 (23.2%)

21 (29.6%)

Personal history

   History of smoke

3(4.4%)

0 (0.0%)

   History of taking OCPs

3 (4.4%)

2 (2.8%)

   History of lactation

61 (88.4%)

55 (77.5%)

   Since the last lactation, median (IQR), months

27.0 (15.0–60.0)

24.0 (15.0–60.0)

   History of lactational mastitis

5 (8.2%)

9 (16.4%)

Time from onset to visit, median (IQR), months

1.0 (0.5–2.0)

1.0 (0.5–2.0)

Fever during the onset of diseaseb

3 (4.4%)

5 (7.0%)

Baseline M-score, median (IQR)

4.0 (3.0–6.0)

4.0 (3.0–6.5)

   M-score\( < \)5

36 (52.2%)

37 (52.1%)

   M-score\(\ge\)5

33 (47.8%)

34 (47.9%)

Nipple retraction

7 (10.1%)

13 (18.3%)

Nipple discharge

0 (0.0%)

1 (1.4%)

Mass size, median (IQR), cm

7.0 (4.2–10.0)

6.0(5.0–9.0)

Mass near NAC

21 (30.4%)

21 (29.6%)

Pain caused by IGMc

49 (71.0%)

50 (70.4%)

   VAS 0-2

42 (60.9%)

40 (56.3%)

   VAS 3-5

25 (36.2%)

21 (29.6%)

   VAS 6-10

2 (2.9%)

10 (14.1%)

Presence of erythema

31 (44.9%)

33 (46.5%)

Presence of fistula

8 (11.6%)

7 (9.9%)

Influence on QoL

  

   No

18 (26.1%)

15 (21.1%)

   Mild

39 (56.5%)

32 (45.1%)

   Significant

12 (17.4%)

24 (33.8%)

Laboratory examinationd

   WBC, median (IQR), 10^9/L

7.7 (6.3–9.6)

7.7 (6.2–9.6)

   Neutrophils, median (IQR), 10^9/L

5.4 (3.9–7.1)

5.2 (3.8–6.6)

   Lymphocytes, median (IQR), 10^9/L

1.9 (1.6–2.1)

1.9 (1.5–2.2)

   ESR, median (IQR), mm/h

20.0 (15.0–28.5)

27.0 (16.0–38.0)

   CRP, \( < \)10, mg/Le

42 (79.2%)

43 (81.1%)

   PRL, median (IQR), ug/Lf

12.9 (7.8–19.2)

16.1 (9.3–26.7)

  1. Abbreviations: BMI, body mass index; OCP, oral contraceptives; NAC, nipple-areolar complex; VAS, visual analog scale; WBC, white blood cell; ESR, erythrocyte sedimentation rate; CRP, C-reactive protein; PRL, prolactin; QoL, quality of life.
  2. aAnalyzed in participants who received randomization.
  3. bThe determination of fever symptoms during the disease onset period relied on self-reporting by the patients. Among those who reported had fever symptoms, 7 (87.5%) of them still presented with a temperature of ≥ 38.0 °C upon their arrival at the clinic.
  4. cThe severity of pain caused by idiopathic granulomatous mastitis was evaluated by researchers with a visual analog scale.
  5. dThe ESR, CRP, and PRL examinations were optional examinations in each center. Available data for ESR (n = 108), CRP (n = 106), and PRL (n = 115).
  6. eIn some research centers, the specific value of CRP was not available if the result fell within the reference range. The reference range is different in each center, and the highest reference threshold of CRP among them is 10.0 mg/L. Reference range here for CRP: 0–10 mg/L.
  7. fFor transformation of levels of PRL: 1 µg/L = 21.3 uIU/mL = 21.3 mIU/L.
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