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Table 2 The results of simplified CDAI, PDAI, IBDQ, Wexner, and VAS scores

From: Autologous adipose-derived stem cells for the treatment of Crohn’s fistula-in-ano: an open-label, controlled trial

 

Observation group (n = 11)

Control group (n = 11)

Treatment difference (95%CI)

pvalue

Simplified CDAI

Baseline

4.3 ± 0.5

4.4 ± 0.7

 

Month 3

2.1 ± 0.3

4.9 ± 0.7

Change from baseline

2.2 ± 0.6

0.5 ± 0.7

1.6 (1.1 to 2.2)

0.000

Month 6

2.5 ± 1.0

4.6 ± 0.7

 

Change from baseline

1.7 ± 1.2

0.5 ± 0.7

1.3 (0.4 to 2.1)

0.006

Month 12

2.7 ± 1.5

4.7 ± 0.6

 

Change from baseline

1.7 ± 1.4

0.5 ± 0.5

1.2 (0.2 to 2.2)

0.023

PDAI

Baseline

8.5 ± 1.4

9.5 ± 1.7

 

Month 3

1.3 ± 1.1

3.5 ± 0.8

Change from baseline

7.3 ± 2.0

6.0 ± 1.3

1.3 (− 0.2 to 0.8)

0.090

Month 6

1.7 ± 1.6

3.5 ± 1.5

 

Change from baseline

6.8 ± 1.8

6.1 ± 1.9

0.7 (− 0.9 to 2.3)

0.361

Month 12

1.9 ± 2.4

3.1 ± 2.1

 

Change from baseline

6.6 ± 2.2

6.5 ± 2.5

0.2 (− 1.9 to 2.3)

0.858

IBDQ

Baseline

143.5 ± 19.8

137.9 ± 29.7

 

Month 3

202.1 ± 19.9

179.5 ± 28.0

Change from baseline

58.6 ± 7.1

41.5 ± 36.6

17.1 (− 7.7 to 41.9)

0.158

Month 6

193.2 ± 31.5

174.1 ± 19.8

 

Change from baseline

49.7 ± 16.1

36.5 ± 32.1

13.2 (− 9.4 to 35.8)

0.238

Month 12

187.8 ± 33.5

166.1 ± 23.4

 

Change from baseline

44.4 ± 17.6

29.1 ± 34.6

15.3 (− 9.2 to 39.7)

0.207

Wexner score

Baseline

1.2 ± 1.3

1.5 ± 0.7

 

Month 3

0.8 ± 1.3

1.4 ± 0.7

Change from baseline

0.4 ± 0.5

0.2 ± 0.4

0.1 (− 0.2 to 0.6)

0.362

Month 6

0.6 ± 1.0

1.2 ± 0.8

 

Change from baseline

0.5 ± 0.7

0.7 ± 0.6

0.2 (− 0.8 to 0.4)

0.530

Month 12

0.5 ± 0.8

1.2 ± 0.8

 

Change from baseline

0.6 ± 0.7

0.7 ± 0.6

0.1 (− 0.7 to 0.5)

0.750

VAS

Baseline

0.8 ± 1.0

1.1 ± 1.0

 

Day 1

1.5 ± 1.5

4.9 ± 0.8

Change from baseline

0.9 ± 1.1

3.8 ± 1.0

2.9 (2.0 to 3.9)

0.000

Day 3

1.1 ± 1.0

4.3 ± 0.8

 

Change from baseline

0.5 ± 0.9

3.2 ± 1.3

2.7 (1.7 to 3.7)

0.000

Day7

0.6 ± 0.5

3.2 ± 0.8

 

Change from baseline

0.4 ± 0.7

2.1 ± 1.3

1.7 (0.8 to 2.6)

0.001

Day 15

0.4 ± 0.5

2.3 ± 0.6

 

Change from baseline

0.6 ± 0.9

1.4 ± 1.1

0.7 (0.2 to 1.6)

0.112